Equitable Access to Research

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The need for improvements in diversity, equity, and inclusion in research subjects has been a hot topic at both PRIM&R and AAHRPP conferences for the last few years. This isn’t a contentious topic—I’ve certainly never heard anyone arguing that researchers and HRPPs are doing just fine with this and don’t need to improve. There have been some interesting sessions over the years focusing on how researchers can increase diverse representation of subjects, often with a focus on community engagement. As interesting and informative as some of these talks have been, I feel that few of them have included clearly actionable processes for HRPPs, being focused primarily on the researcher side of things. Because of that, I was particularly pleased with Jaime Hernandez’s contributions to session A20 - Creating Expectations for Equity and Justice in Research Protocols at 2022 PRIM&R Annual Conference (PRIMR22). PRIM&R sessions are generally classified as either basic or advanced, but I truly feel that the information Jamie provided would be invaluable to people who have never screened a study and to IRB members with a decade or more of experience. In my nearly 12 years of experience, I’ve probably reviewed more than 1,000 new non-Exempt studies, and I can honestly say that I’m going to be thinking about some things differently now.

Criticizing research design in minimal-risk studies is probably one of the most awkward things for an Expedited reviewer—after all, many of us are not researchers ourselves; we’re experts on regulations and (hopefully) the ethical conduct of research. It’s usually at convened IRB meetings where peer review of research design really takes place. Jamie provided some great tips for reviewers to think about when considering if studies truly meet the criteria for equitable inclusion of subjects, all of which can help those of us in HRPPs provide a gentle nudge, or in some cases a push, to move research designs to be more inclusive.

I truly enjoyed Jamie’s focus on the importance of not just the legitimacy of inclusion criteria but also insisting on clear justifications for exclusion criteria. This was not the only session this year to note the importance of exclusionary criteria defended in a research submission rather than just accepted as is, even, or especially, when those criteria exclude vulnerable populations from the research. As HRPPs, we shouldn’t say that a study meets the criteria for approval if it excludes vulnerable populations just because including them would mean a bit of extra paperwork for researchers and us. If we can ensure that the research we approve doesn’t exclude people simply because it’s easier, we can help research become more diverse.

I’m also embarrassed to say that I haven’t been thinking enough about the parts of protocols other than inclusion/exclusion criteria when it comes to equitable inclusion. Recruitment materials, recruitment methods, and reasons why a subject might be withdrawn from a study all play crucial roles in the access to research. Regardless of the inclusion/exclusion criteria, a study that simply isn’t accessible to low-income individuals, for example, is inherently flawed. As HRPP’s I think we do a good job of asking how researchers will minimize risks of participation but need to start asking how they will ensure fair access to research.

Casey Mumaw, CIP, Assistant Director, IU HRPP
Office of Research Compliance, Indiana University.
Casey has been working in the IU Human Subjects Office since 2011, and first earned his CIP credentials nine years ago. At IU, his role includes serving as an IRB member, supervising HRPP staff who review SBER submissions, and serving as a member of office leadership. He regularly provides training and presentations to researchers and has presented at both PRIM&R's AER and AAHRPP's annual conference.

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