The Role of the IRB Within the Greater Research Community
David Borasky, CIPOffice 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