Human Subjects Research

Printer-friendly version

Overview

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.

When to Submit for Review

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.

Important Notes

  • 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:

  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;

Definitions

Research is “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge" (§ 46.102)

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

(1) Data through intervention or interaction with the individual, or;

(2) Identifiable private information;

* Intervention includes both physical procedures by which data are gathered (for example, 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 which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record).  Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.

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

Read More Information about types of research under the IRB’s purview and examples.

Other Types of Research and the IRB

"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 recieved an offical 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.
 
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.
Classroom-Based Research Projects

Help

Contact Your Local IRB