Abstract
OBJECTIVE: To develop decision rules regarding key ethical dimensions in scientific protocols for the National Institute for Mental Health (NIMH) Collaborative HIV/STD Prevention Trial taking place in five countries (China, India, Peru, Russia, and Zimbabwe). DESIGN: Countries had HIV rates from 27 to 0.1%, the standard of care varied from access to antiretroviral drugs to no availability, and the reporting of sexually transmitted diseases (STD) to government agencies was mandatory in some countries and not in others. These variations presented challenges when developing decision rules that could be uniformly adopted across countries and simultaneously follow the ethical principles of beneficence, respect, and justice. METHODS: We used several strategies to identify and resolve ethical dilemmas for this international HIV prevention trial. First, we identified key principles, especially those derived for clinical therapeutic, biomedical preventive, or device trials. We convened a 'workgroup on protecting human participants' and charged them with identifying and implementing optimal procedures for ensuring the ethical and equitable treatment of participants and making recommendations to minimize physical, psychological, and social harm to the participants. Each site had a community advisory board, essential in identifying local ethical issues and possible resolutions to them. The NIMH established a data safety and monitoring board with ultimate responsibility for adjudicating ethical dilemmas and decisions. The protocols were deliberated thoroughly by the Trial steering committee, and approved by nine United States and five in-country institutional review boards. RESULTS: We summarize the decision rules adopted to resolve the ethical dilemmas identified. Especially important were the translation of clinical trials principles for a behavioral intervention trial, strategies for ensuring confidentiality and informed consent, dilemmas relating to partner notification of sexually transmitted infections including HIV, minimizing the risks of social harm, establishing community partnerships, ensuring equity among United States and in-country principal investigators, and building capacity for additional research. CONCLUSION: We document our processes and decisions, and their underlying rationales, and hope they contribute to the development of further thinking and practice regarding the ethics of social and behavioral HIV and STD prevention trials in resource-poor settings.