FREQUENTLY Asked Questions

To what extent is the IRB expected to actively audit and monitor the performance of the investigator with respect to human subject protection issues?

FDA does not expect IRBs to routinely observe consent interviews or the conduct of the study or review study records. However, 21 CFR 56.109(f) gives the IRB the authority to observe, or have a third party observe, the consent process and the research. When and if the IRB is concerned about the conduct of the study or the process for obtaining consent, the IRB may consider whether, as part of providing adequate oversight of the study, an active audit is warranted.

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