title: Ethical Issues to Consider in the Design of HIV Prevention Trials Involving Transgender People.
abstract: Although transgender women have been included in HIV prevention pre-exposure prophylaxis studies, no pre-exposure prophylaxis study has focused exclusively on transgender persons. Drawing on the cardinal principles of ethics espoused in the Belmont Report, this work highlights, among other issues, that (1) the principle of Justice requires the HIV prevention field to focus exclusively on transgender persons, (2) the disclosure of potential study-related risks to study participants demonstrates Respect for Persons, and (3) devising risk mitigation plans, optimizing a proposed study's standard of care, and the provision of ancillary care satisfy the principle of Beneficence.
authors.affiliation: Center for the AIDS Programme of Research in South Africa (CAPRISA), Nelson R. Mandela School of Medicine, Durban, South Africa.
authors.forename: Jerome Amir
authors.initials: JA
authors.lastname: Singh
mesh_terms: D002986:Clinical Trials as Topic / Q000941:ethics*; D004347:Drug Interactions; D032984:Ethics, Research; D005260:Female; D015658:HIV Infections / Q000188:drug therapy / Q000517:prevention & control*; D006801:Humans; D008297:Male; D065129:Pre-Exposure Prophylaxis / Q000941:ethics*; D012107:Research Design; D063106:Transgender Persons / Q000523:psychology