according to federal regulations, the expedite...
According to federal regulations, the expedited review process may be used when a study involves no more than minimal risk to participants and fits specific categories defined in the federal human subjects protection rules.
What “expedited review” means
- It is a streamlined ethics review done by one or more designated IRB members instead of the full IRB committee.
- It is still a full ethical review; it does not mean the study is exempt from regulations or that standards are lowered.
- It is “expedited” only in process (who reviews it and how quickly), not in how carefully risks and protections are considered.
Core federal condition: minimal risk
Federal rules allow expedited review when:
- The research presents no more than minimal risk to human subjects (risk not greater than that ordinarily encountered in daily life or routine exams).
- The procedures fall into one of several federally listed expedited categories (for example, some types of blood draws, noninvasive data collection, or analysis of existing data with adequate protections).
So, in typical multiple‑choice wording, the best completion of
“According to federal regulations, the expedited review process may be used
when the study procedures pose:”
is usually:
“No more than minimal risk to participants and involve only procedures listed as eligible for expedited review. ”
Why not for higher‑risk studies?
- Studies with greater‑than‑minimal risk (e.g., significant invasive procedures, substantial psychological risk) must go to full board review rather than expedited.
- Full board review is required whenever the level or nature of risk goes beyond everyday life or routine medical/psychological exams.
TL;DR: Under federal regulations, expedited review is permitted only when the research activities are on the official expedited list and the study procedures involve no more than minimal risk to participants.
Information gathered from public forums or data available on the internet and portrayed here.