By the time research ethics committees review a study protocol, it’s largely complete. Thus, some ethicists are reluctant to raise the question of whether the study population is adequately diverse.
“But ethics committees and their institutions do have a responsibility to equitable participant selection,” says Barbara E. Bierer, MD, faculty director at Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard University. It’s a balancing act: Researchers must consider the importance of inclusion, while also protecting vulnerable individuals who don’t meet criteria for participation.
Bierer and colleagues developed 25 recommendations to frame the expectations and limits of the role of ethics committees and institutions to promote diversity and inclusion in interventional clinical research. Researchers can use these recommendations to design studies with the intention of including diverse populations (people of diverse race, ethnicity, sex, gender, age, disability, language preference, pregnancy status, and other social and demographic factors). “Ethics committee review is a common, and generally obligate, step for any study prior to initiation,” says Bierer.
The authors hope that ethics committees will use the recommendations to advance consideration of diversity and inclusion in clinical trials, so that the participants represent those people affected by the disease or condition. Research sites and institutions also play an important role in supporting the efforts of investigators to recruit and retain diverse participants, adds Bierer.
“Improving diverse representation will take deliberate action, resources, and commitment,” says Bierer. “We hope these recommendations will advance justice in research for the benefit of all.”
- Meloney LG, Ahmed H, Bierer BE. Review of diversity, equity, and inclusion by ethics committees: A Delphi consensus statement. Med 2023;4:497-504.
