Human Subjects & Institutional Review Boards

Using human subjects in your research

If your research involves human subjects or is regulated by the Food and Drug Administration (FDA), it requires review and approval from an institutional review board (IRB) or the Human Subjects Office.

Start by answering these questions:

1. Is it human subjects research?

  • Is your research a systematic investigation?
  • Is the study designed to contribute to generalizable knowledge?
  • Do you intend to use the findings for publication or presentation outside of IU?
  • Does it involve collecting information or specimens from living individuals through interaction or interventions?
  • Will you collect, use, analyze, or create identifiable information or biospecimens about living individuals?

2. Is it research involving the FDA?

  • Does the research involve the study of a drug, biologic, or device for which administration is dictated by the protocol?
  • Will research data be reported to the FDA?

If you answered yes to either of the above, then your study requires human subjects review and approval. This may mean obtaining review and approval from an institutional review board or confirmation that your human subjects research is exempt from IRB review.

Learn about the levels of review

After you submit your study

After submission, a professional staff member in the Human Subjects Office will pre-review your submission and any attached documents. If the staff member, or screener, has any questions or requests for revisions, the submission will be returned to you with those comments. Your submission will not be processed until you have addressed the screener’s comments and re-submitted your study. If you do not respond within two weeks, your submission may be withdrawn. To keep your study on track, follow these steps for responding to a pre-review.

Once your study is approved, you will receive notifications via email, prompting you to visit KC IRB to retrieve your approval documents, which you will need to keep for your records.

Get training on IU research policies and procedures

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