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  • IRB: ETHICS & HUMAN RESEARCH

When IRBs Review Ethically Challenging Protocols: Views of IRB Chairs about Useful Resources

We interviewed 85 institutional review board chairs from a national sample of IRBs that review mental health research, asking them to rate the helpfulness of various resources that might be accessed when reviewing an ethically challenging research protocol. Each resource was rated on a four-point scale, and spontaneously offered comments were recorded, transcribed, and analyzed as well. A majority of IRB chairs indicated that talking to scientific colleagues and experts, participant representatives, and ethics experts was very helpful when reviewing ethically challenging research. Fewer chairs felt that more guidance from the Office for Human Research Protections would be very helpful. In addition, we found that chairs whose committees reviewed fewer protocols were more likely to consider increased access to Internet resources and research ethics experts to be very helpful. Based on these findings, we hypothesize that increasing IRB access to scientific experts, participant representatives, and ethics experts might aid IRBs in addressing ethical challenges when reviewing protocols, but increased OHRP guidance probably would not, and less experienced chairs may need more targeted resources.

Key words/concepts: human subjects research, institutional review boards, protocol review, ethically challenging research

Nicole Sirotin, Leslie E. Wolf, Lance M. Pollack, Joseph A. Catania, M. Margaret Dolcini, and Bernard Lo, “When IRBs Review Ethically Challenging Protocols: Views of IRB Chairs about Useful Protocols,” IRB: Ethics & Human Research, vol. 32, no. 5: 10-19.