according to federal regulations, which of the following best describes when expedited review of a new, proposed study may be used by the irb?
Expedited review of a new, proposed study may be used by the IRB only when the research involves no more than minimal risk to participants and fits one or more federally defined expedited review categories.
Quick Scoop: Core Rule
Under federal regulations (45 CFR 46.110 and 21 CFR 56.110), expedited review can be used when:
- The study presents no more than minimal risk to human subjects.
- The study involves only procedures listed in specific expedited categories published by HHS/FDA (e.g., certain types of noninvasive data collection, use of existing materials, some behavioral research).
- The research is not classified and does not create more than minimal risk from issues like confidentiality breaches or stigmatization, unless protections reduce those risks to minimal.
So, the “best describes” answer choice in typical exam/quiz format is the one that says something like:
“When the research involves no more than minimal risk and uses only procedures included in the federally designated expedited review categories.”
Extra Context (for exam-style questions)
In many test banks, wrong options include statements like:
- “Whenever all subjects are adults.”
- “Whenever the sponsor needs approval before the next full IRB meeting.”
- “Whenever the study is similar to one previously approved.”
All of those are incorrect , because federal regulations do not base expedited review solely on age, sponsor timelines, or whether the study replicates prior work; they base it on risk level and fit with the expedited categories.
Why It Matters Today
In current IRB practice (and in training modules and exams used in 2025–2026), you’ll consistently see expedited review tied to:
- Minimal risk threshold
- Specific regulatory categories
- Same approval criteria as a full board, just via a streamlined process (IRB chair or designated reviewers instead of convened board).
TL;DR: Pick the option that mentions no more than minimal risk and procedures that fall into federally defined expedited review categories.
Information gathered from public forums or data available on the internet and portrayed here.