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