Human Research Report Digital Newsletter

Protecting Research Subjects and Researchers

Vol. 39, No. 8, August, 2024

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Excerpt from pg. 3 … IRBs To Be Evaluated On Effectiveness (#8)

We continue this month with more details on how IRBs, individual IRB members, and their institutions will be evaluated by federal agencies.

This development appears to be the biggest change to IRB requirements and operations in at least 20 years. It is being led by the Secretary’s Advisory Committee on Human Research Protections (SACHRP), following the release of the GAO report described below.

We resume where we left off in our presentation last month (see the July HRR, pp. 1-2) regarding the federal document titled “SACHRP Recommendation on GAO-23-104721 [Government Accountability Office’s national investigation report], INSTITUTIONAL REVIEW BOARDS: Actions Needed to Improve Federal Oversight and Examine Effectiveness.”

Before moving on to present the next proposed IRB evaluation criterion, we conclude SACHRP’s previous argument that the “reasonableness” of IRBs is something that could, and should, be measured soon.

SACHRP measures this IRB evaluation criterion with the same yardsticks that it used for other evaluation criteria, as follows.