Step 1: Do you need to submit to the IRB?

All NIH investigators conducting activities that meet the definition of both "research" and "human subject" must submit for Institutional Review Board (IRB) approval before beginning any research activity.

IRB approval cannot be retroactive.

If you are not doing Human Subjects Research but would like or need an official IRB determination, you can submit for a Not Human Subject Research (NHSR) determination.

Is it Research?

Research is a "systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge". 45 CFR 46.102(d)

OHRP Is the Activity Research?

Examples of Research

Surveys, interviews, or observations (social sciences)
Natural History Studies
Studies that utilize test subjects for new devices, drugs, or materials (biomedical)

Examples of Not Research

Activities that are only for quality improvement purposes
Program improvement evaluations

Projects for which the results are not intended to contribute to generalizable knowledge

QA-QI vs. Research.pdf

Program Evaluation vs. Research.pdf

Is it a Human Subject?

A human subject is “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”. 45 CFR 46.102(e)

This means that people are human subjects. Existing data or specimens with identifiable, private information are also human subjects. This includes data that was not collected by the researcher herself or specifically for the study in question, but that can be traced back or identified with the individuals from whom it was collected.

If your activity falls under FDA regulations, note that the FDA definition of human subjects research includes the use of test articles (i.e., drugs or devices) on humans or human specimens, whether identifiable or not CFR Title 21

OHRP Does the Research Involve Human Subjects?

Human Subjects Research Decision Tree.pdf

Guidance for Determining Whether Data Constitutes Individually Identifiable Information.pdf

What If I’m Not Sure?

Find your IRB Team's contact information here or call 301-402-3713 to get in touch with an IRB Analyst, or send us an email at IRB@od.nih.gov. You can also refer to OHSRP Policy 100 - NIH HRPP for further information. Finally you could submit a request for a determination.

Does Your Project Require Submission for a Determination of NHSR or IRB Exemption.pdf

What's Next?

If you do need to submit, move on to Step 2 below for more details on the activities necessary before submission.