Expert tips for retaining community members
Education, training are key
Federal regulations require IRBs to include at least one non-affiliated, non-scientist member on the boards, commonly known as the "community member." This requirement is designed to bring in members who are not affiliated with the university, have nonscientific concerns, and represent community rather than institutional interests. Because community members are often not scientists and are unfamiliar with medical terminology, IRBs can run into difficulties finding and retaining community IRB members.
"Getting people to join a board that meets for three or four hours, and uses medical jargon such as 'therapeutic misconception' and 'double-blind placebo' can be a real challenge," says Charlotte Coley, MACT, CIP, director, IRB Educational Programs, Duke University School of Medicine IRB in Durham, NC. "Depending on how your board membership categories are set up and thus your quorum, it can be a real challenge. If you don't have the non-scientist member present, you can't have the meeting."
Non-scientist community members can also feel intimidated when surrounded by physicians when they first join an IRB. Learning the lingo and the regulations can feel like a daunting task when everyone else in the room is perceived to already have a handle on things.
"I truly don't think any of them feel confident at first," says Susan Rose, PhD, executive director in the Office for the Protection of Research Subjects at the University of Southern California in Los Angeles. Rose says community members may feel even more anxious if they are immediately inundated with federal regulations and institutional policies. "I think that's fine for later, but it's intimidating," she says.
Finding and bringing in willing, motivated community members can be a challenge for institutions. The IRBs at USC mainly rely on word of mouth. "People know and recommend other people," Rose says. Occasionally the IRB will seek out certain qualifications needed by the board; for example, Rose called around to find a prison representative to be on the board. Otherwise, "I don't think there's any way for them [IRBs] to advertise," she says.
"Collocative" approach
A problem at Duke University arose several years ago when the IRB was trying to attract and classify new community members. There were Duke-affiliated non-scientists who expressed interest in joining, as well as non-affiliated, retired scientists. "The Duke community has a lot of retirees and professionals who want to remain intellectually active and serve and stay engaged," Coley says. "We had people like that, but no membership slot to put them in. We needed an all-encompassing category to include scientists, non-scientists, affiliated, and non-affiliated members." The policy was to staff the IRB with one member from each of the 18 clinical departments at Duke, plus one person from the theology department, and one community member. This became a problem when the clinical IRBs grew to eight, Coley says.
The category of collocative members was created to include any four combinations of members: affiliated scientist, affiliated nonscientist, unaffiliated scientist, and unaffiliated non-scientist. Coley and colleagues chose "collocative" because it is defined as "the act of...placing together with, or side by side with, something else," according to a 2011 journal article by Coley and colleagues.1
All new members at Duke attend their first meeting as observational, non-voting members in order to get a sense of the meeting process, and get their first primary reviewer protocol after three or four meetings.
Focus on education
The world of IRBs can be foreign and intimidating to members who have never heard the highly technical medical jargon. Community members are more likely to stay on the board longer if they have comprehensive, ongoing education and training, Coley says.
"At one point, I surveyed the members and asked them how long it took to feel comfortable. Those who didn't have orientation reported it took them about a year to be comfortable, while those who did said it took about six months," she says. "It made a huge difference in people deciding not to give up after a year and stay on the board. We have some members who have stayed on for five or 10 years."
At USC, Rose helped develop a resource manual for new USC IRB community members called, "What it Takes to be an IRB Community Member." The booklet, developed six years ago and updated last year, was inspired by one of USC's long-time community members. "When I first came in [10 years ago], there was no training, just observing some meetings," says Malena Avila Hough, a teacher and a long-time member of the USC IRB. "Until I did my first review, I didn't really know what I was doing. I started keeping a notebook and writing down standard rules, terms — anything that could be helpful." When new community members joined, Hough would make copies of her notes and give them to the new members in binders, along with samples of forms. Rose based the resource manual on Hough's need to keep a notebook.
The manual, used nationally, is available online as a PDF file and is divided into two parts: The Basics and Regulations. The Basics outlines what an IRB is, what the community member's roles and responsibilities entail, how to navigate full board meetings, different types of protocol submission and review, and tips for effective protocol review. The Regulations section defines ethical standards, and gives more detail on types of review, informed consent, and what the federal regulations require. There are also appendices that include a glossary of terms, reviewer checklists, and samples of forms, templates, and IRB minutes. The manual can be found at https://oprs.usc.edu/files/2013/05/Community-Member-Booklet-5.1.13.pdf.
USC also requires its community members to take four CITI modules. "Instead of overwhelming them with huge amounts of regulations, we have them do CITI training and give them only easy projects to review initially," Rose says. The IRB also provides mentoring.
The Duke University IRBs have offered a variety of programs: continuing education, mentorship, and a monthly drop-in session where members can discuss any questions they have. There is also a monthly lecture series on various IRB topics and issues, and the lectures are recorded and posted on a password-protected website if members are unable to attend in person. The website also contains PowerPoint orientation modules on the IRB process, regulatory requirements, ethical standards, and institutional practice; copies of current and past educational presentations at IRB meetings; workshops, website links, and a membership directory.
Both institutions send community members to national conferences, such as the Public Responsibility in Medicine and Research (PRIM&R) annual conference. "Over the years we would take one or two [members] to the national meeting and they were able to network with other community members," Coley says. "PRIM&R now has a track for non-affiliated IRB members so they can get some additional training. They have found that really helpful; it placed value on their role and helped make them understand the big picture of what we do and want to stay on the board longer."
"That's really where they [community members] go to get re-energized and refueled and hear the speeches they need to be able to get back and jump in," Hough adds. "It's a great place to find other members to get energized and learn the backbone of what the role is. We hear people from all over the country about the importance of the role. After the national meeting, I'm energized and ready to jump back in again."
Both Rose and Coley say their institutions benefit from having multiple community members on each board. "Always have one or two more than you need, and don't start the meeting unless at least one is present," Rose says.
Collocative, unaffiliated members make up about 20% of the boards at Duke, Coley says. If there are at least two non-scientist collocative members on the board, there is always one present if the other has an emergency. Currently, there are about three or four members. "I think one of the key things is having more than one [community member] on each board," she says. "If you have a small board, then I understand there will only be one or two. If you're at a larger institution, then you can have three or four on the board and give them some comfort of not being the lone outsider and thus feel emboldened to speak out."
It also makes those members feel less alone, she says. "It produced strength in numbers — there isn't just one lone non-Duke member. It makes them feel more a part of the group and more engaged with the board," she adds.
Some community members may think they are not knowledgeable enough to speak up during meetings.
"I was fortunate to have a very good chair who doesn't shy away from moments to educate," Hough says. "If some of us are completely lost, he'll stop and do some teaching."
There are no dumb questions at an IRB meeting, Coley adds. "At orientation I would encourage all the members to speak out. If you can identify a potential risk to patients, you have done your job. You don't want to see a headline that someone died or was harmed on a study. I tell people if something is bothering you or you're curious or it doesn't feel right, speak up. If you're feeling uneasy, someone else may be feeling the same way."
Reference
- Coley C. Solving the IRB "Community member" problem. Journal of Clinical Research Best Practices, August 2011. http://firstclinical.com/journal/2011/1108_Collocative.pdf.
