What are Research Protocol Templates?
Research Protocol Templates serve as a starting point when crafting a Research Protocol document. Templates contain all required elements for Rutgers IRB approval and detailed instructions.
Research Protocol Templates
(HRP-503a) Interventional Research Protocol
This template should be used by biomedical and social-behavioral researchers conducting research in which subjects are assigned to receive one or more interventions so that the researchers can evaluate their effects (e.g. clinical trials, CBT, Behavioral Modification studies, or randomized outcome studies.
(HRP-503b) Non-Interventional Research Protocol
This template should be used by social-behavioral and biomedical researchers to prepare a protocol document for any research involving various types of interactional or observational methodologies: observations, interviews, focus groups, surveys, program evaluations, quality of life or interactional research.
(HRP-503c) Secondary Research With Data Or Biospecimens Protocol Template
To be used by biomedical and social-behavioral investigators proposing secondary research with data—which may include written text, images or audio-/visual-recordings—or biospecimens that were or will be collected for other purposes. This template replaced the Retrospective Chart/Record Review Protocol.
(HRP-503d) Data/Tissue Repository SOP
For investigators who wish to develop standard operating procedures in order to establish a research [tissue or data] bank, otherwise known as a repository. This SOP template may be submitted to the IRB instead of the applicable Rutgers IRB Research Protocol Template.
(HRP-503e) CINJ Application and Protocol for Exempt Research
This template must be used by RCINJ Investigators submitting proposed exempt research in eIRB through the Fast Track Exempt Review Process.
(HRP-503f) Humanitarian Use Device Protocol Template
This template should be used by clinicians planning to provide patients access to a Humanitarian Use Device (HUD) in the clinical context. If the HUD is being used in a clinical investigation to evaluate its safety and effectiveness, either for the HDE-approved indication(s) or for a different indication, please use HRP-503a Interventional Protocol Template instead.
(HRP-508) Local Context Supplement
A Local Context Supplement (LCS) must be completed and submitted to the IRB when a Rutgers Investigator proposes to collaborate with one or more other institutions and Rutgers is not the lead site. In such cases, the Rutgers Investigator must disclose in the LCS what specific research tasks s/he will perform, where the tasks will be performed, and what/how data will be held by Rutgers and/or transferred between collaborating institutions. Other information may be requested by an IRB to learn more about the local context.
What are Consent Templates?
Consent templates and passages found below provide language to use when obtaining informed consent or assent from individuals to take part in human research. Choose the template and passages that best reflect the research and subject population to be enrolled.
General Consent Templates
General consent templates contain all required informational elements when a study poses greater than minimal risks of harm or plans to enroll a vulnerable population (i.e., children, adults lacking decisional capacity, etc.)
- (HRP-502a) Adult Consent Form: Interventional
- (HRP-502b) Adult Consent Form: Non-Interventional
- (HRP-502c) Parental Permission Form: Interventional
- (HRP-502d) Parental Permission Form: Non-Interventional
- (HRP-502e) Surrogate Consent Form: Interventional
- (HRP-502f) Surrogate Consent Form: Non-Interventional
- (HRP-502n) Assent Form: Interventional
- (HRP-502p) Assent Form: Non-Interventional
Surrogate Consent Process
When the research plans to enroll adults who lack decisional capacity, follow the Surrogate Consent Guidance. Use the appropriate Surrogate Consent Template (above) and applicable worksheets (below).
Customized Consent Templates
Customized consent templates contain all required informational elements when a study poses minimal risks of harm under specific research design scenarios.
- Anonymous Data Collection Consent Form
- Debriefing Statement (For Studies Involving Deception or Concealment)
- Informed Consent for Emergency Treatment with an Unapproved Article or Compassionate Use of an Unapproved Medical Device (506)
- Interview Research Consent Form
- Mobile/Electronic Device Or Technology Consent Form
- Online Survey/Questionnaire Consent Form
- Paper Survey/Questionnaire Consent Form
- Research Repository (Data and/or Biospecimens) Consent Form
- (HRP-502g) Humanitarian Use Device (HUD) Consent Form
Special Consent Passages
Special consent passages must be added to the body of the consent document when specific laws or regulations apply to the research.
When a study plans to offer/enroll subjects in optional research activities secondary to the main study, append the appropriate addenda to the end of the consent document for the main study.
- Addendum Consent to Audio or Visually Record or Photograph Subject For Research
- Addendum Consent to Store (Bank) Identifiable Data or Biospecimens Collected in the Main Study for Future Research
- Addendum HIPAA Authorization to Collect Protected Health Information (For CINJ NCI Adult Studies Only)
- Addendum HIPAA Authorization to Collect Protected Health Information (For CINJ NCI Pediatric Studies Only)
- Certificate of Confidentiality Language [CoC]
- ClinCard Addendum Consent
- ClinCard Parental Permission
Non-English Short Forms
When the research plans to enroll individuals who cannot read or write, cannot see, cannot hear, or who do not speak/read English well, follow the instructions below to include the services of an interpreter, witness and/or translator, as applicable. When the Short Form of Consent Process will be used to enroll individuals who cannot read/write English well, use TEMPLATE HRP-507.
- Short Form Consent Forms:
- English (507)
- Chinese [Simplified]
- Chinese [Traditional]
- Haitian Creole
- Certificate of Translation Form (For Translated Document)
- Signature Page Template For Non-English Speakers
- Statement of Translator Qualifications and Confirmation of Translation Form (For Translator)
- Translator Qualifications and Assurances Instruction
- Witness and Interpreter Consent Documentation Instruction
A collection of different toolkit documents used for studies involving External institutions. The Human Research Protection Program Toolkit contains documents required to establish a reliance agreement when an External Institution is relying on Rutgers University to serve as the IRB of Record.
- (HRP-336) WORKSHEET - External IRB
- (HRP-802) SOP - Institutional Profile Management
- (HRP-811) FORM - Basic Site Information
- (HRP-830) WORKSHEET - Communication and Responsibilities
- (HRP-890) FORM - Single Study Authorization Agreement
- (HRP-892) SOP - External IRBs
- (HRP-892a) SOP - WIRB
- (HRP-892b) SOP - Advarra IRB
- (HRP-893) SOP - RU As IRB of Record
- (HRP-1801) WORKSHEET - Authorization Agreement Review
- (HRP-1812A) FORM - Local Clinical Site Information
- (HRP-1812B) FORM - Local Non-Clinical Site Information
What are Standard Operating Procedures (SOPs)?
SOPs are similar to instruction manuals as they detail steps of the IRB review process and policies that guide human subject research review.
Standard Operating Procedures
- (HRP-001) Definitions
- (HRP-012) Observation of Consent Process
- (HRP-013) LARs, Children, and Guardians
- (HRP-020) Incoming Items
- (HRP-021) Pre-Review
- (HRP-023) Emergency Use, Compassionate Use, Indiv Patient Expanded Access
- (HRP-024) Reportable New Information
- (HRP-024a) Allegations of Non-Compliance Protocol Deviations-Violations and Subject Complaints
- (HRP-024b) Complaint Or Allegation Intake Form
- (HRP-024c) Review of Unanticipated Problems to Subjects or Others or Adverse Events
- (HRP-026) Suspension or Termination Issued Outside of Convened
- (HRP-028) Post Approval Monitoring
- (HRP-030) Designated Reviewers
- (HRP-031) Non-Committee Review Preparation
- (HRP-032) Non-Committee Review Conduct
- (HRP-040) IRB Meeting Preparation
- (HRP-041) IRB Meeting Conduct
- (HRP-042) IRB Meeting Attendance Monitoring
- (HRP-043) IRB Meeting Minutes
- (HRP-044) Not Otherwise Approvable Research
- (HRP-050) Conflicting Interests of IRB Members, Ex Officio Members and IRB Staff
- (HRP-051) Consultation
- (HRP-052) Post-Review
- (HRP-055) Financial Conflicts of Interests
- (HRP-060) Annual Evaluations of the HSPP
- (HRP-061) Evaluations of the HSPP
- (HRP-062) Tasks
- (HRP-063) Expiration of IRB Approval
- (HRP-064) NIH GDS Institutional Certification
- (HRP-070) IRB Records
- (HRP-071) Standard Operating Procedures
- (HRP-072) IRB Records Retention
- (HRP-080) IRB Formation
- (HRP-081) IRB Removal
- (HRP-082) IRB Membership Addition
- (HRP-083) IRB Membership Removal
- (HRP-084) IRB Meeting Scheduling and Notification
- (HRP-090) Informed Consent Process For Research
- (HRP-091) Written Documentation of Consent
- (HRP-096) GDPR Review Procedures
- (HRP-101) Human Subjects Protection Program Plan
- (HRP-103) Investigator Manual: A Guide To Human Subjects’ Protection In Research
- (HRP-103a) Investigator Manual - All Appendices
- (HRP-103p) pSite Investigator Manual
- (HRP-105) Manual - Student Handbook: A Guide To Human Subjects Protection in Research
- (HRP-199) COVID-19 Risk Mitigation Planning
- (HRP-802) Institutional Profile Management
- (HRP-803) Site Validation
- (HRP-804) Site Pre-Review
- (HRP-805) Site Updates
- (HRP-892) External IRBs
- (HRP-892a) WIRB
- (HRP-892b) Advarra IRB
- (HRP-893) RU As IRB of Record
What are Manuals & Handbooks?
Manuals and handbooks contain required reading for researchers looking to learn about the main aspects of Human Subjects Research.
What are Checklists?
Checklists are used to document regulatory decisions by the IRB Board and the IRB Office. Researchers can review these documents to see how their project will be evaluated and ensure all elements are addressed prior to the initial review.
- (HRP-319) Limited IRB Review And Exempt Research When HIPAA Applies
- (HRP-333) Certificate of Confidentiality (CoC)
- (HRP-401) Pre-Review Checklist
- (HRP-402) Non-Committee Review
- (HRP-410) Waiver or Alteration of Consent Process
- (HRP-411) Waiver of Written Documentation of Consent
- (HRP-412) Pregnant Women
- (HRP-413) Non-Viable Neonates
- (HRP-414) Neonates of Uncertain Viability
- (HRP-415) Prisoners
- (HRP-416) Children
- (HRP-417) Adults with Impaired Decision-Making Capacity
- (HRP-418) Non-Significant Risk Device
- (HRP-419) Waiver of Consent Process for Emergency Research
- (HRP-430) Investigator Quality Improvement Assessment
- (HRP-430a) Post Approval Monitoring Self-Assessment Drug or Device Clinical Trial
- (HRP-430b) Post Approval Monitoring Self-Assessment Participant File
- (HRP-430c) Post Approval Monitoring Self-Assessment Biomedical Research
- (HRP-430d) Post Approval Monitoring Self Assessment Social Behavioral Research
- (HRP-430e) Post Approval Monitoring Self-Assessment - Humanitarian Use Device
- (HRP-431) Minutes Quality Improvement Assessment
- (HRP-441) HIPAA Waiver of Authorization
What are Worksheets?
Worksheets are used by IRB staff and researchers to assist in regulatory decisions. Researchers can review these documents to see how their project will be evaluated and ensure all elements are addressed prior to the initial review.
- (HRP-301) Review Material
- (HRP-302) Approval Intervals
- (HRP-304) IRB Composition
- (HRP-305) Quorum and Expertise
- (HRP-306) Drugs and Biologics HURON
- (HRP-307) Devices
- (HRP-308) Pre-Review
- (HRP-308a) MA Pre-Review
- (HRP-308b) PA Preliminary Administrative Review (PAR)
- (HRP-308c) Router and IRBA CR
- (HRP-310) Human Research Determination
- (HRP-311) Engagement Determination
- (HRP-312) Exemption Determination
- (HRP-313) Expedited Review
- (HRP-314) Criteria for Approval
- (HRP-315) Advertisements
- (HRP-316) Payments
- (HRP-317) Short Form of Consent Documentation
- (HRP-318) Additional Federal Agency Criteria
- (HRP-320) Scientific or Scholarly Review
- (HRP-321) Review of Reportable Events
- (HRP-322) Emergency Use
- (HRP-323) Criteria for Approval HUD
- (HRP-324) Contracts
- (HRP-325) Device Compassionate Use
- (HRP-326) Performance Evaluation IRB Chair
- (HRP-326a) IRB Member Self Assessment
- (HRP-327) Performance Evaluation IRB ViceChair
- (HRP-328) Performance Evaluation for IRB Staff
- (HRP-330) HIPAA Authorization
- (HRP-331) FERPA Compliance
- (HRP-332) NIH GDS Institutional Certification
- (HRP-334) Quality Activity Determination
- (HRP-335) GDPR Compliance - Data Protection And Privacy
- (HRP-336) External IRB
- (HRP-349a) When CR Applies to Minimal Risk Research per Revised Common Rule
- (HRP-349b) Extended Interval Approvals
- (HRP-390) Surrogate Consent Process Determining Decisional Capacity
- (HRP-391) Surrogate Consent - Selecting a Surrogate
- (HRP-830) Communication and Responsibilities
- (HRP-832) Considerations for Ceding IRB Review
- (HRP-833) Considerations for Serving as the sIRB
Performance Site Approval Forms
When research plans to conduct or engage non-Rutgers sites in human research, the forms below assist the research in documenting approval between Rutgers and the non-Rutgers sites.
General Site Approval Form
If a project plans to conduct research with staff, students, patients or members of any non-Rutgers institution/organization/school (but not engage them as research personnel), use template HRP-504 (below) to document the agreement between parties.
Performance Site Approval Forms
Performance Site approval documentation is required for all research involving any site below which includes systematic participant recruitment, research impacting site staff time, and/or research impacting site financial reimbursement. All research activity at a performance site cannot proceed until the PI receives approval from the Rutgers IRB and the performance site.
Examples of research activities requiring Performance Site Approval: Recruiting on-site, Using hospital staff to provide a service, Using hospital staff as study personnel, Using a room, Using equipment, Accessing medical records (including chart reviews), etc.
- Complete a Research Utilization Group (RUG) form Online Printable Form (Rutgers VPN required if accessing outside the Rutgers network). For questions email RUG Support.
- Submit your completed RUG Form online. It does not have to be approved before your eIRB request is submitted for review.
- Once approved by the RWJUH RUG Committee, attach your approved RUG Form to your eIRB submission and ensure RWJUH is listed as a site for your study in eIRB.
University Hospital UHNJ, Newark (affiliated with the New Jersey Medical School)
- Determine if your study requires “University Hospital Registration” and/or “NJMS Office of Clinical Research Administration (OCRA)" review.
- If yes, your study must have both of the following included in eIRB:
- Add "University Hospital" as a performance site in your eIRB application.
- Your "OCRA confirmation email" should be attached with your eIRB submission to provide proof of registration and/or review.
- ***Please note that University Hospital will not provide final approval for a study until after it has been approved by the IRB. You will be directed in the confirmation e-mail from NJMS-OCRA to forward your IRB approval notice once received, so that the UH registration/approval process can be completed.
- Using a UBHC Human Subject Research Form, obtain site approval from UBHC before submitting your study to the Rutgers IRB.
- Complete the following actions when you submit your study in eIRB:
- Add UBHC as a research site.
- Attach your approved UBHC Human Subject Research Form in your eIRB submission.
These documents are used for active paper studies only.
General Paper Forms
- Addendum HIPAA Protected Health Information [ArtSci]
- Continuing Review:
- For NCI CIRB Studies
- Deviation Report Form:
- Expired Study Form
- Expired Study Report Form:
- Final Study Report/Study Closure For Paper Studies
- Unanticipated Problems / Adverse Events Report Form: