title: 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.
abstract: Given 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.
authors.affiliation: Columbia University College of Physicians and Surgeons, New York, NY 10032USA. rlk2@columbia.edu
authors.forename: Robert
authors.initials: R
authors.lastname: Klitzman
mesh_terms: D016915:AIDS Vaccines / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D002986:Clinical Trials as Topic / Q000941:ethics*; D026724:Ethical Review / Q000592:standards*; D028744:Ethics Committees, Research / Q000941:ethics / Q000458:organization & administration; D032984:Ethics, Research; D005006:Ethnicity / Q000706:statistics & numerical data*; D005260:Female; D015658:HIV Infections / Q000188:drug therapy / Q000517:prevention & control*; D006282:Health Personnel / Q000706:statistics & numerical data*; D006801:Humans; D008297:Male; D008875:Middle Aged; D012107:Research Design; D012108:Research Personnel / Q000706:statistics & numerical data*; D013019:South Africa; D011795:Surveys and Questionnaires; D014481:United States
chemical_list: D016915:AIDS Vaccines