IRBs Can Play a Pivotal Role in Achieving Diversity and Justice in Research

As the research community grapples with addressing the lack of diversity, inclusion, and equity in clinical research, IRBs have the responsibility and authority to play a lead role in advancing these efforts. IRBs are uniquely positioned to require information on inclusion in protocol descriptions and to assess study documents for inclusion “across all relevant dimensions of diversity.”

Those are among the conclusions of “Achieving Diversity, Inclusion, and Equity in Clinical Research,” a comprehensive guidance document issued by the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard (MRCT Center).

The MRCT Center is a research and policy center focused on addressing the conduct, oversight, ethics, and regulatory environment for clinical trials. Authors of the guidance document are Barbara E. Bierer, MD, MRCT Center Faculty Director and Professor of Medicine, Harvard Medical School; Sarah A. White, MPH, MRCT Center Executive Director; Laura G. Meloney, MPH, MS, and Hayat R. Ahmed, MS, MRCT Center Program Managers; David H. Strauss, MD, MRCT Senior Advisor and Special Lecturer, Columbia University; and Luther T. Clark, MD, Deputy Chief Patient Officer, Merck & Co.

The MRCT Center guidance was developed by a workgroup of more than 50 members representing stakeholders across the global research enterprise. Although the group was established before COVID-19, their efforts took on new urgency after the pandemic shined a spotlight on dramatic disparities in health and on institutional racism in the U.S.

“This moment is a—long delayed—call to action,” wrote Dr. Bierer in the guidance document author’s note. “Eliminating racism and racial inequalities begins with eliminating disparities in health, and that necessarily demands deliberate and purposeful inclusion in health research that itself will help lead to equitable access and outcomes.”

The MRCT Center guidance makes the case for diversity in clinical research, identifies barriers to inclusion, and presents potential approaches and solutions. A separate toolkit provides logic models, engagement strategies, checklists, and other resources to help sponsors, investigators, IRBs, and others involved in research increase diversity in clinical trials.

While it acknowledges that achieving representativeness in clinical research must be a collaborative effort, the guidance also argues that IRBs have the authority to make diversity and inclusion provisions an expectation for study approval. The ethical and historical basis for this IRB responsibility is discussed in “Justice, diversity, and research ethics review,” co-authored by three MRCT Center Diversity Workgroup members and published in the March 19, 2021, issue of Science Magazine.

The authors—Dr. Strauss, Ms. White, and Dr. Bierer—cite the Belmont Report, World Health Organization’s International Ethical Guidelines for Health-related Research Involving Humans, and World Medical Association Declaration of Helsinki in concluding that “consideration of diversity is essential to the question of fairness in subject selection and to IRB review.” They urge IRBs to look “beyond the lens of ‘protection,’ to deliberate on the benefits and risks of greater inclusion, and to exercise their authority to promote diversity … as a matter of justice.”

Recommendations for IRBs

The MRCT Center guidance acknowledges the challenges of adding expectations for IRB reviews and offers recommendations for IRBs to consider as they take on this expanded role. For example, IRBs should:

• Include representatives of local underserved and minority communities as members of the IRB.

• Provide training to IRB members and administrators on implicit bias and cultural competence.

• Require investigators to provide demographic characteristics of the proposed study sample as well as a feasibility plan based on the local community at the time of initial IRB review. At continuing review, IRBs should compare participant demographics to the goals in the feasibility plan and request remediation if necessary.

• Designate a member of the IRB to act as a “patient representative,” responsible for ensuring patient, public, and community input; diverse representation; easily understandable (and translated if necessary) consent and other documents; and other measures to meet the needs of underrepresented populations.

• Revise policies, procedures, education requirements, and tools and checklists to incorporate review and oversight of diversity and inclusion in research at initial and continuing review.

Dr. Bierer views the expanded role of IRBs as a supportive one. “We’re not suggesting that IRBs need to act in a punitive way,” she says. Instead, they could ask questions about how a lack of diversity might limit the ability to generalize results. IRBs also could offer to help principal investigators with tasks such as translating documents and creating health-literate resources for participants.

At the same time, IRBs must be able to count on the cooperation and commitment of others. “One of the critical points is that the IRB is not acting alone,” Dr. Bierer says. “To do this work well—to assist principal investigators and their study teams—IRBs will need the support of their institutions.”

She gives a nod to the individuals and organizations, including AAHRPP, whose contributions helped make the guidance document and toolkit possible. Dr. Bierer notes AAHRPP’s assistance in developing tools and resources and providing an understanding on what lies within and beyond the scope of IRB responsibility.

Like the workgroup, “AAHRPP and the institutions it accredits want to see a future that is better than today,” Dr. Bierer says, “one that protects human participants, includes diverse populations in research, and advances science that can help create and implement data-driven, impactful solutions."