Review board model aids IRB's research protection
Researchers meet with community experts
Local context and the targeted populations' particular issues are important when research institutions strive to improve their human research subjects protection. IRBs and their mandate to include community members help meet this challenge. Now there is a new model that supplements the IRB's work by enhancing community involvement through the use of a community review board (CRB).
The CRB doesn't review protocols or have the authority to direct changes. But it can better inform investigators about problems and communication issues with a particular population.
"What we have learned is that the community review board can have a significant impact on how researchers perceive their own work and on how they'll approach the community in the future," says Yvonne Joosten, MPH, assistant professor of medical education and administration at Vanderbilt University of Nashville, TN. Joosten also is the program manager of Meharry Vanderbilt Community Engaged Research Care.
Vanderbilt first formed a community review board about 1.5 years ago as part the Vanderbilt Institute for Clinical and Translational Research (VICTR).
One of the original goals of forming a CRB was to provide researchers with community input during the planning and designing stage of their research projects, Joosten says.
So far, the CRB hasn't evolved along that pathway, but it has proven very helpful to researchers who have met with the board, she adds.
The boards have provided immediate feedback about projects to researchers and have helped to build relationships with community experts. They also have achieved some community stakeholder buy-in, all of which were among the original CRB goals.
Investigators sometimes ask to meet with a CRB because they feel it might help them improve their study recruitment. While this is not the mission of the CRB, sometimes there are CRB members who later decide they would like to become research participants, Joosten notes.
"We never ask them to do that, but if they offer, we say, 'That's entirely up to you, but it's not what the forum is about,'" she adds.
Researchers who provided feedback in a focus group reported that the experience of meeting with the CRB taught them more about stigma and barriers to research and that they would engage the board much earlier in their research process in the future, Joosten says.
Here's how the community review board process works:
• Build CRB infrastructure: The Vanderbilt CRB has a community navigator who helps researchers identify the community experts for their studies.
"Our community navigator has worked in the community for 15 years and brings with her all of those relationships and the social capital," Joosten says.
There also are facilitators who help organize the educational meetings with investigators and the CRB meeting that follows the training.
From six to 10 CRB members are recruited separately for each study, and they include people who are similar demographically and/or medically to the people who will be recruited for the study. They are paid a nominal fee, such as $50, for their time, and they are prepared for the CRB meeting with a brief phone call from the community navigator, Joosten says.
"We tailor the community review board to the study, looking at who they are trying to recruit for the study," Joosten says.
Once someone is recruited to a CRB, the name is kept in a bank that might be used later when another study requires CRB members.
• Prepare researchers: "The initial meeting with the researcher is to sit down and find out what they're looking for, what they want, and to help them phrase this in three or four very specific questions," Joosten explains.
The initial meetings last about an hour and help the researcher prepare for his meeting with the CRB.
"We coach researchers ahead of time and look at their presentations to make sure they are not filled with jargon and data heavy," Joosten says. "We say, 'Your role is to listen here; it's the community members who are the experts.'"
Many investigators will prepare PowerPoint presentations to show the CRB, and facilitators can help them improve these for their audience. For instance, investigators often use slides that are filled with data and words that would be above the health literacy levels of their audiences.
"In an academic environment, that's how you communicate, but if you work with community members and put that in front of them it's overwhelming," Joosten says. "We work with researchers to pare it down and put in clear language and make sure any figures or graphs are simple and easy to understand."
• Meet with CRB: These sessions typically last 1.5 to 2 hours. Occasionally, the community review board members become very enthusiastic and engaged with the session and it could last longer.
For instance, one researcher met with the CRB to discuss his study involving a biomarker for early screening of lung cancer, Joosten recalls.
"We recruited older folks who were smokers for the CRB, and they had a lot of questions about lung cancer," she says. "He was very generous with his time, and he spoke very clearly and directly with the board."
The investigator even did some roleplaying with a member of the CRB, showing the board how informed consent would be conducted, she adds.
"The whole group was involved in the role-playing, and it helped him improve his consent process," she says.
• Assess impact: There is no formal follow-up to the process, but everyone involved fills out an evaluation form, and the researcher receives recorded notes from the meeting, including all recommendations and comments made by members of the board, Joosten says.
"Typically, we will follow-up with community experts to let them know what the outcome was, what happened with their recommendations," Joosten says. "We do that in an email or in writing."
• CRB potential: "When we started the community review boards, we thought we would have researchers engage community members early in their process, maybe during the design of the research project," Joosten says. "We hope eventually to get there, but we learned we need to reach researchers where they are."
"This exposure has helped them realize the value of getting community input," she adds. "So the most important take-away message is to start building these bridges and benefit from the trust on both sides to communicate and strengthen the research to make it more relevant."