IRBs can help bridge community-research gap

Suggestions include greater community representation

IRBs have an important role to play in improving community involvement in cancer clinical trials – everything from increasing their own community membership to working with community advisory boards and pushing for more community-friendly informed consent.

The report "Communities as Partners in Cancer Clinical Trials: Changing Research Practice and Policy," devotes a section to recommendations for IRBs, as well as to other stakeholders such as investigators, sponsors and research sites. The goal of the authors is to help eliminate some of the barriers to a community-based approach to cancer trials.

"I wouldn't say that the IRB was pointed to as the major roadblock in all of this, but it was among challenges that came up frequently," says Sarena D. Seifer, MD, a research associate professor at the University of Washington School of Public Health and Community Medicine in Seattle. "It's why we decided to focus one section of the recommendations on the ethics review piece of it."

Adding community members

Among the recommendations for IRBs:

—Increasing community membership on boards to 25%. Federal regulations require that IRBs have at least one member who is a non-scientist and at least one who is not affiliated with the institution. Their role is to bring a community voice to the review process.

Seifer says her group's 25% goal is not a "magic number" but constitutes a challenging yet attainable target. She says many IRBs aren't using all the resources available to them to recruit and retain community members.

"They're not capitalizing on researchers they have right there on their own campuses, who are doing community-based research, who have community partners," Seifer says. "Putting something in a newsletter or on a list at the university isn't going to reach the people who need to be reached to be a part of this process."

Once those members are recruited, Seifer says it's vital that they be properly prepared, educated and mentored.

"If you just get somebody to serve and you don't do those things, it's not going to go well," she says. "People are going to be frustrated and they're going to say, see, community members really can't play a role here, it's too hard, it's too much of a challenge."

—Encourage use of the OHRP approved "short form" for informed consent. The complexity of cancer trials can lead to long informed consent documents often written at a more than 11th-grade reading level, Seifer says. This can be especially daunting to use in communities where English is a second language.

The federal regulations do allow for use of a "short form" for subjects with limited or no English proficiency, as long as all necessary consent information also is presented orally in a language understood by the participant. But Seifer says many IRBs seem fearful of permitting use of the short form.

"I think part of it is people not really fully understanding what it is, what it can be used for, and the fact that it is federally sanctioned and approved and is out there as resource," Seifer says.

Her group is calling for better education about the short form among IRBs and investigators and improved guidance from OHRP about its use. There is also a need for better use of alternative methods of informed consent, such as oral presentations, pictures or video, she says.

Community advisory boards

—Working with community advisory boards. Seifer says more communities are setting up their own boards to review proposed research in the communities. They consider factors such as obtaining the consent of the community at large and the risks and benefits to the community, rather than simply to the individuals participating in the research.

"I think it's safe to say they're looking at issues that IRBs traditionally don't look at," Seifer says. "It's not a criticism of IRBs; it's not what they were established to do."

She says there's room for community advisory boards to be looking at these issues separately from IRB review, particularly because it might be impractical for IRBs to have necessary representation from all the various local communities on its own board.

"So if there's some community advisory board or review committee for that study or that community, that's another way of getting that input," Seifer says. "The IRB still needs to make its own determination of the ethics of the research."

As an example of this system that's already in place, she points to universities whose IRBs won't approve research done in Indian communities without approval from tribal IRBs.

Seifer hopes that publication of the report, and seed grants the group is offering to partners who implement some of its recommendations, will spur interest among IRBs.

"After we get in applications for seed grants, it will be interesting to see how many IRBs take us up on an opportunity to try to do something," she says.