According to federal regulations, the expedited review process may be used when the study procedures pose no more than minimal risk and the research activities fall within regulatory categories identified as eligible for expedited review.

Quick Scoop: What This Really Means

  • The risk to participants must be no greater than what they’d encounter in daily life or routine exams.
  • The research must fit into one of the federal expedited categories (for example, certain types of data collection, noninvasive procedures, or use of existing data/specimens with safeguards).
  • Expedited review can also be used for minor changes to previously approved research, as long as those changes do not increase risk beyond minimal.

In contrast, expedited review cannot be used when:

  • The study involves more than minimal risk.
  • Identification of subjects or their responses could reasonably put them at risk of criminal/civil liability, financial harm, reputational damage, or stigmatization , unless strong protections bring that risk back down to minimal.
  • The justification is only that the sponsor “needs it fast,” that all subjects are adults, or that the study simply replicates prior higher‑risk research; those are not qualifying reasons on their own.

Mini FAQ Style Breakdown

1. What is “minimal risk”?

Federal guidance describes minimal risk as the probability and magnitude of harm not greater than those ordinarily encountered in daily life or during routine physical or psychological exams.

Example:

  • Completing anonymous, non‑sensitive surveys usually fits minimal risk.
  • An interventional drug trial with significant side‑effect potential does not.

2. Who does the expedited review?

  • The review is done by the IRB chair or one or more experienced IRB members designated by the chair, rather than the full convened IRB.
  • The study still receives a full ethical review; it’s just a streamlined route reserved for low‑risk, listed categories.

3. Key regulatory hook

Under federal regulations such as 45 CFR 46.110 and analogous FDA rules, expedited review applies to:

  • Certain categories of research involving no more than minimal risk ; and
  • Minor changes in previously approved research during the approval period.

TL;DR (in exam-style wording)

According to federal regulations, the expedited review process may be used when the study procedures pose no more than minimal risk and the research activities fall within regulatory categories identified as eligible for expedited review.

Information gathered from public forums or data available on the internet and portrayed here.