Education And Debate

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

BMJ 2003; 327 doi: https://doi.org/10.1136/bmj.327.7410.337 (Published 07 August 2003) Cite this as: BMJ 2003;327:337
  1. Bernard Lo, professor (bernie@medicine.ucsf.edu)1,
  2. Ronald Bayer, professor2
  1. 1Program in Medical Ethics, University of California, 521 Parnassus Avenue, San Francisco CA 94143-0903, USA
  2. 2Program in the History and Ethics of Public Health, Department of Sociomedical Sciences, Joseph P Mailman School of Public Health, New York, USA
  1. Correspondence to: B Lo
  • Accepted 2 June 2003

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).15 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.


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Street theatre can improve community knowledge and enable informed consent

Credit: GIACOMO PIROZZI/PANOS PICTURES

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 nations15

  • 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 …

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