Look to support groups for community members
Groups bring unique perspective
Support groups for people who suffer from chronic or life-threatening illnesses can be a valuable source of community members for IRBs, says a woman who founded a support group and serves on two boards.
But community members such as herself need careful training and strong support from IRB staff and members to help them contribute the valuable experience they have to offer, says Gigi McMillan, co-founder of the We Can, Pediatric Brain Tumor Network in Manhattan Beach, CA.
Her association with IRBs grew out of her experiences as the mother of a brain tumor survivor. Her son Ben was diagnosed with cancer 10 years ago and currently is in remission. In the course of his treatment and recovery, McMillan started a support group for other families whose children had brain tumors. She also became involved in patient advocacy.
"I became kind of known in the brain tumor community as a parent who helped other parents figure things out," McMillan says. "And part of that was how you deal with clinical trials, because most of our kids are in clinical trials."
She worked with hospitals in Southern California and was asked to speak at continuing education programs for nurses. She often found herself at meetings with IRB representatives, so when the UCLA IRB was looking for a community member, "I was a choice for them," she says.
McMillan says she was both excited and afraid at the prospect of joining the IRB at UCLA — excited because she hoped to put her experiences as a parent to good use. "It was almost like squeezing the most out of the experience that I had and I really wanted to be able to use that experience for the good of other people," she says.
She says she was a little intimidated by the prospect of sitting at a table with doctors and being expected to hold her own. But she knew that her experience made her uniquely able to handle the task.
"I wasn’t exactly horribly intimidated because that’s why they’d invited me — I’d been talking to doctors for 10 years," McMillan says.
She credits the IRB staff with preparing her well for her role, with intensive training to overcome what she describes as a steep learning curve.
McMillan notes that support groups are an ideal place for IRBs to search for community members who can bring something extra to the board.
"First of all, they are sophisticated in a way, they’ve been through a medical emergency, they’ve got that experience," she says. "Secondly, they’ve got a personal need to do this. It’s almost overwhelming; they’re inspired to be part of the community.
"The third thing is that they don’t want their experience to have been in vain. Whatever pain they’ve been through, whatever trauma they’ve been through, if they can use that to help other people, it helps them feel a little more power over this thing that happened to them. Those are three very powerful motivators."
McMillan suggests visiting local support groups with a twofold purpose: first, to educate the groups about the process of clinical trials that they or their family members might participate in; and second, to put out the word that the IRB is looking for members such as themselves. "They’d walk out with five names every time they do it," she says.
McMillan says distributing fliers at meetings is another way IRBs can recruit from the support group community.
Members need training, peer support
Once chosen, these members, like any community members, require intensive IRB training, she says.
McMillan proposes that preparation for new community members include:
— An explanation of the history of human subjects protection. "That in itself is what got me all fired up, because it’s such an incredibly dramatic story," she says.
— A description of the history of clinical trials and what clinical trials are.
— A detailed breakdown of the process of review. She says a member of the IRB should sit down with the community member and take a protocol apart page by page, explaining what everything is, and what kind of review is required of the community member.
For example, the community member might be told to pay special attention to how information in the protocol summary is translated into the informed consent.
"Those kind of things need to be specifically explained to a community member and pointed out on the form where they are, because sometimes these protocols are 100 pages long," she says. "Where do they look? It’s easy for an untrained eye to get lost in all that verbiage."
— An opportunity to meet with other community members periodically, away from the main board, to discuss issues they might have. Perhaps the IRB could give them a chance to have lunch with a staffer, "without the docs," McMillan says.
"I think that they need a chance to say, I am intimidated when a doctor says this,’ or I don’t feel comfortable when I have to give my comments before the scientific review,’" she says. "I think that’s empowering to them and would help them be more participatory in meetings."
McMillan says she’s noticed that on her own IRB, she’s the most vocal community member, perhaps because she’s dealt with so many doctors during her son’s illness, perhaps, she says with a laugh, "because I’m married to an attorney, so I’m just not afraid of these guys."
She describes the relationship between the scientific and community members on her IRB at UCLA as collegial, but notes there are occasional tensions. McMillan says a doctor once asked her why she always insists that side effects be listed in a table format rather than straight prose.
"I’m a strong enough person to say, Because I need to see it like that in order to understand it; and yes, I think every list of side effects needs to be listed that way.’"
McMillan says the chairman immediately leapt to her defense. "He said, Thank you, Mrs. McMillan, that’s exactly why you’re sitting at this table.’
"I still haven’t had a chance to share my feelings about that with the other community members," she says. "I want to say to them, look guys, do you see how our chair values us? You could even speak up about more stuff. We don’t have to be afraid we’ll be attacked and not defended."
The gut check IRBs need
McMillan says community members perform a vital gut check on research, which enhances the scientific review.
"When a layperson reads this study, what gut reaction do they have? That is a very important piece of information. I think that even community members don’t realize the value of that."
McMillan says as confident as she is, she has hesitated to bring up concerns after a really detailed scientific review, thinking they’re too minor to mention.
"Eventually, if it bothers me enough, I will mention it and all of a sudden I’ll be seeing all the other heads around the table nodding in agreement," she says. "It was an important thing, and the reason I caught it was that they were focused on the scientific detail, whereas I was relying on my gut reaction to whatever it was."
McMillan says that at last fall’s PRIM&R conference, she learned about a Midwestern IRB that allows community members to speak before the scientific review, an idea she really appreciates.
"I think that the role of the community member is more important than the community members think it is," McMillan says. "I think they don’t generally understand how vital their opinion or their contribution is to these committees. I think they need to have a little more education, and I think they need to be shown their worth so they can participate more fully."
Support groups for people who suffer from chronic or life-threatening illnesses can be a valuable source of community members for IRBs, says a woman who founded a support group and serves on two boards.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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