IRBs should consider effect on community
IRBs should consider effect on community
Regulations 'a floor, not a ceiling'
While tribal and community IRBs can bring a unique perspective to the study of a specific population, all IRBs should consider community concerns in their reviews, says William Freeman, MD, MPH, CIP, human protections administrator at Northwest Indian College in Bellingham, WA.
"I don't think it's unique to tribes," Freeman says. "This applies to lots of groups — be it the breast cancer community, schizophrenia community, autism community, a rare genetic disease community, an ethnic community and so on.
"In any research there may be harms to that community that could be minimized with the proper review process — harms that even well-intentioned, experienced and knowledgeable researchers in that community may not understand." He notes that while federal regulations do not explicitly require consideration of potential community harms and benefits, they don't preclude it, either.
"It's always been said: The regulations are a floor, not a ceiling," Freeman says.
Gaining community perspective can mean suggesting or even requiring the researcher to present the study plan to a community organization, and report the results to the IRB. "'What did you learn? What did they suggest you change? Can you change it?' That's one way to do it," he says.
The Waianae Coast Comprehensive Health Center in Waianae, HI, has created an advisory board to deal with community-based participatory research that researchers conduct through the center, says Mary Frances Oneha, APRN, PhD, director of quality and performance for the center.
"We were getting a few requests where they each wanted to have their own community board, and we thought we would just exhaust community residents having a board for every proposal," Oneha says. "So we just decided to develop a community advisory board that researchers can tap into."
The IRB can seek to have representatives of the community being studied as members of the IRB. But Freeman says even that doesn't diminish the need for outside help from community organizations.
Avoiding stigma
Controversies over tribal research have pointed out the problems that can occur when communities are identified as having a stigmatizing medical problem. But those type of issues can occur in other communities as well, Freeman says.
For example, publishing HIV/AIDS prevalence rates in a particular geographic location or within a specific named community can be stigmatizing to everyone in that community, infected or not.
Tribes concerned about being identified have often been given the chance to review an article before it's published, so that it can then decide whether to be named, Freeman says.
Another key point in reviewing a study for community concerns is maximizing the benefit to the community after the study is completed, he says. That could include the tribe being the first to get results, before they're published.
"Researchers need to let the tribe know what the results are and how the research results can to help the tribe, so that the tribe can do something to improve — a health program, whatever it is," Freeman says. "In my experience, this is what almost all tribes want to know; they want to improve their life directly from this research."
Oneha says her health center is in the process of revamping its policies regarding the return of research findings to the community. In the past, she says, it was difficult to enforce.
"Now, not only must the scholarly work come to our review committee (before publication), but also the researcher must produce some type of media that would be useful for the lay public to use regarding their findings," she says. "That could be in the form of a brochure, a flier, a curriculum, a policy brief. We have ideas if researchers were interested in figuring out what would work in the community."
While tribal and community IRBs can bring a unique perspective to the study of a specific population, all IRBs should consider community concerns in their reviews, says William Freeman, MD, MPH, CIP, human protections administrator at Northwest Indian College in Bellingham, WA.Subscribe Now for Access
You have reached your article limit for the month. We hope you found our articles both enjoyable and insightful. For information on new subscriptions, product trials, alternative billing arrangements or group and site discounts please call 800-688-2421. We look forward to having you as a long-term member of the Relias Media community.