IRB Ready

Do I Need IRB Review?

Use this short decision pathway to determine whether your project likely requires IRB review. This is educational guidance — your institution's IRB office makes the final determination.

Text-based checklist (all paths)

If the interactive tool is not working, answer these questions in order.

  1. Is your project research? A systematic investigation designed to develop or contribute to generalizable knowledge (45 CFR 46.102(l)). If NO, IRB review is typically not required.
  2. Does it involve human subjects? Living individuals from whom you obtain data through intervention, interaction, or identifiable private information (45 CFR 46.102(e)). If NO, IRB review is typically not required.
  3. Vulnerable populations? Minors, prisoners, pregnant individuals, or adults with cognitive impairment? If YES, likely full board review.
  4. More than minimal risk? If YES, likely full board review.
  5. Identifiable or sensitive data? If YES, likely expedited review.
  6. Fits an exempt category? Anonymous surveys, standard educational activities, benign behavioral interventions, or analysis of existing de-identified data (45 CFR 46.104). If YES, likely exempt. If NO, likely expedited.

Possible outcomes

  • IRB review not required — project is not research or does not involve human subjects.
  • Likely exempt — 45 CFR 46.104. Submit a determination request; turnaround 1–3 weeks.
  • Likely expedited — 45 CFR 46.110. Minimal risk, reviewed by one IRB member; 2–6 weeks.
  • Likely full board — greater than minimal risk or vulnerable populations; 4–10 weeks.
  • Consult your IRB — situation is ambiguous. Submit a written determination request.

This tool is educational guidance only. Your institution's IRB office makes the final determination.