According to federal regulations, the expedited review process may be used when the study procedures pose
- A minor increase over minimal risk and the sponsor needs approval before the next IRB meeting.
- More than minimal risk, but the study replicates previously approved research.
- Any level of risk, but all the subjects are adults.
- No more than minimal risk and the research activities fall within regulatory categories identified as eligible.
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IRB Law Questions with Certification Exam Answers
