All research involving human subjects that meets the criteria set forth in 45 CFR 46.102 (d) and (f), irrespective of funding and/or funding source, conducted at Rutgers University and/or by any Rutgers’ faculty, staff or students (full-time/part-time status and/or undergraduate/graduate level), must be reviewed by a Rutgers’ Institutional Review Board (IRB).
No research activities involving human subjects may commence until the IRB has reviewed and approved the protocol and sent an offical Notice of Approval via e-mail.
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:
(i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
(ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
***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.
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.
Examples of Rutgers University Engaged in Human Subjects Research
- 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.
More information about the different types of IRB review can be found in the Review Types Section.
Research Under The IRB’s Purview
Other Types of Research and the IRB
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.
View Guidance For Quality Activities.
View guidance for Classroom-based student research projects.
When to Submit for Review
The Principal Investigator must submit their study/project to the IRB when he/she:
- conducts their own study; OR
- 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.
- Investigators cannot self-exempt. Only the IRB can determine if your research is "Not Human Subjects Research" (meaning it does not require formal IRB Approval)
- 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.
OHRP's Human Subject Regulations Decision Charts
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.
WARNING: These charts have not been updated by OHRP for the 2018 Revised Common Rule.
The Human Subject Regulations Decision Charts address decisions on the following:
- whether an activity is research that must be reviewed by an IRB;
- whether the review may be performed by expedited procedures, and;
- whether informed consent or its documentation may be waived;