Establishing ethical trials for treatment and prevention of AIDS in developing countries

Developing countries have been hardest hit by HIV but often cannot afford the expensive drugs or high tech health care used in Western countries. How can researchers and sponsors of trials investigating treatment and prevention of HIV in developing countries make sure they take proper account of local conditions? As the HIV epidemic continues to spread, clinical and prevention trials are needed in developing nations to learn how best to alleviate suffering. Such international trials, however, raise ethical concerns because of great disparities in wealth, power, and medical infrastructure and a history of exploitation. Several reports suggest broad ethical and policy guidelines for trials in developing countries (box 1).1–5 However, such guidelines may be too general to resolve many controversies that arise in the context of specific trials.4 Because of substantive disagreements regarding such international trials, measures that assure procedural fairness are vital. We argue that partnerships between developed and developing countries are essential to working out ethical problems that arise in particular trials and propose steps to ensure that such partnerships are effective. For research to be effective, partnerships must be established with researchers, government agencies, and community leaders in host countries at the planning stage of trials. It is all too common for host country partners to be presented with detailed protocols developed primarily by investigators and sponsors from developed nations and then given the opportunity to comment.6 This is too little, too late. #### Box 1: Guidelines for clinical and prevention trials in developing nations1–5