HIV This Week

Klitzman R. 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 Committees. Dev World Bioeth. 2008;8(3):207-18.

Given the ethical controversies concerning HIV vaccine trials, Klitzman aimed to understand through an exploratory study how members of institutional review boards in the United States and research ethics committees in South Africa view issues concerning the process and content of reviews of these studies. The author mailed packets of 20 questionnaires to 12 United States institutional review board chairs and administrators and seven research ethics committee chairs to distribute to their members. Klitzman received 113 questionnaires (76 from the United States and 37 from South Africa). In both countries, members tended to be white males with advanced academic degrees. Compared to the United States, South African members called for ‘major changes’ in HIV vaccine trial protocols more frequently (p = 0.004), and were less likely to think that HIV vaccine trial 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 HIV vaccine trial participants who became infected during the HIV vaccine trial), but agreed that they needed more training. Of the South African 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 institutional review boards/research ethics committees, thus suggests key similarities and differences (e.g. compared to South African respondents, United States 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 institutional review boards, research ethics committees, 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.

Editors’ note: This study did not take into account the 2007 UNAIDS/WHO Ethical considerations in biomedical HIV prevention trials document which contains explicit guidance on treatment for trial participants who acquire HIV infection during the course of a trial. Nonetheless, the comparative findings reported here suggest that lack of ethnic diversity in committee membership is a problem for institutional review boards/ethics committees in both the South African and US contexts. South African research ethics committee members may have had more field experience – they had better awareness of how trial participants might or might not comprehend key issues. This supports the idea that local institutional review boards/ethics committees are best placed to assess whether procedures and practices are likely to ensure that consent is truly informed.