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IRB members: It takes all types for all boards
Continuing education is key
IRBs have to adhere to regulations on diversifying their board memberships, but specifically finding the appropriate expertise for any particular meeting and finding dedicated non-scientist members are major challenges IRBs face.
"To join a clinical research board is very intimidating; the science is intimidating," says Charlotte H. Coley, MACT, CIP, director of IRB educational programs at Duke University Medical Center in Durham, NC.
"Our IRBs attract a lot of retired scientists, which helps with finding community representation," Coley notes. "But it doesn't help with the non-scientist slot."
Being on an IRB requires time, dedication, and altruism since it's a volunteer position. So it's been difficult even finding clergy who are interested.
"Our meetings are long so that has made it a challenge for us to find someone who has five hours they can take away from their church time," Coley says. "Plus there is a lot of preparation time."
Duke has eight IRBs that meet monthly, plus a Rapid Response Board that meets as needed, Coley says.
"The IRB membership includes representatives from each of the clinical departments in the medical school, plus clinical research trainees, who are third-year medical students and residents," Coley adds. "The challenge was finding community and non-scientist members for the eight IRBs."
Duke University's solution to this dilemma is to create a different category of IRB membership. It's a composite category called a Collocative member that includes theologians, hospital chaplains, community members, study coordinators, hospital social workers, and non-scientists, Coley explains.
"For another twist, we said you could either be affiliated with the institution or unaffiliated with the institution," Coley says. "So someone who is retired and active in the community but who is serving on the board of the pediatric hospital could be an affiliated member of the IRB."
Each of the eight IRBs now has three or four members who are in the Collocative member category.
"There's strength in numbers, and they're not as intimidated or outnumbered by the scientists in the room," Coley says. "Some of the Collocative Members could be study coordinators who work at Duke, but who went to divinity school and got interested in working with clinical research."
For example, one IRB member has a master's in Christian education and also is a study coordinator who works in pediatrics, Coley says.
"I sent this person's resume to the Office of Human Research Protection (OHRP) and asked whether this person would be considered a scientist or non-scientist," Coley says. "The feedback I got from OHRP was that he was a non-scientist."
The key to finding community and non-scientist IRB members is to think outside the box and look for people who may have had careers in one area, but who have developed an interest in research later in their lives.
"I put out the word to our IRB members when there is a need for a new Collocative member, and I ask if any of their friends or people they know might be interested in serving on a board," Coley says.
Coley looks for potential recruits among her circle of friends, as well.
"I had one friend who had been laid off after a long career," she says. "I said, 'While you're job-hunting serve on the IRB."
Her friend liked being on an IRB so much that she ended up serving on two boards, Coley adds.
Some board members have brought in their neighbors or made other referrals.
The IRBs have had members who were retired telephone company employees, a florist, a lawyer, and professionals with backgrounds in regulatory affairs and research ethics, Coley says.
The retired florist had previously worked in research and survey design, Coley notes.
"We have one gentleman who is a retired film critic, and he's a very fine board member and reviewer," Coley says.
Another key element to finding and developing good IRB members is to provide comprehensive training and education.
"What we do for all board members that helps us retain them is to offer an orientation and continuing education program," Coley says. "Continuing education is especially important for community members."
There is a two-hour training session held monthly. It can be opened up to all IRB members when it covers a topic that might interest everyone. For example, when the new genome bill (GINA) was passed, an IRB vice chair, who has a PhD in genetics, spoke along with a faculty member from the university's genetics institute, she adds.
"It gives them additional tools and gives them an opportunity to meet together so they're not as overwhelmed by their responsibility or the process," she explains. "Then they begin to have fun as board members and begin to enjoy the role."
The training covers clinical research, the different types of clinical trials, what data safety monitoring boards do, and the informed consent process among other topics.
"I've videotaped guest speakers who did presentations, and as new members join, I give them a workbook of DVD presentations and PowerPoint handouts," Coley explains.
IRB members begin to see the fringe benefits of meeting people in different university departments and involving themselves in an intellectually stimulating enterprise.
"The protection of research subjects is never dull," Coley notes. "There's always a slightly new and different twist with each study reviewed."
Another strategy for recruiting and retaining IRB members is to make some practical changes in how the IRB operates.
For instance, long meetings are a negative for both attracting and retaining IRB members. So Duke added extra IRBs so the meetings could be shortened to four to five hours, Coley says.
"We try to provide nice box lunches," Coley says. "The IRBs meet at 1 p.m. and run until 4 p.m. or 5 p.m. at the monthly meetings."
This strategy has worked well, and it's also opened the door for more involvement by those who seek more IRB time.
"Some of the Collocative members have asked if they could attend additional IRB meetings, so we have some members who serve on two or even three boards because they like it," Coley says. "We give them a free lunch, free parking, and a tray full of candy bars and crackers to provide extra energy as needed."
The boards' retention is high with most members having served for at least three years and some for as long as 10 or more years, Coley adds.
"We've had good retention for most of our Collocative members," Coley says. "If someone joins and leaves quickly it usually is because of a change in their life, like they moved away or started a new job."