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Views of the Process and Content of Ethical Reviews of HIV Vaccine Trials Among Members of US Institutional Review Boards and South African Research Ethics CommitteesGiven the ethical controversies concerning HIV vaccine trials (HVTs), we aimed to understand through an exploratory study how members of institutional review boards (IRBs) in the United States (US) and research ethics committees (RECs) in South Africa (SA) view issues concerning the process and content of reviews of these studies. We mailed packets of 20 questionnaires to 12 US IRB chairs and administrators and seven REC chairs to distribute to their members. We received 113 questionnaires (76 from the US and 37 from SA). In both countries, members tended to be white males with advanced academic degrees. Compared to the US, SA members called for 'major changes' in HVT protocols more frequently (p = 0.004), and were less likely to think that HVT participants understood risks and benefits (p = 0.033) or informed consent forms (p = 0.000). In both countries, members were divided on several critical issues (e.g. the minimum standard for treatment for HVT participants who became infected during the HVT), but agreed that they needed more training. Of the SA respondents, 40% reported that they were 'self-taught' in ethics. This study, the first we know of to offer quantitative data comparing US vs. non-US IRBs/RECs, thus suggests key similarities and differences (e.g. compared to SA respondents, US respondents appeared to overestimate participants' understanding of informed consent), along with needs for education. These initial exploratory data in this area have important implications for IRBs, RECs, policy-makers and scholars concerning future practice, training, policy, and investigations in research ethics, and prevention and treatment of HIV and other diseases in the developing world and elsewhere.
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Impact of Institutional Review Boards on Cancer ResearchKennedy is Director of Medical Oncology at the University of Minnesota Medical School. He criticizes institutional review board (IRB) policies as impeding cancer research but acknowledges the need for informed consent and surveillance of research on human subjects. He argues that the administrative work involved in complying with IRB regulation wastes researchers' time and consumes research money, and that the required consent process discourages subject participation. Wigodsky counters that government involvement in IRB regulation was necessary to guarantee the right of self determination in health care when the research community failed to act. He also notes that present regulations, which reflect changes proposed by researchers, can still be revised; that IRBs as local institutions should reflect community values; and that the IRB is not the investigator's adversary but the research subject's champion. (KIE abstract)