Irbs and Ethically Challenging Protocols: Views of IRB Chairs About Useful Resources (In THE Field) (Report‪)‬

Institutional review boards (IRBs) often review research protocols that raise significant ethical issues. Such issues include informed consent for research with vulnerable populations, including those who may lack decision-making capacity; potential risks of studies that involve medication withdrawal; the use of placebo-controlled trials; and the privacy and confidentiality of sensitive research data. (1) Yet some IRBs may not have experience reviewing protocols that raise these and other ethical challenges. Various types of resources have been proposed to provide specific and practical guidance to help IRBs achieve their goals of protecting research participants. These include education and training programs, (2) increased guidance from the federal Office for Human Research Protections (OHRP), (3) Web site development, (4) and increased access to experts in science and clinical medicine, as well as to the perspectives of research participants. (5) Little is known, however, about what resources IRBs consider useful in providing guidance about how to respond to ethically challenging research. As part of a larger interview study of IRB chairs who review mental health research, we asked the chairs to rate the helpfulness of specific resources for assisting their IRBs with reviewing research protocols. IRB chairs are an important source of information on this issue because, compared to the average IRB member, they typically have more experience reviewing research protocols. Thus, IRB chairs may function as the "long-term memory" of the IRB and as a consequence, their opinions carry considerable weight on their IRBs. (6)