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

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Abstract
Partnerships with stakeholders 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 Research must be responsive to the needs of host nations and consistent with their priorities for health care Although it may sometimes be ethically appropriate to provide participants in the control group with a lower standard of care than in developed countries, such discrepancies need to approved by the ethics review committee in the host country Researchers and sponsors need to make reasonable efforts to secure access after the trial to experimental interventions that were proved effective Informed consent must be obtained from participants, although the documentation of consent may vary Sponsors and researchers from developed countries need to help build capacity for clinical trials and ethical review of research in developing countries Partnerships between researchers in host and sponsoring nations will ensure that the proposed research meets the needs of the host country and can be carried out successfully. As the number of researchers in host countries and their skills are often limited, sponsors and researchers may have to invest in a host nation's infrastructure. Partnerships are also important with government agencies, such as ministries of health, which have political authority.7 Ideally, such cooperation will assure that a proposed project fits the host nation's health priorities and that interventions that are proved effective will become available. Partnerships with community leaders and with people who might be eligible for the clinical trial are more challenging but essential. Researchers and government officials in the host country may have very different social and educational backgrounds from participants and thus not appreciate participants' views or how their concerns might be met.2 Risks that are considered minimal in the United States, such as from drawing blood, may be regarded as serious in cultures with a different explanatory model of illness.2 4 Community based partners can help identify issues that complicate the informed consent process, such as customs of deference to husbands, other relatives, or community leaders.2 4 They can also suggest how to strengthen the informed consent process—for example, using street theatre to educate the community before seeking consent from individual participants.2 In some instances, government agencies are uninterested in, or even hostile to, research that host nation researchers and community partners strongly support. When legal, such research may go forward without government approval. Finally, partners who have been active in the design of the project might also suggest how to improve recruitment and follow up.8 Footnotes Contributors and sources BL was a member of the National Bioethics Advisory Committee, serves on a data and safety monitoring board for a clinical trial of preventing perinatal HIV transmission in Africa, has advised investigators on several international clinical trials funded by the National Institutes of Health, and has taught in China about ethical issues in research. He is codirector of the Policy and Ethics Core at the Center for AIDS Prevention Studies at the University of California San Francisco. RB has studied ethical challenges posed by the AIDS epidemic since the early 1980s. He has served on several Institute of Medicine committees that addressed these challenges and written and edited books on the subject. Members of the ethics working group participated in discussions of the topic and provided feedback and suggestions on drafts of manuscripts. Sources of information for this article include HIV Prevention Trials Network researchers, staff, and community advisory board members, reports on research in developing countries, and PubMed searches with the key words human experimentation, community, and third party consent. Funding The HIV Prevention Trials Network is sponsored by the National Institute of Allergy and Infectious Diseases, National Institute of Child Health and Human Development, National Institute on Drug Abuse, National Institute of Mental Health, and Office of AIDS Research, of the National Institutes of Health, US Department of Health and Human Services (through a Cooperative Agreement to Family Health International, U01-AI-46749). The views in this article do not necessarily represent the views of the National Institutes of Health or the HIV Prevention Trials Network. Competing interests The authors receive research funding from the National Institutes of Health.

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