Vol. 38, No. 12, December, 2023

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Excerpt from pg. 3 … IRBs To Be Evaluated On Effectiveness (#1)

In the last few HRRs we have been excerpting key highlight portions of an IRB development which we believe will change U.S.-based IRBs forever. This development is unique and appears unstoppable.

This movement is being orchestrated largely by federal IRB-related bodies that are focusing on IRB effectiveness and ways to measure the same. To our knowledge, this issue has never been raised to this level of interest or activity before.

Since a major force in this process (i.e., the federal SACHRP) has now revised their plans, we now turn our attention away from their previous drafts to present their latest proposals that were issued on October 19th.

The Office for Human Research Protections (OHRP) has requested that the Secretary’s Advisory Committee on Human Research Protections (SACHRP) provide a recommendation for identifying, measuring, and improving IRB effectiveness in protecting research participants in response to the General Accounting Office’s report entitled, INSTITUTIONAL REVIEW BOARDS: Actions Needed to Improve Federal Oversight and Examine Effectiveness (GAO Report 23-104721), released on February 16, 2023“…