IRBs’ lay members want more education, respect

Nonscientist members are committed

Nonaffiliated and nonscientist members of IRBs — the so-called "lay" or "community" members — say they need more introductory education and ongoing training to better meet the challenges of their roles.

That’s the message from a survey of nonaffiliated and nonscientist members from research institutions across the country conducted by Sohini Sengupta, PhD, MPH, assistant professor in the department of social medicine at the University of North Carolina, Chapel Hill, and Bernard Lo, MD, professor of medicine and director of the Program in Medical Ethics at the University of California at San Francisco. An article on Sengupta and Lo’s research, conducted in 2000, was published in the February 2003 issue of Academic Medicine.

Sengupta says that while the 32 members interviewed for the survey had generally positive experiences, they did report what they described as instances of intimidation and disrespect from the scientist IRB members.

Still, she says, the group was notable for its strong sense of commitment to the cause of human subjects protection. She notes that the mean tenure on the board was more than eight years.

"That gives you some idea that these are committed individuals," Sengupta says. "One of the main reasons they wanted to be on the IRB was to represent human subjects. They wanted to give a voice to the community of human subjects at large."

A highly educated group

Sengupta and Lo chose their interview subjects from IRBs at public institutions that received more than $25 million in funding from the National Institutes of Health during fiscal year 1999. Further restrictions included only surveying members who had served more than six months on IRBs that were medically focused.

The authors contacted more than 20 IRBs, drawn from different geographical regions, and eventually were given access to 32 lay members from a total of 11 boards. They conducted telephone interviews, asking both open- and close-ended questions regarding the types of education members had received, their interactions with other IRB members and recommendations for improvement.

Nonscientist members include lawyers, ethicists, cancer survivors and religious leaders who serve on the IRBs. Nonaffiliated members might be scientists, but are not affiliated with or related to anyone affiliated with the IRB’s parent institution.

Sengupta says the lay members she and Lo interviewed are a highly educated group; 23 of them, or 72%, held graduate or professional degrees. Three were lawyers, six had PhDs, and one was a dentist.

"One can argue that this is a limitation of the lay members," she says. "Are they really representing the community in this sense?"

Several told her that they had become interested in serving on an IRB because of personal experience with human subjects research.

"A lot of people brought in their experiences — one might be a mother whose son or daughter participated in clinical trials," Sengupta says. "And this is the reason they wanted to be on the IRB, because they didn’t like the way their son or daughter was shuttled through the medical system, within this context of research."

She says that while 94% of participants report positive experiences working with the scientist members of their IRBs, 88% say they occasionally had experienced disrespect or intimidation serving on the boards.

One member, who had a background in research, but was considered a nonscientist, complains that nonprofessional members of his panel never participated in the discussions. He describes what happened when he once offered comments regarding a drug being studied.

"Now it turns out that I know something about Drug A, and I simply asked the question, Has anybody looked into whether the two adverse events were related to noncompliance?’" he recalled. "They kind of look at you like you just landed from Krypton. And the conversation goes on."

Some say they thought they were merely tolerated on the IRBs because their presence was federally mandated.

But most believe they make real contributions to the work of the boards, particularly in the area of improving the clarity and readability of consent forms, Sengupta says.

More education needed

In the survey, members say they need more initial training and continuing education to prepare for their work on the IRBs.

Out of the 32 members surveyed, 23 (72%) say they were given printed information, such as a manual or a copy of the Belmont report, in advance of attending meetings. Ten, or nearly a third, sat in on sessions to observe how the IRB worked, and only seven, or 22% , had a formal orientation period.

"That [formal orientation] could be anything from a one-hour conversation with the IRB administrator and chair to an actual half-day of going through the materials they’ve been presented, asking questions, etc.," Sengupta says.

Twenty-two members, or 69%, had attended the annual conference of Public Responsibility in Medicine and Research (PRIM&R). One member says the conference provided a chance to talk to other nonaffiliated and nonscientist members and find support.

Sengupta says future PRIM&R conferences could offer specific workshops for new lay members, so that they could learn from each other, as well as from experienced nonscientist and nonaffiliated members. Recommendations identified in the study include:

  • Better education. Members say they want more training in ethics and other research issues, not just for lay members, but for everyone on the board.
  • More lay members. Some suggested increasing the number of nonaffiliated or nonscientist members. "On some of the IRBs I spoke to, it sounded like one person was taking on the role of nonscientist and nonaffiliated member," Sengupta says. "It really should be separated."
  • More involvement. Lay members should have the opportunity to participate fully in the process, without being assigned tasks that they lack the education or specialized training to complete.
  • Better leadership. Sengupta says that ultimately, the IRB’s leadership is responsible for how lay members are seen by other board members.

"I think the chairs have a responsibility to change the culture of the IRBs, so lay members aren’t feeling like they’re not respected, or they’re just an editor for consent forms," she says.

"I don’t necessarily think [IRB chairs] would be happy to hear that — they already think they have too much to do. But the chair is one of the scientist members, and the culture of the group will only change if there’s a change in the way the scientist members respond to the lay members."

Sengupta says that in the future, she’d like to examine the work of private IRBs, as well as replicating this study with IRBs that focus more on behavioral science and humanities.

Reference

1. Sengupta, S, Lo, B. The roles and experiences of nonaffiliated and nonscientist members of institutional review boards. Acad Med 2003; 78(2):212-8.