Much Remains for IRBs to Learn About Performance Measurement
Concerns over the performance of IRBs and the need for measuring their quality are well established.1 “However, compared to performance measurements in healthcare, which has a long and successful history, performance measurements in IRB is still in its infancy,” says Min-Fu Tsan, MD, PhD.
Tsan authored a recent review of the performance measurement data literature on IRBs.2 To measure IRB quality, it is necessary to first determine what it means — in other words, what specific elements constitute a high-quality IRB.
“Unfortunately, the IRB community has not been able to agree on a definition for IRB quality,” says Tsan, senior research scientist at McGuire Research Institute in Richmond, VA.
Standardized measures are lacking to assess and improve the quality and performance of IRBs. “Unlike the healthcare system, where there are thousands of standardized performance measures available at the National Quality Measures Clearinghouse to choose from, there is none for measuring the quality and performance of IRBs,” Tsan asserts.
One school of thought holds that IRB quality should be judged by how well IRBs protect human subjects participating in research. Others contend IRB quality should be judged by the integrity of their reviews or by how consistently boards make decisions.3,4 “However, IRB oversight alone is insufficient in protecting human subjects, and we don’t know how to measure human subjects protections, the quality of IRB reviews, or IRB decisions,” Tsan says.
Tsan argues a more appropriate definition of IRB quality is how well the board implements the Common Rule — not just mere compliance, but how well boards put the Common Rule into effect. A review of 104 protocols approved by 20 IRBs from 10 leading academic medical centers revealed only 20% of these protocols had satisfied all eight Common Rule-required approval criteria.5 For example, 21% of IRB reviews failed to address risk minimization, and 57% of reviews failed to address risk/benefit comparison. “High-quality IRBs, so defined, will likely provide more contributions to human subjects protections, a higher quality of IRB reviews, and better IRB decisions,” Tsan says.
- Office of Inspector General. Institutional Review Boards: A Time for Reform. June 1998.
- Tsan MF. Improving the quality and performance of institutional review boards in the U.S.A. through performance measurements. J Empir Res Hum Res Ethics 2021;16:479-484.
- Tsan MF. From moving beyond compliance to quality to moving beyond quality to effectiveness: Realities and challenges. J Empir Res Hum Res Ethics 2019;14:204-208.
- Rosenfeld SJ. Institutional review board assessment - balancing efficiency and quality. Oschner J 2020;20:50-55.
- Lidz CW, Appelbaum PS, Arnold R, et al. How closely do institutional review boards follow the Common Rule? Acad Med 2012;87:969-974.
One researcher argues a more appropriate definition of IRB quality is how well the board implements the Common Rule — not just mere compliance, but how well boards put the Common Rule into effect.
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