Table S1 - HIV Pre-Exposure Prophylaxis (PrEP)—A Quantitative Ethics Appraisal

Number of study teams reporting each ethics checklist item. In this table, the 8 principles are guidance terms or expressions representing best practices “that should underlie the conduct of biomedical and behavioral research involving human subjects” (US National commission for the Protection of Human Subjects of Biomedical and Behavioural Research. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. 1979). The 31 benchmarks are specific and practical considerations that are “to guide researchers and research-ethics committees in assessing how well the enumerated ethical principles have been fulfilled in particular cases”. The 8 principles and 31 benchmarks presented here were proposed in 2004 (Emanuel EJ, Wendler D, Killen J, Grady C. What makes clinical research in developing countries ethical? The benchmarks of ethical research. J Infect Dis 2004; 189(5):930). The 101 ethics checklist items were formulated by the authors of the present article (MBK, DAF, DWC). n = number of trials reporting checklist item. N = number of trials for which checklist item is relevant. * item irrelevant for the 1 trial designed to be conducted in the USA only. ** item irrelevant for the 2 trials not designed to focus on efficacy/effectiveness. *** item irrelevant for the 2 trials designed to include only men. (DOC)