Ethical issues in clinical trials in developing countries

The vertical transmission trials conducted in a variety of developing countries by researchers from more developed countries illustrate a variety of crucial ethical issues. Three crucial issues are the injustice of the use of placebo control groups, the coerciveness of the offer to participate, and the exploitation of Third World countries. This paper examines each of these issues separately. It develops a new standard for when such control groups are acceptable. It concludes that the issue of coercive offers is not well founded. It also concludes that concerns about exploitation are better addressed by assurances about the future care of the subjects in the trial than by assurances of availability of the drugs in the country in general. Copyright (C) 2002 John Wiley Sons, Ltd.