Bioethics. 2018;1–8. wileyonlinelibrary.com/journal/bioe | 1 © 2018 John Wiley & Sons Ltd 1 | INTRODUCTION In 2004, the first multi‐sited clinical trial was conducted to deter‐ mine if an anti‐retroviral drug, tenofovir, could be taken to prevent HIV transmission—a biomedical technology known as pre‐exposure prophylaxis (PrEP). Before the trial began, AIDS researchers charac‐ terized PrEP as a revolutionary breakthrough not just in pharmaceu‐ tical innovation but also in HIV prevention; they framed PrEP as a necessary humanitarianism for which researchers were ethically compelled to save the world’s poorest from the AIDS epidemic. 1 However, as soon as the trials began to recruit volunteers, contro‐ versy erupted at most PrEP trial sites, which were located at research institutions in Phnom Penh, Cambodia; Yaoundé, Cameroon; Accra, Ghana; Lilongwe, Malawi; Ibadan, Nigeria; and Bangkok, Thailand. 2 Although reasons for disputes differed across locales, at stake for all sites were questions of ethics and scientific rationales outlined in the trial protocol. 3 Ultimately, three PrEP sites shut down and one refused Institutional Review Board (IRB) approval, which lead to one of the biggest controversies that the world of AIDS research and activism experienced. 1 Kingori, P. (2015). When the science fails and the ethics works: ‘Fail‐safe’ ethics in the FEM‐PrEP study. Anthropology & Medicine, 22(3), 309–325. 2 The Center for Disease Control (CDC), the National Institutes of Health (NIH), and UC San Francisco, among others, conducted the trials. FHI360, largely funded by the U.S. government, administered the trials. Gilead Sciences, the manufacturer, supplied tenofo‐ vir medication, and the Gates Foundation funded five research sites ($6.5 million). The National Institutes of Health (NIH) awarded $2.1 million to UC San Francisco to conduct a trial in Cambodia. The Center for Disease Control was awarded $3.5 million to conduct the trial in Botswana, Thailand and the U.S. 3 Haire, B. G. (2011). Because we can: Clashes of perspective over researcher obligation in the failed PrEP trials. Developing World Bioethics, 11(2), 63–74; Peterson, K., Folayan, M. O., Chigwedere, E., & Nthete, E. (2015). Saying ‘No’ to PrEP in Malawi: What constitutes ‘failure’ in offshored HIV prevention research? Anthropology & Medicine, 22(3), 278–294; Ukpong, M., & Peterson, K. (Eds.). (2009). Oral tenofovir controversy II – Voices from the field. Lagos: New HIV Vaccines and Microbicides Society. As Bridget Haire astutely points out, unresolved HIV clinical trial issues that emerged in the late 1990s re‐emerged during the early tenofovir trials. In the 1990s, academics and researchers debated their obligations in HIV research – specifically regarding the use of a placebo in HIV antiretroviral therapy that tested mother‐to‐child HIV transmission after Lurie and Wolfe published their find‐ ings on the 076 AZT trials held in Uganda. See Lurie, P., & Wolfe, S. M. (1997). Unethical trials of interventions to reduce perinatal transmission of the human immunodeficiency virus in developing countries. New England Journal of Medicine, 337(12), 853–856. According to Haire, some of the issues that arose in the 1990s trials are similar to those brought up in the 2004–2005 PrEP trials. These included unresolved logistics pertaining to care and support mechanisms as well as compensation to trial volunteers who serocon‐ vert. However, the early HIV prevention trials raised new questions about assumptions and the production of scientific knowledge raised by African research scientists. DOI: 10.1111/bioe.12470 ORIGINAL ARTICLE Ethics and HIV prevention research: An analysis of the early tenofovir PrEP trial in Nigeria Kristin Peterson | Morenike O. Folayan Correspondence Kristin Peterson, Anthropology, 3151 Social Science Plaza, University of California, Irvine, CA 92697 Email: kris@uci.edu Abstract In 2004, the first ever multi‐sited clinical trials studied the prospect of HIV biomedi‐ cal prevention (referred to as pre‐exposure prophylaxis—‘PrEP’). The trials were im‐ plemented at several international sites, but many officially closed down before they completed. At most sites, both scientists and community AIDS advocates raised con‐ cerns over the ethics and scientific rationales of the trial. Focusing on the Nigerian trial site, we detail the controversy that emerged among mostly Nigerian research scientists who scrutinized the research design and protocol. While some of the dis‐ putes, especially those pertaining to community engagement mechanisms, were ulti‐ mately resolved in international fora and implemented in later PrEP trials, concerns over science rationales and assumptions were never addressed. We argue that scien‐ tific rationales should be treated as ethical concerns and suggest that such concerns should be deliberated at host sites before the trial protocol is finalized. KEYWORDS clinical trials, community engagement mechanisms, ethics, HIV prevention, Nigeria, PrEP, public private partnerships