Identifying Human Subject Research

Research (HHS §46.102 (l))  means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities. 

Human Subject (HHS §46.102 (e)(1)) means a living individual about whom an investigator (whether professional or student) conducting research:

1. Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
2. Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

Engaged in Research (Institutional Level): Rutgers University is engaged in a non-exempt human subjects research project, when its employees or agents for the purposes of the research project obtain:

1. data about the subjects of the research through intervention or interaction with them;
2. identifiable private information about the subjects of the research; or
3. the informed consent of human subjects for the research.

An institution is not considered engaged in human subjects research when the institution permits use of its facility to investigators from another institution or when its agents only conduct the following activities. More Information Including "Non-engaged" Scenarios.

No research activities involving human subjects may commence until the IRB has reviewed and approved the protocol and sent an official Notice of Approval via e-mail.

Definitions:

• Intervention includes both physical procedures by which information or biospecimens are gathered (e.g., venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.
• Interaction includes communication or interpersonal contact between investigator and subject.
• Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record).
• Identifiable private information is private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information.

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The Office for Human Research Protections (OHRP) provides decision charts as a guide for institutional review boards (IRBs), investigators, and others who decide if an activity is research involving human subjects that must be reviewed by an IRB under the requirements of the U.S. Department of Health and Human Services (HHS) regulations at 45 CFR part 46.

The Human Subject Regulations Decision Charts address decisions on the following:

1. whether an activity is research that must be reviewed by an IRB;
2. whether the review may be performed by expedited procedures, and;
3. whether informed consent or its documentation may be waived;

View Charts

Identifying Human Subject Research For "Research Involving Private Information or Biospecimens Flowchart"

Learn More

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

Researchers based in a wide range of disciplines may conduct human subject research with a behavioral, educational and/or with another social sciences. The following examples illustrate common types of human subject research. In all cases, it is the IRB’s responsibility (and not the responsibility of the individual investigator(s)) to determine if the proposed research activity falls under the purview of the IRB, which requires formal review and approval. These are examples only and not intended as an exhaustive list of all types of human subject research.

1. Social, Behavioral, and Educational Research: Social Research involves the scientific study of how people and groups interact. This research may explore social behavior and mental processes but with an emphasis on how humans think about each other and how they relate to each other. Behavioral Research is the scientific study of the interactions and activities of people in naturalistic settings. The focus of this type of research can include both the exploration of the decision processes and individual functioning. Educational Research often involves the scientific study of how humans (both adults and children) learn in various educational settings, while examining the effectiveness of educational interventions, or attempting to understand the constructive teaching methods or curricula, in addition to investigating the social psychology of academic settings (i.e., schools as an organization).

The goal of social, behavioral, and educational research is similar to that of biomedical research -- to establish a body of knowledge and to evaluate interventions -- but the content and procedures often differ. Social, behavioral, and educational research involving human subjects focuses on individual and group behavior, mental processes, or social constructs and usually generates data by means of surveys, interviews, observations, focus groups, studies of existing records, and experimental designs involving exposure to some type of stimulus or environmental intervention.

1. Clinical Research. Clinical research involves the evaluation of biomedical or behavioral interventions related to disease processes or normal physiological functioning. (These types of studies are usually reviewed by the Rutgers Health Sciences IRB)
2. Biomedical Research. Biomedical research involves research (i) to increase scientific understanding about normal or abnormal physiology, disease states, or development; and (ii) to evaluate the safety, effectiveness or usefulness of a medical product, procedure, or intervention. Vaccine trials, medical device research, and cancer research are all types of biomedical research. (These types of studies are usually reviewed by the Rutgers Health Sciences IRB)
3. Ethnography Research. Ethnography research involves the study of people in their natural environments where people live and work or in any other surrounding where people interact (such as a hospital where a parent interacts with a healthcare professional who is caring for a sick child). It is a set of research methods and techniques used in various disciplines such as anthropology, geography and sociology, among other fields. The main ethnographic method requires a well-trained researcher using skilled observations of people by immersing him or herself in diverse environments, cultures, and populations in order to study a particular phenomenon. The ethnographic researcher begins his or her research by establishing a relationship with people in various social contexts. These techniques allow for the researcher to begin interacting with others either through direct participation or by direct observation. The researcher may also observe people’s dialogue to uncover their attitudes, beliefs, perceptions, and values, as well as the unspoken cultural patterns that shape either the individual’s behavior or the norms of a given culture.
4. Epidemiology Research. Epidemiology research targets specific health outcomes, interventions, or disease states and attempts to reach conclusions about cost-effectiveness, efficacy, interventions, or delivery of services to affected populations. Some epidemiology research is conducted through surveillance, monitoring, and reporting programs (e.g. those employed by the Centers for Disease Control and Prevention (CDC)).  Other epidemiology research may review past medical, public health, and/or other records. Because epidemiology research often involves the aggregate examination of data, it may not always be necessary to obtain individually identifiable information. When this is the case, the research may qualify for an exemption or expedited review. 
5. Pilot Studies. A pilot study is typically defined as an initial or smaller-scale investigation or a study to either test out new experimental designs (including survey or instrument development) or methods of treatment. Pilot studies are synonymous with feasibility studies, where the investigation proposed is planned to identify various issues (e.g., relating to design of an instrument, analysis of power concerns and recruitment strategies) to determine that the larger study of the same subject matter has the greatest potential to successfully test the intended research hypotheses. Pilot studies involving human subjects are considered human subject research and require IRB review. A researcher planning to conduct a pilot study must provide sufficient details to address how a smaller scale investigation is worth pursuing with a goal of obtaining results that may add to the generalizable knowledge while minimizing any anticipated risks to the subjects. There must be a well-detailed literature review and most importantly, the researcher must justify the need for the number of subjects required.
6. Case Studies. A case report for IRB purposes is a retrospective analysis of one, two, or three clinical cases given that a retrospective analysis of the experience of a single patient's (or up to three individual patients') experience with standard treatments, would not likely meet an IRB’s definition of research and would not require review or exemption by the IRB. If the analysis includes more than 3 case studies, then this activity meets the definition of human research and requires an eIRB submission and review & approval by the IRB before analysis can be done. Please note that the IRB cannot provide retroactive IRB approval for the analysis of 3 or more case studies.
7. Repository Research. Research that utilizes stored data (retrospective or prospective data, various outcome measures or artifacts, photographs and recordings) or materials (cells, tissues, fluids, and body parts) from individually identifiable living persons qualifies as human subject research, and requires IRB review. When data or materials are stored in a bank or repository for use in future research, the IRB will need to review a protocol detailing the repository’s policies and procedures for obtaining, storing, and sharing its resources, for verifying informed consent provisions, and for protecting subjects’ privacy and maintaining the confidentiality of data. The IRB may then determine the parameters under which the repository may share its data or materials with, or without, IRB review of individual research protocols.
8. Quality Assurance Activities. Quality assurance activities attempt to measure the effectiveness of programs or services. Such activities may constitute human subject research, and require IRB review, if they are designed or intended to contribute to generalizable knowledge. Quality assurance activities that are designed solely for internal program evaluation purposes with no external application or generalization may not require IRB review. In the event that a disagreement arises about whether a quality assurance activity constitutes human subject research, the IRB, not the individual investigator, will determine when IRB review of such activities is required

Examples Of Research Under the IRB’s Purview

• A psychologist studying interpersonal behaviors in a group of individuals with mental disorders;
• A computer scientist or an engineer engaged in collecting information about various human performance characteristics and/or limitations or studying the human factors related to a newly designed artifact;
• An instructor evaluating classroom techniques or activities with the intent of publishing the findings;
• A nurse researcher surveying African American adults about their attitudes toward organ donation;
• A researcher analyzing archival or prospectively collected records or data with or without identifying a subject, but without directly interacting with a human subject. For example, chart reviews or database reviews;
• An historian engaged in gathering oral histories recording Vietnam Veterans’ experiences with the war and Post Traumatic Stress Disorder (PTSD), which also include an interpretation of these events to generalize findings to influence public policy;

*This is not an exhaustive list.

Overview

Guidance on Engagement of Institutions in Human Subjects Research
(As interpreted from the Office for Human Research Protection/U.S. Department of Health & Human Services)

Purpose

This webpage provides information for determining whether the Rutgers University is engaged in a non-exempt human subjects research project. The Rutgers University is engaged when its employees or agents for the purposes of the research project obtain:

1. data about the subjects of the research through intervention or interaction with them;
2. identifiable private information about the subjects of the research or;
3. the informed consent of human subjects for the research;

Examples

Rutgers University Engaged in Human Subjects Research

1. Rutgers University receives an award through a grant and all research activities involving human subjects are performed by employees or agents at another institution.
2. An RU faculty member performs invasive or noninvasive procedures (collection of blood, utilizing physical sensors, implantation of medical devices) for research purposes.
3. An RU staff member interacts with a subject through direct communication, such as administering a survey for research purpose.
4. An RU medical resident, on behalf of the principal investigator, obtains informed consent of human subjects, for research that will be conducted at University Hospital.
5. An RU student obtains private information or specimens from any source for research purposes. This includes, but is not limited to: observing or recording private behavior, using, studying or analyzing private information or specimens provided by another institution or already in the possession of the investigator.
6. RU Faculty member is given a subcontract to assist on a funded project. RU Faculty subawardee will help be a consultant as to provide expertise, will develop survey measures, will code and analyze identifiable data.
7. RU Faculty member will help collect and measure air samples on a collaborative project looking at the quality of air/pollution in individuals’ homes. RU Faculty member will not be recruiting or consenting subjects but rather will collect samples, have access to data and will help with publications.
8. RU Faculty member will help a colleague at another institution recruit students to participate on study looking at eating habits and keeping food diaries. The RU faculty will help recruit/consent subjects. S/he will not administer the intervention but have access to de-identified data. S/he plans to publish separately.
9. RU Faculty member worked on a project while completing their PhD at another university. Part of the study included therapy sessions to treating alcoholism among children of alcoholics. Study is an ongoing, multi-year project which s/he is no longer involved with recruiting/consenting/administration of measures but has access to identifiable data. S/he wishes to help analysis data and publish with and separately from his/her colleagues.

Institutions Not Engaged in Human Subjects Research

1. Commercial service: A RU student is hired to transcribe the audio recording of a focus group discussion conducted at health center. (Rutgers University is not engaged in human subjects research).
2. Routine medical/clinical service: A private practice provides routine medical services and releases the data to the RU investigator as a service. (The private practice is not engaged in human subjects research).
3. Administration of study interventions on a one time/short-term basis: A subject receives chemotherapy at University Hospital as part of a clinical trial because the subject unexpectedly goes out of town; however, University Hospital is not a research site. (University Hospital is not engaged in human subjects research).
4. Distribution of research study information to prospective subjects: An RU faculty member informs students about a research study being conducted at William Paterson University. The RU faculty member is not an investigator on that protocol. (Rutgers University is not engaged in human subjects research).
5. Institutions that permit use of their facilities: An RU investigator distributes a survey at a local community center. (The community center is not engaged in human subjects research).
6. Institutions that release identifiable private information or identifiable biological specimens: A high school releases student tests scores to an investigator from RU School of Public Health. (The high school is not engaged in human subjects research).
7. Obtain coded private information from another institution while maintaining the link but are unable to discover the identity of the subjects: The Department of Pathology receives coded specimens from Newark Beth Israel Hospital to analyze but has an agreement that the link will not be released to anyone within that department. (The Department of Pathology is not engaged in human subjects research).
8. Utilizing identifiable private information when visiting an institution engaged in research and approved by an IRB: An RU resident visits St. Peter’s University Medical Center, a research site conducting a clinical trial, and accesses identifiable private information (as long as their research activities are overseen by the IRB of the institution that is engaged in the research). (Rutgers University is not engaged in human subjects research).
9. Accessing identifiable information for auditing purposes: Patients’ records from University Hospital are audited by the hospital for compliance purposes. (University Hospital is not engaged in human subjects research).
10. FDA reporting requirements: An employee of University Hospital obtains identifiable private information to satisfy the reporting requirements to the U.S. Food and Drug Administration. (University Hospital is not engaged in human subjects research).

Examples of Research Studies that Involve Rutgers University Sites and Non-Rutgers Sites

*Although the Non-Rutgers site is not engaged in research, the IRB requests that the investigator obtain a “Letter of Authorization” from the Non-Rutgers site to conduct research activities (e.g., subject recruitment). The letter must be submitted to the IRB for review.

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• Rutgers University receives an award through a grant and all research activities involving human subjects are performed by employees or agents at another institution.
• An RU faculty member performs invasive or noninvasive procedures (collection of blood, utilizing physical sensors, implantation of medical devices) for research purposes.
• An RU staff member interacts with a subject through direct communication, such as administering a survey for research purpose.
• An RU medical resident, on behalf of the principal investigator, obtains informed consent of human subjects, for research that will be conducted at University Hospital.
• An RU student obtains private information or specimens from any source for research purposes. This includes, but is not limited to: observing or recording private behavior, using, studying or analyzing private information or specimens provided by another institution or already in the possession of the investigator.
• RU Faculty member is given a subcontract to assist on a funded project. RU Faculty subawardee will help be a consultant as to provide expertise, will develop survey measures, will code and analyze identifiable data.
• RU Faculty member will help collect and measure air samples on a collaborative project looking at the quality of air/pollution in individuals’ homes. RU Faculty member will not be recruiting or consenting subjects but rather will collect samples, have access to data and will help with publications.
• RU Faculty member will help a colleague at another institution recruit students to participate on study looking at eating habits and keeping food diaries. The RU faculty will help recruit/consent subjects. S/he will not administer the intervention but have access to de-identified data. S/he plans to publish separately.
• RU Faculty member worked on a project while completing their PhD at another university. Part of the study included therapy sessions to treating alcoholism among children of alcoholics. Study is an ongoing, multi-year project which s/he is no longer involved with recruiting/consenting/administration of measures but has access to identifiable data. S/he wishes to help analysis data and publish with and separately from his/her colleagues.

Note: This is not an exhaustive list.

Once an activity is determined to involve Rutgers as an institution being engaged in human subjects research, whether it be involved in some aspect of the research, then research is required to be reviewed by Rutgers IRB.

Once an activity is determined to involve Rutgers as an institution being engaged in human subjects research, then it is required to be reviewed by Rutgers IRB.

1) "Non-Human Research" Determinations

Only the Rutgers IRB can determine if your study is Non-Human Research. If your study is determined to be "Non-Human Research (NHR)", it does not require IRB review and on-going monitoring

A Few Examples of NHR Research:

• Cadavers, autopsy specimens or specimens/information from subjects now deceased. This is not human subject research because the subjects are deceased.
• Observational studies of public behavior (Including television and internet chat rooms). This is not human subject research because there is no intervention or interaction and the behavior is not private.

• Studies based on individual data which is publicly available. This is not human subject research because the data is "publicly available". Note, this is not the same as easily accessible or posted or accessed with authorization.

Submit your study in eIRB to received an official NHR determination. If you need to amend your NHR Study in the future, as compared to what was initially reviewed by the IRB, you may need to review the changes with the IRB to see if your changes did not affect its NHR status.

2) QA/QI Projects

Quality Assurance (QA) and Quality Improvement (QI) consist of activities that are undertaken to measure the effectiveness of standard accepted processes, programs, or services, the results of which are intended to be shared only with individuals associated with the process, program or service being evaluated. QA/QI projects cannot expose individuals to any additional risks.

• View Guidance For Quality Activities

3) Pilot Studies

A Pilot Study is a small-scale experiment or set of observations undertaken to decide how and whether to launch a full-scale project. A pilot would not contribute to generalizable knowledge and therefore is not considered research and does not require IRB review. Data collected from a pilot study cannot be used as research data.

• Pilot Studies: Common Uses and Misuses (NIH.gov)

The Principal Investigator must submit their study/project to the IRB when he/she:

1. conducts their own study; OR
2. performs designated research-related activities and acts as an agent of Rutgers (as an institution) when engaged in human subjects research;

If a study involves Human Subjects and/or Human Subjects Data, the Principal Investigator must submit their project to the IRB to determine if the project qualifies as “Research” which requires IRB review and approval.

View the main reasons which require you to register your study on ClinicalTrials.gov.

Contact Your Local IRB.