HRPP Guidance Topics

Overview

Research data to be collected by investigators is done either as anonymous data collection or as confidential data collection but cannot be both. Data that is collected as confidential data can be anonymized but the initial data collection is considered confidential and should be treated as such. Risks associated with data collection stem from possible invasion of privacy and breaches of confidentiality, such as the possibility that disclosure of the information could reasonably place the subject at risk of criminal or civil liability and/or be damaging to the subject's financial standing, employability, or reputation. Therefore, each investigator must have a data security plan to minimize such risks to ensure that any collected data is maintained in a secure manner to prevent accidental exposure of identifiable information or to prevent  data from being lost or stolen, especially when using portable storage or recording devices (e.g. portable thumb drives/digital recorders). The investigator remains responsible to outline specified methods to protect the data.

Types of Data

Anonymous:  Data are recorded such that no identifier whatsoever exists to link a subject's identity to that subject's response. No one can link an individual person to the responses of that person, including the investigator. For

Examples: (1) subject fills out and mails back to the investigator a questionnaire that does not provide subject's name, social security number, phone number, or does not utilize tracking codes or any other identifier; (2) investigator interviews subject by phone and notes responses, but does not have any record connecting any response to any phone number.  Previously identifiable data that have been de-identified and for which a code or other link no longer exists. A provider, third party or investigator would not be able to link anonymized information back to a specific individual. For this reason, face-to-face interviews are never anonymous.

Confidential: There exists a documented linkage between a subject's identity and his/her response in the research, and the investigator provides assurance in the protocol and in the informed consent form that the identity of any individual subject will not be revealed in any report of the study.  Confidential means that the investigator can (or could) identify individuals who participated in a study, perhaps through a code.

Example: a subject's data record is assigned a code, and a "master list" that links the code to the subject's identity is maintained in a secure location.

Although the identities may be recorded, data can be kept private if they are carefully coded (e.g. if face sheets and consent documents are separated from survey instruments or if computer sheets and other papers are properly disposed) and if access to any identifiable data is limited and if data are stored in secured locations (e.g., encrypted clouds/password-protected computers/files etc.). More detailed procedures may be appropriate for research especially those involving sensitive data that may involve a greater risk should confidentiality be breached. Investigators may want to seek Certificates of Confidentiality to protect such data from subpoena (also see the Certificates of Confidentiality guidance section). Investigators have a responsibility to ensure any research staff handling confidential data are educated about the importance of protecting any collected data. Confidential surveys that are not anonymous typically are not eligible for exemption review using these criteria.

Privacy and Data Security

Pertains to the actual treatment of the personal information once it is obtained. In other words, now that the researcher has obtained private information, how will it be used, stored, and reported in a way that is consistent with the manner under which it was originally obtained from the individual? Information from public records, and information obtained under a relationship of trust, as in the doctor-patient relationship, will require different considerations for protecting confidentiality.

Privacy and Data Security can be defined in terms of having control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) or information about oneself with others. In the context of research, privacy risk pertains primarily to the methods used to obtain information about subjects. Whereas privacy risks are obviously very low in studies when a subject actually consents to providing personal information, they are much higher, in records-based research, when information is obtained for research purposes without the consent of subjects.

Overview

Certificates of Confidentiality (CoC) are an important tool to protect the privacy of research study participants. Certificates of Confidentiality are issued by the National Institutes of Health (NIH) to protect identifiable research information from forced disclosure. They allow the investigator and others who have access to research records to refuse to disclose identifying information on research participants in any civil, criminal, administrative, legislative, or other proceeding, whether at the federal, state, or local level. By protecting researchers and institutions from being compelled to disclose information that would identify research subjects, Certificates of Confidentiality help achieve the research objectives and promote participation in studies by helping assure confidentiality and privacy to participants.

They allow the investigator and others who have access to research records to refuse to disclose identifying information on research participants in any civil, criminal, administrative, legislative, or other proceeding, whether at the federal, state, or local level. By protecting researchers and institutions from being compelled to disclose information that would identify research subjects, Certificates of Confidentiality help achieve the research objectives and promote participation in studies by helping assure confidentiality and privacy to participants.

When is a CoC Required

• An individual is identified; or
• For which there is at least a very small risk, that some combination of the information, a request for the information, and other available data sources could be used to deduce the identity of an individual.

This includes studies which are:

1. Non-government funded;
2. Not funded;
3. Studies not related to the PHS / NIH;

How to Obtain a CoC

• How to Get a Certificate of Confidentiality (nih.gov)
• UPDATE: New Certificates of Confidentiality System for Non-NIH Funded Research

  NIH has updated its Certificate of Confidentiality request process for non-NIH funded research through a new online system. The new system simplifies the request process by using self-certification statements and shortened text fields, rather than attachments. Note that the new Certificates of Confidentiality system requires direct submission by the authorized institutional official, rather than by the investigator or another research team member.

  NIH will no longer accept Certificates of Confidentiality requests through the current system as of March 11, 2020. See the Guide Notice for important details about the transition to the new system.

  ***Current users who need a copy of their Certificate or associated documentation should access the Certificate of Confidentiality system to download these files prior to March 13, 2020. Users will no longer have access to the current Certificate of Confidentiality system as of March 13, 2020.

Recommended CoC Language For Use in a Consent to Research Form

When research data is protected by a Certificate of Confidentiality (CoC), the parameters of its protections should be disclosed to subjects whose data is protected by it. The following is NIH recommended language to be included in the section of the consent document that explains how you plan to keep research data private or confidential. If the research is protected by a CoC from a different Federal Department or Agency—such as DOJ—use the language provided by them (learn more).

This research is covered by a Certificate of Confidentiality from the National Institutes of Health. This means that the researchers cannot release or use information, documents, or samples that may identify you in any action or suit unless you say it is okay. They also cannot provide them as evidence unless you have agreed. This protection includes federal, state, or local civil, criminal, administrative, legislative, or other proceedings. An example would be a court subpoena.
 
There are some important things that you need to know. The Certificate DOES NOT stop reporting that federal, state or local laws require. Some examples are laws that require reporting of child or elder abuse, some communicable diseases, and threats to harm yourself or others. The Certificate CANNOT BE USED to stop a sponsoring United States federal or state government agency from checking records or evaluating programs. The Certificate DOES NOT stop disclosures required by the federal Food and Drug Administration (FDA). The Certificate also DOES NOT prevent your information from being used for other research if allowed by federal regulations.
 
Researchers may release information about you when you say it is okay. For example, you may give them permission to release information to insurers, medical providers or any other persons not connected with the research. The Certificate of Confidentiality does not stop you from willingly releasing information about your involvement in this research. It also does not prevent you from having access to your own information.

Required Institutional Assurances

The following assurances are required and should be inserted verbatim into the assurance letter to be submitted with your request:

• View Required Institutional Assurances Language (NIH.gov) 

Additional Information

• NIH Certificates of Confidentiality Policy (NIH.gov)
• Frequently Asked Questions About Certificates of Confidentiality (CoC) (NIH.gov)
• National Institutes of Health: Certificate of Confidentiality Website

Help

Please contact the IRB staff for assistance.

Overview

Data and safety monitoring is used to ensure adherence to the IRB-approved investigative plan, the validity of data collected and most importantly, the safety of those subjects who participate in the project.  A data monitoring plan might be required for projects that involve investigation items/devices or are clinical trials, no matter the risk level. Data and safety monitoring usually occurs with the formation of a Data and Safety Monitoring Board (DSMB). The DSMB is an independent group of experts that advises the principal investigator and if applicable any co-Investigators. The members of the DSMB serve in an individual capacity and provide their expertise and recommendations.

The primary responsibilities of the DSMB are to:

1. Periodically review and evaluate the accumulated study data for participant safety, study conduct and progress, and, when appropriate, efficacy, and
2. Make recommendations to Principal Investigator concerning the continuation, modification, or termination of the trial. The Principal Investigator is responsible for forwarding these recommendations, as well as taking the appropriate actions, to the IRB concerning the continuation, modification, or termination of the trial The DSMB considers study-specific data as well as relevant background knowledge about the disease, test agent, or patient population under study.

Initial IRB Submission Requirements

Where applicable, investigators who will include a DSMB for their project, must also summarize the data monitoring plan in the IRB new study application. Investigators should have a full plan for data monitoring included in the study records, which may be part of the written protocol or a manual of standard operating procedures.

IRB Reporting Requirements

• Any Data and safety monitoring or Audit reports must be submitted to the IRB, within two weeks of receipt and sent to an IRB Administrator.
• Any Data and safety monitoring or Audit reports that identify potential unanticipated problems that involve risks to participants should be submitted to the IRB (see guidance topic 'Reportable Events 2: Unanticipated Problems and Adverse Events for more information').

Does Your Research Require Data and Safety Monitoring?

Most social/behavioral research projects will not need a separate provision for monitoring the data outside of what’s stated in the IRB-approved Protocol. Pursuant to Federal Regulations of Human Subjects Research, 45 CFR 46.111(a)(6) states the following requirement for IRB approval of human subjects research: "When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects." Principal Investigators are advised to take this regulation into consideration and when appropriate, to provide a plan to ensure safety of subjects with details of how data will be monitored.

The NIH Policy for Data and Safety Monitoring states that all NIH funded clinical trials require a Data and Safety Monitoring Plan and that monitoring should be commensurate with risk. Most NIH Institutes/Centers have individual Data and Safety Monitoring policies. Visit the NIH site for the links to Institute/Center specific policy and guidance.

Does Your Research Require a Data and Safety Monitoring Board?

Data and Safety Monitoring Boards (DSMBs) are specifically required for multi-site clinical trials with interventions that entail risk(s) to participants.

DSMBs are generally required for Phase III clinical trials.

A DSMB may be required for Phase I, Phase II or Phase III clinical trials if any of the following criteria apply:

• The clinical trial is blinded
• The clinical trial involves high risk intervention(s)
• The clinical trial includes vulnerable population(s)

Further Guidance on a Data and Safety Monitoring for Phase I and Phase II Trials

References

NIH Policies

• NIH Policy for Data and Safety Monitoring

FDA Policies

• Guidance for Clinical Trial Sponsors

Related Policies

• Registration of Clinical Trials
• Clinical Trials.gov

Overview

Investigators are required to maintain records of their human-subjects research activities. Good records are essential for verifying the quality of study data produced and demonstrating investigator compliance with good clinical practice guidelines and applicable regulatory requirements. In general, investigators should establish two sets of files for each study:

1. Regulatory documents
2. Study subject information

I.  Regulatory Documents. Regulatory documents should be maintained for all studies, regardless of sponsor/funding source, or whether the research is funded. These documents are typically organized within a regulatory binder, either paper or electronic. Some documents that may be common to more than one study, such as CVs and professional licenses, may be filed centrally. The regulatory binder should contain the essential documents listed below.

Basic regulatory documents required for all studies (non-funded, non-FDA-regulated, non-published):

1. Personnel:
   1. CVs document qualifications and eligibility to conduct a study and provide supervision of subjects. CVs should be signed and dated. It is recommended that CVs be updated every two years to verify that the information is accurate and current.
   2. Valid licenses and certifications for all professional study staff
   3. Mandatory human subjects protection training such as CITI.
   4. Institution’s financial disclosure form: signed/dated copies of financial disclosure for all investigators and staff listed on the protocol.
   5. Staff Signature/Delegation of Responsibility log: documents the signature and initials for all staff that collect and record study data, and lists the study-related procedures each has been delegated by the Principal Investigator
2. Protocol: all versions should be numbered and dated
   1. Initial submission; Continuing reviews; Modifications/Amendments
   2. Copy of all IRB-approved versions of the consent form and assent form (if applicable).
   3. Blank copies of all data collection forms, questionnaires, CRFs, and/or study instruments.
   4. Recruitment materials
   5. Educational materials or other study information designed for subjects
3. IRB Correspondence:
   1. All IRB correspondence including approval letters and/or notifications
   2. IRB-approved recruitment materials
   3. IRB-approved educational materials or other study information distributed to subjects
4. Monitoring Records: document any study-related activity performed to monitor study progress or the accuracy and completeness of study records.
   1. Data Safety and Monitory Board (DSMB) reports
   2. Sponsor monitor reports
   3. Audit reports, internal and/or external
5. Laboratory documents (if applicable): These materials document the competency of all lab facilities being used in the study and support the reliability of test results.
   1. Updated copies of laboratory certification,
   2. The Lab Director’s CV
   3. The normal lab/reference values
6. Reportable Events:
   1. Any study violations/deviations
   2. “On-site” adverse events
   3. Unanticipated problem reports
7. Others (if applicable):
   1. IBC  
   2. Radiation Reports

Additional regulatory documents required for Funded, non-FDA regulated studies:

1. NIH/Funding agency grants applications and progress reports.
2. Correspondence/contract with study sponsor/funding agency.

Additional regulatory documents required for FDA-regulated investigational drug or device studies:

1. Policies and procedures for dispensing, security, and storage of study drugs/devices.
2. Copies of all Form FDA 1572s (Statement of Investigator) and Form FDA 1571s (Investigational New Drug Application), if applicable.
3. Drug/device shipment and receipt records (may be maintained by the Research Pharmacy or Investigational Drug Service (IDS)).
4. Drug/device accountability log (drug accountability log may be maintained by the Research Pharmacy or IDS).

II. Study Subject Information

• General Subject Information
  1. Potential subject/Screening log: capture s all potential subjects who appear to be qualified for the study.
  2. Enrollment/Randomization log: captures all subjects who have signed an IRB-approved consent form or, with IRB approval, have given verbal consent or had informed consent waived; and have been randomized if applicable.  
• Individual Subject Files: There should be a separate file for each subject enrolled in or screened for a study. The following documents are placed in each file:
  1. An eligibility checklist, signed and dated by the person determining eligibility, lists specific inclusion/exclusion criteria. Copies of source documentation to support medical criteria should be available in the subject’s medical record, and retained to corroborate entries on the data collection instruments.
  2. Original signed and dated consent form
  3. Individual case report forms (CRF)
  4. Study instrument(s) used to capture all data required by protocol for each subject, such as data collection forms, questionnaires, and/or subject diaries
• Subject Compensation Documentation
  1. A full accounting of all funds provided to subjects.

Federal Regulations

As per Federal Regulations, the HHS protection of human subjects regulations require both institutions and Principal Investigators to retain research-related records. The institution must maintain records of IRB activities and certain other records frequently held by investigators for at least three years after completion of the research (45 CFR 46.115(b)). In addition, other regulations may apply and require retention of these records for a longer period of time.

Documentation of the informed consent of the subjects - either the signed informed consent form, the short form  or signed assent form in addition to other project related materials including the written research summary  must be retained by Principal Investigator for at least three years after completion of the research, unless the IRB waived the requirement for informed consent or the requirement for documentation of informed consent (45 CFR 46.117).

If investigators have been designated to retain certain records (e.g. informed consent documents signed by subjects) on behalf of the institution as required by the HHS regulations at 45 CFR 46.115(b), they must retain the records in some form. Such records may be preserved in hardcopy, electronic or other media form (e.g. on a secure cloud or encrypted hard-drive) and must be accessible for inspection and copying by the IRB or authorized representatives of HHS at reasonable times and in a reasonable manner (45 CFR 46.115(b)). Retention of multiple copies of each record is not required. Investigators must comply with all Rutgers policies and procedures for retaining records.

HIPAA Requirements: Disposal of Protected Health Information

(2) Implementation specification: Retention period. A covered entity must retain the documentation as required by paragraph (c)(1) of this section for 6 years from the date of its creation or the date when it last was in effect, whichever is later.

§ 164.105 HIPAA Administrative Regulation Text [PDF]

HIPAA Requirements: Research that involves collection of protected health information (PHI) is subject to the HIPAA regulations. Research records including signed consent forms that contain the HIPAA authorization must be retained for 6 years after the date on which the subject signed the consent form or the date when it last was in effect, whichever is later.

Disposal of Protected Health Information (HIPAA FAQ) (HHS.gov)

Sponsor Requirements

If a research project is funded or sponsored, then the investigator must also comply with the terms for record retention outlined in the contract with the sponsor or with the study funder's requirements.

Record Keeping and Record Retention Requirements

Records Retention At-a-Glance:  Below is the minimum requirement for research record retention. However, the University recommends maintaining these records indefinitely.

University Policy

• 30.4.5 Records Management (Rutgers Policy Library)

Destruction of Data / Records After Retention Period

Instructions: How to Destroy Data Properly

Regulations

U.S. FDA Regulations CFR Title 21 Part 11: Electronic Records; Electronic Signatures

Related Offices

Rutgers University Records Management (Document Archiving and Destruction)

Overview

Each person with access to the Rutgers, The State University of New Jersey, computing resources is responsible for their appropriate use and by their use agrees to comply with all applicable University, School, and departmental policies and regulations, and with applicable State and Federal laws and regulations.

Security for “Non-Public Personal Information” (NPPI)

Security for “Non-Public Personal Information” (NPPI), as mandated by federal and state law, as well as Rutgers policy.

NPPI consists of financial, health information, social security numbers, driver license numbers and similar data. Certain NPPI, specifically electronic Protected Health Information (ePHI), has additional federally mandated requirements. All units and staff responsible for creating, storing, or transmitting this information are required to do so in a manner which protects NPPI and maintains compliance with regulation and policy. Any breach of security or compromise of systems containing NPPI must be reported immediately to the Office of Information Protection and Security (IPS) (rusecure@rutgers.edu) and your local unit head. Please take this opportunity to meet with your staff to review the following practices. Learn More About Non-Public Personal Information (NPPI)

Securing University Data

All data records are not the same. The classification of data ensures that university information is properly identified, classified, and handled according to its value, legal requirements, sensitivity, and criticality to the University. Consideration should be given to protect data based upon its classification. Information on the classification of data can be found by visiting Rutgers OIT’s Data Classification and Storage Matrix webpage.

Hard Copy Records: Hardcopy records of NPPI (e.g. paper payroll documents, DVD’s or tape backups with personal information) should be kept in locked cabinets, behind locked doors. Protected hard copy data should be shredded as part of the disposal process. The retention and appropriate disposition of these records should be in accordance to the Rutgers Records Management Policy 30.4.5.

If there is a need to send NPPI to another department or external agency, the documents should be sent in a sealed envelope or other packaging, marked confidential, and addressed to a specific recipient. If NPPI is sent in email the message must be encrypted. Where applicable, instructions should be provided regarding the return, storing, and appropriate disposal of documents containing NPPI.

Electronic Records: If you are maintaining NPPI or ePHI in electronic form, access should be strictly controlled and the information encrypted. If you are unsure whether your electronic systems hold NPPI, OIT/IPS has tools that can help. NPPI is often found in locally developed databases, personnel systems and spreadsheets, email files, class rosters, and files created by faculty and staff.

Portable Devices (Rutgers/Work Use Only): Due to the vulnerability of information on portable/mobile devices, such as laptops, external hard drives or USB memory sticks, we recommend that all information on these devices be encrypted (For help on How to Encrypt Data, contact your IT Department);

Portable Devices (Personally Owned): NPPI and ePHI may not be stored on personal portable/mobile devices including laptops, cell phones, USB memory sticks, and tablets.  The Office of Information Technology - Division of Information Protection and Security (OIT/IPS) can provide guidance.

Cell Phones and Tablets: Cellphones and tablets that have access to NPPI must utilize additional security measures such as strong access codes, disabling location services, time-out screen locking, and account lockout and/or remote wiping.

Cloud Services (Online Data Storage): There are additional risks that need to be taken in consideration when using cloud or third party providers. Using a third party cloud service or provider to handle data does not absolve you from the responsibility of ensuring that the data is properly and securely managed. It remains your responsibility to assure that the data is maintained with comparable security, as required by university guidelines. The use of cloud services for the storage of ePHI data must have a signed Business Associate agreement with the service provider. University data housed on portable devices (laptops, cellphones, tablets, pen drives, etc.) or transmitted to and/or stored on "cloud services" should be encrypted with the encryption key separate from the device.

Traveling with Electronic Devices

Travel with electronic devices requires special precautions. Remote devices and the information they contain should be protected while accessing the Internet or not physically under your control. University transmissions should only be performed through a VPN (virtual private network). Read more about IT Security Guidelines for Domestic and International.

Rutgers University Policies

• 70.1.1 Acceptable Use Policy for Information Technology Resources
• Minimum Security Standards for Data Protection

Help

If you have any questions regarding the above, please contact Rutgers University OIT/IPS at 848-445-8011 or via email: rusecure@rutgers.edu.

Overview

A Data Use Agreement (DUA) is a written contract used to govern the transfer and use of data between organizations, which has been developed by nonprofit, government or private industry, where the data is nonpublic or is otherwise subject to some restrictions on its use and will be used for research purposes. Often, this data is a necessary component of a research project and it may or may not be human subject data from a clinical trial, or a Limited Data Set as defined in HIPAA. Universities want to ensure that DUA terms protect confidentiality when necessary, but permit appropriate publication and sharing of research results in accordance with University policies, applicable laws and regulations, and federal requirements. 

Data Use Agreement (DUA) Approval Process

To create and submit a Data Use Agreement for approval by the Research Contract Services, you must submit your request in RAPSS under Document Review.

Effect on Research

Whenever restricted data is transferred to or from a researcher at Rutgers University, a Data Use Agreement and/or a Business Associate Agreement must be created between the parties involved.

This must be included in your submission to the IRB. If the agreement is not ready at the time of submission, please mention this issue in a cover-memo with your submission.

Help

For more information regarding HIPAA Business Associate Agreements, visit our HIPAA guidance section.

Contact the Research Contract Services for assistance with Data Use Agreements.

Research Contract Services Staff

Research Contract Services FAQs

Overview

The following guidelines were created to assist clinicians with submission of an emergency use of an investigational drug, biologic and/or device for patients with consent, process, and sponsor acknowledgement.

Emergency Use is defined as the use of a test article (e.g investigation drug/biologic or device) on a human subject in a life-threatening situation in which no standard acceptable treatment is available and in which there is not sufficient time to obtain IRB approval for the use. The clinician is still required to obtain informed consent under these circumstances.

The IRB may allow for “emergency treatment" use of a test article with an IND or IDE in accordance with FDA regulations in clinical care situations without prior convened IRB review, when the only way to help a patient is with the use of an investigational drug, biologic and/or device.

Qualifying for Emergency Permission

For Drug/Biologic

The clinician must meet all four of the following conditions to qualify for emergency permission:

1. life threatening situation necessitating the use of the test article
2. where the subject is unable to provide effective consent.
3. there is insufficient time in which to obtain consent from the subject’s legally authorized representative (court appointed guardian for research)
4. there is no available alternative method of approved or generally recognized therapy of equal or greater likelihood of saving the subject’s life [21 CFR 50.23 (a) (1) – (4)]

For more information review:

• U.S. FDA: PART 50 Subpart B--Informed Consent of Human Subjects Sec. 50.23 Exception from general requirements
• U.S. FDA: Emergency Use of an Investigational Drug or Biologic - Information Sheet

For Devices

The clinician must meet all four of the following conditions to qualify for emergency permission:

1. the device is intended to treat or diagnose a serious or immediately lifethreatening disease or condition
2. there is no comparable or satisfactory alternative device or other therapy available to treat or diagnose that stage of the disease or condition in the intended patient population
3. the device is under investigation in a controlled clinical trial for the same use under an approved IDE, or such clinical trials have been completed
4. the sponsor of the investigation is actively pursuing marketing approval/clearance of the investigational device with due diligence [21 CFR 812.36 (b) (1) – (4)]

CFR - Code of Federal Regulations Title 21

Emergency Use of an Investigational Drug or Biologic - Information Sheet

If the clinician needs an acknowledgement letter from the IRB before the manufacturer/sponsor will ship the drug/biologic and/or device, the IRB will provide such a letter to the manufacturer/sponsor stating that the IRB is aware of the situation and will require a written status report from the clinician within five (5) business days from the usage of the device and/or drug. [21 CFR 56.104]

Physician Reporting Requirements for Emergency Use

The IRB will provide a written response acknowledging the physician’s submission of the emergency request information. The acknowledgement will remind the physician that she/he must submit safety reports or adverse event reports to either:

• the sponsor who holds the IND/IDE for the test article;
• to the FDA as required by regulation (if the PI holds the emergency IND);

A copy of such reports should be sent to the IRB Office to the attention of the IRB chair who issued the acknowledgment.

FDA exempts from IRB review the emergency use of a test article so long as the emergency use is reported to the IRB within five working days of its occurrence. Items needed from the clinician before usage:

1. Clinical condition of the patient requiring emergency permission
2. Why the clinician believes it is necessary
3. Information about the drug/biologic and/or device
4. Consent to be used

Limits on Use of Data Obtained from Emergency Use under FDA Exemption

To be exempt from the requirement for IRB review for the emergency use of a test article in a life threatening situation, an investigator must not use the data in a systematic investigation designed to develop or contribute to generalizable knowledge or else the exemption no longer applies. To comply with this limitation, investigators must follow these three rules:

1. Do not use the emergency use exemption to circumvent the general requirements for prior IRB review;
2. Do not use data from an emergency in a prospective research study; and
3. Do not report data from an emergency use in a retrospective research study, unless granted specific approval by the IRB.

PLEASE NOTE: Emergency permission is granted on a one-time, one-usage basis. If the clinician wishes to treat other subjects, they must complete and submit an IRB application with a consent form.

Consenting a Patient in an Emergency Use Situation

NOTE: Consent for emergency use of a test article either provided by a sponsor or by the physician must:

• Contain all of the FDA required elements;
• Be reviewed and signed by the subject/subject’s representative even in emergency use cases;

**Research consent must be obtained either by the subject or by the legally authorized representative.**(court appointed guardian for
research)

Related Forms

• Emergency Permission Consent Template

Additional Information

FDA Emergency Use Guidance

Contact Us

Non-Emergency Situation

• Contact the Rutgers IRB by email: irboffice@research.rutgers.edu

Emergency Situation: Emergency Use Assistance is available 24 hours a day

• The Human Research Protection Program (HRPP)/IRB Director at 732-245-6625.
• The Assistant Vice President (AVP) of Regulatory Affairs at 848-702-9553.

Overview

The General Data Protection Regulation (GDPR) is a regulation in EU law on data protection and privacy for all individual citizens of the European Union and the European Economic Area. It also addresses the transfer of personal data outside the EU and EEA areas. It impacts human subject research when it involves the collection of personal data from residents in the EU and EEA.  

• View the full General Data Protection Regulations

Selected GDPR Compliance Toolkit Items

• Determine If Your Study Is Governed By GDPR: HRP-335 - WORKSHEET - GDPR Compliance: Data Protection and Privacy
• List of Required GDPR Elements [To address in your protocol and consent form]: GDPR Elements
• Required GDPR Special Consent Passage [To add to your consent form]: General Data Protection Regulation [GDPR]
• Rutgers IRB Approval Process For GDPR Studies: HRP-096 - SOP - GDPR Review Procedures

Help

For GDPR-related study inquiries, contact University Ethics and Compliance.

For IRB-related inquiries, contact the Rutgers IRB. 

Overview

The Genetic Information Nondiscrimination Act, also referred to as GINA, is a federal law enacted in 2008. It provides a baseline level of protection against discrimination for all Americans in health coverage and employment on the basis of genetic information. GINA, together with already existing nondiscrimination provisions of the Health Insurance Portability and Accountability Act (see HIPAA guidance), generally prohibits health insurers or health plan administrators from requesting or requiring genetic information of an individual or the individual’s family members, or using it for decisions regarding coverage, rates, or preexisting conditions. The law also prohibits most employers from using genetic information for hiring, firing, or promotion decisions, and for any decisions regarding terms of employment. GINA’s health coverage nondiscrimination protections do not extend to life insurance, disability insurance and longterm care insurance. Further, GINA’s employment provisions do not apply to employers with fewer than 15 employees.

More information on GINA

Definition of Genetic Research

Rutgers defines genetic research as research that involves the analysis of DNA, RNA, chromosomes, proteins, or certain metabolites which might act as or identify markers associated with a known or suspected predisposition to disease or behavior. Usually genetic research involves the collection of human biological material such as blood, skin or other tissues, nail clippings or hair. Genetic research also may include the construction of pedigrees (maps of the distribution of a particular trait or condition among related individuals or family medical histories). Although gene transfer is another form of genetic research, this guidance document does not apply to gene transfer research.

GINA and Research

GINA protects the privacy of and guards against the misuse of genetic information obtained through research. The law reassures research participants that they can volunteer for studies without it harming their job or health insurance.

• Guidance on the Genetic Information Nondiscrimination Act: Implications for Investigators and Institutional Review Boards

Definition of Genetic Information

GINA defines genetic information as information about:

• An individual’s genetic tests (including genetic tests done as part of a research study);
• Genetic tests of the individual’s family members (defined as dependent and up to and including 4th degree relatives);
• Genetic tests of any fetus of an individual or pregnant family member, and genetic tests of any embryo legally held by an individual or family member utilizing assisted reproductive technology;
• The manifestation of a disease or disorder in family members (family history); or
• Any request for, or receipt of, genetic services or participation in clinical research that includes genetic services (genetic testing, counseling, or education) by an individual or family member.

Genetic information does not include information about the sex or age of any individual.

Additional Consent Form Language Requirements From GINA

The following two statements contain required information about GINA which must be communicated as part of the informed consent process to individuals participating in a research study (including anonymous studies) with a genetic component. Since breaches of privacy and confidentiality of genetic data may have potential economic harms to participants, then following mandatory risks of economic harm language provided by GINA must appear in the consent document after the risks section:

1. A statement with a description of any reasonably foreseeable risks or discomforts to the subjects (45 CFR 46.116(a)(2)):

"Since some genetic variations can help to predict the future health problems of you and your relatives, this information might be of interest to health providers, life insurance companies, and others. Therefore, your genetic information potentially could be used in ways that could cause you or your family economic stress."

2. A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained (45 CFR 46.116(a)(5)). Investigators and IRBs must ensure that descriptions of the reasonably foreseeable risks of genetic research and any statements describing the extent to which confidentiality of records identifying the subject will be maintained do not overstate the protections provided by GINA (45 CFR 46.116(a)):

"There are state and federal laws that protect against genetic discrimination. A federal law, the Genetic Information Nondiscrimination Act makes it illegal for health insurance companies, group health plans, and most employers to discriminate against you based on your genetic information. This law generally will protect you in the following ways: (1) health insurance companies and group health plans may not request your genetic information that we get from this research; (2) health insurance companies and group health plans may not use your genetic information when making decisions regarding your eligibility or premiums; and (3) employers with 15 or more employees may not use your genetic information that we get from this research when making a decision to hire, promote, or fire you or when setting the terms of your employment. However, it does not protect you against discrimination by companies that sell life insurance, disability insurance, or long-term care insurance."

Additional BioSafety Requirements

All experiments, research, and other activities involving human derived samples (including purchased human cell lines) performed at Rutgers University require BioSafety Approval.

Contact the Rutgers Environmental Health and Safety Department (REHS) for more assistance.

Forms

Consent Forms (See Resources)

Regulations

Genetic Information Nondiscrimination Act (HHS.gov)

Overview

Genomics Research is the study of the entirety of an organism's genes – called the genome. A gene is a sequence of nucleotides in DNA or RNA that codes for a molecule that has a function. Genomics Research should not be confused with Genetics Research, which involves the study of specific and limited numbers of genes, or parts of genes, that have a known function. Whole-genome sequencing (WGS) is one of several techniques used in Genomic Research for analyzing entire genomes. Sequencing simply means determining the exact order of the bases in a strand of DNA. The order of these bases is what determines DNA's instructions, or genetic code. Researchers can use DNA sequencing to search for genetic variations and/or mutations that may play a role in the development or progression of a disease.

Why Genomic Research May Require IRB Approval

Genomic Research that meets the definition "Human Subjects Research" requires IRB Approval. 

• "Research" means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge" (45 CFR § 46.102).
• "Human Subject" is "a living individual about whom an investigator (whether professional or student) conducting research 45 CFR 46(e):
  • Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
  • Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens"

Examples of Genomic Human Subject Research:

• Even with de-identified bio-specimens which the Researcher did not collect, Whole Genome Sequencing (WGS) results in the creation of the complete DNA sequence of an individual's genome which is identifiable private information which involves Human Subjects.
• OHRP does not consider research involving fully de-identified or fully anonymized information to involve human subjects but if you are collecting samples even without Identifiers, you are conducting an intervention with a human subject.

Requirements for IRB Approval (Collecting Genomic Data)

• View NIH Funded dbGaP Study IRB Requirements [PDF] which contains the following:

  • Background

  • Protocol Requirements

  • Consent Requirements

  • Additional Required Supporting Documents

• View NIH Funded NIDDK Studies / GWAS IRB Requirements [PDF] which contains the following:

  • Background

  • Protocol Requirements

  • Consent Requirements

  • Additional Required Supporting Documents

***For Non-NIH Funded or unfunded studies involving Whole-Genome Sequencing, contact your local IRB for guidance.

IRB and Institutional Considerations When Reviewing Genomic Studies

The Rutgers Institutional Review Boards (IRB) will consider the following when reviewing plans for the submission of genomic and phenotypic data from research studies to data repositories:

• View IRB and Institutional Considerations When Reviewing Genomic Studies [PDF]
  • Points to Consider for Institutions and Institutional Review Boards in Submission and Secondary Use of Human Genomic Data under the National Institutes of Health Genomic Data Sharing Policy
  • Additional Important Risks To Consider-Genomic Research

Related Links

• NIH Genomic Data Sharing (GDS) Policy 
• NIH Genomic Data Sharing Policy 
• Browse GWAS on Clinicaltrials.gov 
• NIH Data Sharing Repositories (data accessible for reuse)
• NIH Data Sharing Brochure (PDF) – Printable brochure that summarizes main elements of the NIH Data Sharing Policy
• A Brief Guide to Genomics (Genome.gov).
• Informed Consent for Genomics Research: The Informed Consent Resource (NIH)
• Updated FAQs on Informed Consent for Use of Biospecimens and Data (HHS.gov)
• NIH Informed Consent Resource for Genomic Research (Genome.gov)

Help 

For IRB Application Help: Contact Us.

For Grant Application or study budget help: Contact the Research and Sponsored Programs team. 

Overview

The following glossary is not intended to be a complete biomedical and social behavioral research glossary, but the intent of this glossary is to cover concepts that are important in the completion of IRB applications. This glossary does not include terms specific to any one research project.

• IRB Terms Glossary [WORD]

Overview

Good Clinical Practice (GCP) is an international quality standard. GCP Guidelines include standards on how clinical trials should be conducted and define the roles and responsibilities of clinical trial sponsors, clinical research investigators, and monitors. Adherence to the principles of GCP, including adequate human subject protection, is universally recognized as a critical requirement to the conduct of research involving human subjects. Many countries have adopted GCP principles as laws and/or regulations.

The links below will provide you with the specific GCP requirements of the Food and Drug Administration (FDA) and the International Conference on Harmonisation (ICH)

• FDA Good Clinical Practice (GCP)
• ICH Good Clinical Practice (GCP)

Overview

HIPAA is a federal law known as the Health Insurance Portability and Accountability Act of 1996 (HIPAA). The law protects the privacy of individually identifiable patient information, provides for the electronic and physical security of health and patient medical information , and simplifies billing and other electronic transactions through the use of standard transactions and code sets (i.e., billing codes).

The HIPAA is broken down into 3 rules:

1. HIPAA Privacy Rule: The HIPAA Privacy Rule regulates the use and disclosure of certain information held by "covered entities" (generally, health care clearinghouses, employer sponsored health plans, health insurers, and medical service providers that engage in certain transactions). It establishes regulations for the use and disclosure of Protected Health Information (PHI). PHI is any information held by a covered entity which concerns health status, provision of health care, or payment for health care that can be linked to an individual.
2. HIPAA Security Rule: The HIPAA Security Rule defines and regulates the standards for covered entities’ basic security safeguards to protect electronic protected health information (ePHI). Security is the ability to control access to electronic information, and to protect it from accidental or intentional disclosure to unauthorized individuals and from alteration, destruction or loss. The standards include administrative, technical, and physical safeguards designed to protect the confidentiality, integrity and availability of ePHI.
3. Electronic Transactions Rule: The HIPAA Electronic Transactions Rule defines how electronic exchanges involving the transfer of information between two parties for specific purposes can be done. In the HIPAA regulations, the Secretary of Health and Human Services (HHS) adopted certain standard transactions for Electronic Data Interchange (EDI) of health care data. These transactions are:  claims and encounter information, payment and remittance advice, claims status, eligibility, enrollment and disenrollment, referrals and authorizations, coordination of benefits and premium payment.  Under HIPAA, if a covered entity conducts one of the adopted transactions electronically, they must use the adopted standard– either from ASC X12N or NCPDP (for certain pharmacy transactions)  Covered entities must adhere to the content and format requirements of each transaction.  Under HIPAA, HHS also adopted specific code sets for diagnoses and procedures to be used in all transactions. The HCPCS (Ancillary Services/Procedures), CPT-4 (Physicians Procedures), CDT (Dental Terminology), ICD-9 (Diagnosis and hospital inpatient Procedures), ICD-10 (As of October 1, 2014) and NDC (National Drug Codes) codes with which providers and health plan are familiar, are the adopted code sets for procedures, diagnoses, and drugs.  Finally, HHS adopted standards for unique identifiers for Employers and Providers, which must also be used in all transactions.

Protected Health Information (PHI)

Any information, whether oral or recorded in any form or medium, that: (1) Is created or received by a health care provider, health plan, public health authority, employer, life insurer, school or university, or health care clearinghouse; and (2) Relates to the past, present, or future physical or mental health or condition of an individual; the provision of health care to an individual; or the past, present, or future payment for the provision of health care to an individual.

HIPAA and Rutgers

Since Rutgers provides healthcare services, which fits into “health care provider” category. Further, Rutgers as institution is considered a “hybrid entity”. This means that Rutgers is a single legal entity that is a covered entity whose business activities include both covered and non-covered functions and that designates its health care components. At Rutgers,  the Office of Enterprise Risk Management, Ethics and Compliance can provide assistance to researchers with HIPAA-related concerns, prior to an IRB submission of a research protocol that might involve PHI. For more information about Rutgers' HIPAA information, please visit University Ethics & Compliance HIPAA.

Personal Identifiers versus Protected Health Information (PHI)

• Personal Identifiers are not PHI.  Personal Identifiers are any data that can be used to identify a unique individual (e.g. name, medical record number, social security numbers, address).
• PHI or Protected Health Information is protected by HIPAA and includes information about an individual’s physical or mental health, health care or payment for health care so long as that health information is identifiable (i.e. linked to some personal identifier). 
• So, PHI includes both personal identifiers and health information and must be protected (i.e., consent must include the HIPAA Authorization section or the researcher must request the IRB grant an Authorization waiver). 

Examples of Personal Identifiers (45 CFR 164.514)

Information containing any one of the following 18  identifiers is considered to be identifiable:

1. Names;
2. All geographical subdivisions smaller than a State, including street address, city, county, precinct, zip code, and their equivalent geocodes, except for the initial three digits of a zip code, if according to the current publicly available data from the Bureau of the Census: (1) The geographic unit formed by combining all zip codes with the same three initial digits contains more than 20,000 people; and (2) The initial three digits of a zip code for all such geographic units containing 20,000 or fewer people is changed to 000.
3. All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, date of death; and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older;
4. Phone numbers;
5. Fax numbers;
6. Electronic mail addresses;
7. Social Security numbers;
8. Medical record numbers;
9. Health plan beneficiary numbers;
10. Account numbers;
11. Certificate/license numbers;
12. Vehicle identifiers and serial numbers, including license plate numbers;
13. Device identifiers and serial numbers;
14. Web Universal Resource Locators (URLs);
15. Internet Protocol (IP) address numbers;
16. Biometric identifiers, including finger and voice prints;
17. Full face photographic images and any comparable images; and
18. Any other unique identifying number, characteristic, or code (note this does not mean the unique code assigned by the investigator to code the data);

There are also additional standards and criteria to protect individual's privacy from re-identification. Any code used to replace the identifiers in datasets cannot be derived from any information related to the individual and the master codes, nor can the method to derive the codes be disclosed. For example, the unique code cannot include the last four digits (in sequence) of the social security number. Additionally, the researcher must not have actual knowledge that the research subject could be re-identified from the remaining identifiers in the PHI used in the research study. In other words, the information would still be considered identifiable is there was a way to identify the individual even though all of the 18 identifiers were removed.

Examples of WHAT IS or IS NOT CONSIDERED PHI

Protected Health Information (PHI) under HIPAA means any information that identifies an individual and relates to at least one of the following:

• The individual’s past, present or future physical or mental health
• The provision of health care to the individual
• The past, present or future payment for health care

For example, PHI is used in research studies involving review of existing medical records for research information, such as retrospective chart review. Also, studies that create new medical information because a health care service is being performed as part of research, such as diagnosing a health condition or a new drug or device for treating a health condition, create PHI that will be entered into the medical record.  Another example are sponsored clinical trials that submit data to the U.S. Food and Drug Administration involve PHI and are therefore subject to HIPAA regulations.

What Is Not PHI

In contrast, some research studies use data that is individually-identifiable because it includes personal identifiers such as name, address. However, it is not considered to be PHI because the data are not associated with or derived from a healthcare service event (treatment, payment, operations, medical records),  or not entered into the medical records.  For example: research conducted in educational settings or using school records; or survey research on people’s opinions. 

The following are examples that are not considered as PHI:

• Employee Records
• Student Family Educational Rights and Privacy Act (FERPA) Records
• Research records that were not created as a result of providing health care services
• Health Information by itself without the 18 PHI identifiers

Health information by itself without any of the 18 identifiers is not considered to be PHI. For example, a dataset of vital signs by themselves do not constitute protected health information. However, if the vital signs dataset includes medical record numbers, then the entire dataset must be protected since it contains an identifier. PHI is anything that can be used to identify an individual such as private information, facial images, fingerprints, and voiceprints and can be associated with medical records, biological specimens, biometrics, or data sets.

How Can Researchers Use PHI and Comply With HIPAA Requirements?

Researchers accessing or using PHI can obtain:

• Authorization to Use PHI
• Waiver or partial waiver of authorization
• Alteration of authorization

HIPAA Authorization if your study involves PHI:

In the course of conducting research, researchers may obtain, create, use, and/or disclose individually identifiable health information. Under the Privacy Rule, covered entities are permitted to use and disclose protected health information for research with individual authorization, or without individual authorization under limited circumstances set forth in the Privacy Rule. If your study will involve access to or use of Protected Health Information (PHI), then your application must also include a HIPAA Authorization Section: (Waiver or Alteration of Consent: HIPAA Form).

Although similar to informed consent, the HIPAA Authorization focuses on privacy risks and the use or disclosure of PHI. The HIPAA Authorization is attached to the end of the informed consent form. In the HIPAA Authorization, researchers must state how, why, and to whom the PHI will be used and/or disclosed for research purposes. An Authorization may not require an expiration date; consult state and/or local law. However, a research participant has the right to revoke (in writing) his/her Authorization at any time. The participant or the participant’s authorized representative must be given a signed copy of the Authorization and researchers must keep a signed copy of participants’ Authorization for six years.

If the study does not involve health information, you do not need to include the HIPAA Authorization Section. 

Waivers or Alteration of HIPAA Authorization

The following three criteria must be satisfied for the IRB to approve a waiver or alteration of authorization under the Privacy Rule: 

1. The use or disclosure of protected health information involves no more than a minimal risk to the privacy of individuals, based on, at least, the presence of the following elements:
   • an adequate plan to protect the identifiers from improper use and disclosure; 
   • an adequate plan to destroy the identifiers at the earliest opportunity consistent with conduct of the research, unless there is a health or research justification for retaining the identifiers or such retention is otherwise required by law; and 
   • adequate written assurances that the protected health information will not be reused or disclosed to any other person or entity, except as required by law, for authorized oversight of the research project, or for other research for which the use or disclosure of protected health information would be permitted by this subpart; 
2. Waiver will not adversely affect the privacy rights and the welfare of the individuals;
3. The research could not practicably be conducted without the waiver or alteration; and 
4. The research could not practicably be conducted without access to and use of the PHI. 

Alteration of Authorization

The requirement to obtain Authorization for use of PHI may also be “altered” for a specific study. An alteration allows a change in certain Authorization requirements, while still requiring authorization for the use of PHI. Examples include making an exception to the required language in an authorization or to the requirement to obtain a signed Authorization. To be granted, an alteration must meet the same criteria above as a waiver or partial waiver.

If the study involves use of PHI and you would like to request a wavier or alteration of HIPAA Authorization, then complete Section B of the Waiver or Alteration of Consent: HIPAA Form must be completed.  Section B of the Waiver or Alteration HIPAA form must accompany the initial IRB submission (exempt/expedited or full board) or must accompany an amendment request.

Informed Consent Process

Table of Contents

• Background
• Definition
• Documentation
• Guidelines for Preparation of Consent Form or Oral Script
• The Basic Elements of Informed Consent
• Special Requirements for Obtaining Consent for Cognitively Impaired Individuals
• Special Requirements of 45 CFR 46 Subpart D - Additional DHHS Protections for  Children Involved as Subjects in Research
• Prisoners
• Pregnant Women, Human Fetuses and Neonates
• Assent of Children
• Permission of Parents
• Wards of State
• Informed Consent in Studies that Include Deception
• Oral History
• Additional Elements of Informed Consent
• Waiver of Requirement for Signed Consent Document
• Required IRB Stamps for Consent Forms and Recruitment Materials
• Regulatory Links

Background

The concept of informed consent is rooted in two important historical documents: The Nuremberg Code and The Belmont Report. The Nuremberg Code, which came about as a result of the Nazi War Crimes Tribunal, was the first internationally recognized code of research ethics and provided the foundation for regulations to protect human research subjects in the United States. In recognition of the importance of informed consent, "The voluntary consent of the human subject is absolutely essential", was listed as the primary tenet of the Nuremberg Code.

On July 12, 1974, the National Research Act (Pub. L. 93-348) was signed into law, thereby creating the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. One of the charges to the Commission was to identify the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects and to develop guidelines that should be followed to ensure that such research is conducted in accordance with those principles. The Belmont Report attempts to summarize the basic ethical principles identified by the Commission in the course of its deliberations. It is a statement of basic ethical principles and guidelines that should assist in resolving the ethical problems that surround the conduct of research with human subjects.

Three principles, or general prescriptive judgments, that are relevant to research involving human subjects are identified in this statement: respect of persons, beneficence and justice. Other principles may also be relevant. These three are comprehensive, however, and are stated at a level of generalization that should assist scientists, subjects, IRB reviewers and interested citizens in understanding the ethical issues inherent in research involving human subjects. These principles cannot always be applied so as to resolve beyond dispute particular ethical problems. The objective is to provide an analytical framework that will guide the resolution of ethical problems arising from research involving human subjects.

Informed consent is one of the primary ethical requirements underpinning research with human subjects; it reflects the basic principle of respect for persons. It is too often forgotten that informed consent is an ongoing process, not a piece of paper or a discrete moment in time. Informed consent assures that prospective human subjects will understand the nature of the research and can knowledgeably and voluntarily decide whether or not to participate. This assurance protects all parties: both the subject, whose autonomy is respected, and the investigator, who otherwise faces legal hazards.

Definition

Informed consent is a process that includes the presentation of information to the prospective subject, adequate opportunity for the subject to ask questions and have them answered, and documentation of the voluntary decision to participate. It is a fundamental mechanism to ensure respect for persons through provision of thoughtful consent for a voluntary act. The procedures used in obtaining informed consent should be designed to educate the subject population in terms that they can understand. Therefore, informed consent language and its documentation (especially explanation of the study's purpose, duration, experimental procedures, alternatives, risks, and benefits) must be written in "lay language", (i.e. understandable to the people being asked to participate). The written presentation of information is used to document the basis for consent and for the subjects' future reference. The consent document should be revised when deficiencies are noted or when additional information will improve the consent process.

Requirements for informed consent are contained within Title 45 of the Code of Federal Regulations, Part 46 (45 CFR 46), which is the primary federal statute pertaining to the protection of human subjects in research that is conducted using federal funds. Rutgers University maintains a Federalwide Assurance (FWA00003913) with the federal Department of Health and Human Services (DHHS), Office for Human Research Protections (OHRP), which extends the federal regulations to all research conducted by individuals who are affiliated with the University, regardless of the source or lack of funding. The complete text of 45 CFR 46 [1] may be found online.

Documentation

Informed consent shall be documented by the use of a written consent form that is approved by the IRB, and signed by the subject or the subject's legally authorized representative. A copy shall be given to the person signing the form. The consent form has two purposes: (1) to provide adequate information to potential research subjects to allow them to make an informed choice as to their participation in a study, and (2) to document their decision to participate. Under certain very specific circumstances, (described later in this document), the IRB is authorized to waive the requirement for written documentation of informed consent, or approve a consent procedure that alters or waives some or all of the elements of informed consent.

The consent form may be either of the following:

1. A written consent document that embodies the elements of informed consent required by 45 CFR 46.116.

• This form may be read to the subject or the subject's legally authorized representative, but in any event, the investigator should give either the subject or the representative adequate opportunity to read it before it is signed.

2. A short form written consent document, stating that the elements of informed consent required by 45 CFR 46.116 have been presented orally to the subject or the subject's legally authorized representative.

• When this method is used, there shall be a witness to the oral presentation. Also, the IRB shall approve a written summary of what is to be said to the subject or the representative.
• Only the short form itself is to be signed by the subject or the representative.
• However, the witness shall sign both the short form and a copy of the summary, and the person actually obtaining consent shall sign a copy of the summary.
• A copy of the summary shall be given to the subject or the representative, in addition to a copy of the short form.

Please note that the Short Form Written Consent is rarely used.  Instead, it is recommended that investigators wishing to present informed consent to subjects orally, request from the IRB a Waiver of the Documentation of Informed Consent --as explained later on below.

Guidelines for Preparation of Consent Form or Oral Script

In order to make an informed choice, potential subjects must understand the study, how they are involved in the study, what kind of risks it poses to them, and who they can contact if a problem arises. This information must be presented to the subject by the principal investigator, and re-stated in the consent document.

• The language used to describe these factors must be understandable to all potential subjects. To this end, the consent form should be written at a sixth-grade reading level, and all technical terms should be explained in lay language. Use of scientific jargon and legalese is not appropriate. Think of the document primarily as a teaching tool, not as a legal document.
• It is recommended that the second person perspective (e.g., you, your child) be used. Use of the first person (e.g., "I understand that ...") can be interpreted as suggestive, may be relied upon as a substitute for sufficient factual information, and can constitute coercive influence over a subject.  To this end, please do not use "I" or terms such as "I understand" in the consent form.
• For consent forms containing more than one page: it is recommended that a notation with the title of the study and the name of the investigator be added to the top of each page (except the first).
• If non-English speaking subjects will be involved, a consent form that has been translated into the relevant language is required.  Provide a description of the credentials of the person responsible for the translation.  This person can be a native speaker and does not need to be a certified translator, so long as they are clearly proficient in the native language of the subjects.
• If the protocol involves videotaping, audiotaping, or photographing of subjects, the consent form must include either a separate statement of agreement for these procedures within the consent document, with signature line, or an addendum to the consent form describing the recording procedure with a statement of agreement and signature line. The purpose of the distinct signature for these procedures is to ensure that the subject is aware of their inclusion, and if the study design permits, to allow the subject to participate in the study without being recorded.
• Exculpatory language (i.e., that which waives or appears to waive any legal rights of subjects) is prohibited. Subjects should not be given the impression that they have agreed to or are without recourse to seek satisfaction beyond the institution's voluntarily chosen limits.
• The consent form is to be read and signed by each subject who participates in the study before they begin participation in the study. Signature lines for the Principal Investigator and the subject, with corresponding lines for the date of each signature, are required. Signature lines for a legally authorized representative or minor subject may also be necessary, depending upon the type of subject population that is involved. A witness signature is not required in most cases; exceptions are oral consent verification (below) and situations in which a legally authorized representative signs for the subject.

Required Basic Elements of Informed Consent (8)

Unless specifically waived by the IRB, each of the following elements must be included in each consent form:

1. A statement that the study involves research. For example, "You are invited to participate in a research study" or "I will be conducting a research study."
2. An explanation of the purposes of the research. For example, "The purpose of this research project is (state the purpose)" or "We invite you to participate in a clinical research study that is designed to help us understand (describe the theory, disease, or condition)."
3. The expected duration of the subject's participation. State the number of sessions in which the subject will be involved, the amount of time required of the subject per session, and the time period over which the session will be held. For example, "Your participation in this study will last for about 6 months, and include two 15-minute sessions per month" or "You will take part in two interviews that will be scheduled two weeks apart, and each will last about 30 minutes."
4. A description of the procedures to be followed. List all procedures, preferably in chronological order, which will be employed in the study. For example, "Participation in this study will involve the following:" or "Your child will be asked four questions about the months of the year. This activity will take place during regular classroom time, when the other children are doing work at their desks. Positive feedback will be given to each child regardless of the complexity of their answers." If the procedures are extensive, numbered items may be helpful.
5. Identification of any procedures which are experimental. For example, a new drug, extra tests, separate research records, or nonstandard means of management, such as flipping a coin for random assignment to a treatment regimen. In treatment protocols, routine medical care which is not part of the research should not be included.
6. A description of any reasonably foreseeable risks or discomforts to the subject. Inform the subject of potential harms, discomforts, inconveniences and risks that are associated with the research activity, and any measures which will be used to minimize them. For example, "Use of Drug X has been known to cause the following side effects:" or "The primary risks are possible embarrassment from answering personal questions, and breach of confidentiality". When there is a lengthy list of potential side effects, they should be subdivided into groups such as "more likely to occur" or "not likely to occur."
7. An description of who to contact for both information about the research and rights that a subject has a research participant. The subject needs to be provided with the contact information of the principal investigator if they have any questions regarding the research, as well as the telephone number for the IRB and e-mail.
8. A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

Additional Elements of Informed Consent

When determined to be appropriate by the Institutional Review Board (IRB), subjects must be provided with one or more of the following additional elements of information during the informed consent process (see 45 CFR 46.116(b) [3]):

1. a statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable;
2. anticipated circumstances under which the subject’s participation may be terminated by the investigator without regard to the subject’s consent;
3. any additional costs to the subject that may result from participation in the research;
4. the consequences of a subject’s decision to withdraw from the research and procedures for orderly termination of participation by the subject;
5. a statement that significant new findings developed during the course of the research which may relate to the subject’s willingness to continue participation will be provided to the subject; and
6. the approximate number of subjects involved in the study.

It is up to the IRB to determine in a particular instance whether some or all of the above additional elements must be included as part of the informed consent process for a particular study. The IRB should make this determination based on the nature of the research and its knowledge of the local research context. If the IRB determines that additional elements are appropriate to the research study, this additional information should be considered just as essential as the eight basic elements of informed consent described in the HHS regulations at 45 CFR 46.116(a) [3].

Furthermore, an IRB may require that additional information beyond the basic [4] and additional elements be given to subjects during the informed consent process, when in the IRB’s judgment the additional information would meaningfully add to the protection of the rights and welfare of the subjects 45 CFR 46.109(b) [5]).

Subject Risk

Studies that involve only surveys, interviews, or focus groups may not pose physical risks to subjects, but often present other types of risk, and these must be listed. Plans for referral for counseling, if needed, should be included.

For example, "If you require counseling after your participation in this study, you will be referred to (facility name). This service (is free) or (will be billed to your health insurance carrier).  The counseling center can be reached at: telephone of counseling service."

If additional risks are identified during the course of the research, the consent process and documentation will require revisions to inform subjects as they are re-contacted or newly contacted.

Risks may be:

• Physical - pain, physical discomfort, injury, illness or disease brought about by the methods and procedures of the research;
• Psychological - anxiety, fear, stress, confusion, embarrassment, depression, guilt, shock, loss of self-esteem, and/or altered behavior, occurring during the research situation or later, as a result of participation;
• Social - alterations in relationships with others that are to the disadvantage of the subject, including embarrassment, loss of respect of others, labeling with negative consequences, or diminishing the subject's opportunities and status in relation to others;
• Economic - cost to subjects for procedures, loss of wages or income, damage to employability;
• Legal - risk of criminal prosecution or civil lawsuit when research methods reveal that the subject has or will engage in conduct for which the subject or others may be criminally liable;
• Loss of confidentiality - confidentiality is presumed and must be maintained unless the investigator obtains the express permission of the subject to do otherwise. Risks include invasion of privacy, as well as the social, economic, and legal risks outlined above.

These other elements of informed consent may also be required by the IRB, and investigators are encouraged to include them during the informed consent process and document:

1. A description of any benefits to the subject or to others which may reasonably be expected from the research. Describe direct benefits to the subject that may reasonably be expected. Do not promise any benefits which do not exist or are speculative. If the subject will not benefit directly, indicate how society or medical science may benefit. For example, "Participation in this study may not benefit you directly. However, the knowledge that we obtain from your participation, and the participation of other volunteers, may help us to better understand....." or "You may benefit from participation by gaining insight into your students' learning styles."
2. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject. If there are no alternative treatments, then this should be stated. All alternatives to participation should be listed, including standard therapy, if applicable. For example, "You may choose not to participate in this study and instead receive routine treatment and care, as there are no other treatment options available at this time" or "An alternative to participation in this research project may be to participate in other research studies for which you may receive the same research credit. Consult your instructor for options."
3. A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained. Some studies require disclosure of information to other parties. Others inherently are in need of a Certificate of Confidentiality which protects the investigator from involuntary release (e.g.,subpoena) of the names or other identifying characteristics of research subjects. If a Certificate of Confidentiality will be obtained by the investigator to provide protection from involuntary release of the subject names or other identifying information, this should be indicated. Information regarding the procedure to obtain a Certificate of Confidentiality may be obtained from the IRB office or NIH via the web at:  <http://grants1.nih.gov/grants/policy/coc [6]>.

If the data collected contain no identifying information that could link the data to the subject, then "confidential" should be replaced by "anonymous" in this section.

Definition of Anonymous: Data are recorded such that no identifier whatsoever exists to link a subject's identity to that subject's response. Examples: (1) subject fills out and mails back to the investigator a questionnaire that does not provide subject's name, social security number, phone number, or any other identifier; (2) investigator interviews subject by phone and notes responses, but does not have any record connecting any response to any phone number.

Definition of Confidential: There exists a documented linkage between a subject's identity and his/her response in the research, and the investigator provides assurance in the protocol and in the informed consent form that the identity of any individual subject will not be revealed in any report of the study. Example: a subject's data record is assigned a code, and a "master list" that links the code to the subject's identity is maintained in a secure location.

Sample text: "The information in the study records will be kept strictly confidential. Data will be stored securely in a locked cabinet and/or restricted-access computer and will be made available only to persons conducting the study unless you specifically give permission in writing to do otherwise. No reference will be made in oral or written reports which could link you to the study."

The IRB will determine the level of adequate requirements for confidentiality in light of its mandate to ensure minimization of risk.

1. For research involving more than minimal risk, an explanation as to whether any compensation is available, and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained. State precise amounts of financial compensation, if applicable, and explain the pro-rating scheme of payment that will apply if the subject withdraws before completing the study. For example, "For participating in this study you will receive (describe compensation). Other ways to earn the same amount of credit are (describe options here). If you withdraw from the study prior to its completion, you will receive (describe partial compensation system)" or "If you are harmed by being in this study, we will provide or arrange care as needed. Payment will be your responsibility, or that of your health insurance carrier (or Medicaid, etc.)."
2. An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject. Two statements are required: contact information for the investigator, and contact information for the IRB. For example, "Any questions about this study should be directed to the principal investigator at (phone number) (Note: email address is optional)" and "If you have any questions about your rights as a research subject, you may contact the IRB at Rutgers by phone (732) 235-9806, Email us or write us at 335 George Street, Liberty Plaza Suite 3200, New Brunswick, NJ 08901."
3. A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits, to which the subject is otherwise entitled. For example, "Your child's participation in this study is completely voluntary and you may withdraw your child at any time without prejudicing your child's present or future care" or "Your participation in this research is voluntary. You may refuse to answer any questions with which you are not comfortable, and you may withdraw from the study at any time without penalty."

Special Requirements of 45 CFR 46 Subpart D - Additional DHHS Protections for Children Involved as Subjects in Research

• Assent of Children

Assent is defined as, " A child's affirmative agreement to participate in research. Mere failure to object should not be construed as assent [45 CFR 46.402(b [7])]". While children may be legally incapable of giving informed consent, they nevertheless may possess the ability to assent to or dissent from participation. Out of respect for children as developing persons, children should be asked whether or not they wish to participate in the research, particularly if the research: (1) does not involve interventions likely to be of benefit to the subjects; and (2) the children can comprehend and appreciate what it means to be a volunteer for the benefit of others. The IRB must determine for each protocol - depending on such factors as the nature of the research and the age, status, and condition of the proposed subjects - whether all or some of the children are capable of assenting to participation. Where appropriate, IRB’s may choose to review on a case-by-case basis whether assent should be sought from given individual subjects.

• There is no required format for assent, the text of which must be submitted to the IRB with the protocol for review. It must, however, be age appropriate, offer an explanation of the study, and provide the child with the opportunity to agree to participate or refuse participation. Written documents, as well as oral scripts, are acceptable. The child may be asked to sign a document or agree verbally; in cases where verbal assent is obtained, the investigator must document the assent. (I.e., the format and content of an assent statement is highly variable, but must be tailored to the particular child or children involved.)
• Even where the IRB determines that the subjects are capable of assenting, the IRB may still waive the assent requirement under circumstances, in which consent may be waived in accord with 45 CFR 46.116 of Subpart A (waiver requirements described earlier in this document). Note: See the Consent Form Waivers [8] Section for more information.
• If the IRB determines that the capability of some or all of the children is so limited that they cannot reasonably be consulted, or that the intervention or procedure involved in the research holds out a prospect of direct benefit that is important to the health or well-being of the children, and is available only in the context of the research, the assent of the children is not a necessary condition for proceeding with the research (i.e., assent may be waived if the children are not cognitively able to understand the concept of participating in a particular study, or if participation is likely to benefit the child, and the benefit can only be obtained by participation).
• In determining whether children are capable of assenting, the IRB must take into account the ages, maturity, and psychological state of the children involved. This judgement may be made for all children to be involved in research under a particular protocol, or for each child, as the IRB deems appropriate (i.e., in some cases, all children who participate in a particular study may be capable of providing assent, and in other cases, only some of the children may be capable; the IRB may leave this judgement up to the investigator and is not obligated to require that ALL of the children in a study must or must not agree to participate).
• The IRB must determine that adequate provisions are made for soliciting the assent (agreement) of the children, when in the judgment of the IRB the children are capable of providing assent. Assent is usually required in addition to parental permission; in rare cases, the requirement for parental permission may be waived (see Section 2, item d. in the Parental Permission section below).
• Children are defined as persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted (usually state law, which may vary according to the child's situation, e.g., emancipated minor).

• Parental Permission

Permission from one or more parents is required when a minor is involved in research. Assent (agreement) from the child may or may not be required, depending upon the study and characteristics of the child (see Assent of Children section above). Under very specific circumstances, the requirement for parental permission may be waived by the IRB (see below). Otherwise, the information below describes the circumstances under which the permission of either one or both parents is required. If you cannot make a determination after reading each section, please contact an IRB Administrator for guidance.

The permission of one parent is sufficient for research in which: no greater than minimal risk to children is presented;

If more than minimal risk to children is presented by an intervention or procedure that holds out the prospect of direct benefit for the individual subject, or by a monitoring procedure that is likely to contribute to the subject's well-being. The following conditions apply:
            (a) the risk must be justified by the anticipated benefit to the subjects;
            (b) the relation of the anticipated benefit to the risk must be at least as favorable to the subjects as that presented by available alternative approaches; and
            (c) adequate provisions are made for soliciting the assent of the children and permission of their parents or guardians.

Both parents must give their permission, unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child, for research in which:

• more than minimal risk to children is presented by an intervention or procedure that does not hold out the prospect of direct benefit for the individual subject, or by a monitoring procedure which is not likely to contribute to the well-being of the subject. ALL of the following conditions apply:

(a) the risk represents a minor increase over minimal risk;

(b) the intervention or procedure presents experiences to subjects that are reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social, or educational situations;

(c) the intervention or procedure is likely to yield generalizable knowledge about the subjects' disorder or condition which is of vital importance for the understanding or amelioration of the subjects' disorder or condition; and

(d) adequate provisions are made for soliciting assent of the children and permission of their parents or guardians.

Both parents must give their permission, unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child, for research that is:

• Not otherwise approvable (i.e., not included in categories a. or b. described above) which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children. The following conditions apply:

(a) the research must present a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children; and

(b) if the project is funded by DHHS, the DHHS Secretary, after consultation with a panel of experts in pertinent disciplines (for example: science, medicine, education, ethics, law) and following opportunity for public review and comment, must determine either:

(1) that the research in fact satisfies the conditions of categories a. or b. previously described; or

(2) the following:

(i) the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children;

(ii) the research will be conducted in accordance with sound ethical principles;

(iii) adequate provisions are made for soliciting the assent of children and the permission of their parents or guardians, as set forth in 45 CFR 46.408.

If the project is not funded by DHHS, the IRB must determine that the conditions set forth in (2) are satisfied.

If the IRB determines that a research protocol is designed for conditions or for a subject population for which parental or guardian permission is not a reasonable requirement to protect the subjects (for example, neglected or abused children), it may waive the consent requirements as previously described, provided an appropriate mechanism for protecting the children who will participate as subjects in the research is substituted, and provided further that the waiver is not inconsistent with Federal, state or local law.

Additional Vunerabilities Which Affect the Informed Consent Process

If your project includes one or more of the following additional vunerabilities, then the following information may apply:

Wards of the State (i.e. Foster Children)

Children who are wards of the State or any other agency, institution, or entity can be included in research described in categories b. and c. under "Parental Permission" only if such research is:

(1) related to their status as wards; or

(2) conducted in schools, camps, hospitals, institutions, or similar settings in which the majority of children involved as subjects are not wards.

If the research is approved under paragraph (a) of this section, the IRB shall require appointment of an advocate for each child who is a ward, in addition to any other individual acting on behalf of the child as guardian or in loco parentis. One individual may serve as advocate for more than one child. The advocate shall be an individual who has the background and experience to act in, and agrees to act in, the best interests of the child for the duration of the child's participation in the research and who is not associated in any way (except in the role as advocate or member of the IRB) with the research, the investigator(s), or the guardian organization.

Cognitively Impaired Individuals

Consent to research involving cognitively impaired subjects through any of the intramural programs of the National Institutes of Health (e.g., the National Institute of Mental Health, the National Institute of Neurological and Communicative Disorders and Stroke, the National Institute on Aging, and the National Institute on Alcohol Abuse and Alcoholism) is guided by NIH policy on consent to research with impaired human subjects. This policy sets out, in matrix form, conditions under which cognitively impaired subjects may participate in research of varying risk.

As a general rule, all adults, regardless of their diagnosis or condition, should be presumed competent to consent unless there is evidence of serious mental disability that would impair reasoning or judgment. Even those who do have a diagnosed mental disorder may be perfectly able to understand the matter of being a research volunteer, and quite capable of consenting to or refusing participation. Mental disability alone should not disqualify a person from consenting to participate in research; rather, there should be specific evidence of individuals' incapacity to understand and to make a choice before they are deemed unable to consent.

Persons formally adjudged incompetent have a court-appointed guardian who must be consulted and consent on their behalf. Officials of the institution in which incompetent patients reside (even if they are the patient's legal guardians) are not generally considered appropriate, since their supervisory duties may give rise to conflicting interests and loyalties. Family members or others financially responsible for the patient may also be subject to conflicting interests because of financial pressures, emotional distancing, or other ambivalent feelings common in such circumstances. IRBs (and investigators)should bear this in mind when determining appropriate consent procedures for cognitively impaired subjects.

Procedures can sometimes be developed to enhance the possibility that subjects can consent for themselves. Criteria for determining competence might vary according to the degree of risk or discomfort presented by the research procedures and the extent to which therapeutic gains can be anticipated. The setting in which consent is sought and the person seeking it can also influence a potential subject's ability to comprehend or appreciate what is being asked. An uncomfortable chair, a room that is either too noisy or lacking in privacy, or a physician the patient dislikes may all create anxiety or resistance that would not exist if the information were presented by another person, at another time, or in another place. The National Commission recommended that, in certain cases, a consent auditor be appointed by the IRB to determine whether proposed subjects consent, assent, or object to their participation in research, especially if the research involves more than minimal risk and no foreseeable direct benefit.

Consent documents for individuals who are determined to be incompetent to consent must contain a signature line for a legally authorized representative, in addition to the elements of informed consent described earlier in this document. The subject may also be asked to provide assent, if it is determined that they are capable of doing so. A sample certification statement that may be included in consent forms intended for legally authorized representatives of subjects who are cognitively impaired follows: "As the legally authorized representative, your signature authorizes the participation of (name of subject) in this research study, which has been explained to you. The investigator has offered you the opportunity to ask questions, and they have been satisfactorily answered."

Pregnant Women, Human Fetuses and Neonates

Under the terms of 45 CFR 46, Subpart B, Pregnant Women, Human Fetuses and Neonates are considered to be members of a vulnerable population and therefore entitled to special protections if they participate in research activities. Subpart B defines both the types of permissible research with Pregnant Women, Human Fetuses and Neonates, and the safeguards that must be followed.

For additional information, review the regulations at: Subpart B: Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research [10].

Prisoners

Under the terms of 45 CFR 46, Subpart C, prisoners are considered to be members of a vulnerable population and therefore entitled to special protections if they participate in research activities. Subpart C defines both the types of permissible research with prisoners, and the safeguards that must be followed.

For additional information, review the regulations at: Subpart C: Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects. [11]

Informed Consent in Studies that Include Deception

Some behavioral research is designed to deceive the subjects about the true purpose of the study because the subjects' behavior would be altered if they knew the real objectives, and the data would then be inaccurate. Whenever possible, deception should be avoided to minimize the potential negative effects that may result as a consequence: guilt, embarrassment, psychological stress. However, when the research will not have scientific validity without the use of deception, the investigator and the IRB must carefully consider whether the human subjects that will be involved are adequately protected.

• The proposed subject population must be suitable for the purposes of the study (i.e., an IRB may find that individuals with diminished mental capacity or those with paranoid tendencies may not be suitable subjects for a protocol that involves deception, whereas the same study may be approved if a subject population that has normal mental capacity and no history of mental illness is used).
• If a study involves deception, than it may be proposed that the subject not be fully informed when they agree to participate in the study. They may be told that the actual objectives of the study will not be known to them until after their participation has ended, or they may be intentionally mislead about the intent of the research. The IRB must decide whether the study is so designed that the subjects will be adequately protected without having given informed consent, and if a waiver of some or all of the elements of informed consent can be approved. According to the regulations, research should not be permitted at all if the risk to subjects is more than minimal and the subjects are not being informed of things they would consider material to a decision to participate. In deciding whether to waive or alter consent requirements, IRBs must consider the risks to which subjects will be exposed. To receive a waiver of consent requirements, the study must present no more than minimal risk. Further, the waiver must not adversely affect the rights and welfare of subjects, and must be essential to the ability to carry out the research. A final condition for waiving some or all of the elements of informed consent is that, whenever appropriate, subjects will be given additional pertinent information after they have participated in such a study. The IRB must decide if subjects should be debriefed either after participating in research unwittingly or after knowingly participating in research that involved some form of deception.
• A debriefing statement that informs the subjects of the true nature of the study is required for most studies that involve deception. However, there are some instances in which debriefing may cause more harm than good, and is therefore not recommended (e.g., if the study results would provide subjects with information that is disturbing about themselves). Debriefing is appropriate if it contributes to the subject's welfare, e.g., by reducing stress or correcting misconceptions about themselves that resulted from participation in the study. After debriefing, the subject must be given the opportunity to confirm or rescind their consent. In essence, this is the actual informed consent for the subject's participation in the study, and should be prepared, presented and documented in accordance with the guidelines for informed consent.

Waiver of Informed Consent Documentation

An IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects.

IMPORTANT: A Waiver of Consent Documentation is not a waiver to skip the whole consent process!!!

Please visit the Waiver of Informed Consent Guidance Topic [12] for more information.

Oral History Projects and Informed Consent

If the archived data will be made publicly available then the research must be prospectively reviewed and approved by the Rutgers IRB before the research project begins. The IRB requires that the researcher make provisions for obtaining informed consent from all participants and document the process. Participants in oral history projects should be allowed to review the material prior to public archive and decide if they wish any or all of the oral history archived.

Informed Consent Form Stamps

• IRB Stamps on Consent Forms
  • IRB policy requires that approved consent forms, advertisements, recruitment notices, etc. provided to subjects display one of the following:
  1. The IRB Approval stamp, indicating the date of approval and expiration for the protocol, OR;
  2. The following statement: "This informed consent form [substitute advertisement or applicable term] and research protocol was approved by the Rutgers Institutional Review Board for the Protection of Human Subjects on [Date of approval], and expires on [date of expiry]."
• Sample Templates are provided by the IRB via the Human Subjects Protection Program Toolkit.

Regulatory Links

• OHRP Informed Consent Checklist: https://www.hhs.gov/ohrp/regulations-and-policy/guidance/checklists/index.html [14]
• OHRP Informed Consent Tips: https://www.hhs.gov/ohrp/regulations-and-policy/guidance/informed-consent-tips/index.html [15]
• OHRP Informed Consent FAQs: https://www.hhs.gov/ohrp/regulations-and-policy/guidance/faq/informed-consent/index.html [16]

References

OPRR IRB Guidebook, 1993, Robin Levin Penslar, J.D., principal author and editor: http://ohrp.osophs.dhhs.gov/irb/irb_guidebook.htm [17]

For FDA Regulated Research

Obtaining the informed consent of individuals before involving them in research is a central protection afforded by federal regulation and a key ethical expression of respect for persons. Among other things, the consent process should ensure that investigators provide adequate information about the research, communicate it in a way that is easy for the individual to understand, and discuss the research in a context that ensures a subject's decision to participate is voluntary.

Federal regulations require certain informational elements to be present in consent documents to facilitate ‘informed consent’ in various circumstances (i.e., adult consent, assent of a minor, surrogate consent for the decisionally-impaired, consent of non-English speaking persons, etc.). You may adopt the template language or use it to guide the development of a custom consent that best suits your research needs and effectively communicates to the potential population you ask to participate in your research.

Please note that other HRPP Guidance we list may also link to sample consent templates for use. For example, the Research Tissue/Data Banks, we offer a main consent template for the development of a registry or repository and an addendum consent template for a secondary study.

Elements of Informed Consent

Written informed consent for research must have these elements.

1. A statement that the study involves research, an explanation of the purposes of the research and the expected duration of subject's participation, a description of what procedures will be followed, and which ones are experimental;
2. A description of any foreseeable risks or discomforts;
3. A description of benefits to the subject or others who may benefit;
4. Disclosure of appropriate alternative procedures or treatments that may be advantageous to the subject;
5. A statement describing the extent of confidentiality of records identifying the subject;
6. Research involving more than minimal risk must include explanations regarding
   1. Whether any compensation is available for participation
   2. Whether medical treatments are available for injuries, and if so, a description of them or where more information is available;
7. Whom to contact for answers to questions about the research; answers to questions about subject's rights; if a research-related injury occurs;
8. A statement that participation is voluntary, that refusal to participate will not penalize the subject, and consent to participate can be withdrawn at any time.

Additional Elements of Informed Consent - When Appropriate:

1. A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are current unforeseeable;
2. Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent;
3. Any additional costs to the subject that may result from participation in the research;
4. The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject;
5. A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject; and
6. The approximate number of subjects involved in the study.

STEM CELL RESEARCH

GUIDELINES FOR RESEARCH USING HUMAN PLURIPOTENT STEM CELLS

Informed Consent for the use of Pluripotent Stem Cells should include:

1. A statement that the embryos will be used to derive human pluripotent stem cells for research that may include human transplantation research;
2. A statement that the donation is made without any restriction or direction regarding the individual(s) who may be the recipient(s) of transplantation of the cells derived from the embryo;
3. A statement as to whether or not information that could identify the donors of the embryos, directly or through identifiers linked to the donors, will be removed prior to the derivation or the use of human pluripotent stem cells;
4. A statement that derived cells and/or cell lines may be kept for many years;
5. Disclosure of the possibility that the results of research on the human pluripotent stem cells may have commercial potential, and a statement that the donor will not receive financial or any other benefits from any such future commercial development.
6. A statement that the research is not intended to provide direct medical benefit to the donor; and
7. A statement that embryos donated will not be transferred to a woman’s uterus and will not survive the human pluripotent stem cell derivation process.

Regulations

U.S. FDA Regulations CFR Title 21 Part 50: Protection of Human Subjects, Informed Consent

Help

If you have additional questions about how to create consent documents based on our templates, please contact your local IRB Office.

Research Involving International Sites

IRB review of international research raises additional considerations related to obtaining local knowledge of applicable laws, institutional commitments and regulations, standards of professional conduct and practice, cultural norms, and local community attitudes.  Physical, social, and psychological risks may vary from those in the local community surrounding Rutgers University.  Assessing the risks and benefits of research conducted internationally may raise challenges if there is not adequate knowledge of the local setting or population to be included.  Care must be taken to ensure that the cultural norms of the host country are respected and that the participants will not suffer adverse consequences from participation, such as being subjected to retaliation from local authorities or the local community.

Research projects that take place outside the United States require compliance with RU policies and the relevant laws of the host country.  International research must also comply with 45 CFR 46 or equivalent standards, such as the 2016 Council of International Organization of Medical Sciences (CIOMS) International Ethical Guidelines for Health-related Research Involving Human Subjects, the International Conference on Harmonization (ICH) standards, the 2018 Medical Research Council of Tri-Council Policy Statement on Ethical Conduct for Research Involving Humans (Canadian Institutes of Health Research), and/or the General Data Protection Regulation (GDPR), when applicable. [See Toolkit item HRP-103a – SOP: Investigator Manual – All Appendices]

It is important for researchers to provide information to address these considerations and for the IRB to gain sufficient knowledge of the research locale to accurately assess the risks and benefits of participation and to provide appropriate protections to subjects. In addition to the protocol, sample consent(s), and related study materials, submit also to the IRB with your application completed form HRP-285 – International Research for Expedited/Full Board Studies or HRP-286 – International Research for Exempt Studies, as applicable. In addition to the protocol, this form offers the investigator a place to provide additional information that is required to be submitted by the IRB about the international setting, qualifications of the research team to conduct research in the proposed international setting, and much more. The IRB will consider the following bulleted items, in addition to, the regular review requirements as described in HRPP SOPs.

IRB Review of International Research

1. Addressing the Needs, Issues, or Benefits of the Local Community

The research protocol should generally be designed to address issues characteristic of the local setting, or conditions that affect the local setting, particularly in developing countries.  If the research is greater than minimal risk, then the research should be designed to provide a potential benefit to the subjects and/or to the local community.  If a research study is not designed accordingly, the investigator should provide satisfactory justification as to why the study is proposed to be conducted in the given setting(s).

b.   Local Context - In an effort to gain knowledge of the local setting, the IRB will consider the most appropriate means of obtaining this information.   The type of research, level of risk, study population, location of the research and whether collaborative efforts are involved are all factors that will affect the means of obtaining the knowledge of the local setting.

      For all international research studies that are greater than minimal risk, researchers must provide details of the local context within the protocol to provide a basis for the IRB review. 

      The IRB may obtain local knowledge from literature, documentation, or available written information, or by the inclusion of a consultant knowledgeable of the local setting.  For a review of minimal risk studies, obtaining knowledge of the local setting by these means may be adequate.

      For greater than minimal risk studies, consideration should be given to enhance the local knowledge by obtaining review and approval from an ethical review committee that is local to the study site or has particular knowledge of the local setting.  One source for the identification of potential international ethical review committees or IRBs is the list of IRBs registered with ORHP at International Compilation of Human Research Standards | HHS.gov. 

      Investigators should recognize that international ethical review committees which are affiliated with an institution may not be willing to review research conducted by investigators outside their institution.  Access to local ethical review committees may be facilitated when researchers collaborate with researchers at the local institution.

      The local ethical review committee or IRB should comply with the IRB composition requirements of 45 CFR 46.107 or 21 CFR 56.107, as applicable.  In order to increase efficiency, review and approval by the local ethics committee or IRB should usually be obtained after review by the RU IRB or designated IRB on the FWA. 

      If a review by a local human research ethics committee cannot be obtained for greater than minimal risk research, the IRB review will include consultation by an expert who is independent of the research team and is familiar with the local site’s culture and norms.  The research team may refer such an individual to participate in the review by the convened RU IRB.

c.   Informed Consent - Obtaining informed consent in accordance with 45 CFR 46 and 21 CFR 50 in certain international settings may raise challenges due to a difference in the norms of the host country.  The process for obtaining and documenting informed consent must comply with U.S. regulations and with RU policy.

If the legal age of an adult differs in another country from state law (e.g., 18 years of age), the IRB should accept the local age of majority when considering who may provide their own consent.  

d.   Translation - When consent and recruitment documents have already been translated into a language other than English, the researcher should provide a copy of the document in English, a copy in the language to be used in the foreign location, and certification from an appropriate individual that the translated version of the document is complete and does not contain information that is not presented within the context of the approved English version of the document. 

When the RU IRB-approved informed consent document in the local language is reviewed by an international IRB or ethics committee, the local approved consent document should be back-translated into English by an appropriate individual who will certify that the resulting English version and the local consent document are consistent in content, style, and level of readability.   [See GUIDANCE: Non-English Speaking Subjects for further information about enrolling subjects who speak a language other than English.]

e.   Approval by the Institution Where the Research Will be Conducted

When the research will be conducted in an institution or organization such as a school, business, or hospital that is not otherwise involved in the research, a letter(s) of the agreement should be submitted from the appropriate official(s) (e.g., government officials, school officials, community officials, chief executive officers, etc.) indicating that the research protocol, and any and all instruments to be used, have been reviewed and that the study is acceptable to be conducted in the institution or organization.  The letter of agreement must be on letterhead stationery and carry an original signature, or otherwise meet acceptable professional standards for a signed document.

f.    Plan for Oversight of the Research

The research study should provide a plan for oversight of the research that will be conducted in an international setting, particularly when the RU research staff will not be present at the foreign site.

g.   Plan for the Collection and Transmission/Transport of Research Data or Biological Samples - The research study should provide a plan for data collection, protecting the confidentiality of the data, and transport of the data back to RU, or elsewhere in the U.S. or another region.

1.   If data will be collected by an individual(s) other than those on the RU research team, that (those) individual(s) must be identified, and letters of agreement to protect confidentiality should be presented to the IRB.  If the non-RU researcher(s) will have access to the data for research purposes, the extent of the access should be specified.

2.   Methods for assuring anonymity and/or confidentiality of all data must be specified, particularly if the analysis will occur away from RU.

3.   Processes for transporting data from the international location to RU, with particular reference to protecting the confidentiality of the data while in transit, must be addressed.

4.   If personal health information with identifiers will be transmitted to the U.S., HIPAA requirements must be addressed.

5.   If the research study will collect tissues or any other biological samples, the study should provide a plan for the storage and use of the samples, and a plan to protect the confidentiality of the samples.  If the samples will be transported back to RU or the U.S., the protocol must provide a plan for shipment of the samples that are in accordance with both the local country and U.S. regulations and policies.

Unsterilized specimens of human and animal tissues (such as blood, body discharges, fluids, excretions, or similar material) containing an infectious or etiologic agent require a permit in order to be imported (USPHS 42 CFR 71) to the U.S.  Details on the regulatory requirements, the process for obtaining a permit, and shipping and handling of such issues can be found on the CDC website at http://www.cdc.gov/od/eaipp/.

If the material being imported has been rendered sterile (e.g., radiation or chemical treatment) and is known not to contain infectious agents for humans, a permit is not required for importation.

Be sure to consult with other relevant RU Departments regarding work in international settings and/or use and transport of specimens, such as Export Control, Office of Information Technology, and BioSafety Committee, to name a few.

The IRB recognizes that there are instances for which parts of the guidance cited above for international studies would be inappropriate, such as with ethnographic research, both domestic and international, where researchers observe, interact, and may live with subjects in their native environment, often for long periods of time.  Research that presents concerns that are unique to a population and its culture would, by necessity, require careful consideration by the IRB and the researcher as to how best to protect the rights and welfare of the subjects.

For Further Information, Toolkit Documents, and Guidance

Visit HRPP Toolkit to obtain referenced Toolkit Forms & Templates
Visit HRPP Guidance Topics to obtain referenced Guidance documents.
Contact your IRB Office at https://go.rutgers.edu/ContactUs if you need further assistance.

Overview

Computer- and internet-based methods of collecting, storing, utilizing, and transmitting data in research involving human participants are developing at a rapid rate. As these new methods become more widespread in research in the social, psychological, and social sciences, they present new challenges to the protection of research participants. The Institutional Review Board (IRB) believes that computer- and internet-based research protocols must address fundamentally the same risks (e.g., violation of privacy, legal risks, psychosocial stress) and provide the same level of protection as any other types of research involving human participants.

All studies including those using computer and internet technologies must (a) ensure that the procedures fulfill the principles of voluntary participation and informed consent, (b) maintain the confidentiality of information obtained from or about human participants, and (c) adequately address possible risks to participants including psychosocial stress and related risks.

At the same time, the IRB recognizes that computer- and internet-based research presents unique problems and issues involving the protection of human participants. The IRB further recognizes that computer and internet technologies are evolving rapidly, that these advances may pose new challenges to the protection of human participants in research, and that both the IRB and researchers employing new technologies must maintain their diligence in addressing new problems, issues, and risks as they arise in the coming years.

The purpose of these guidelines is to help researchers plan, propose, and implement computer- and internet-based research protocols that provide the same level of protection of human participants as more traditional research methodologies. The guidelines are comprised of requirements and recommendations that are consistent with the basic IRB principles applied to all research involving human participants.

When Minimal Risk Study May Not Apply

Internet-based research may not be suitable for greater than minimal risk studies where the research involves data that:

1. places participants at risk of criminal or civil liability, or
2. could damage their financial standing, employability, insurability, reputation, or
3. could be stigmatizing, or
4. could result in stolen identity.

Internet Research vs. Research Conducted in the "Actual" World

Much of the research done using the computer- and internet (as a tool or mechanism) follows similar methodology to that done elsewhere. However, there are at least four reasons that standard methodologies and the protection of subjects and data must be considered when using the Internet for research:

1. Data that would be ephemeral in other contexts (e.g., things observed, read, or heard during participant observation; interviews conducted with subjects, etc.) become permanent or semi-permanent when they become cached web pages, data stored on host servers, and/or email and chat conversations between the researcher(s) and subjects that are stored on subjects' computers or on their email/chat servers.
2. Data that would be ordinarily be preserved for a minimum of three years and then destroyed — e.g., surveys, and field notes and/or transcriptions of the sorts of data  — also become permanent or semi-permanent.
3. May be searchable using widely-available search engines.
4. The Internet is a context in which people are often creative in their presentation of self and in their conduct. For example, pseudonyms are often carefully protected by subjects because these are the names attached to reputations, social networks, and claims to special knowledge. Misuse of these pseudonyms poses new risks to subjects and their social networks and virtual social worlds.

Analyzing and/or Freely Quoting Information Without Consent

In certain cases, information may be freely quoted and/or analyzed without consent. The three relevant questions / issues to consider to see if this applies to your situation are:

1. Information that is officially and publicly archived — i.e., is intended to be information for the general public and is not protected by a password or login. AND
2. Site policy does not prohibit the direct quotation of material from the site (or prohibit research more generally). AND
3. Information in which the topic covered is not greater than minimal risk. Rutgers classifies data into restricted, limited access, and public data. Refer to the document Minimum Security Standards for Networked Devices, for examples of specific definitions used by Rutgers.

For everything else, consent would typically be required.

Obtaining Consent

Informed Consent Process For Internet-Based Research:

• For anonymous internet-based surveys, include "I agree" or "I do not agree" buttons on the website for participants to click to indicate their active choice of whether or not they consent to participate.  For anonymous surveys sent to and returned by participants through email, include an information sheet with consent information and inform participants that submitting the completed survey implies their consent.
• If the IRB determines that written consent is required, the consent form can be mailed or emailed to the participant who can then sign the form and return it via fax or postal mail.
• Researchers conducting web-based research should be careful not to make guarantees of confidentiality or anonymity, as the security of online transmissions is not guaranteed.  A statement in the informed consent form indicating the limits to confidentiality is typically required.  The following statement may be used:
  "Your confidentiality will be maintained to the degree permitted by the technology used. Specifically, no guarantees can be made regarding the interception of data sent via the Internet by any third parties."

From Whom Must The Researcher Obtain Consent

If research is being done on a site or chat platform that requires consenting to a EULA (End User License Agreement), TOS (Terms of Service), or other site or platform rules, users must follow the guidelines that users agree to when accepting the EULA, TOS, and/or site or platform rules. If this includes requiring permission from the host site's administrator(s), users must first obtain consent from the administrator(s).

Given the nature of the information transmitted via the internet, researchers may also be required to obtain consent from individual subjects.

How to Obtain Consent in Internet Research

The process of requesting consent should not disrupt the normal activity of a site that is not expressly set up for research purposes and for which the researcher is not the administrator. In real-time environments (including chatrooms, virtual worlds, multiplayer gaming, etc.) the process of requesting consent publicly is often perceived as disruptive or worse. In such cases, consider announcing publicly that you are conducting research. Researchers may then request that people contact them via PM (private messaging using the site or platform in question), IM (instant messaging on another platform), email, website, etc.

Following the guidelines below, researchers may then obtain consent.

• If the risks to subjects are greater than minimal:
  • researchers may be required to obtain consent with a signature on paper, which is then returned to the researcher(s) via fax or conventional mail.
• If the risks to subjects are not greater than minimum:
  • Researchers may use a web-based assent form, which utilizes checkboxes, if you follow the steps outlined below.
  • Researchers may use a document-based consent form, which can be signed electronically — subjects scan a picture of their signature and insert the picture in the signature line.
• If subjects are minors or otherwise not permitted to provide consent for themselves:
  • The consent of parents or guardians may be obtained on paper (sent to the researcher(s) via fax or conventional mail) if the research is not greater than minimal risk.
  • The consent of parents or guardians may be required to be obtained by hard copy if the research is greater than minimal risk.

Gaining Consent Online with a Checkbox

For not greater than minimal risk research, a single checkbox (similar to that used by a software company) may be acceptable.

For greater than minimal risk research, a single checkbox (similar to that used by a software company) may not acceptable. Since Internet culture is such that people often check such boxes without reading the content of that to which they are consenting, one cannot assume that their consent is informed. Instead of a single checkbox at the end of a consent form, researchers may use a checkbox for each item in the consent form, taking subjects through each step of the informed consent process. It is also possible that researchers will be required to obtain signed print copies of consent in some circumstances. A statement about how to opt-out of the study should also be included.

Recruitment Tips

• Computer- and internet-based procedures for advertising and recruiting potential study participants (e.g., internet advertising, e-mail solicitation, banner ads) must follow the IRB guidelines for recruitment that apply to any traditional media, such as newspapers and bulletin boards.  All advertising and recruitment material must be reviewed and approved by the IRB.
• Investigators are advised to review the University’s policy on Use of Student Directory Information from the University’s Registrar. Contact the University's Office of Student Affairs Compliance for individual policies regarding lists of student directory information.
• Investigators are advised to review the University’s policy on Use of Official Email Lists prior to soliciting participants by email.  Contact list moderators for individual list policies regarding solicitations.

Data Collection Tips

• It is strongly recommended that any data collected from human participants over computer networks be transmitted in encrypted format.  This helps insure that any data intercepted during transmission cannot be decoded and that individual responses cannot be traced back to an individual respondent.
• The level of security should be appropriate to the risk. For most research, standard security measures like encryption and secure socket layer (SSL) will suffice. However, with sensitive topics additional protections include certified digital signatures for informed consent, encryption of data transmission, technical separation of identifiers.
• Researchers are cautioned that encryption standards vary from country to country and that there are legal restrictions regarding the export of certain encryption software outside US boundaries.
• Internet-based survey instruments must be formatted in a way that will allow participants to skip questions if they wish or provide a response such as “I choose not to answer.” Also, at the end of the survey, there should be two buttons: one to allow participants to discard the data and the other to submit it for inclusion in the study. Finally, if applicable, online surveys must include mechanisms for withdrawal. For example, if a participant decides to withdraw, there should be a mechanism for identifying the responses of a participant for the purposes of discarding those responses.
• Researchers working with children online are subject to Children’s Online Privacy Protection Act (COPPA) in addition to human subjects regulations. Researchers are prohibited from collecting personal information from a child without posting notices about how the information will be used and without getting verifiable (likely written) parental permission. For minimal risk research written permission may be obtained by via paper mail or fax. If the research is more than minimal risk, parental permission should be obtained in a face-to-face meeting.
• Screen out minors by checking for internet monitoring software such as SafeSurf and RSACi rating or using Adult Check systems.

Server Administration

Use of SurveyMonkey.com, Psychsurveys.org, Qualtrics, Amazon MTurk and other online survey tools is permitted for minimal risk studies that do not involve the collection of sensitive data.  As noted above, the IRB recommends that data be transmitted in a secure format.  Therefore, researchers who wish to use SurveyMonkey should upgrade to a Professional account which offers SSL encryption.  Psychsurveys offers SSL encryption for all studies.  The level of encryption used by the online survey tool must be described in the IRB-1 and IRB-5. 

For more than minimal risk studies that involve the collection of sensitive data, the IRB recommends it be housed on an Rutgers server.  The server should be administered by a professionally trained person with expertise in computer and internet security.  Access to the server should be limited to key project personnel.  The server should receive frequent, regularly scheduled security audits.

Data Storage/Disposal Tips

• If a server is used for data storage, personal identifying information should be kept separate from the data, and data should be stored in encrypted format. Use of Social Security Numbers is not permitted.
• It is recommended that data backups be stored in a safe location, such as a secure data room that is environmentally controlled and has limited access.
• It is recommended that competent data destruction services be used to ensure that no data can be recovered from obsolete electronic media.
• Researchers must adhere to the University’s Device and Media Control Policy or University Policy 70.2.3.

Frequently Asked Questions

• May researchers quote verbatim from subjects who have given consent?
  • For not greater than minimal risk research, this is acceptable provided the data pose only minimal risk to subjects. Details that would be harmful to subjects if revealed should be omitted or modified so that it cannot be linked/identified.
  • For greater than minimal risk research, quotes should be paraphrased so that they are not searchable. Searchable data may be traced back to individuals, thereby putting them at risk.
• May researchers use subjects' Internet pseudonyms?
  • For not greater than minimal risk research, pseudonyms and real names may be used with permission of individual subjects — provided the use of identifying information is not prohibited by other IRB guidelines.
  • For greater than minimal risk research, pseudonyms and other identifying information (place, organizational affiliation, institutional names, etc.) should be changed. Additionally, false details may be deliberately introduced to further protect research subjects.

Overview

An Investigational New Drug Application (IND) is a request for authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans. Such authorization must be secured prior to interstate shipment and administration of any new drug or biological product that is not the subject of an approved New Drug Application or Biologics/Product License Application.

Investigational Drug Studies

Studies involving the use of an investigational drug will be conducted in compliance with 21 CFR 312 Subchapter D, Drugs for Human Use / Investigational New Drug Application (IND). An IND is required for experimental drugs if the drugs are used for the purpose of developing information about their safety or efficacy. Approved, marketed drugs also require an IND if the proposed use in research is different from its previously FDA-approved use or administered by an unapproved route or method of delivery or an altered dosage.

Examples of when an IND may be required include:

• When the principal intent of the investigational use of a test article is to develop information about the product’s safety or efficacy, including FDA approved drugs
• If the intent of the research is to generate data that will lead to a new advertising claim, a new clinical indication, or a new formulation of the product

When an IND is required, the sponsor (usually a pharmaceutical company, but sometimes an individual) must submit to the FDA a completed and signed FDA Statement of Investigator Form 1572 in order to participate in the research investigation. Unless contacted by the FDA, an investigator may begin clinical trials 30 days after the FDA receives the IND application.

Investigators will be responsible for conducting the investigation in accordance with the signed investigator statement, the investigational plan, and applicable regulations and policies; and for protecting the rights, safety and welfare of participants in their care.

Exemptions from 21 CFR 312

The IRB may determine that a clinical investigation of a lawfully marketed drug(s) is exempt from the regulation if all of the following conditions apply:

• the investigation is not intended to be reported to the FDA as a well-controlled study in support of a new indication for use nor intended to be used to support any other significant change in the labeling for the drug;
• if the drug is lawfully marketed as a prescription drug product, the investigation is not intended to support a significant change in the advertising for the product;
• the investigation does not involve a route of administration or dosage level or use in a patient population or other factor that significantly increases the risk (or decreases the acceptability of the risk) associated with the use of the drug product;
• the investigation is conducted in accordance with the requirements of institutional review and informed consent as set forth in 21 CFR 50;
• the investigation is conducted in compliance with part 312.7 regarding the promotion and charging for investigational drugs

A clinical investigation involving an in vitro diagnostic biological product (blood grouping serum; reagent red blood cells; and anti-human globulin) is exempt if it is intended to be used in a diagnostic procedure that confirms the diagnosis made by another, medically established, diagnostic product or procedure and it is shipped in compliance with the requirements set forth in 312.160.

Investigational Device Studies

A medical device is defined, in part, as any health care product that does not achieve its primary intended purposes by chemical action or by being metabolized.

An investigational device is a medical device that is the object of a clinical study designed to evaluate the effectiveness and/or the safety of the device. All investigational device use must have prior IRB review and approval by the IRB in accordance with applicable laws and regulations [FDA 21 CFR 812 and 814 Subpart H].

Clinical investigations of medical devices will comply with regulation 21 CFR 812 unless otherwise exempt, as noted below.

Significant Risk (SR) and Non-Significant Risk (NSR)

There are two possible classifications for investigational medical devices:

• Significant Risk (SR) or
• Non-Significant Risk (NSR)

Unless exempt from Investigational Device Exemption (IDE) regulations, an investigational device must be categorized as either a Significant Risk (SR) device or a Non-Significant Risk (NSR) device. The initial risk assessment is determined by the sponsor, but the IRB must review the sponsor’s SR or NSR determination and will modify the determination if the full board disagrees with the sponsor. When the FDA makes the SR or NSR determination for a study, its determination is final.

Significant Risk (SR)

SR device studies must be conducted in accordance with the full IDE requirements [21 CFR part 812], and may not commence until 30 days following the sponsor's submission of an IDE application to FDA. The study may not commence until FDA has approved the IDE application and the IRB has approved the study.

A SR device study is defined as a study of a device that presents a potential for serious risk to the health, safety, or welfare of a subject and

1. is intended as an implant, or
2. is used in supporting or sustaining human life, or
3. is of substantial importance in diagnosing, curing, mitigating or treating a disease, or otherwise prevents impairment of human health, or
4. otherwise presents a potential for serious risk to the health, safety, or welfare of a subject

Non-Significant Risk Device (NSR)

A NSR device study is one that does not meet the definition of a SR study. NSR are not necessarily minimal risk studies.

NSR device studies do not require submission to the FDA. These studies must comply with the abbreviated regulations set forth in 21 CFR 812.2(b) that require a device fulfill the following requirements:

• The device is not a banned device
• The sponsor labels the device in accordance with 21 CFR 812.5
• The sponsor obtains IRB approval of the investigation after presenting the reviewing IRB with a brief explanation of why the device is not a significant risk device, and maintains such approval.
• The sponsor ensures that each investigator participating in an investigation of the device obtains from each subject under the investigator's care, consent und 21 CFR 50 and documents it, unless documentation is waived.
• The sponsor complies with the requirements of 21 CFR 812.46 with respect to monitoring investigations;
• The sponsor maintains the records required under 21 CFR 812.140(b) (4) and (5) and makes the reports required under 21 CFR 812.15(b)(1) through (3) and (5) through (10);
• The sponsor ensures that participating investigators maintain the records required by 21 CFR 812.140(a)(3)(i) and makes the reports required under 812.150(a) (1), (2), (5) and (7); and
• The sponsor complies with the prohibitions in 21 CFR812.7 against promotion and other practices.

Additional Information: Significant Risk and Nonsignificant Risk Medical Device Studies (PDF) (HHS.gov)

Investigational Device Exemption (IDE)

An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support requests to legally market the device.

Investigational use also includes clinical evaluation of certain modifications or new intended uses of legally marketed devices. All clinical evaluations of investigational devices, unless exempt, must have an approved IDE before the study is initiated.

In general, requirements for clinical evaluation of devices that have not been cleared for marketing include the following:

• If the study involves a significant risk device (see below), the IDE must be approved by the FDA and the IRB, and
• Informed consent must be obtained from all subjects, and
• Labeling must indicate that the device is for investigational use only, and
• Provisions must be made for monitoring of the study, and
• Required records and reports must be submitted, as applicable (e.g., to the IRB, the sponsor or the FDA).

Regulations

• U.S. FDA Regulations CFR Title 21 Part 312: Investigational New Drugs
• U.S. FDA Regulations CFR Title 21 Part 812: Investigational Devices
• U.S. FDA Regulations CFR Title 21 Part 814: Medical Devices, Pre-Market-Approval (PMA)
• U.S. FDA Regulations CFR Title 21 Part 860: Medical Devices, Classification Procedures

Overview

The inability to understand spoken English or read and comprehend documents written in English creates a practical barrier for non-English speaking persons to make an informed decision to or actually participate in research. Consistent with its mission to reflect the diversity of its communities in its services and research endeavors, Rutgers’ guides investigators to provide research study information in a language potential subjects can understand to:

1. Facilitate persons’ autonomy to consent to participate in research and;
2. Ensure equitable and fair procedures for the inclusion of diverse populations in research.

The steps outlined below are intended to provide guidance to investigators on appropriate methods to ensure that non-English speaking persons (or their legally authorized representative or surrogate) are provided with sufficient information in order to exercise informed consent to participate in research and how to document that process in the research record.

Procedures For Long Form Method

This Method includes written translation of an IRB-approved English language consent document and any accompanying study materials.

When must I use the Long Form Method?

Rutgers requires investigators to use the Long Form Method, a written translation of the entire English language consent document approved by the IRB, assent document and any accompanying study materials (i.e., brochures, questionnaires, etc., unless the documents have not been validated for use in non-English speaking populations) into a language understandable by potential participants in research when:

• The research targets a specific population that is non-English speaking;
• A significant proportion of participants are anticipated to be non-English speaking; or
• However unanticipated, when five or more persons enrolled in the research do not speak English, but share another language in common.

NOTE: Investigators who request a waiver of necessity for translated consents when conducting pilot studies in environments where non-English speaking participants are anticipated must demonstrate how exclusion of non-English speaking participants in the pilot study will not later negatively impact equitable access, participant comprehensibility or research tool applicability to diverse populations that may be solicited for participation in the full research.

What steps should I follow to ensure an accurate translation?

After obtaining IRB-approval of the English language consent document to be used in your research study, have a qualified translator translate the IRB-approved document in its entirety. The translation from English to another language may be completed by a person who is a member of the research team, providing they possess the necessary qualifying language competency. If the study is deemed greater than minimal risk, or is otherwise required by the IRB, a back translation must be completed by a qualified person who is independent of the research. Back translations are not required if the original translation is provided by a certified translator. [Note: To conserve resources, first obtain IRB approval for the English version of the consent document before translating it.]

If paragraphs within a proposed consent document were translated by different sources (e.g., some paragraphs were translated by NIH, NSF or NCI, while other paragraphs were provided by department personnel within Rutgers), a back translation of the consent document must be conducted to ensure the pieced together consent maintains the integrity and meaning of the original sources.

How do I obtain IRB approval?

Translations of the consent documents must be reviewed and approved by the IRB before their use. It is recommended that investigators first obtain approval for the English version of the consent document, and then submit translation(s) of other language(s) and back translations, if applicable, as a modification to the approved protocol. The following items should be submitted for IRB review and approval of the foreign language translation of the full consent document:

1. IRB-approved English language consent document;
2. Consent document translated into the desired language;
3. A letter or other written documentation confirming that the translation (and back translation, as applicable) is accurate and consistent in content, style, and level of readability with the IRB-approved document and, for non-certified translators, an explanation of the translator(s)’ qualifications. (See Translator Qualifications and Assurances Instruction and Certificate of Translation Form at HRPP Toolkit.) The letter or other written documentation should reference the study title and IRB approval number, as well as document identifier(s) (i.e., title and IRB-approved version date) that is unique to each IRB-approved item being translated (and back-translated, as applicable); and
4. A plan to ensure an adequate consent process and an outline of how communication between the non-English-speaking person (or their legally authorized representative or surrogate) will be facilitated throughout the course of the research.

The accuracy of documents translated must be confirmed by a qualified translator whose credentials are acceptable to the IRB. The IRB will use its discretion in determining whether the credentials of the translator are acceptable, based on the nature and level of risk involved in the proposed research study:

1. Consent and supporting documents must be translated by a qualified translator for minimal risk studies;
2. Consent and supporting documents must be translated by a qualified translator and then back- translated by another qualified translator for greater than minimal risk studies. However, if the research is a minor increment over minimal risk, the IRB may waive the requirement of the back translation into English;
3. Certified translated consent and supporting documents do not require back-translation, regardless of risk determination; and
4. The IRB may require a certified translation depending on the complexities of the proposed research.

What consent process must I follow when using the Long Form Method?

The following consent process should be followed when using the Long Form Method to ensure that non-English speaking participants can provide meaningful informed consent:

• If a member of the study staff obtaining consent is not fluent in the potential participant’s language, a qualified interpreter fluent in English and the participant’s language must orally interpret the consent conversation, ask if the participant has any questions and then be available to answer their questions. Interactive 3-way communication is essential to ensure informed consent; and
• The person, if agreeing to participate, and a member of the research team obtaining consent must sign and date the IRB-approved non-English language version of the consent document. If a qualified interpreter is present, they should also sign the consent. If a qualified telephone interpreter is used, their participation should be appropriately documented on the consent document and the research record by the research staff (document the date, time, language, interpreter ID#, and interpreting company used) (See Form Witness and Interpreter Consent Documentation Instructions at HRPP Toolkit Section Non-English-Speaking Subjects for recommended documenting format.)

Procedures For Short Form Method

This method includes Oral Presentation of the IRB-Approved Consent Document and a Written Translation of an Abbreviated, or Short Form, Consent Document.

When may I use the Short Form Method?

The short form method—the use of an oral presentation of the IRB-approved consent document and a written translation of an abbreviated, or short form, consent document stating that the elements have been presented orally to the potential participant (or their legally authorized representative) in a language understandable to the participant—may be used when all of the following apply:

1. The research does not target a non-English speaking population;
2. The research is classified as minimal risk or greater than minimal risk but with prospect for direct benefit;
3. The participant (or legally authorized representative) speaks only a language(s) that was not anticipated in the potential study population. Note: The Short Form Method may not be used when the potential participant is represented by a surrogate—only use the Long Form Method in these instances;
4. An appropriately translated consent document in the participant’s language has not been approved by the IRB; and
5. Fewer than 5 participants enrolled in the research do not speak English but do share another language in common.

What steps should I follow to ensure an adequate oral presentation and short-form written translation?

Templates for the short form consent in English and a number of other languages are available at the HRPP Forms and Templates webpage HRPP Toolkit. Choose the short form consent written in the language the subject is fluent. Have a qualified translator translate the study title and insert it at the top of the short form. If the study is greater than minimal risk, a back-translation of the title by a second qualified translator is recommended. If the translator is certified, a back translation is not necessary.

How do I obtain IRB approval?

When you wish to enroll a non-English speaking person in IRB-approved research but do not have a written translation of the entire English language consent document approved by the IRB, you must notify the IRB and request use of a non-English language abbreviated short form consent. Investigators should contact and then submit to the IRB (1) a modification request; (2) the translated short form consent; and (3) documentation of translator(s) qualifications. (See Certificate of Translation Form at HRPP Toolkit.) The IRB will respond to the request within 48-72 hours. NOTE: IRB approval of the non-English language short form consent document and process is required prior to their use, even when using the HRPP downloadable templates.

When five or more persons enrolled in the research do not speak English, but share another language in common, the investigator must obtain an IRB-approved translation of the IRB-approved consent document and follow the long form method outlined above.

What consent process must I follow when using the Short Form Method?

The following consent process should be followed when using the Short Form Method to ensure that non-English speaking persons can provide meaningful informed consent:

• A qualified interpreter fluent in English and the potential participant’s language must orally present the entire English language IRB-approved consent form in a language understandable to the participant (or his/her legally authorized representative). The interpreter must also ask if the participant (or his/her legally authorized representative) has any questions and then be available to answer their questions. Interactive 3-way communication is essential to ensure informed consent. The interpreter may be a member of the research team. If a bilingual investigator serves as the qualified interpreter, there must also be a witness to the presentation who is fluent in English and the language understood by the potential participant (or his/her legally authorized representative). The witness may not be the person obtaining consent.
• The potential participant (or his/her legally authorized representative) is provided a copy of the abbreviated short form consent written in the language they are fluent in to review;
• A witness to the oral presentation fluent in English and the participant’s (or their legally authorized representative) language is required to attest to the adequacy of the consent process and to the participant’s (or their legally authorized representative’s) voluntary consent. An interpreter may serve in the dual role as interpreter and witness, if s/he is not the study member obtaining consent.

Requirements for documenting the consent process when using the short form:

• The participant (or their authorized representative) must sign and date the short form consent written in the appropriate language, if agreeing to participate;
• The principal investigator or research team member obtaining consent must sign and date a written copy of the orally presented IRB-approved English language consent long form;
• The witness, who may not be the person obtaining consent, must sign and date the foreign language short form and the orally presented IRB-approved English language long form consent;
• A copy of the signed short form in the participant’s language and the orally presented IRB-approved English language consent form must be given to the participant (or their authorized representative); and
• The consent process, including the language used and presence of interpreters and witnesses, should be appropriately documented on the consent form and in the research record (by study staff (document the date, time, language, interpreter ID#, and interpreting company used). (See Form Witness/Interpreter Consent Documentation Instructions at HRPP Toolkit.)

Informed consent is a process that requires investigators to continuously reassess the participant’s understanding of the nature of the research, its risks of harm and potential for benefit. Adequate communication between the research staff and participant must occur throughout the research to ensure the participant’s willingness to continue participation in the research, the safety and welfare of the participant and the integrity of the research data. To avoid delay in participant recruitment and enrollment, investigators are urged to anticipate the presentation and language requirements of potential non-English speaking persons.

RWJ Hospital

Robert Wood Johnson University Hospital (RWJUH) is committed to providing the best communication process for all of our patients. Any patient who requires special techniques or equipment in order to communicate more effectively will be provided these services at no charge and in a timely manner. Click here for more information.

University Hospital

The Patient Relations Department coordinates the language interpretation and document translation services for University Hospital. Please see these links for additional information:

• University Hospital Translation Resources [PDF]

Rutgers Approved Translation/Interpreting Services

Rutgers Procurement maintains approved local companies that offer certified interpreter and translation services. You can find this information online on the Rutgers Procurement Services page and then selecting "Find Products & Services" in the "I want to..." dropdown menu. In this area, you can use Procurement's "Find a Universityide Contracted Supplier" to search by keyword.

Definitions

Back Translation: When a document translated from English to another language is translated back into English to confirm the accuracy of the original translation.

Certified Interpreter/Translator and/or Services: While no national licensing or certification program for medical research translator/interpreters exists in the United States, some universities, independent companies, and professional associations provide training and testing in translation and interpretation services. [Two notable professional associations that offer testing of trained translators/interpreters are The National Board of Certification for Medical Interpreters, and the American Translators Association]. For purposes of this policy, a certified interpreter or translator is a person with professional interpreter or translator training and English and foreign language competency demonstrated successfully passing a test offered by a university, company or association.

Long-Form Consent Translation: A written translation of the entire English consent document approved by the IRB into a language understandable by non-English speaking persons (or their authorized representative or surrogate) being recruited for research.

Non-English-Speaking Participant: An individual (or their legally authorized representative or surrogate) who is unable to verbally comprehend spoken English or read and comprehend documents written in English.

Qualified Interpreter:  A qualified interpreter, fluent in both English and the language understood by the subject/representative, must orally present the entire English language IRB-approved consent form. The interpreter must also ask if the subject/representative have any questions and then be available to answer their questions. A qualified interpreter may be a certified interpreter, native speaker, or someone who possesses dual language fluency by education or training, and is able to orally communicate complex ideas and procedures, as applicable, about the research. Family members may not serve as interpreters for the consent process except in emergency, life- threatening situations. Skill and impartiality are key qualities of an interpreter.  NOTE: The IRB or research site where the consent process will take place may require that the interpreter be certified by a national organization or employed by the site or through a contracted interpreting agency.

Qualified Translator: A translator is someone who converts a written text from one language to another. A qualified translator is someone who possesses competency in English and a foreign language, such as a certified translator, native speaker, or provides other evidence of dual language fluency, and possesses an appropriate scientific or medical background. A qualified translator may also be an external sponsor which provides a certifiable translation, such as NIH, NSF, NCI, or private industry which provides a certified translation.

Short-Form Consent Translation: The short-form is an abbreviated consent document written in language understandable to the prospective participant recruited for research stating that the elements of informed consent, which are outlined on the long-form consent in general terms, have been presented orally and are understood by the participant (or their authorized representative or surrogate).

Witness: An adult who is fluent in both English and the language understandable to the prospective participant who witnesses the entire consent process between an English-speaking study staff member, a qualified interpreter, and the non-English speaking participant when a “short-form” translated consent is used. The witness is required to verify the adequacy of the consent process and the participant’s voluntary consent. The witness must be independent of the study and must be present for the consent discussion. An interpreter may serve as a witness if s/he is not also the person obtaining consent.

Oral History that Does Not Require IRB Review and Approval 

Oral history activities that document a specific historical event or the experiences of individuals but are not designed to draw conclusions or generalize findings are excluded from the oversight of the University’s Institutional Review Board for the Protection of Human Subjects (“IRB”) because such projects do not fall under the regulatory definition of “research,” (See 45 CFR 46.102(l)(1)). The regulatory definition of research is “systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.” (Ibid) As noted by Mary Larson (2013), questions asked of research participants in oral history projects are not the same as research, but are contingent on the context and participant’s experience, and thus do not rise to the level of systematicity required in the definition of research above.

Examples of Oral History Activities Not Considered Human Subject Research 

• Example 1: Holocaust Survivor Oral History Project  

An oral history video recording of interviews with Holocaust survivors is created for viewing in the Holocaust Museum. The videotape does NOT intend to draw conclusions, inform policy, or generalize findings. The sole purpose is to create a historical record of specific personal events and experiences related to the Holocaust and provide a venue for Holocaust survivors to tell their stories. 

• Example 2: Veterans Oral History Project   

A student is planning a dissertation on the long-term social impact of the Vietnam War on American culture. The student wants to conduct life histories of a group of veterans for the sake of documenting the broad meaning of the war on the rest of their lives. The interviews will be contributed to the Veterans Oral History Project at the Smithsonian Institution, which offers professional training to oral historians, the cost of which was underwritten by Congress. To ensure that oral histories are conducted in a professional manner, the student will follow the protocols and guidance developed for this project by the Smithsonian, as well as the guidelines of the National Oral History Association.  The Oral history activities will compare policies, procedures, or events to identify general commonalities or inform policy decisions without collection of information about identified individuals. 

• Example 3: The Queer Newark Oral History Project 

The Queer Newark Oral History Project (QNOHP) is community-based and community-directed, which involves interviews with people who are LGBTQ+ living in Newark, New Jersey about their lives.

For further information and resources for oral history, visit www.oralhistory.org/resources.

Oral History that Requires IRB Review and Approval 

For studies using methods such as participant observation and ethnographic studies, in which historians (or investigators) look to gather information from individuals to understand the beliefs, customs, and practices, not only of those individuals but also of the community or group to which they belong would represent “generalizable knowledge” and therefore are not excluded from IRB review. For example, an oral history project involving open-ended interviews designed to draw conclusions about experiences or generalize to other contexts, individuals, or populations, requires IRB approval. Therefore, this oral history research which aims for generalizability or systematicity requires IRB approval because it meets the regulatory definition of research set forth in 45 CFR 46.102(I). 

Examples of Oral History Activities Considered “Human Subject Research”

• Example 1: Interviews with Gulf War Veterans    

A student wishes to conduct various open-ended interviews of surviving Gulf War veterans to document their experiences and to draw conclusions about their experiences, which they can generalize. These findings may then be used to inform current social or governmental policies.  Since this project’s aims are designed to draw conclusions about experiences and/or generalize to other contexts, individuals, or populations, then this project requires IRB approval.

• Example 2: Long-term, Post-Traumatic Stress Disorder in Vietnam War Veterans  

A faculty member is planning to conduct oral histories to gain an understanding of the impacts of the Vietnam War on post-traumatic stress disorder. The faculty member wants to work with a veterans’ Post-Traumatic-Stress-Disorder (PTSD) support group to take life histories to see how the war influenced the rest of the veterans’ lives. The group agrees in writing to allow the faculty member to meet with the members as a part of the group and individually. One goal of the research, in addition to understanding general ways in which the war affected the subsequent lives of soldiers, is to make assessments that will allow the faculty member to predict what kinds of exposure in war situations lead to the development of PTSD.  To prepare for this analysis, the faculty member will consult published research done on PTSD with reference to Vietnam veterans and will use PTSD-related materials specific to the individuals in the group. While the veterans want to contribute their memories to the National Veterans Oral History Project run by the Smithsonian, they want to keep specific information, like how PTSD affected their life histories, private. The faculty member and/or the clinician who runs the support group plans to use the data collected through these life histories to prepare a scientific presentation.       

Since the intent of the archive is to create a repository of information for other investigators to conduct research, the creation of such an archive would constitute research under 45 CFR 46.  

• Example 3: Interviews with Former Members of the Negro League Baseball

Open-ended interviews are conducted with surviving Negro League Baseball players to create an archive for future research. Since the intent of the archive is to create a repository of information for other investigators to conduct research, the creation of such an archive would constitute research under 45 CFR 46.

Additional Information

• For IRB and/or human subjects-related questions, contact the IRB office at irboffice@research.rutgers.edu.
• If you have any questions about Oral History Best Practices: Oral History Association, visit www.oralhistory.org/best-practices for more information and/or, where applicable, contact your faculty advisor. 
• References: 
  • Larson, Mary. 2013. “Steering Clear of the Rocks: A Look at the Current State of Oral History Ethics in the Digital Age.” 
  • The Revised Common Rule, 45 CFR 46 (2018). 

Overview

Quality Assurance, Quality Improvement, Program Evaluation, Evidence-Based Practice and Benchmarking are quality activities used to evaluate and/or (continuously) improve the effectiveness of organizational processes and practices, products, programs or services, as well as, to develop the appropriate benchmarks. The purpose of quality activities, and their conclusions, are local and specific, aiming to improve organizational efficiencies and effectiveness and ensuring educational, clinical or program decisions rest on sound evidence.

Quality activities do not generally require IRB review or approval because they do not meet specific federal regulatory criteria of what constitutes Human Subjects Research. However, because quality activities are data-driven and often involve human participants, there can be overlap with methodologies common to human subjects’ research. In cases where overlap exists, the federal regulations that require IRB oversight may apply.

QA vs. HSR Flowchart

The QA vs. HSR Flowchart was developed, reviewed, and approved by a multidisciplinary group. This resource should be used to assist an investigator in determining if a project is human subject research or a quality activity, and provides guidance on when IRB review and approval is required. This flowchart is a self-service tool, and IRB staff should be consulted to provide subject matter expertise if a proposed activity falls into a gray area or if there are any uncertainties with how to interpret and apply this guidance.
 
We would like to acknowledge the following individuals for their role on the multidisciplinary group that developed this resource:

Vice Chancellor for Population Health Team: Ethan Halm, Jack Hemphill, and Joyce Porter
NJACTS Team: Farah Anwar and Nancy Reilly
Human Research Protection Program Team: Hila Berger, Angela Cartmell-McGlyn, and Jason Lin

Steps To Determine If Your Project Requires IRB Review

The three steps outlined below are designed to assist researchers in discerning whether a proposed quality project—or one or more activities embedded in it—requires IRB review.  FAQs (Frequently Asked Questions) about quality activities are found at the end of this webpage.

Step 1: Quality Activities And Research

Select and review a Reference Guide below, based on the type of project you are planning to perform. These Reference Guides will assist you to understand the various types of quality activities and learn what distinguishes them from research.

• Reference Guide: Quality Assurance [PDF]
• Reference Guide: Quality Improvement/Continuous Quality Improvement [PDF]
• Reference Guide: Program Evaluation [PDF]
• Reference Guide: Evidence-Based Practice [PDF]
• Reference Guide: Benchmarking [PDF]
• Definition: Human Subjects Research

Step 2: Determine If IRB Review Will Be Required For Your Project

HRP-309 WORKSHEET: Quality Activity Determination

The purpose of this worksheet is to provide support for making Quality Activity determinations when there is uncertainty regarding whether the quality activity contains Human Research requiring IRB Review. It does not need to be completed or retained.

For a proposed project to be classified as containing only quality activities—which do not require IRB review—the answers to all of the questions in the WORKSHEET must be ‘TRUE’ for each activity proposed in the project. If one or more answers is ‘FALSE or NOT SURE’, the project requires IRB review.

• TRUE / FALSE or NOT SURE: The intent of the proposed activity is to assess and/or improve the quality of a practice, product or program to ensure established educational, clinical or program service standards are met or best evidentiary practices attained.
• TRUE / FALSE or NOT SURE: No activity proposed provides less than standard of care, services or instruction to participants.
• TRUE / FALSE or NOT SURE: No practice, product or program changes proposed are experimental and no test interventions or research questions are added that go beyond established or evidentiary best practice.
• TRUE / FALSE or NOT SURE: The proposed activity does not: (1) include a ‘control group’ in whom care, products, services or educational instruction are intentionally withheld to allow an assessment of its efficacy or (2)  assign participants to receive different procedures, therapies or educational instruction based on a pre-determined plan such as randomization.
• TRUE / FALSE or NOT SURE: The proposed activity does not involve the prospective evaluation of a drug, procedure or device that is not currently approved by the FDA for general use (including “off-label” indications).
• TRUE / FALSE or NOT SURE: The proposed activity does not test an intervention or add research questions that go beyond established evidentiary best practice and/or are intended to generate generalizable knowledge.
• TRUE / FALSE or NOT SURE: The proposed activity would not increase harm—physical, psychological, social or economic—than would normally be encountered by the individual if s/he was not participating in this activity.
• TRUE / FALSE or NOT SURE: The lead person on the project has organizational responsibility and authority to recommend or impose a corrective action plan based on the outcome(s) of the activity, as applicable.
• TRUE / FALSE or NOT SURE: Interpretation of the data or any feedback to those who would benefit from the findings will not be deliberately delayed.
• TRUE / FALSE or NOT SURE: The proposed activity has merit and will likely be conducted regardless of any possibility of publication or presentation that may result from it

Step 3: Next Step

If You Know Your Project Does Not Include Human Subjects Research

There is no need to submit your project to the IRB for review. However, check with your Departmental and/or work location to secure any necessary approvals from them to conduct your Quality project.

***Read IMPORTANT NOTE below.

If You Know Your Project Includes Both A Quality Activity And Human Subjects Research

Submit the human subjects’ research portion of your project to the IRB for review and approval prior to its conduct. Consider the following practicalities:

• If it is possible to separate the quality activities from the human subjects’ research activities submit only the activity or activities that reflect human subjects research to the IRB for review/approval. The quality activities embedded in the project need not undergo IRB review. If it makes sense, initiate the quality activities while you wait for the IRB to complete its review of the research component of the project.

• If it is not possible to separate the activities, submit a protocol outlining the whole project—both quality and human subjects research—activities to the IRB for review. In this scenario, you may not initiate any portion of the project until the IRB has completed its review and approved the project in its entirety.

***Read IMPORTANT NOTE below.

If You Are Not Sure Whether Your Project Requires IRB Review

Depending on the complexities of and nuances between activities, some projects may not be easily characterized. If questions or uncertainty remain, contact your IRB Office for further guidance (Contact Us) or submit your project to the IRB for a determination of whether it, or portions of it, constitute human subjects research (How To Submit Your Project For IRB Review).

FAQs

Other Questions You May Have About Quality Activities and IRB Review

Q. If I started a quality project and now wish to expand it to add activities with human subjects that will generate generalizable knowledge, what should I do?

A. Submit an IRB application for the additional proposed activities. Wait for IRB approval before initiating them. The existing quality activities may continue while you await IRB approval for the proposed activities.

Q. If I started a quality project and realized during its conduct that it likely includes activities that qualify as human subjects’ research, what should I do?

A. Stop the research activities and submit an application to the IRB for review. Note: Data collected before IRB approval may not be used in the final analysis of the research.

Q. Can results of quality projects that do not include human subjects’ research be published even without IRB approval?

A. Yes. The insights learned may be worthy to share with others. To avoid confusion and delays, however, do not use the word ‘research’ in the article submitted. Out of an abundance of cause, Journal editors (and regulatory agencies) may request evidence of an IRB approval or determination of non-human subjects research for the project when the word ‘research’ appears in an article, particularly if the article reflects data gathering techniques that are also used in human subjects research.

General Guidance

Investigators are required to maintain records of their human-subjects research activities. Good records are essential for verifying the quality of study data produced and demonstrating investigator compliance with good clinical practice guidelines and applicable regulatory requirements. In general, investigators should establish two sets of files for each study:

1. Regulatory documents
2. Study subject information

I.  Regulatory Documents. Regulatory documents should be maintained for all studies, regardless of sponsor/funding source, or whether the research is funded. These documents are typically organized within a regulatory binder, either paper or electronic. Some documents that may be common to more than one study, such as CVs and professional licenses, may be filed centrally. The regulatory binder should contain the essential documents listed below.

Basic regulatory documents required for all studies (non-funded, non-FDA-regulated, non-published):

1. Personnel:
   1. CVs document qualifications and eligibility to conduct a study and provide supervision of subjects. CVs should be signed and dated. It is recommended that CVs be updated every two years to verify that the information is accurate and current.
   2. Valid licenses and certifications for all professional study staff
   3. Mandatory human subjects protection training such as CITI.
   4. Institution’s financial disclosure form: signed/dated copies of financial disclosure for all investigators and staff listed on the protocol.
   5. Staff Signature/Delegation of Responsibility log: documents the signature and initials for all staff that collect and record study data, and lists the study-related procedures each has been delegated by the Principal Investigator
2. Protocol: all versions should be numbered and dated
   1. Initial submission; Continuing reviews; Modifications/Amendments
   2. Copy of all IRB-approved versions of the consent form and assent form (if applicable).
   3. Blank copies of all data collection forms, questionnaires, CRFs, and/or study instruments.
   4. Recruitment materials
   5. Educational materials or other study information designed for subjects
3. IRB Correspondence:
   1. All IRB correspondence including approval letters and/or notifications
   2. IRB-approved recruitment materials
   3. IRB-approved educational materials or other study information distributed to subjects
4. Monitoring Records: document any study-related activity performed to monitor study progress or the accuracy and completeness of study records.
   1. Data Safety and Monitory Board (DSMB) reports
   2. Sponsor monitor reports
   3. Audit reports, internal and/or external
5. Laboratory documents (if applicable): These materials document the competency of all lab facilities being used in the study and support the reliability of test results.
   1. Updated copies of laboratory certification,
   2. The Lab Director’s CV
   3. The normal lab/reference values
6. Reportable Events:
   1. Any study violations/deviations
   2. “On-site” adverse events
   3. Unanticipated problem reports
7. Others (if applicable):
   1. IBC  
   2. Radiation Reports

Additional regulatory documents required for Funded, non-FDA regulated studies:

1. NIH/Funding agency grants applications and progress reports.
2. Correspondence/contract with study sponsor/funding agency.

Additional regulatory documents required for FDA-regulated investigational drug or device studies:

1. Policies and procedures for dispensing, security, and storage of study drugs/devices.
2. Copies of all Form FDA 1572s (Statement of Investigator) and Form FDA 1571s (Investigational New Drug Application), if applicable.
3. Drug/device shipment and receipt records (may be maintained by the Research Pharmacy or Investigational Drug Service (IDS)).
4. Drug/device accountability log (drug accountability log may be maintained by the Research Pharmacy or IDS).

II. Study Subject Information

• General Subject Information
  1. Potential subject/Screening log: capture s all potential subjects who appear to be qualified for the study.
  2. Enrollment/Randomization log: captures all subjects who have signed an IRB-approved consent form or, with IRB approval, have given verbal consent or had informed consent waived; and have been randomized if applicable.  
• Individual Subject Files: There should be a separate file for each subject enrolled in or screened for a study. The following documents are placed in each file:
  1. An eligibility checklist, signed and dated by the person determining eligibility, lists specific inclusion/exclusion criteria. Copies of source documentation to support medical criteria should be available in the subject’s medical record, and retained to corroborate entries on the data collection instruments.
  2. Original signed and dated consent form
  3. Individual case report forms (CRF)
  4. Study instrument(s) used to capture all data required by protocol for each subject, such as data collection forms, questionnaires, and/or subject diaries
• Subject Compensation Documentation
  1. A full accounting of all funds provided to subjects.

Federal Regulations

As per Federal Regulations, the HHS protection of human subjects regulations require both institutions and Principal Investigators to retain research-related records. The institution must maintain records of IRB activities and certain other records frequently held by investigators for at least three years after completion of the research (45 CFR 46.115(b)). In addition, other regulations may apply and require retention of these records for a longer period of time.

Documentation of the informed consent of the subjects - either the signed informed consent form, the short form  or signed assent form in addition to other project related materials including the written research summary  must be retained by Principal Investigator for at least three years after completion of the research, unless the IRB waived the requirement for informed consent or the requirement for documentation of informed consent (45 CFR 46.117).

If investigators have been designated to retain certain records (e.g., informed consent documents signed by subjects) on behalf of the institution as required by the HHS regulations at 45 CFR 46.115(b), they must retain the records in some form. Such records may be preserved in hardcopy, electronic or other media form (e.g,. on a secure cloud or encrypted hard-drive) and must be accessible for inspection and copying by the IRB or authorized representatives of HHS at reasonable times and in a reasonable manner (45 CFR 46.115(b)). Retention of multiple copies of each record is not required. Investigators must comply with all Rutgers policies and procedures for retaining records.

HIPAA Requirements: Disposal of Protected Health Information

(2) Implementation specification: Retention period. A covered entity must retain the documentation as required by paragraph (c)(1) of this section for 6 years from the date of its creation or the date when it last was in effect, whichever is later.

§ 164.105 HIPAA Administrative Regulation Text

HIPAA Requirements: Research that involves collection of protected health information (PHI) is subject to the HIPAA regulations. Research records including signed consent forms that contain the HIPAA authorization must be retained for 6 years after the date on which the subject signed the consent form or the date when it last was in effect, whichever is later.

Disposal of Protected Health Information (HIPAA FAQ) (HHS.gov)

Sponsor Requirements

If a research project is funded or sponsored, then the investigator must also comply with the terms for record retention outlined in the contract with the sponsor or with the study funder's requirements.

Recordkeeping and Record Retention Requirements

Records Retention At-a-Glance:  Below is the minimum requirement for research record retention. However, the University recommends maintaining these records indefinitely.

University Policy

• 30.4.5 Records Management (Rutgers Policy Library)
• Regulatory Binder Instructions (PDF)

Destruction of Data / Records After Retention Period

Instructions: How to Destroy Data Properly

Regulations

U.S. FDA Regulations CFR Title 21 Part 11: Electronic Records; Electronic Signatures

Related Offices

Rutgers University Records Management (Document Archiving and Destruction)

Overview

Advertising Materials are used to encourage or persuade a pool of subjects to become part of your research study.

Guidelines For Providing Information

Advertising may be the first information about research seen by subjects and is most often used in recruitment. It cannot be coercive or make false promises or claims. The process of informed consent is often conceptualized to begin at the recruitment stage.

Additionally, some areas to consider with respect to recruitment include:

• Laws, guidelines, or institutional policies that govern advertising for study subjects, particularly in multi-site research;
• Whether compensation for study volunteers is allowed where the research is proposed, and how it will be noted in recruitment materials;
• What the "norms" for recruiting are in the particular location where recruitment will occur and with the proposed population.

Required IRB Stamps

All Recruitment materials are require to be stamped by the IRB. The stamps will contain an Approved Date and an Expiration Date (if applicable). Any stamped materials which have expired can not longer be used.

You are required to use only the current, IRB-approved document when recruiting subjects. However, the IRB allows you to choose one of following methods to provide a “dated” copy of the Recruitment Materials to subjects:

1. You may either copy the original of the stamped Recruitment Materials, and use the copies, OR;
2. You may type the approval and expiration dates on the bottom of each page of an un-stamped version of the approved Recruitment Materials and use copies of those documents. If you choose to type the dates on an un-stamped copy, the following statement should be used: “This document was approved by the Rutgers University Institutional Review Board for the Protection of Human Subjects on (Date); approval of this form expires on (Expiration Date)”.
3. For Exempt Studies Only (for protocol IRB#s that begin with “E”: e.g., E14-001): If you choose to type the dates on an un-stamped copy, the following statement should be used: “This document was approved by the Rutgers University Institutional Review Board for the Protection of Human Subjects on (Date, fill in with the exact date listed on the approval notice); Currently, there is no expiration on the approval of this document”.

Examples of Advertising Materials

• Flyer   
• Newspaper Ad (Instead of the above IRB Stamping Statement, simply state "This ad was approved by Rutgers IRB").   
• Radio or Television Announcement
• Bulletin Board Tear-Off         
• Internet Posting           
• Poster
• E-mail Invitation
• Facebook Request
• Cold Calls via Telephone/
• Emails or Calls of Membership from Listservs or Company Lists)
• Word-of-Mouth (Verbal Scripts)
• Text Messages
• Oral Scripts for Snowball Recruitment

*Not an Exhaustive List

Elements That Must be Included in Advertisements/Recruitment Materials

1. The location of the research and the person or office to contact for further information;
2. Research project title;
3. A description of the type of research and purpose of the research;
4. The word “research” must be included in the description;
5. Specific location of the research;
6. The name and address of the clinical investigator and/or research facility;
7. The condition under study and/or purpose of the research;
8. In summary form, the criteria that will be used to determine eligibility;
9. A brief list of benefits (e.g. no-cost health examination);
10. The time or other commitment required of subjects;
11. Footer with version # and date. ( Rutgers IRB requirement);

Research Staff Do’s and Do not’s Prior to IRB Submission

Do...

• Do make plain that the solicitation is for the purpose of participation in research and not for the provision of medical care.
• Do use the term “research” when describing the study.
• Do use the term “investigational” if a test article or treatment is referenced in the advertisement.
• Do indicate that the research involves the “investigational use” of an approved drug if applicable to the study.
• Do make sure that the material complies with applicable state and local laws and institutional or IRB policies.
• Do submit the material in final format, including site-specific information as appropriate and graphics that will be used.
• Do submit radio and television scripts for IRB review before production of the recording is started.
• Do submit final recordings for IRB review and approval prior to broadcast.
• Do read radio scripts for live broadcast exactly as approved by the IRB.

Do Not....

• Do not use language or graphics that may be coercive or misleading.
• Do not state or imply a guarantee of benefits, cures, or favorable outcomes.
• Do not emphasize “free” treatment or study products.
• Do not claim the study product or treatment is safe, effective, equivalent, or superior to other options when it is investigational.
• Do not place emphasis on payment, including bolding or highlighting the compensation language.
• Do not use the terms “safe,” “effective,” “new,” “best,” “cure,” “treatment,” “therapy,” or “free.”

Revised Common Rule Highlights

The human subjects regulations are changing. The federal Office for Human Research Protections (OHRP) has scheduled the regulatory changes to be implemented on January 21, 2019. These changes have been referred to as the “Revised Common Rule.” Although these regulations were delayed twice in the past, the regulations appear to now be ready for implementation in January.  
 
What this means to you: Changes have been underway to the eIRB system, institutional policies, and templates in preparation for the Revised Common Rule. Some of the key proposed revisions to the Common Rule are listed below. 

Revised Common Rule Impact On Studies With Pending Approval on January 21, 2019

The Common Rule, a key federal regulation that regulates human research, has been revised. The revisions—most notably to: the consent process and form, what qualifies for exempt review, and when continuing review is required—become effective January 21, 2019. Because the effective date and the implementation date of the Revised Common Rule are the same, some studies in the queue may need to be updated while awaiting approval. The date when your study was or will be approved, determines whether you must comply with the Revised Common Rule changes or can continue to follow the Pre-2018 Common Rule, as outlined below:

(1) Studies which are Approved With Stipulations are considered Approved. 

(2) An Exempt or Expedited Study which is Approved With Conditions, must satisfy all conditions before January 21, 2019 or else it must comply with the New Revised Common Rule.

(3) A Full-Board Study which is Approved With Conditions, will have an approval date based on the date of the Full-Board Meeting when it was originally approved.         

Special Circumstances

For Department of Justice (DOJ) Sponsored Studies: The Department of Justice (DOJ), a previous signatory to the Common Rule, has not yet signed on to the Revised Common Rule, so the Pre 2018 Common Rule will still apply to DOJ-sponsored research.

For FDA Regulated Studies: The U.S. Food and Drug Administration (FDA) is not a signatory, nor are its regulations harmonized yet with the new Final Rule. FDA-regulated research must comply with the FDA regulations which differ in some respects from the Common Rule regulations.

Converting Existing Studies to Follow Revised Common Rule

There may be some circumstances under which studies that must comply with the Pre 2018 Common Rule may switch to comply with the Revised Common Rule. Guidance on which circumstances allow such a conversion will be posted in the future.

Questions?

Do you have a question about the Revised Common Rule? 

You can now email one of our HRPP Professionals for guidance: Contact Us.

Changes

The changes will only impact new protocols: meaning those approved after the Revised Common Rule goes into effect on January 21, 2019.  There are changes that will reduce the burden on researchers, and other requirements that will increase researcher responsibilities. New protocols include all types of new submissions (e.g. NHS, exempt, expedited, etc.). 
 

Learn More

• Complete CITI's Revised Common Rule Course (NetID Required)
• View HHS.gov's Revised Common Rule Educational Materials

Help

Do you have a question about the Revised Common Rule? 

You can now email one of our HRPP Professionals for guidance: rCommon E-Mail.

Overview

Databases, registries (data banks), and repositories (tissue banks) all involve the collection and storage of information and/or biological specimens over time. Some registry/repositories serve diagnostic or clinical purposes, while others are solely for research. Many serve more than one purpose.

Research use data/biospecimens that are stored in registry/repositories is governed by the federal human subject protection regulations known as the common rule (45 CFR 46 (link is external)) and the HIPAA privacy rule (link is external) (45 CFR 160 & 164) and by Rutgers University IRB policies and procedures. Specific requirements depend upon how and why the information or specimens in the resource are collected, stored, used, and shared.

The requirements for and extent of IRB oversight depends on the whether or not the data/biospecimens include or are linked to individually identifiable health information and the terms of the informed consent under which the data/biospecimens were originally collected.

Data and tissue banks registries, data banks, and tissue banks are all considered synonymous with the term repositories for regulatory purposes. For the purposes of this webpage they will be referred to as repositories or registry/repositories and the contents as data, biospecimens or data/biospecimens.

Non-Research Databases And Repositories

Databases and repositories are frequently created and maintained for purposes totally unrelated to research. For example, Rutgers University maintains a variety of electronic health records and data warehouse intended for diagnosis, treatment, billing, marketing, and quality improvement/control purposes. Individual departments and divisions use their own databases that have been established for clinical and quality improvement purposes. Examples include the following:

• Anesthesia electronic record system used in the operating room to record preoperative history and physical examination data, store the vital signs and anesthetic medication administration and create anesthetic records for every procedure.
• Pathology department biospecimens and records for all of the materials received for diagnostic or treatment purposes.
• Operating room management database
• EPIC
• Quality assurance/quality improvement initiatives

These databases and repositories serve predominantly non-research purposes. However, the information they contain can be used to address important scientific questions. IRB approval is not required for creation or use of a non-research database or Biospecimen collection but is required to use these resources for research purposes. See what must be reviewed by the IRB for more details.

Research Databases

Research databases may be maintained after the completion of a study. Additional questions may arise in the future that can be addressed using the same dataset. If there is an intent to set up a registry, then the informed consent document should include language for subjects to opt-in or opt-out of storage of their data for future research purposes. The subject's decision as indicated on the consent/authorization must be respected and tracked. IRB oversight is required for each new research protocol that uses identifiable or re-identifiable information contained in the database.

A research database may also be created specifically as a resource for future research. IRB oversight is required to set up and maintain a research database.

Examples of research databases include:

• Data compiled from a clinical trial
• A list of names, diagnosis, and contact information developed and maintained to identify prospective research subjects
• A collection of medical information intended for use in future research studies

Some databases created and maintained to serve multiple purposes. Examples include:

• A collection of patients' diagnosis, treatment, and follow-up information intended for and used to conduct (i.) Internal quality assurance programs and (ii) generalizable studies on the effectiveness of particular treatment interventions.
• A compilation of patient information that was originally created and used for billing purposes but is now also routinely used to identify prospective research subjects.

Research Repositories

Biospecimens may be collected to achieve one or more of the objectives of a single study with disposal of the leftover materials at the end of the study. A repository is created if the leftover materials are stored for future use. If there is an intent to set up a repository, then the informed consent document should include language for subjects to opt-in or opt-out of storage of their data for future research purposes. The subject's decision as indicated on the consent/authorization must be respected and tracked.

Specimens may also be collected specifically for the purposes of future research. IRB oversight is required for each new research protocol that creates a reposit

Developing & Maintaining A Research Registry/Repository

For the purposes of the remainder of this page, both registries and repositories will be referred to as repositories. The advantage to investigators of creating, maintaining, and/or using a research repository lies in the prospective collection, the safe storage and back-up, controlled access to and use of data/biospecimens. The information and specimens can be accessed by multiple investigators for multiple research projects. Some of the potential research uses may be anticipated at the time of collection but most cannot be specified at the time the repository is created.

A repository protocol may be submitted to the IRB either to:

• Define the operating parameters for establishing and maintaining a research repository; or
• Convert an existing research database, non-research database, or non-research repository into a research repository.

The IRB can approve relatively broad parameters for collecting, storing, sharing, and using the repository's information and/or specimens in research, provided the protocol incorporates a series of research protections that permit multiple uses of repository information and/or specimens by multiple investigators and/or for multiple research projects with minimal additional review by the IRB. To maximize the utility of the data/biospecimens retained in the repository requires careful planning and clear operating policies and procedures (SOP). The mechanisms put in place will determine the requirements for IRB oversight of future uses of the materials in the repository.

Responsibilities Of The Repository

Researchers who wish to develop or maintain a repository that is being developed for the purposes of current or future research, need to submit an application for IRB review and approval. IRB approval is required before initiating any repository-related activity. Operators of the repository must implement physical and procedural mechanisms for the secure receipt, storage, and transmission of information and specimens. These procedures must be reviewed and approved by the repository IRB and must be sufficient to ensure the protection of subjects' privacy and the confidentiality of subjects' information.

In addition to the usual information contained in a human research protocol and an IRB application, the IRB expects that will include at least the following specific information:

• The specific conditions under which data/biospecimens may be accepted into the repository, including requirement for the FWA number for each site IRB and a copy of the IRB approval letter;
• A detailed description of the physical and procedural mechanisms for the secure receipt, storage, and transmission of information and specimens to ensure the protection of subjects' privacy and the confidentiality of subjects' data/specimens,
• The specific conditions under which data and/or specimens may be shared with or released to research investigators including policies pertaining prohibiting or permitting the sharing of phi associated with the data/biospecimens,
• Protocol for the collectors of data/specimens
• Template consent and written authorization or combined consent/authorization for the collection sites that includes a clear description of each of the following:
  • The general concept and purpose of repository;
  • The name and location of the repository(ies);
  • The nature and types of future research in as much specific detail as possible;
  • A summary of the physical and procedural mechanisms for protecting subjects' privacy and the confidentiality of data/biospecimens;
  • The conditions (if any) under which subject's may withdraw their consent/authorization to use of specimens;
  • The conditions and requirements under which data/biospecimens and materials derived from biospecimens may be shared with recipient-investigators;
  • The elements of phi (if any) to be shared with recipient investigators;
  • Itemization of the risks related to a breach of confidentiality including impact on privacy, insurability, stigmatization, etc.;
  • Where human genetic research is anticipated, information about the consequences of dna typing (e.g., regarding possible paternity determinations, impact on insurability, etc.) And related confidentiality risks.

Developing A Repository Protocol

The IRB has created a registry-repository protocol template. It is available on our protocol template page, and it includes guidance on developing a protocol for a repository. This template will need to be modified, with sections added or deleted depending on the specifics of the data and specimens collected, the potential future uses for the data/specimens, the potential for returning results, the intent to include other sites, the intent to share the data/specimens and research results with other investigators, the structure of the oversight of the repository and other issues.

Developing A Consent Form For A Repository

The IRB has created an example biorepository consent form for studies where the sole procedure is collection of data and specimens for a repository. This form is an example only and might need to be modified substantially depending on the nature of the data and specimens that will be collected, the types of tests routinely performed on the specimens and the potential future uses for the materials collected. (See Rutgers Consent Template at bottom of webpage)

Responsibilities Of The Collector

Investigators who collect the data/biospecimens (the collector) that will be stored in a repository must agree in writing to specific conditions stipulated by the repository IRB (the IRB exercising oversight of the repository. Collectors other responsibilities include:

• Obtaining appropriate IRB approval from their local IRB
• Obtaining and documenting informed consent/authorization as required by their IRB;
• Following the protocol procedures including:
  • Obtaining the required data/biospecimens in the appropriate form and storage medium and at the specified time points;
  • Coding and labeling the samples before shipping or uploading the data/biospecimens to the registry/repository;
  • Removing all unnecessary phi from the data/biospecimens;
  • Methods for maintaining and securing phi associated with the data/biospecimens sent to the registry/repository and any links (key) between the donor and the data/biospecimens as specified in the protocol.

Responsibilities Of The Recipient

Investigators receiving data/biospecimens from the repository (the recipient) must also agree in writing to specific conditions required by the repository IRB and must adhere to local IRB oversight requirements. The nature of the local IRB oversight requirements depends upon whether or not the received data/biospecimens are potentially identifiable.

Sharing And Using Data/Biospecimens From Research Repositories

Ensuring that comprehensive subject protection mechanism are in place at the time the registry/repository is created, permits new collecting investigators, new research projects, and new recipient investigators to be added to the repository's activities without protracted IRB review. Many new activities may require only expedited review by the IRB. Under some circumstances, they may simply require timely notification of the IRB or may not require IRB review and approval at all. The use and disclosure of information/specimens from a research repository are determined by the following:

• The requirements of the repository IRB who is responsible for the review, approval, and oversight of the repository; and
• The requirements of the local IRB who is responsible for research at the site where the information/specimens will be used.

Repositories Located Within Rutgers University

The IRB is responsible for any research repository maintained at Rutgers University or its affiliates, including their employees or agents (e.g., Rutgers university faculty). Data/biospecimens from these repositories may be accessed, used, shared, or disclosed in accordance with the IRB-approved repository protocol and consent/authorization and any additional approval conditions stipulated by the IRB. Once provided to recipient-investigators outside Rutgers University and its affiliates, use and disclosure of the data/specimens must also comply with any additional requirements of the recipient institution and its IRB.

Repositories Outside Of Rutgers University

When data/biospecimens are received by Rutgers university investigators, their use and disclosure must comply with any conditions stipulated by the sending institution's IRB. Rutgers University policies and procedures for the protection of human subjects and the use and disclosure of protected health information must also be observed.

• Receipt of de-identified data/biospecimens does not engage Rutgers University or its investigators in human subjects research.
• Receipt of a limited dataset requires a duly executed data use agreement between the Rutgers university investigator and the provider of the data/biospecimens.
• When data/biospecimens contain phi, it is up to the IRB, not the investigator, to determine the human subject protection and privacy rule protections required for any research activities. Investigators should consult the IRB before initiating any research involving data/biospecimens obtained from outside repositories (including outside data banks, tissue banks, and registries) if the materials will include phi.

Rutgers University Repository Documents

• Data/Tissue Repository SOP Template Protocol
• Addendum Consent Template For Tissue Collection For Future Study-Secondary to Main Study [WORD]
• Consent Template For Research Tissue Bank or Research Bank [WORD]
• NCI's Glossary of Terms

Additional Guidance

• SACHRP FAQs, Terms and Recommendations on Informed Consent and Research Use of Biospecimens (PDF)
• A Multidisciplinary Approach to Honest Broker Services for Tissue Banks and Clinical Data (link is external)
• An 'Honest Broker' mechanism to maintain privacy for patient care and academic medical research (link is external)

 Related Government Guidance

• OHRP's Guidance on Coded Private Information or Biological Specimens (link is external)
• OHRP: Issues to Consider in the Research Use of Stored Data or Tissues (link is external)
• NCI: Office of Biorepositories and Biospecimen Research (link is external)
• NCI: Best Practices for Biospecimen Resources (revised 2010) (link is external)
• NIDDK data repository: a central collection of clinical trial data (link is external)

Overview

During the course of the research, investigators may encounter certain types of occurrences or situations such as unanticipated problems or adverse events, protocol deviations and protocol violations, which investigators must report to the IRB.

Please note that the guidance below is for reporting to the IRB only and does not satisfy required reporting by an investigator (professional or student) to other internal or external oversight bodies or departments (e.g. NSF/NIH, the FDA, Other External Sponsors, RU Compliance Office, DSMB, or Privacy Offices).

Principal Investigator's Responsibilities

Federal regulations [45 CFR 46.103(b)(5) and 21 CFR 56.108(b)(1)] require the IRB to ensure that investigators promptly report “any unanticipated problems” or adverse events.  An essential element of human subjects protection is identifying, analyzing the causes of, and responding appropriately to expected and unexpected adverse events, as well as unanticipated problems involving risks to subjects or others. Investigators are required to identify and help analyze the events and to determine any appropriate changes or to formulate responses to such events. In addition, investigators must inform the IRB promptly of all such events and/or protocol deviations as described below. The IRB is required to make independent judgments concerning the significance of events and information in the context of the research project and the need for changes to the study protocol and/or informed consent process to protect research subjects.

Investigators and their designated research staff are responsible for reporting information concerning the approved research to the IRB in a timely fashion, understanding and adhering to the reporting guidance provided here and on the detail pages linked below, and not implementing any changes to the research prior to IRB approval of the change via an amendment. The ONLY exception to this policy is when an unanticipated event occurs in a study that could lead to imminent harm to the subject [45 CFR 46.103(b)(4)(iii) and 21 CFR 56.108(a)(4)]. 

Federal Regulations requires the Principal Investigator to report any unanticipated problems, protocol deviations and/or violations on their IRB-approved protocol to their respective IRB. Rutgers IRB requires the Rutgers Investigator to report such incidents to:

1. Rutgers IRB using the appropriate form within the deadlines as described;
2. Study Funders/Sponsors, RU Compliance Office etc, where applicable;

Reporting Timeframes

The Principal Investigator must notify the IRB according to the following timelines:

1. Study-related death or Serious Adverse Event: 24 hours;
2. Other Unanticipated Problems or Adverse Events: 5 business days - from date of discovery;
3. Protocol Deviations/Violations: 5 business days - from date of discovery;
4. Anticipated Problems:
   • Expedited/FB Studies: Include with next Continuing Review;
   • Exempt Studies: Contact the IRB for additional guidance;

NOTE: If it is the opinion of the Principal Investigator that a fatal or life-threatening event is likely related to the protocol, then all research activity should stop until the IRB has reviewed the adverse event and consulted with the Principal Investigator. If only one or two of the above criteria have been met, you do not have to report the event; however, if you are unsure whether an event qualifies as a reportable event, it is recommended that you report it.

Types of Reportable Events

1. Unanticipated Problems and/or Adverse Events

An  Unanticipated problem  is any problem or event which in the opinion of the local investigator was unanticipated, reflects new or increased risk to the subjects and was possibly related to the research procedures.

An Adverse Event is defined as: (1) any medical, physiological, psychological, behavioral, social or economic event that is undesirable and unintended, although not necessarily unexpected; (2) an event in which the outcome is fatal or life threatening, causes permanent disability, causes hospitalization or prolongation of hospitalization; (3) an overdose; or (4) a complaint by a research subject or family member of a research subject concerning the research or the protocol. Any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject’s participation in the research, whether or not considered related to the subject’s participation in the research (modified from the definition of adverse events in the 1996 International Conference on Harmonization E-6 Guidelines for Good Clinical Practice). Adverse events encompass both physical and psychological harms.  They occur most commonly in the context of biomedical research, although on occasion, they can occur in the context of social and behavioral research. 

Examples of Unanticipated Problems or Adverse Events (See Resources)

An Unanticipated Problem or Adverse Event is an event that meets all three of the following criteria:

1. It is unexpected in terms of nature, severity or frequency, given the research protocol, investigator’s brochure, IRB-approved informed consent document, product labeling and other sources of information, and given the characteristics of the subject population being studied(expected natural progression of subjects’ disease, disorder or condition or predisposing risk factor profiles);
2. It is related or possibly related to participation in the research (i.e. is there a definite or reasonable possibility that the incident, experience or outcome may have been caused by the research drug/device or research procedures) ; and
3. The event suggests that the research potentially places subjects or others at a greater risk of harm (including physical, psychological, economic or social harm) than was previously known or recognized).

The IRB notes that an incident, experience, or outcome that meets the three criteria above generally will warrant consideration of substantive changes in the research protocol or informed consent process/document or other corrective actions in order to protect the safety, welfare, or rights of subjects or others.

NOTE: Anticipated Problems which are already described as potential risks in the consent form (i.e., Consent mentioned that risks include experimental therapy might not be effective at controlling subject’s underlying condition. For example, subject with depression is participating on a intervention protocol and becomes hospitalized for flare-up of depression symptoms) and/or Unrelated Events (e.g., subject is injured in a car accident and misses their scheduled study session) do not meet the above definition and should only be reported in summary form to the IRB at time of continuing review. However, a study sponsor/funder (e.g., NIH/NSF) might require investigators to report this problem/event to them in a separate process of which the investigator must seek guidance directly from their study sponsor/funder.

1. Protocol Deviations and/or  Protocol Violations

A protocol deviation is any change, divergence, or departure from the study design or procedures of a research protocol that is under the investigator's control and that has not been approved by the IRB. Upon discovery, the Principal Investigator is responsible for reporting protocol deviations to the IRB.

A protocol violation is a deviation from the IRB approved protocol that may affect the subject's rights, safety, or well-being and/or the completeness, accuracy and reliability of the study data. Protocol Violations must be submitted for Full Board IRB review. If the deviation meets any of the following criteria, it is considered a protocol violation.

Protocol deviations and protocol violations can be broken down into the following two categories: Minor deviation or violation OR Major deviation or violation.

• Minor Deviations and/or Minor Violations: A minor deviation or minor violation is viewed by the IRB as an event that does not impact subject safety, compromise the integrity of study data and/or affect a subject’s willingness to participate in the study. Minor deviations or violations will be reviewed under expedited procedures by a single reviewer. The reviewer will determine whether the event is accepted as a minor deviation/violation and can recommend a corrective course of action. The deviation will be sent to the fully convened IRB meeting where the board will discuss and determine if any additional actions are required, where applicable and as necessary. If the event meets any of the following criteria, it is considered a minor deviation or minor violation.

• Major Deviations and/or Major Violations: A major deviation or violation is viewed by the IRB as an event that may impact subject safety, affect the integrity of study data and/or affect a subject’s willingness to participate in the study. Major protocol deviations/violations are treated as noncompliance. These reports will be reviewed at the fully convened IRB meeting where the board will discuss the major deviations and/or major violations and determine of the appropriate course of action. If the event meets any of the following criteria, it is considered a major deviation or major violation.

Acknowledgement of Reportable Events by the IRB

Once a Principal Investigator submits a report concerning a reportable event, the Rutgers IRB will send the report to the fully convened meeting for review. Rutgers IRB will follow up with the PI before or after the meeting regarding any appropriate changes or any next steps. Once an event is acknowledged, the Principal Investigator will receive an "Acknowledgement Letter" via e-mail from the Rutgers IRB. The Principal Investigator is responsible for communicating any IRB-required actions, changes or acknowledgements with study staff and/or study sponsors.

Another Type of Reportable Event: Data & Safety Monitoring Reports

Data and safety monitoring is used to ensure both adherence to the IRB-approved investigative plan, the validity of data collected and most importantly, the safety of those subjects who participate in the project.  A data monitoring plan might be required for projects that involve investigation items/devices or are clinical trials, no matter the risk level. Data and safety monitoring usually occurs with the formation of a Data and Safety Monitoring Board (DSMB). The DSMB is an independent group of experts that advises the principal investigator and if applicable any co-Investigators.  For More Detailed Information on DSMBs

Forms: For paper studies only

• Adverse Events / Unanticipated Problems Form (see Forms and Templates)
• Protocol Deviation / Protocol Violations Form (see Forms and Templates)

Government Regulations

Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events

Overview

Under 45 CFR 46 "unanticipated problems" involving risk to subjects or others must be reported to the IRB, institutional officials, study sponsor and OHRP. In addition, under 21 CFR parts 56, 312 and 812, adverse drug events and unanticipated adverse device effects that are 'unanticipated problems" must be reported to the IRB, study sponsor, and FDA.

All deaths in interventional studies that occur within 30 days of the intervention must be reported to the IRB within 24 hours of discovery whether or not considered study-related when Rutgers is the IRB of record.

Incidents, experiences, outcomes and adverse events which meet all the criteria below also must be reported to the Rutgers IRB:

• unexpected in terms of nature, severity or frequency, given the research protocol, investigator's brochure, IRB-approved informed consent document, product labeling and other sources of information, and given the characteristics of the subject population being studied (expected natural progression of subjects' disease, disorder or condition or predisposing risk factor profiles).
• related or possibly related to participation in the research, i.e., is there a definite or reasonable possibility that the incident, experience or outcome may have been caused by the research drug/device or research procedures?
• potentially place the research subjects or others at a greater risk of harm (including physical, psychological, economic or social harm) than was previously known or recognized.

Unanticipated problems which are serious adverse events must be reported within one week of discovery. All other unanticipated problems must be reported to the IRB within two weeks of discovery.

For eIRB Studies:

Submit an Unanticipated Problems - Adverse Event Report. If any changes are required, a Modification will need to be submitted as well.

For Paper Studies:

The following must be included in the submission of an Unanticipated Problems / Adverse Events in Human Subjects Research Report:

• Unanticipated Problems/Adverse Events in Human Subjects Research Report

If changes are to be made in the approved study protocol or documents in response to the event, then the following must also be included with the submission:

• Rutgers Paper Study Modification Request Form outlining what changes have been made and where.
• All revised documents with proposed changes highlighted.
• Any revised documents with no highlighting for approval stamping.

Following review, the Unanticipated Problem/Serious Adverse Event will receive one of the following status determinations: Accepted or Not Accepted. This determination will be provided to the principal investigator, outlining follow-up steps as deemed necessary by the committee.

Policy

Reportable Events Policy

Overview

Databases, registries (data banks), and repositories (tissue banks) all involve the collection and storage of information and/or biological specimens over time. Some registry/repositories serve diagnostic or clinical purposes, while others are solely for research. Many serve more than one purpose.

Research use data/biospecimens that are stored in registry/repositories is governed by the federal human subject protection regulations known as the common rule (45 CFR 46 (link is external)) and the HIPAA privacy rule (link is external) (45 CFR 160 & 164) and by Rutgers University IRB policies and procedures. Specific requirements depend upon how and why the information or specimens in the resource are collected, stored, used, and shared.

The requirements for and extent of IRB oversight depends on the whether or not the data/biospecimens include or are linked to individually identifiable health information and the terms of the informed consent under which the data/biospecimens were originally collected.

Data and tissue banks registries, data banks, and tissue banks are all considered synonymous with the term repositories for regulatory purposes. For the purposes of this webpage they will be referred to as repositories or registry/repositories and the contents as data, biospecimens or data/biospecimens.

Non-Research Databases And Repositories

Databases and repositories are frequently created and maintained for purposes totally unrelated to research. For example, Rutgers University maintains a variety of electronic health records and data warehouse intended for diagnosis, treatment, billing, marketing, and quality improvement/control purposes. Individual departments and divisions use their own databases that have been established for clinical and quality improvement purposes. Examples include the following:

• Anesthesia electronic record system used in the operating room to record preoperative history and physical examination data, store the vital signs and anesthetic medication administration and create anesthetic records for every procedure.
• Pathology department biospecimens and records for all of the materials received for diagnostic or treatment purposes.
• Operating room management database
• EPIC
• Quality assurance/quality improvement initiatives

These databases and repositories serve predominantly non-research purposes. However, the information they contain can be used to address important scientific questions. IRB approval is not required for creation or use of a non-research database or Biospecimen collection but is required to use these resources for research purposes. See what must be reviewed by the IRB for more details.

Research Databases

Research databases may be maintained after the completion of a study. Additional questions may arise in the future that can be addressed using the same dataset. If there is an intent to set up a registry, then the informed consent document should include language for subjects to opt-in or opt-out of storage of their data for future research purposes. The subject's decision as indicated on the consent/authorization must be respected and tracked. IRB oversight is required for each new research protocol that uses identifiable or re-identifiable information contained in the database.

A research database may also be created specifically as a resource for future research. IRB oversight is required to set up and maintain a research database.

Examples of research databases include:

• Data compiled from a clinical trial
• A list of names, diagnosis, and contact information developed and maintained to identify prospective research subjects
• A collection of medical information intended for use in future research studies

Some databases created and maintained to serve multiple purposes. Examples include:

• A collection of patients' diagnosis, treatment, and follow-up information intended for and used to conduct (i.) Internal quality assurance programs and (ii) generalizable studies on the effectiveness of particular treatment interventions.
• A compilation of patient information that was originally created and used for billing purposes but is now also routinely used to identify prospective research subjects.

Research Repositories

Biospecimens may be collected to achieve one or more of the objectives of a single study with disposal of the leftover materials at the end of the study. A repository is created if the leftover materials are stored for future use. If there is an intent to set up a repository, then the informed consent document should include language for subjects to opt-in or opt-out of storage of their data for future research purposes. The subject's decision as indicated on the consent/authorization must be respected and tracked.

Specimens may also be collected specifically for the purposes of future research. IRB oversight is required for each new research protocol that creates a reposit

Developing & Maintaining A Research Registry/Repository

For the purposes of the remainder of this page, both registries and repositories will be referred to as repositories. The advantage to investigators of creating, maintaining, and/or using a research repository lies in the prospective collection, the safe storage and back-up, controlled access to and use of data/biospecimens. The information and specimens can be accessed by multiple investigators for multiple research projects. Some of the potential research uses may be anticipated at the time of collection but most cannot be specified at the time the repository is created.

A repository protocol may be submitted to the IRB either to:

• Define the operating parameters for establishing and maintaining a research repository; or
• Convert an existing research database, non-research database, or non-research repository into a research repository.

The IRB can approve relatively broad parameters for collecting, storing, sharing, and using the repository's information and/or specimens in research, provided the protocol incorporates a series of research protections that permit multiple uses of repository information and/or specimens by multiple investigators and/or for multiple research projects with minimal additional review by the IRB. To maximize the utility of the data/biospecimens retained in the repository requires careful planning and clear operating policies and procedures (SOP). The mechanisms put in place will determine the requirements for IRB oversight of future uses of the materials in the repository.

Responsibilities Of The Repository

Researchers who wish to develop or maintain a repository that is being developed for the purposes of current or future research, need to submit an application for IRB review and approval. IRB approval is required before initiating any repository-related activity. Operators of the repository must implement physical and procedural mechanisms for the secure receipt, storage, and transmission of information and specimens. These procedures must be reviewed and approved by the repository IRB and must be sufficient to ensure the protection of subjects' privacy and the confidentiality of subjects' information.

In addition to the usual information contained in a human research protocol and an IRB application, the IRB expects that will include at least the following specific information:

• The specific conditions under which data/biospecimens may be accepted into the repository, including requirement for the FWA number for each site IRB and a copy of the IRB approval letter;
• A detailed description of the physical and procedural mechanisms for the secure receipt, storage, and transmission of information and specimens to ensure the protection of subjects' privacy and the confidentiality of subjects' data/specimens,
• The specific conditions under which data and/or specimens may be shared with or released to research investigators including policies pertaining prohibiting or permitting the sharing of phi associated with the data/biospecimens,
• Protocol for the collectors of data/specimens
• Template consent and written authorization or combined consent/authorization for the collection sites that includes a clear description of each of the following:
  • The general concept and purpose of repository;
  • The name and location of the repository(ies);
  • The nature and types of future research in as much specific detail as possible;
  • A summary of the physical and procedural mechanisms for protecting subjects' privacy and the confidentiality of data/biospecimens;
  • The conditions (if any) under which subject's may withdraw their consent/authorization to use of specimens;
  • The conditions and requirements under which data/biospecimens and materials derived from biospecimens may be shared with recipient-investigators;
  • The elements of phi (if any) to be shared with recipient investigators;
  • Itemization of the risks related to a breach of confidentiality including impact on privacy, insurability, stigmatization, etc.;
  • Where human genetic research is anticipated, information about the consequences of dna typing (e.g., regarding possible paternity determinations, impact on insurability, etc.) And related confidentiality risks.

Developing A Repository Protocol

The IRB has created a registry-repository protocol template. It is available on our protocol template page, and it includes guidance on developing a protocol for a repository. This template will need to be modified, with sections added or deleted depending on the specifics of the data and specimens collected, the potential future uses for the data/specimens, the potential for returning results, the intent to include other sites, the intent to share the data/specimens and research results with other investigators, the structure of the oversight of the repository and other issues.

Developing A Consent Form For A Repository

The IRB has created an example biorepository consent form for studies where the sole procedure is collection of data and specimens for a repository. This form is an example only and might need to be modified substantially depending on the nature of the data and specimens that will be collected, the types of tests routinely performed on the specimens and the potential future uses for the materials collected. (See Rutgers Consent Template at bottom of webpage)

Responsibilities Of The Collector

Investigators who collect the data/biospecimens (the collector) that will be stored in a repository must agree in writing to specific conditions stipulated by the repository IRB (the IRB exercising oversight of the repository. Collectors other responsibilities include:

• Obtaining appropriate IRB approval from their local IRB
• Obtaining and documenting informed consent/authorization as required by their IRB;
• Following the protocol procedures including:
  • Obtaining the required data/biospecimens in the appropriate form and storage medium and at the specified time points;
  • Coding and labeling the samples before shipping or uploading the data/biospecimens to the registry/repository;
  • Removing all unnecessary phi from the data/biospecimens;
  • Methods for maintaining and securing phi associated with the data/biospecimens sent to the registry/repository and any links (key) between the donor and the data/biospecimens as specified in the protocol.

Responsibilities Of The Recipient

Investigators receiving data/biospecimens from the repository (the recipient) must also agree in writing to specific conditions required by the repository IRB and must adhere to local IRB oversight requirements. The nature of the local IRB oversight requirements depends upon whether or not the received data/biospecimens are potentially identifiable.

Sharing And Using Data/Biospecimens From Research Repositories

Ensuring that comprehensive subject protection mechanism are in place at the time the registry/repository is created, permits new collecting investigators, new research projects, and new recipient investigators to be added to the repository's activities without protracted IRB review. Many new activities may require only expedited review by the IRB. Under some circumstances, they may simply require timely notification of the IRB or may not require IRB review and approval at all. The use and disclosure of information/specimens from a research repository are determined by the following:

• The requirements of the repository IRB who is responsible for the review, approval, and oversight of the repository; and
• The requirements of the local IRB who is responsible for research at the site where the information/specimens will be used.

Repositories Located Within Rutgers University

The IRB is responsible for any research repository maintained at Rutgers University or its affiliates, including their employees or agents (e.g., Rutgers university faculty). Data/biospecimens from these repositories may be accessed, used, shared, or disclosed in accordance with the IRB-approved repository protocol and consent/authorization and any additional approval conditions stipulated by the IRB. Once provided to recipient-investigators outside Rutgers University and its affiliates, use and disclosure of the data/specimens must also comply with any additional requirements of the recipient institution and its IRB.

Repositories Outside Of Rutgers University

When data/biospecimens are received by Rutgers university investigators, their use and disclosure must comply with any conditions stipulated by the sending institution's IRB. Rutgers University policies and procedures for the protection of human subjects and the use and disclosure of protected health information must also be observed.

• Receipt of de-identified data/biospecimens does not engage Rutgers University or its investigators in human subjects research.
• Receipt of a limited dataset requires a duly executed data use agreement between the Rutgers university investigator and the provider of the data/biospecimens.
• When data/biospecimens contain phi, it is up to the IRB, not the investigator, to determine the human subject protection and privacy rule protections required for any research activities. Investigators should consult the IRB before initiating any research involving data/biospecimens obtained from outside repositories (including outside data banks, tissue banks, and registries) if the materials will include phi.

Rutgers University Repository Documents

• Data/Tissue Repository SOP Template Protocol [PDF]
• Addendum Consent Template For Tissue Collection For Future Study-Secondary to Main Study [WORD]
• Consent Template For Research Tissue Bank or Research Bank [WORD]
• Repository Glossary [PDF]

Additional Guidance

• SACHRP FAQs, Terms and Recommendations on Informed Consent and Research Use of Biospecimens (PDF)
• A Multidisciplinary Approach to Honest Broker Services for Tissue Banks and Clinical Data (link is external)
• An 'Honest Broker' mechanism to maintain privacy for patient care and academic medical research (link is external)

 Related Government Guidance

• OHRP's Guidance on Coded Private Information or Biological Specimens (link is external)
• OHRP: Issues to Consider in the Research Use of Stored Data or Tissues (link is external)
• NCI: Office of Biorepositories and Biospecimen Research (link is external)
• NCI: Best Practices for Biospecimen Resources (revised 2010) (link is external)
• NIDDK data repository: a central collection of clinical trial data (link is external)

Overview

The IRB has developed certain procedures to reduce the element of coercion or influence when faculty or instructional staff use Rutgers students as subjects in research projects. 

These procedures DO NOT apply to students studying research techniques in courses that require them to perform experiments but apply to any research that uses students or employees, not as investigators, but as subjects.

The ethical principles of professional societies insist that research subjects voluntarily consent to participate in research and that all potential subjects must be treated as autonomous agents, with the right to choose whether or not to take part in experiments.  Federal regulations (e.g., 45 CFR 46.116) are explicit:  "An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence." The Rutgers Board of Governors has decided that all human subjects research in this university that involves human subjects must conform to federal regulations and be reviewed by the IRB.

Vulnerability

The problem with student participation in research conducted at the university is the possibility that their agreement to participate (consent) might not be freely given. While researchers may be careful to avoid potentially coercive behavior, the very nature of the relationship with the subject can create the perception of coercion. Students or employees may volunteer to participate out of a belief that doing so will place them in good favor with faculty or supervisors (e.g., that participating will result in receiving better grades, recommendations, employment, or the like), or that failure to participate will negatively affect their relationship with the investigator or faculty or supervisor generally (i.e., by seeming "uncooperative," not part of the scientific community). For this reason, all researchers should be aware of the potential for coercion that exists when a research subject is also a student, employee, colleague, or subordinate of the researcher.

Information about how students and employees will be recruited and how coercion will be avoided should be included in the application and/or protocol information submitted to the IRB for review. A way to protect against coercion is for faculty-investigators to advertise for subjects generally (e.g., through notices posted in the school or department) rather than recruit individual students directly. Requiring participation in research for course credit (or extra credit) is also controversial, though common in the social and behavioral sciences. As with any research involving a potentially vulnerable subject population, IRBs pay special attention to the potential for coercion or undue influence and consider ways in which the possibility of exploitation can be reduced or eliminated.

Procedures For Using Students as Subjects

Consequently, individual faculty members and instructional staff, students, and departments that use students or employees as experimental subjects, or that maintain "subject pools" of students from which investigators may draw research participants, are asked to adopt procedures that meet the following conditions:

1. Whenever possible, researchers should avoid using their own students if another population of subjects is equally suited to the research question, e.g., another class section not taught by the researcher, recruitment by another instructor, or blinded/coded data collected by an associate so that subjects are not identified to the instructor.
2. If there is a course requirement that students serve as research subjects in such experiments, students must be informed of the possibility that they may be asked to serve as research subjects in experiments under direction of the faculty before they enroll in the course.
3. Students should be given an opportunity to decline participation without penalty. If there is a course requirement that students serve as research subjects in such experiments, then faculty must provide students with alternative ways to meet this requirement. Students should receive a written description of the various ways of meeting the requirement during the first week of class.
4. Each department that regularly requires students to act as research subjects should establish a committee composed of faculty and students to review the research projects involved.  This committee should be responsible for hearing and acting on any student complaints in connection with the research-participation requirement.
5. Unless the research is directly related to class material, or the study process is being used as a teaching opportunity, such as in a research methods class, the IRB discourages the use of class time to recruit subjects or class time used to complete study instruments, etc.

Family Educational Rights and Privacy Act (FERPA)

The Family Educational Rights and Privacy Act (FERPA) (20 U.S.C. § 1232g; 34 CFR Part 99) is a Federal law that protects the privacy of student education records. The law applies to all schools that receive funds under an applicable program of the U.S. Department of Education.

• Read More Information (ed.gov)
• HRP-331 FERPA Compliance
• FERPA Resources

Procedures For Using Employees as Subjects

1. Researchers who recruit colleagues or subordinates as research subjects must be able to provide a rationale, other than convenience, for this kind of subject selection. In addition, researchers must show that the recruitment method does not lead colleagues or subordinates to think they will face retaliation, poor performance appraisals or other kinds of risks by choosing not participate in the research. Employees, colleagues or subordinates must be given an opportunity to decline participation, at any point, without penalty.
2. All members of the faculty who invite students to act as subjects in their research must be acquainted with the ethical standards that govern such activities, such as those promulgated by the American Psychological Association and other professional organizations, or those in the so-called Belmont Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.  A copy of the latter report is obtainable from ORRA-IRB.

Overview

Authorization letters are required from research sites that are not affiliated with Rutgers University (e.g. schools). A letter of authorization/cooperation is a letter from the head of an organization/group granting you permission to carry out your research either at: their facility; with their employees; with their attendees or members; with their non-public or identifiable dataset, etc. Due to the individual nature with each organization’s authorization, the IRB doesn’t have any existing templates for letters of authorization.

Site Authorization/Letters of Cooperation

A letter of cooperation is a letter from the head of an organization/group granting you permission to carry out your research either at: their facility; with their employees; with their attendees or members; with their non-public or identifiable dataset, etc. 

Each letter must include Investigator’s name, the title of the study, include details of the project to be conducted with the organization and spell out his/her explicit support of the intended project and/or authorization for the release of any data or private information for the research. In order for Investigators to start research at any site, investigators must have a letter of cooperation and forward this letter to the IRB BEFORE the commencement of any research activities.

If the research site will not issue approval until the Investigator has obtained Rutgers IRB approval and provide them with a copy, please use a cover memo to include with your application indicating this issue.

The IRB must be in receipt of each letter with original signature(s). Investigators may send the IRB an email containing a PDF of the actual letter, instead of a mailed hardcopy letter. The IRB will not accept any email correspondence in lieu of an actual authorization letter. Sorry, but, fax copies of this letter will not be accepted. Please retain a copy of any authorization for your records. The IRB is not responsible for misdirected snail mail or emails.

Authorizations from Participating School Sites

Research conducted in schools typically require approval for the investigator to conduct the project. It’s the Investigator’s responsibility to know what type of approval (i.e., District IRB, Board of Education, School District's Superintendent or School Principal approval, depending on the requirements of a particular school district) is required and to obtain approval before the commencement of research activities at that site(s).

If the school site will not issue approval until the Investigator has obtained Rutgers IRB approval and provide them with a copy, please use a cover memo to include with your application indicating this issue.

The school-based authorization letter to be obtained must state that the School’s Signatory Authority grants the investigator permission to carry out the research at their given school site with administration/other school employees, teachers and/or with students.

The IRB must be in receipt of each letter with original signature(s). Investigators may send the IRB an email containing a PDF of the actual letter, instead of a mailed hardcopy letter. The IRB will not accept any email correspondence in lieu of an actual authorization letter. Sorry, but, fax copies of this letter will not be accepted. Please retain a copy of any authorization for your records. The IRB is not responsible for misdirected snail mail or emails.

Forms

The Rutgers IRB provide a template: See Forms and Templates.

Summary Of Statutes Of Limitation That May Affect Research Protocols

Statutes of limitations set forth the time period within which the state must commence a case for a crime. If the state tries to bring an action against someone after the applicable time period has passed, the person charged can have the case dismissed. The statute of limitations in a criminal case is "an absolute bar to the prosecution of the offense”. It is designed to protect a defendant from being put to his defense after memories have faded, witnesses have died or disappeared, and evidence has been lost. Statutes of limitations "protect individuals from charges when the basic facts have become obscured by time."

In general, violent crimes have a longer statute of limitations, and with some crimes there is no statute of limitations. In certain instances, the statute of limitations may be tolled, or suspended, which grants the state additional time to commence a legal action. A few crimes have no statute of limitations; sexual assault is one of them. I have listed the statutes that would cover what we deal with in some of our protocols.

Basically, if a PI/KP gets a report/info of sexual assault to a child/minor who is a subject in their protocol, that must be reported. If the subject was subjected to any form of sexual assault, even if the child is now an adult, since there is no statute of limitations, that needs to be reported. Criminal sexual contact (some form of touching without penetration) or endangering welfare of child (neglect, assault, etc.) when the victim is under 18 must be brought within 5 years after victim turns 18 or 2 years of discovery of offense by victim, whichever is later. For example, if a subject is 20, and reports child abuse that occurred when the subject was a minor, no matter what age, that would have to be reported.

On a side note, if a subject reports that he/she was sexually assaulted as an adult that presents a different issue. No adult victim has to report their victimization or proceed with a prosecution. If the prosecution becomes aware of the crime they have the discretion to “force” the victim to go forward, but that is rare. No citizen is required to report a crime where the victim was an adult, whether they witness the crime or was merely told of it.

Sentencing/Punishment For informational purposes, New Jersey categorizes their criminal statutes as degrees, not felonies. A crime can be designated as a first, second, third or fourth degree crime. Those crimes would be the same as a felony in any other state. The most serious is a first degree crime with fourth degree crime being the least serious. A person convicted of a first or second degree crime has a statutory presumption of incarceration (prison) even if the person has no criminal record. A conviction for a third or fourth degree has a statutory presumption of non-incarceration if the person has not previously been convicted.  A  disorderly person is akin to a misdemeanor in the “felony” type states. A conviction for a disorderly person’s offense usually results in a fine, and possibly a probationary period. While a conviction for a disorderly person’s offense is not very serious, it will show up on any criminal history check.

STATUTES (New Jersey Statutes Annotated [NJSA])

NJSA 2C:1-6. Time Limitations.

a. (1) A prosecution for any offense set forth in N.J.S.2C:11-3, N.J.S.2C:11-4, (Homicide) N.J.S.2C:14-2(Sexual Assault) …. may be commenced at any time.

NJSA 9:6-8.10. Report of abuse.

3.     Any person having reasonable cause to believe that a child has been subjected to child abuse or acts of child abuse shall report the same immediately to the Division of Child Protection and Permanency by telephone or otherwise. Such reports, where possible, shall contain the names and addresses of the child and his parent, guardian, or other person having custody and control of the child and, if known, the child's age, the nature and possible extent of the child's injuries, abuse or maltreatment, including any evidence of previous injuries, abuse or maltreatment, and any other information that the person believes may be helpful with respect to the child abuse and the identity of the perpetrator.

9:6-8.14. Violations including failure to make report; disorderly person

Any person knowingly violating the provisions of this act including the failure to report an act of child abuse having reasonable cause to believe that an act of child abuse has been committed, is a disorderly person.

NJSA 9:6-8.9. "Abused child" defined

For purposes of this act:

"Abused child" means a child under the age of 18 years whose parent, guardian, or other person having his custody and control:

1. Inflicts or allows to be inflicted upon such child physical injury by other than accidental means which causes or creates a substantial risk of death, or serious or protracted disfigurement, or protracted impairment of physical or emotional health or protracted loss or impairment of the function of any bodily organ;
2. Creates or allows to be created a substantial or ongoing risk of physical injury to such child by other than accidental means which would be likely to cause death or serious or protracted disfigurement, or protracted loss or impairment of the function of any bodily organ; or
3. Commits or allows to be committed an act of sexual abuse against the child;
4. Or a child whose physical, mental, or emotional condition has been impaired or is in imminent danger of becoming impaired as the result of the failure of his parent or guardian, or such other person having his custody and control, to exercise a minimum degree of care (1) in supplying the child with adequate food, clothing, shelter, education, medical or surgical care though financially able to do so or though offered financial or other reasonable means to do so, or (2) in providing the child with proper supervision or guardianship, by unreasonably inflicting or allowing to be inflicted harm, or substantial risk thereof, including the infliction of excessive corporal punishment or using excessive physical restraint under circumstances which do not indicate that the child's behavior is harmful to himself, others or property; or by any other act of a similarly serious nature requiring the aid of the court;
5. Or a child who has been willfully abandoned by his parent or guardian, or such other person having his custody and control;
6. Or a child who is in an institution as defined in section 1 of P.L.1974, c. 119 (C. 9:6-8.21) and

(1) has been so placed inappropriately for a continued period of time with the knowledge that the placement has resulted and may continue to result in harm to the child's mental or physical well-being or (2) has been willfully isolated from ordinary social contact under circumstances which indicate emotional or social deprivation.

A child shall not be considered abused pursuant to subsection f. of this section if the acts or omissions described therein occur in a day school as defined in section 1 of P.L.1974, c. 119 (C. 9:6-8.21).

NJSA 9:6-8.21 - Definitions.

1. As used in P.L.1974, c.119 (C.9-8.21 et seq.), unless the specific context indicates otherwise:

1. "Parent or guardian" means any natural parent, adoptive parent, resource family parent, stepparent, paramour of a parent, or any person, who has assumed responsibility for the care, custody, or control of a child or upon whom there is a legal duty for such care. Parent or guardian includes a teacher, employee, or volunteer, whether compensated or uncompensated, of an institution who is responsible for the child's welfare and any other staff person of an institution regardless of whether or not the person is responsible for the care or supervision of the child. Parent or guardian also includes a teaching staff member or other employee, whether compensated or uncompensated, of a day school as defined in section 1 of P.L.1974, c.119 (C.9:6-8.21).
2. "Child" means any child alleged to have been abused or neglected.
3. "Abused or neglected child" means a child less than 18 years of age whose parent or guardian, as herein defined, (1) inflicts or allows to be inflicted upon such child physical injury by other than accidental means which causes or creates a substantial risk of death, or serious or protracted disfigurement, or protracted impairment of physical or emotional health or protracted loss or impairment of the function of any bodily organ; (2) creates or allows to be created a substantial or ongoing risk of physical injury to such child by other than accidental means which would be likely to cause death or serious or protracted disfigurement, or protracted loss or impairment of the function of any bodily organ; (3) commits or allows to be committed an act of sexual abuse against the child; (4) or a child whose physical, mental, or emotional condition has been impaired or is in imminent danger of becoming impaired as the result of the failure of his parent or guardian, as herein defined, to exercise a minimum degree of care (a) in supplying the child with adequate food, clothing, shelter, education, medical or surgical care though financially able to do so or though offered financial or other reasonable means to do so, or (b) in providing the child with proper supervision or guardianship, by unreasonably inflicting or allowing to be inflicted harm, or substantial risk thereof, including the infliction of excessive corporal punishment; or by any other acts of a similarly serious nature requiring the aid of the court; (5) or a child who has been willfully abandoned by his parent or guardian, as herein defined; (6) or a child upon whom excessive physical restraint has been used under circumstances which do not indicate that the child's behavior is harmful to himself, others, or property; (7) or a child who is in an institution and (a) has been placed there inappropriately for a continued period of time with the knowledge that the placement has resulted or may continue to result in harm to the child's mental or physical well-being or (b) who has been willfully isolated from ordinary social contact under circumstances which indicate emotional or social deprivation. A child shall not be considered abused or neglected pursuant to paragraph (7) of subsection c. of this section if the acts or omissions described therein occur in a day school as defined in this section. No child who in good faith is under treatment by spiritual means alone through prayer in accordance with the tenets and practices of a recognized church or religious denomination by a duly accredited practitioner thereof shall for this reason alone be considered to be abused or neglected.
4. "Law guardian" means an attorney admitted to the practice of law in this State, regularly employed by the Office of the Public Defender or appointed by the court, and designated under P.L.1974, c.119 to represent minors in alleged cases of child abuse or neglect and in termination of parental rights proceedings.
5. "Attorney" means an attorney admitted to the practice of law in this State who shall be privately retained; or, in the instance of an indigent parent or guardian, an attorney from the Office of the Public Defender or an attorney appointed by the court who shall be appointed in order to avoid conflict between the interests of the child and the parent or guardian in regard to representation.
6. "Division" means the Division of Child Protection and Permanency in the Department of Children and Families unless otherwise specified.
7. "Institution" means a public or private facility in the State which provides children with out of home care, supervision, or maintenance. Institution includes, but is not limited to, a correctional facility, detention facility, treatment facility, day care center, residential school, shelter, and hospital.
8. "Day school" means a public or private school which provides general or special educational services to day students in grades kindergarten through 12. Day school does not include a residential facility, whether public or private, which provides care on a 24-hour basis.

L.1974, c.119, s.1; amended 1977, c.209, s.1; 1987, c.341, s.6; 1994, c.58, s.39; 1999, c.53, s.55;

2004, c.130, s.27; 2005, c.169, s.1; 2006, c.47, s.47; 2012, c.16, s.31.

NJSA 2C:14-2 Sexual assault.

2C:14-2. Sexual assault. a. An actor is guilty of aggravated sexual assault if he commits an act of sexual penetration with another person under any one of the following circumstances:

1. The victim is less than 13 years old;
2. The victim is at least 13 but less than 16 years old; and
3. 1. The actor is related to the victim by blood or affinity to the third degree, or
4. 2. The actor has supervisory or disciplinary power over the victim by virtue of the actor's legal, professional, or occupational status, or
5. 3. The actor is a resource family parent, a guardian, or stands in loco parentis within the household;
6. The act is committed during the commission, or attempted commission, whether alone or with one or more other persons, of robbery, kidnapping, homicide, aggravated assault on another, burglary, arson or criminal escape;
7. The actor is armed with a weapon or any object fashioned in such a manner as to lead the victim to reasonably believe it to be a weapon and threatens by word or gesture to use the weapon or object;
8. The actor is aided or abetted by one or more other persons and the actor uses physical force or coercion;
9. The actor uses physical force or coercion and severe personal injury is sustained by the victim;
10. The victim is one whom the actor knew or should have known was physically helpless or incapacitated, intellectually or mentally incapacitated, or had a mental disease or defect which rendered the victim temporarily or permanently incapable of understanding the nature of his conduct, including, but not limited to, being incapable of providing consent.

Aggravated sexual assault is a crime of the first degree.

Except as otherwise provided in subsection d. of this section, a person convicted under paragraph (1) of this subsection shall be sentenced to a specific term of years which shall be fixed by the court and shall be between 25 years and life imprisonment of which the person shall serve 25 years before being eligible for parole, unless a longer term of parole ineligibility is otherwise provided pursuant to this Title.

b. An actor is guilty of sexual assault if he commits an act of sexual contact with a victim who is less than 13 years old and the actor is at least four years older than the victim.

c. An actor is guilty of sexual assault if he commits an act of sexual penetration with another person under any one of the following circumstances:

1. The actor uses physical force or coercion, but the victim does not sustain severe personal injury;
2. The victim is on probation or parole, or is detained in a hospital, prison or other institution and the actor has supervisory or disciplinary power over the victim by virtue of the actor's legal, professional or occupational status;
3. The victim is at least 16 but less than 18 years old and:
4. 1. The actor is related to the victim by blood or affinity to the third degree; or
5. 2. The actor has supervisory or disciplinary power of any nature or in any capacity over the victim; or
6. 3. The actor is a resource family parent, a guardian, or stands in loco parentis within the household;
7. The victim is at least 13 but less than 16 years old and the actor is at least four years older than the victim.

Sexual assault is a crime of the second degree.

NJSA 2C:14-3 Aggravated criminal sexual contact; criminal sexual contact

1. An actor is guilty of aggravated criminal sexual contact if he commits an act of sexual contact with the victim under any of the circumstances set forth in 2C:14-2a. (2) through (7).

Aggravated criminal sexual contact is a crime of the third degree.

2. An actor is guilty of criminal sexual contact if he commits an act of sexual contact with the victim under any of the circumstances set forth in section 2C:14-2c. (1) through (4).

Criminal sexual contact is a crime of the fourth degree.

L.1978, c.95; amended 1979, c.178, s.27; 1997, c.194, s.2.

Overview

The IRB has developed certain procedures to reduce the element of coercion or influence when faculty or instructional staff use Rutgers students as subjects in research projects. 

These procedures DO NOT apply to students studying research techniques in courses that require them to perform experiments but apply to any research that uses students or employees, not as investigators, but as subjects.

The ethical principles of professional societies insist that research subjects voluntarily consent to participate in research and that all potential subjects must be treated as autonomous agents, with the right to choose whether or not to take part in experiments.  Federal regulations (e.g., 45 CFR 46.116) are explicit:  "An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence." The Rutgers Board of Governors has decided that all human subjects research in this university that involves human subjects must conform to federal regulations and be reviewed by the IRB.

Vulnerability

The problem with student participation in research conducted at the university is the possibility that their agreement to participate (consent) might not be freely given. While researchers may be careful to avoid potentially coercive behavior, the very nature of the relationship with the subject can create the perception of coercion. Students or employees may volunteer to participate out of a belief that doing so will place them in good favor with faculty or supervisors (e.g., that participating will result in receiving better grades, recommendations, employment, or the like), or that failure to participate will negatively affect their relationship with the investigator or faculty or supervisor generally (i.e., by seeming "uncooperative," not part of the scientific community). For this reason, all researchers should be aware of the potential for coercion that exists when a research subject is also a student, employee, colleague, or subordinate of the researcher.

Information about how students and employees will be recruited and how coercion will be avoided should be included in the application and/or protocol information submitted to the IRB for review. A way to protect against coercion is for faculty-investigators to advertise for subjects generally (e.g., through notices posted in the school or department) rather than recruit individual students directly. Requiring participation in research for course credit (or extra credit) is also controversial, though common in the social and behavioral sciences. As with any research involving a potentially vulnerable subject population, IRBs pay special attention to the potential for coercion or undue influence and consider ways in which the possibility of exploitation can be reduced or eliminated.

Procedures For Using Students as Subjects

Consequently, individual faculty members and instructional staff, students, and departments that use students or employees as experimental subjects, or that maintain "subject pools" of students from which investigators may draw research participants, are asked to adopt procedures that meet the following conditions:

1. Whenever possible, researchers should avoid using their own students if another population of subjects is equally suited to the research question, e.g., another class section not taught by the researcher, recruitment by another instructor, or blinded/coded data collected by an associate so that subjects are not identified to the instructor.
2. If there is a course requirement that students serve as research subjects in such experiments, students must be informed of the possibility that they may be asked to serve as research subjects in experiments under direction of the faculty before they enroll in the course.
3. Students should be given an opportunity to decline participation without penalty. If there is a course requirement that students serve as research subjects in such experiments, then faculty must provide students with alternative ways to meet this requirement. Students should receive a written description of the various ways of meeting the requirement during the first week of class.
4. Each department that regularly requires students to act as research subjects should establish a committee composed of faculty and students to review the research projects involved.  This committee should be responsible for hearing and acting on any student complaints in connection with the research-participation requirement.
5. Unless the research is directly related to class material, or the study process is being used as a teaching opportunity, such as in a research methods class, the IRB discourages the use of class time to recruit subjects or class time used to complete study instruments, etc.

Family Educational Rights and Privacy Act (FERPA)

The Family Educational Rights and Privacy Act (FERPA) (20 U.S.C. § 1232g; 34 CFR Part 99) is a Federal law that protects the privacy of student education records. The law applies to all schools that receive funds under an applicable program of the U.S. Department of Education.

• Read More Information (ed.gov)
• Rutgers FERPA Student Affairs Compiance Guidance
• Rutgers IRB FERPA Guidance

Procedures For Using Employees as Subjects

1. Researchers who recruit colleagues or subordinates as research subjects must be able to provide a rationale, other than convenience, for this kind of subject selection. In addition, researchers must show that the recruitment method does not lead colleagues or subordinates to think they will face retaliation, poor performance appraisals or other kinds of risks by choosing not participate in the research. Employees, colleagues or subordinates must be given an opportunity to decline participation, at any point, without penalty.
2. All members of the faculty who invite students to act as subjects in their research must be acquainted with the ethical standards that govern such activities, such as those promulgated by the American Psychological Association and other professional organizations, or those in the so-called Belmont Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.  A copy of the latter report is obtainable from ORRA-IRB.

Overview

The Study Management Tools are intended to be used as an aid to help the researcher and research team. This templates provide a general format applicable to all types of research. After choosing the appropriate template, it should be modified to reflect the unique attributes of the study. Additional clinical research study logs may be obtained from NIH’s NCCIH Clinical Research Toolbox:

• https://www.nccih.nih.gov/grants/toolbox
• https://www.nimh.nih.gov/funding/clinical-research/clinical-research-toolbox/nimh-clinical-research-toolbox 

Logs:

Overview

Researchers may pay research subjects for their participation or provide reimbursement for their expenses, but the incentive or payment arrangements must be disclosed to and approved by the IRB and are subject to a stringent review. Subjects are not paid to assume risk, but can be compensated for the time, travel and commitment involved in participating. Payments are not to be considered a benefit to research participation, but a recruitment incentive.

Payment arrangements affect the fairness of recruitment plans, the balance of risks and benefits, and the adequacy of informed consent. Although there are no fixed formulas for determining whether payment plans are acceptable, the IRB will consider the subject population in the proposed research and will ensure that payment arrangements are not coercive and do not pose undue influence. Payment should not encourage subjects to participate or continue to participate against their better judgment.

Reimbursement vs Compensation

• Reimbursement is used when the subject is paid back for some or all out-of-pocket costs for research participation, such as travel expenses, parking, lodging, meals, etc.
• Compensation is "payment" for things such as time commitment, discomfort, participation. Compensation can include monetary (cash, gift cards, etc.) and/or non-monetary (small toys, T-shirts, books etc.) provided to subjects.

Amount of Payment

There is no set amount or limit that an investigator may provide as compensation. Instead, the amount paid to subjects must correspond to the burdens of participation. Payments may also be scaled to the time that subjects spend in a study or to the biological materials they donate. The minimum wage provides a ready baseline for hourly rates for participation, and the Blood Bank's payment scale for plasma and other blood products offers a guideline for compensating subjects for biological materials.

Researchers are encouraged to offer non-monetary items, gift certificates/gift cards, or grocery vouchers rather than cash or checks. If subjects are going to be paid by a University check, it is important to communicate to them that the University must process the check request(s) which can take a few days to a few weeks. When children and adolescents are the subjects, researchers are encouraged to reimburse parents for parking or transportation and give an age-appropriate token payment to the child subject (e.g., a toy for a young subject, a gift card for a teenager).

For clinical studies which involve recurrent follow up visits, Greenphire’s ClinCard, a reloadable debit card system, is available to Rutgers researchers and is the preferred method of payment.

Timing of Payment

Subjects can choose not to participate and/or may withdraw at any time during the study procedures without any penalty to them. It is recommended that subjects should receive at least partial, or a prorated payment should they withdraw from a study, in which the prorated payment is based upon the length of time that the subjects participated. Investigators must specify the amount of compensation and/or RU points that will be prorated in the application/protocol and consent forms, which is typically based on the length of time that the subjects participate. Investigators should also specify in the protocol and consent forms when subjects will receive compensation/reimbursement. Compensation should not be dependent on subjects’ performance (i.e., this is not an acceptable practice). Whether subjects are compensated for their participation or not is irrelevant to how well they perform in the research.

For long term studies or studies that have multiple follow up visits, withholding all payment until participation is complete is perceived to be coercive, as this might influence a subject’s decision on whether to withdraw from the study.  For short term studies (e.g., studies involving a one-time survey or interview, studies lasting a few days), a single payment may be made at the end of the study.  

Clearly outline the amount and schedule of all payments to subjects in the informed consent form.  See the example below for sample consent language:

EXAMPLE:

You will receive $ 15.00 for taking part in this study according to the following schedule:

• $ 5.00 at your first visit
• $ 5.00 at your second visit (2-year visit)
• $ 5.00 at your third visit (4-year visit)

Completion Bonus

A modest completion bonus can be paid as an incentive for a subject's completed participation if the arrangement is thoroughly documented in the consent form. The completion bonus should not be so large as to unduly influence subjects to remain in the study. It also cannot exceed half the total payment provided to subjects. However, subjects may not be compensated for their performance (which is a part of the experimental nature of the study).

Third-Party Payments via Online Platforms

Research may be conducted via online platforms who have their own payment structure (I.e., third- party payors). Third-party payor systems are permissible so long as the third-party payor does not have any known data security issues (researchers must review the site’s privacy policy). Researchers are required to inform their participants that their contact information (e.g., name and email) will be shared by the research team with the third-party payor to provide the incentive without any additional confidential information. These details must be included in the research protocol. 

Use of Attention Checks: Many survey platforms sites include the ability for researchers to reject the work before issuing payment.  For example, Qualtrics has an option to use Attention checks for surveys. Before employing the use of an attention check or filter, please note that these might affect the quality of the data (https://www.qualtrics.com/blog/using-attention-checks-in-your-surveys-may-harm-data-quality/). Qualtrics recommends not using them to improve data quality since they seem to degrade data quality.  It is required that subjects be informed about this aspect upfront on the recruitment flyer and consent document.  with suggested language below on both the recruitment and consent forms.  Suggested language: For your participation in this research, you will be offered $xx.xx. If you miss 2 or more attention filter checks, then your HIT will be rejected, and payment cannot be issued. Please note that data of any rejected HITS are not used but removed. Of course, we expect and hope that you will find this study interesting and enjoyable. If you are still interested, please accept this HIT and follow the instructions below.

Raffles / Lotteries

Please note that lottery drawings and raffles are subject to New Jersey state laws and regulations governing games of chance and are generally discouraged.

Tax Reporting Requirements

If a research subject receives compensation of $600.00 or more per year in income from Rutgers University for any reason, the Internal Revenue Service (IRS) requires the University report it to the IRS and issue an IRS form 1099-MISC, Miscellaneous Income.  

Any additional questions about tax reporting requirements regarding human subject fees and/or payments should be sent to the Rutgers’ Office of the University Controller.

Please note: If your study provides compensation of over $600 to the participants, please include this information in the consent document.

Overview

Advertising Materials are used to encourage or persuade a pool of subjects to become part of your research study.

Guidelines For Providing Information

Advertising may be the first information about research seen by subjects and is most often used in recruitment. It cannot be coercive or make false promises or claims. The process of informed consent is often conceptualized to begin at the recruitment stage.

Additionally, some areas to consider with respect to recruitment include:

• Laws, guidelines, or institutional policies that govern advertising for study subjects, particularly in multi-site research;
• Whether compensation for study volunteers is allowed where the research is proposed, and how it will be noted in recruitment materials;
• What the "norms" for recruiting are in the particular location where recruitment will occur and with the proposed population.

Required IRB Stamps

All Recruitment materials are require to be stamped by the IRB. The stamps will contain an Approved Date and an Expiration Date (if applicable). Any stamped materials which have expired can not longer be used.

You are required to use only the current, IRB-approved document when recruiting subjects. However, the IRB allows you to choose one of following methods to provide a “dated” copy of the Recruitment Materials to subjects:

1. You may either copy the original of the stamped Recruitment Materials, and use the copies, OR;
2. You may type the approval and expiration dates on the bottom of each page of an un-stamped version of the approved Recruitment Materials and use copies of those documents. If you choose to type the dates on an un-stamped copy, the following statement should be used: “This document was approved by the Rutgers University Institutional Review Board for the Protection of Human Subjects on (Date); approval of this form expires on (Expiration Date)”.
3. For Exempt Studies Only (for protocol IRB#s that begin with “E”: e.g., E14-001): If you choose to type the dates on an un-stamped copy, the following statement should be used: “This document was approved by the Rutgers University Institutional Review Board for the Protection of Human Subjects on (Date, fill in with the exact date listed on the approval notice); Currently, there is no expiration on the approval of this document”.

Examples of Advertising Materials

• Flyer   
• Newspaper Ad (Instead of the above IRB Stamping Statement, simply state "This ad was approved by Rutgers IRB").   
• Radio or Television Announcement
• Bulletin Board Tear-Off         
• Internet Posting           
• Poster
• E-mail Invitation
• Facebook Request
• Cold Calls via Telephone/
• Emails or Calls of Membership from Listservs or Company Lists)
• Word-of-Mouth (Verbal Scripts)
• Text Messages
• Oral Scripts for Snowball Recruitment

*Not an Exhaustive List

Elements That Must be Included in Advertisements/Recruitment Materials

1. The location of the research and the person or office to contact for further information;
2. Research project title;
3. A description of the type of research and purpose of the research;
4. The word “research” must be included in the description;
5. Specific location of the research;
6. The name and address of the clinical investigator and/or research facility;
7. The condition under study and/or purpose of the research;
8. In summary form, the criteria that will be used to determine eligibility;
9. A brief list of benefits (e.g. no-cost health examination);
10. The time or other commitment required of subjects;
11. Footer with version # and date. ( Rutgers IRB requirement);

Research Staff Do’s and Do not’s Prior to IRB Submission

Do...

• Do make plain that the solicitation is for the purpose of participation in research and not for the provision of medical care.
• Do use the term “research” when describing the study.
• Do use the term “investigational” if a test article or treatment is referenced in the advertisement.
• Do indicate that the research involves the “investigational use” of an approved drug if applicable to the study.
• Do make sure that the material complies with applicable state and local laws and institutional or IRB policies.
• Do submit the material in final format, including site-specific information as appropriate and graphics that will be used.
• Do submit radio and television scripts for IRB review before production of the recording is started.
• Do submit final recordings for IRB review and approval prior to broadcast.
• Do read radio scripts for live broadcast exactly as approved by the IRB.

Do Not....

• Do not use language or graphics that may be coercive or misleading.
• Do not state or imply a guarantee of benefits, cures, or favorable outcomes.
• Do not emphasize “free” treatment or study products.
• Do not claim the study product or treatment is safe, effective, equivalent, or superior to other options when it is investigational.
• Do not place emphasis on payment, including bolding or highlighting the compensation language.
• Do not use the terms “safe,” “effective,” “new,” “best,” “cure,” “treatment,” “therapy,” or “free.”

For FDA Regulated Studies

• Read More About Guidance regarding FDA regulated advertisements
• Recruiting Study Subjects
• SACHRP Recruitment Recommendations

Overview

When proposing to enroll adults who lack decisional capacity—persons with cognitive impairments, lack of capacity, or serious physical or behavioral conditions and life-threatening diseases—in medical research conducted in New Jersey, the research must comply with NJ State Statute 26:14.1-14.5 concerning how and from whom to obtain informed consent for their participation in the research. The following guidance provides direction on the process for assessing decisional capacity of an adult, who may serve as a surrogate and what information must be provided in order to obtain informed consent. When conducted outside of New Jersey, the research must comply with the applicable surrogacy laws in the jurisdictions where the research is taking place. Be sure to reference applicable laws in the protocol.

Investigator Responsibilities

IRB Approval

The investigator must apply to the IRB for use of surrogate consent that is specific to the study being reviewed. Upon approval by the IRB, the investigator shall apply the use of surrogate consent on a case-by-case basis within that protocol.

New Studies: The investigator must indicate in the e-IRB Application for Initial Review that the research plans to use a surrogate consent process to enroll adults lacking decisional capacity in the research. The protocol must describe the plans for determining an adult’s lack of capacity to consent, selecting a surrogate and the consent process, whether assent will be obtained from all, some or none of the adult subjects lacking the capacity to consent, selecting a witness to the consent process, and safely removing subjects from the research, if applicable.

An investigator must receive IRB approval prior to implementing surrogate consent procedures for a specific study.

Ongoing Studies: If an investigator decides to utilize the surrogate consent process for a Study that has already received IRB approval, submit a Request for Modification Form [in e-IRB if electronic] as well as a revised Protocol Section 4.5D reflecting the research plan to obtain surrogate consent.

An investigator must receive IRB approval for this modification prior to implementation of surrogate consent procedures for a specific study.

Assessing Adult Capacity to Consent

1. Whenever possible, investigators will attempt to obtain informed consent directly from the subject.
2. If the subject has an Advance Directive for healthcare and has indicated that s/he does not wish to participate in a research study, the potential subject must not be included in the study.
3. A determination that the subject is unable to consent, as well as the extent of the incapacity and the likelihood that s/he will regain decision-making capacity, must be made by an attending physician with no connection to the study. This determination must be documented in the medical and research record by the attending physician making the determination. Subjects must be periodically reassessed for capacity, as applicable, and reconsented if they regain decision-making capacity. (See Section F If a Subject Regains Decisional-Capacity)
   
   For purposes of this section, inability to consent shall mean that a subject is unable to voluntarily reason, understand, and appreciate the nature and consequence of proposed health research interventions, including the subject’s diagnosis and prognosis, the burdens, benefits, and risks of, and alternatives to, any such research, and to reach an informed decision.
4. The investigator must assure that the determination of incapacity is promptly given to the subject and to at least one person at the highest category reasonably available on the list of surrogates in subsection C3 below.
5. For more information, see HRP-390 Worksheet: Surrogate Consent - Determining Decisional Capacity               

Selecting a Surrogate

1. If the investigator believes that a subject lacks decision-making capacity, the investigator shall inform the subject about the study and of the investigator’s intention to seek a surrogate to provide consent.
2. If the subject expresses resistance or dissent to participation or to the use of a surrogate for consent, the investigator must exclude the subject from the study.
3. Surrogate informed consent must be obtained from an authorized representative with reasonable knowledge of the subject, who shall include any of the following persons, in the following descending order or priority:
   1. The guardian of the subject with the authority to make health care decisions;
   2. The health care representative pursuant to an advance directive for health care;
   3. The spouse or civil union partner;
   4. A domestic partner;
   5. An adult son or daughter;
   6. A custodial parent;
   7. An adult brother or sister;
   8. And adult grandchild; OR
   9. An available adult relative with the closest degree of kinship.
4. The investigator must make a good faith effort to contact the individual at the highest level of priority. Potential surrogates must be advised that if a higher-ranking surrogate is identified at any time, the investigator whenever feasible will defer to the higher-ranking surrogates’ decision regarding the subject’s participation in the research.
5. The investigator must assure that if one of two or more available persons in the same order or priority expresses opposition to the participation of the subject in the study, the investigator must exclude the subject from the study.
6. The investigator must assure that when two or more available persons are in different orders of priority, refusal to consent by a potential surrogate who is of a higher priority controls and cannot be superseded by the consent of a person who is of a lower priority.
7. For more information, see HRP-391 WORKSHEET: Surrogate Consent - Selecting a Surrogate which serves as a guide on how to select a surrogate at the highest level of priority consistent with State law.

Obtaining Surrogate Consent

1. Surrogates for a potential research subject may not receive financial compensation for providing consent. ​​​​
2. The investigator or designee must orally review each element included in the Surrogate Consent Form with the surrogate. This oral review must be in non-technical terms and in a language in which the surrogate is fluent.
3. The investigator must assure that a copy of the Surrogate Consent Form is given to the surrogate.
4. The written consent form is signed and dated by a person, who is not the subject, his guardian or authorized representative, or the investigator, and who can attest that the requirements for informed consent to the medical research has been satisfied. NOTE: Check with the facility where surrogate consent will occur to determine if they have any rules around who may serve as a witness.
5. If the surrogate does not speak English, NJ State Statute does not allow the use of a short form surrogate consent. The surrogate long-form consent must be translated into the language the surrogate understands.

Documentation of Consent

The principal investigator must use a study-specific, IRB-approved Surrogate Consent Form and ensure that:

• The subject’s surrogate signs and date the Surrogate Consent Form.
• The principal investigator or his/her designee signs and dates the Surrogate Consent Form.
• The Surrogate Consent Form is signed and dated by a witness who is not the subject, the subject’s guardian, surrogate, or member of the research team, and who can attest that the requirements for informed consent to the study have been satisfied.

In all cases involving the use of a surrogate, the principal investigator, or his/her IRB- approved designee obtaining surrogate consent shall file a completed Surrogate Consent Form in both the medical and research records.

The determination of a subject’s incapacity to consent to study participation by the physician making the determination must be documented and retained in both the medical and research records. This documentation must be retained as part of the permanent source documents for the IRB-approved study.

Obtaining Subject Assent

An adult unable to provide informed consent to participate in research may be capable of communicating a preference to take part, or not, in research. That is, they may be able to assent even though it has been determined they cannot legally consent to participation. An IRB may determine that assent of some or all the adult subjects who lack decisional capacity should be obtained. If assent is not required of some adults, the IRB will indicate which adults (e.g., individuals with severe dementia) should not be asked to assent. Notwithstanding an IRB’s decision, an investigator may determine on a case-by-case basis that the capability of an individual subject may be so limited that the subject cannot reasonably be consulted to assent.

The assent process, when conducted, must include the basic elements of informed consent and are to be provided in language appropriate for an adult with diminished decision-making capacity, based on the nature of the study and the expected ability of the prospective subject(s) to understand the purpose and procedures involved in the research. An investigator may wish to consider conducting the assent process simultaneously with the surrogate consent process (i.e., potential subject and surrogate together during assent and consent discussion). The protocol must reflect details for assenting subjects when applicable to the research and required by the IRB.

If a subject expresses resistance or dissent to participation or to the use of a surrogate for consent, the investigator must exclude the subject from the study. [NOTE: Mere lack of objection by subjects should not be interpreted as assent.] If a subject expresses dissent only to a component of a study and not to participation in the study as a whole, the investigator may consider returning at a later point and see whether the subject is willing to undergo the procedures involved in that component. However, if a subject dissents repeatedly to participation in a component of a study, s/he should be withdrawn from that component and, if necessary, from the study. If a dissenting subject cannot be withdrawn from a study or component of a study for medical or safety reasons, s/he should be kept on the study intervention under compassionate use or off-label use, if possible and applicable to the research. Contact the IRB when such circumstances arise.

Documentation of Assent

Investigators may: (a) add a signature block to the assent form to document subject assent; or (b) add the assent signature block to the surrogate consent form if the surrogate and adult subject will meet together with the investigator for the consent/assent process. Alternatively, the IRB may decide that documentation of assent is not warranted. If verbal assent will be obtained, the IRB will review a written description, or script, of the information the investigator will provide to potential subjects during the assent process. A statement may be added to the surrogate consent form to document verbal assent occurred. The assent form template and surrogate consent form template complete with signature block examples are available at HRPP Toolkit.

If a Subject Regains Decision-Making Capacity

In the event that a subject regains decisional capacity to consent to participation in the study, the Investigator must assure that the subject is promptly consented using standard consent procedures.

IRB Responsibilities

In order to approve the use of a surrogate in a study, the IRB must determine and document that the research involves individuals who have cognitive impairments, lack of capacity, or serious physical or behavioral conditions and life-threatening diseases and either:

1. offers the prospect of direct benefit to the subject, provided that the IRB has determined that the risk is justified by the anticipated benefits and that the relation of the anticipated benefit to the risk is at least as favorable to the subject as that presented by available alternative approaches. If a currently recognized treatment exists, the subject, guardian, or surrogate shall be presented with the choice of the recognized treatment and the research protocol;
2. ​does not offer the prospect of direct benefit to the subject, provided that the IRB has determined that it: (1) is likely to yield generalizable knowledge about the subject’s disorder or condition; (2) by its very nature cannot be conducted without the participation of decisional incapacitated persons as subjects; and (3) involves no more than a minor increase over minimal risk. “Minimal risk” means that the probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during the performance of routine psychological exams or tests.

The IRB will evaluate whether:

1. The proposed plan for the assessment of the capacity to consent is adequate;
2. Assent of the subjects is required and, if so, whether the plan for obtaining assent is adequate; and
3. Documentation of assent is warranted.

The effectiveness of procedures for obtaining the assent of subjects who cannot consent will be considered at initial and continuing IRB reviews, if applicable.

The IRB must ensure that all the following elements are specified in the approved Surrogate Consent Form in nontechnical terms and in a language in which the subject or the subject’s guardian or authorized representative is fluent:

1. an explanation of the procedures to be followed in the study and any drugs or devices to be utilized, including:
   • the purposes of the procedures, drugs, or devices;
   • the use of placebo controls, when applicable;
   • the process by which persons will be assigned to control groups.
2. an explanation of any potential direct benefits to the subject. If no such direct benefits are reasonably expected, that fact should be made clear.
3. a description of any attendant discomfort and reasonably foreseeable risks to the subject.
4. ​​​​​​​a disclosure of any appropriate alternative procedures, drugs or devices that might be advantageous to the subject, and their relative risks and benefits.
5. ​​​​​​​an estimate of the expected duration of the study.
6. ​​​​​​​the name, institutional affiliation, and address of the person or persons actually performing and primarily responsible for the conduct of the study;
7. ​​​​​​​an offer to answer any inquiries concerning the study or the procedures involved; and
   • ​​​​​​​whom to contact for answers to pertinent questions about the study;
   • ​​​​​​​whom to contact in the event of a study-related injury; and
   • ​​​​​​​contact information for the institutional review board; and
   • ​​​​​​​the name, address, and phone number of an impartial third party, not associated with the research to whom the subject/surrogate may address complaints.
8. ​​​​​​​instruction to the subject or surrogate that he/she is free to withdraw consent and discontinue participation in the study at any time, without prejudicing the subject’s medical treatment outside the study;
9. ​​​​​​​a statement regarding the Investigator’s plan to safely remove a subject from the study and any consequences of abruptly ending participation in the study;
10. ​​​​​​​the name of the sponsor or funding source, if any, or manufacturer if the study involves a drug or device, and the organization, if any, responsible for the general direction of the study; and
11. ​​​​​​​the material financial stake or interest, if any, that the investigator or research institution has in the study. (For purposes of this section, “material” means $10,000 or more in securities or other assets valued at the date of disclosure, or relevant cumulative salary or other income, regardless of when it is earned or expected to be earned or as otherwise determined by the institution.)

An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent for research that is minimal risk as set forth in Section 45 CFR 46.116(f)(3).

An IRB may not approve a Short Form Consent for research proposing to obtain surrogate consent when NJ law applies.  

An IRB or designated reviewer must complete and satisfy HRP-314 WORKSHEET: Criteria for IRB-Approval and HRP-417 CHECKLIST: Adults with Impaired Decision-Making Capacity before approving research proposing to include adults represented by a surrogate for consent.

Overview

The conditions under which an IRB may waive the requirement for obtaining informed consent or parental permission or may approve a consent procedure that leaves out or alters some or all of the elements of informed consent derive from four sources in the HHS regulations.

1. At 45 CFR 46.116(c), the regulations identify when IRBs may waive or approve an alteration of informed consent in some research examining state or local public benefit or service programs, or certain features of those programs.
2. At 45 CFR 46.116(d) the regulations identify when IRBs may waive or approve an alteration of informed consent in research that meets four specified criteria.
3. At 45 CFR 46.408(c), the regulations identify when IRBs may approve waiver of parental permission in certain research involving children.
4. Under the provisions of 45 CFR 46.101(i), the Secretary, HHS, has waived the general requirements for obtaining informed consent in a limited class of research in emergency settings.

Oral Consents

According to DHHS (45 CFR 46.117), an IRB may allow waiver of a signed consent document in either of the following circumstances:

• The consent would be the only link between the research and the subject and the principal risk to the subject would be due to a breach of confidentiality, and each subject will be asked if they want consent to be documented.
• Study participation presents minimal risk of harm to the subject and the research involves no procedures requiring consent outside the context of participation in a research study.
• The investigator may be required by the IRB to provide a written summary about the research to the subject if either of these methods is used.

Waiver of Consent Documentation

An IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either:

1. That the only record linking the subject and the research would be the consent document, and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern; or
2. That the research presents no more than minimal risk of harm to subjects, and involves no procedures, for which written consent is normally required outside of the research context.

In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research.

1. Waiver of Documentation of informed consent.
   • The IRB may waive the requirement for written documentation of informed consent (45 CFR 46.116), if it finds and documents either of the following:
     • Signed consent is the only record linking the subject to the research and the greatest risk of the research is a breach of confidentiality;
     • The research presents no more than minimal risk and involves procedures for which consent wouldn't normally be obtained outside of the research context.
2. Waiver of some or all of the elements of informed consent be waived.
   1. Consent is required from any human subject in research unless informed consent has been specifically waived by the IRB.
      1. The IRB may waive consent under two sets of circumstances:An IRB may approve a consent procedure, which does not include, or which alters, some or all of the elements of informed consent set forth in this section, or waive the requirements to obtain informed consent, provided the IRB finds and documents that either of the following apply:
      2. The research or demonstration project is to be conducted by, or subject to the approval of, state or local government officials, and is designed to study, evaluate, or otherwise examine:
         1. (i) public benefit or service programs;
         2. (ii) procedures for obtaining benefits or services under those programs;
         3. (iii) possible changes in or alternatives to those programs or procedures; or
         4. (iv) possible changes in methods or levels of payment for benefits or services under those programs; and the research could not practicably be carried out without the waiver or alteration.  Please note that most projects do not qualify under this subpart.
      3. The research involves no more than minimal risk to the subjects; the waiver or alteration will not adversely affect the rights and welfare of the subjects; the research could not practicably be carried out without the waiver or alteration; and whenever appropriate, the subjects will be provided with additional pertinent information after participation.

IMPORTANT: A Waiver of Consent Documentation is not a waiver to skip the whole consent process!!!

Waiver of Parental Consent or Child Assent

Parental Consent: The IRB must determine that adequate provisions are made for soliciting the assent (agreement) of the children, when in the judgment of the IRB the children are capable of providing assent. Assent is usually required in addition to parental permission; in rare cases, the requirement for parental permission may be waived (see Section 2, item d. in the Parental Permission section below).

• Waiver of Parental Consent: §46.408 (c):  (c) In addition to the provisions for waiver contained in §46.116 of subpart A, if the IRB determines that a research protocol is designed for conditions or for a subject population for which parental or guardian permission is not a reasonable requirement to protect the subjects (for example, neglected or abused children), it may waive the consent requirements in subpart A of this part and paragraph (b) of this section, provided an appropriate mechanism for protecting the children who will participate as subjects in the research is substituted, and provided further that the waiver is not inconsistent with federal, state, or local law. The choice of an appropriate mechanism would depend upon the nature and purpose of the activities described in the protocol, the risk and anticipated benefit to the research subjects, and their age, maturity, status, and condition.

Assent of Children: Permission from one or more parents is required when a minor will be involved in research. Assent (agreement) from the child may or may not be required, depending upon the particular study and characteristics of the child (see Assent of Children section above). Under very specific circumstances, the requirement for parental permission may be waived by the IRB (see item d. below). Sections a. through c. that follow describe the circumstances under which the permission of either one or both parents is required.

• Waiver of Consent: If the IRB determines that the capability of some or all of the children is so limited that they cannot reasonably be consulted or that the intervention or procedure involved in the research holds out a prospect of direct benefit that is important to the health or well-being of the children and is available only in the context of the research, the assent of the children is not a necessary condition for proceeding with the research. Even where the IRB determines that the subjects are capable of assenting, the IRB may still waive the assent requirement under circumstances in which consent may be waived in accord with §46.116 of Subpart A (§46.408(a)) and §46.408 (b).

Consents Given Via Telephone

Documentation of informed consent is required by DHHS 45 CFR 46 unless a waiver of documentation is granted by the IRB. The regulations dictate that the signature must be the subject's or the subject's legally authorized representative. DHHS guidance regarding informed consent can be found at OHRP's FAQs. DHHS does allow the exchange of consent information to take place face-to-face or by mail, telephone, fax or video. Unlike the FDA, however, DHHS does not specifically say that the signatures for informed consent can be obtained via fax.

Forms

• Waiver Of Informed Consent & HIPAA Privacy Rule Authorization Form (see templates and forms)

Criteria for Alternate Method/Waiver of Consent for Research & Privacy Of Individually Identifiable Health Information (HIPPA)

CRITERIA FOR ALTERNATE METHOD/WAIVER OF CONSENT FOR RESEARCH &

PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION (HIPAA)

Researchers using identifiable health information must provide the following for IRB review to obtain a waiver of consent.

1. Use or disclosure is sought solely to review protected health information as necessary to prepare a research protocol or for similar purposes preparatory to research.
2. Assurance that no protected health information will be removed from Rutgers University by the researcher in the course of the review.
3. The protected-health information for which use is sought is necessary for research purposes.
4. Research on descendant's information includes a representation that the use or disclosure is sought solely for research on the protected health information of descendants.
5. That the use or disclosure of protected information involves no more than minimal risk to individuals.
6. The waiver provided by the IRB will not adversely affect the privacy rights and welfare of individuals.
7. The research could not practically be conducted without the alteration or waiver.
8. The privacy risks to individuals whose protected health information is to be used or disclosed are reasonable in relation to the anticipated benefits, if any, to individuals and the importance of the knowledge that may reasonably be expected to result from the research.
9. There is an adequate plan to protect the identifiers from improper use and disclosures.
10. There is an adequate plan to destroy the identifiers at the earliest opportunity consistent with conduct of the research, unless there is a health or research justification for retaining the identifiers, or such retention is otherwise required by law.
11. There is adequate written assurances that the protected information will not be reused or disclosed to any other person or entity except as required by law, for authorized oversight of the research project, or for other research for which the use or disclosure of protected health information would be permitted.
12. Protected health information needed.  A brief description of the protected health information for which use or access is requested.

• FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic: Guidance for Industry, Investigators, and Institutional Review Boards 3.27.20 [PDF]
• Understanding the Definition of a Clinical Trial and What That Means for You (8min Audio File)
• Overview of New NIH Policies on Human Subjects Research and Clinical Trials (15min Video)
• OHRP's Frequently Asked Questions About Human Research
• Hiring of Survey Vendors (hhs.gov)
• Guidance Policy on Wearable Medical Devices (PDF File)
• A Guide to Informed Consent - Information Sheet (FDA.gov)
• Enforcement Activity Statistics Summary (FDA.gov)
• Off-Label and Investigational Use of Marketed Drugs, Biologics, and Medical Devices (FDA.gov)
• Rigor and Reproducibility in NIH Applications (NIH.gov)

• International Council for Harmonisation (ICH) Guidelines
• Best Practices in Clinical Research Protocol Writing: Eight Tips From An IRB Member (kinetiqideas.com, 2016, PDF)