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Institutional Review Boards Must Address the Ethics of Inclusion in Clinical Research

illustration of diverse group
IRBs must incorporate ethical oversight of diversity in their procedures the Policy Forum authors write.| Angelina Bambina/ iStock

To make critical progress understanding how diverse populations are impacted by different diseases and treatment approaches, institutional review boards — bodies charged with reviewing and approving regulated clinical research — must step up, encouraging enrollment of minorities, say authors of a March 19 Science Policy Forum.

"[T]he specific value of institutional review boards (IRBs)…in promoting diversity has been underrecognized and its authority underutilized," they write.

In the United States, this issue has come into clear view following the disproportionate impact of COVID-19 on certain populations, such as Black, Latinx, and Indigenous populations. This is part of a broader global trend of biomedical research not reflecting the demographic composition of the general population, with racial and ethnic minorities and the young and the elderly, among others, being consistently underrepresented.

During the COVID-19 pandemic, there has been some progress including more representative groups in trials. "The clinical trials leading to the approval of the first two COVID-19 vaccines demonstrated success following a focused effort to study a representative sample of the U.S. population," said author David Strauss, associate professor of psychiatry at Columbia University Medical Center in New York, New York.

In their Policy Forum, Strauss and colleagues focus on the role of institutional review boards in better addressing the ethics of inclusion in clinical research going forward. IRBs are charged with safeguarding the rights and well-being of human participants in accordance with the foundational tenets of respect for persons, beneficence, and justice.

"The requirements of justice cannot be met…when there is de facto exclusion of understudied populations," write Strauss and colleagues.

The authors lament the "scant" regulatory consideration in the United States, and the little formal discussion within the biomedical field, as to whether diversity falls within the IRB's remit. "As entities that hold investigators accountable, IRBs are themselves accountable to their ethical and regulatory mandates and ultimately to those who serve as participants in research," they say. "It is the obligation of an IRB to maximize benefits through the inclusion of understudied groups," they write.

Strauss and colleagues encourage institutions to establish policies to ensure that reviewing IRBs fulfill this obligation, outlining specific approaches to help IRBs incorporate ethical oversight of diversity in their procedures.

For example, an IRB can require modification of a clinical research project to recruit a more representative sample when the makeup of the proposed sample deviates substantially from that of the demographics of the condition being studied in the general population, or for whom the intervention is intended, and where no valid scientific justification is offered, the authors say.

To support this process, an IRB should provide feedback to help aid successful recruitment of specific populations, including about language use, translation, placement of advertisements, and workforce characteristics.

"How commonly [IRBs are doing this now] has not been studied," said Strauss. But, he noted, some IRBs do require the simplification, translation, and subsequent review of study materials to facilitate engagement of non-native language speakers; offer feedback or suggest alternative venues for advertisement such as Spanish-language newspapers or radio stations, community centers, or church groups; and require alternate recruitment locations, clinic hours, and payment and reimbursement schemes to encourage diverse enrollment.

IRBs should also identify common practices that limit enrollment of immigrant or minority language speakers in multilingual communities, restrict the participation of women of child-bearing potential, and introduce bias in participant selection by using overly subjective criteria such as "investigator discretion."

When a study proposes to recruit a sample that is composed predominantly or solely of a racial, ethnic, or other minority, the IRB might reasonably ask why the selection of this sample is scientifically necessary, how the findings are generalizable, and whether an alternative recruitment strategy might yield a more diverse or less burdened, stigmatized, or disadvantaged population, write Strauss and colleagues.

They note that some studies, such as small exploratory, proof-of-concept, early phase studies, or research that seeks to learn about specific communities, would not be expected to be representative of those affected by the condition. Studies of very rare conditions that may evaluate very small numbers of research participations would also fall into this category.

"In other cases," Strauss noted, "a trial may be designed to examine safety or efficacy or biomarker of disease, treatment response, or disease progression in a specific racial, ethnic, or age group. For instance, sometimes a population has already been studied extensively in one population and the research question is whether the intervention works in another group."

The authors emphasize that the IRB itself should be diverse. "A diverse IRB will be better attuned to the experience and needs of participants and better able to offer input from the perspective of varied populations," they say.

"Of course," they note, "the obligation to promote diversity in clinical research does not rest solely on the IRB or REC [research ethics committees] or the investigators." Sponsors, regulators, research and academic institutions, funders, patients and patient advocates, and others must build capacity and infrastructure, too.


Meagan Phelan

Communications Director, Science Family of Journals

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