Some see including minorities in CR as an IRB/ethical CR responsibility

IRB's role could be educational

Research ethicists and others have long described the value of recruiting more minorities in clinical research (CR) trials, but the question is whether or not IRBs have a role to play in advancing this goal.

Is it enough to ask investigators to work toward greater inclusion, or should IRBs take part in both clinical research staff education and educating the greater community about the research enterprise and minority participation?

"We do believe there is a role for the IRB to simply monitor the inclusion of the women and minority component of the National Institutes of Health (NIH) guidelines," says Stephen Thomas, PhD, professor and founding director of the Maryland Center for Health Equity, and a professor of health services administration at the school of public health, University of Maryland in College Park, MD.

IRBs could ask researchers to outline their efforts to recruit minorities when they submit protocols, but it might be better to address recruitment inclusiveness from an institutional perspective, some experts say.

"I personally have a bias against using the regulatory arm — i.e., the IRB — in terms of telling investigators what to do," he adds. "The IRB has a role to play, but a greater role is needed from the institution."

IRBs can help a research institution with developing a more inclusive recruitment strategy by using their own data to assess the big picture.

For instance, the IRB can see what type of recruitment has taken place at hundreds or thousands of clinical trials, says Sandra Crouse Quinn, PhD, professor of family science and associate dean for public health initiatives in the school of public health at the University of Maryland.

"IRBs can have a sense of the big picture," she adds. "Potentially, if they had the resources, they could serve a role at the institution of looking at how successful investigators are in recruiting diverse populations."

IRBs also are in a good position to note best practices and success stories in recruitment.

"A good IRB staff could learn a lot from seeing what's submitted to them — what's successful and what's not," Quinn says.

At the University of Maryland, the IRB director joins other experts in working on a curriculum for educating researchers and minority communities about research participation, says Mary A. Garza, PhD, MPh, an assistant professor in the department of behavioral and community health at the University of Maryland School of Public Health and associate director for the Maryland Center for Health Equity.

Also, IRBs could expand to include more community members and make an effort to recruit members of minority communities, Garza suggests.

"IRBs play a very strategic role, and this is their opportunity to make sure they can help the population," she adds.

For research institutions, the key to encouraging more minority participation in CR might be to separate regulatory authority from educational influence. The IRB could be helpful in the realm of educating the research community, but regulatory actions might be left to the government.

"To add a regulatory function might be too much," Quinn says. "But they may have opportunities to spark dialogue because they have the big picture perspective."

IRBs could hold brown bag lunches with investigators to highlight those who are successful at recruiting minorities and to encourage information sharing, she notes.

There is some benefit in putting regulatory teeth to any guidelines regarding minority inclusion in trials. For instance, the NIH exercises some of that clout by giving research sites a lower score if they have fewer women and minorities in their trials, Thomas says.

"We have been struggling in trying to determine where would be the best home for that responsibility [for minority inclusion]," he says. "So we think that current principal investigators and their research staff need formal training in recruitment and retention of racial and ethnic minorities in research."

Online bubble forms are insufficient. The training should be about more than tools and techniques, he adds.

"It should truly be transformative training that also impacts attitudes and beliefs," Thomas says.

"We don't want this area to carry all of the baggage of having the IRB ask researchers to do one more thing," Thomas says. "So we're trying to find an institutional, administrative home for who is responsible for ensuring researchers and research staff get appropriate training in minority recruitment and retention."