The Role of the IRB Within the Greater Research Community David Borasky, CIP Office of International Research Ethics Family Health International
Two Questions How can we enhance community representation on institutional review boards (IRBs)? How can we encourage collegial relationships between investigators, IRBs, and communities for advancing ethically-sound science that has community utility?
Community Members & IRBs 45 CFR 46.107 / Common Rule –The IRB must be able to consider “cultural backgrounds and... community attitudes….” –“Each IRB shall include … at least one member whose primary concerns are in nonscientific areas.” –“Each IRB shall include at least one member who is not otherwise affiliated with the institution….”
Current Sources of Community Members for IRBs Retired faculty Non-scientific faculty Friend of faculty / IRB members Local church / mosque / synagogue
Problems with current system Often just one or two members Lack of training / do not understand role Feel intimidated Not representative of entire community Meet the letter of the regs, but not the spirit!
How do we enhance community representation on IRBs? Recruit study participants and/or their families Provide them with better training Increase number of community reps on IRBs –Norwegian IRBs – 50% community reps –DeGette bill (2 members or 20%) Establish standing Community Advisory Boards
“What we’ve got here is failure to communicate.” IRBs and Investigators
Why Are We Failing? IRBs –Heavy workload –Focus on regulatory compliance Investigators –Time pressures –Belief that IRB is another “hoop” to jump through
Improving Communication Make the IRB office more businesslike Conflict resolution training Transparency –More face to face communication –Reason behind IRB decisions Respect
Summary IRBs must reconsider how they connect with the community –Review membership –Reevaluate how community members participate Improving communication –Establishing collegial relationships take work –Payoff is worth the effort
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