Ethical complexities of conducting research in developing countries

N Engl J Med. 1997 Oct 2;337(14):1003-5. doi: 10.1056/NEJM199710023371411.


PIP: Ethical challenges are posed by attempts to conduct clinical trials in developing countries. Such trials must seek interventions that could realistically benefit the population involved. An inadequate understanding of the complexity of such trials has led to unfair charges that developing country trials of interventions to prevent maternal-infant transmission of HIV are comparable with the infamous Tuskegee study where subjects were deprived of available treatment for syphilis. The system of ethical protection developed after the Tuskegee scandal called for respect for persons, beneficence, and justice in research trials. To apply these principles to research in developing countries requires the support and involvement of the host country as well as an understanding of how conditions in the host country may differ from conditions in the partner country and, thus, may require different types of clinical trials. The current debate hinges on the morality of using a placebo control when the AIDS Clinical Trials Group protocol 076 is being effectively used in other parts of the world. The 076 protocol, however, has not been proved effective in developing country settings, and its per person treatment cost exceeds that which can be assumed by developing countries. The most compelling response to criticisms of the placebo-control test designs is that it provides definitive answers to safety and effectiveness questions in the study setting. Debate on this issue is healthy but should be informed by adequate knowledge of local factors that influence research.

MeSH terms

  • Beneficence
  • Clinical Trials as Topic* / methods
  • Clinical Trials as Topic* / standards
  • Control Groups*
  • Developing Countries*
  • Ethical Review
  • Ethics, Medical*
  • Federal Government
  • Female
  • HIV Infections / drug therapy
  • HIV Infections / prevention & control
  • HIV Infections / transmission*
  • Humans
  • Infectious Disease Transmission, Vertical / prevention & control*
  • Internationality
  • Personal Autonomy
  • Placebos
  • Pregnancy
  • Pregnancy Complications, Infectious / drug therapy*
  • Pregnant Women*
  • Risk Assessment
  • Therapeutic Human Experimentation*
  • Zidovudine / economics
  • Zidovudine / therapeutic use


  • Placebos
  • Zidovudine