Benagiano of the World Health Organization's (WHO) Special Program of Research, Development, and Research Training in Human Reproduction (HRP) stresses that the high standards of safety demanded in the testing and use of contraceptives should apply whether the subjects recruited to the studies are from developed or developing countries. The author of this commentary, however, with particular regard to transcervical quinacrine pellet research for nonsurgical female sterilization, criticizes the ethical and professional stand of Benagiano and HRP. He instead argues that the only sensible global standard for contraceptive research is a risk-benefit one which will vary according to the circumstances of the country involved in the research. Benagiano's September 3 letter is criticized as omitting an historical perspective and failing to discuss the differences of opinion concerning the appropriateness of proceeding with current and expanded clinical trials concurrently with additional toxicology testing. The author argues that in applying a developed country standard for contraceptive research to a developing country, HRP is making a value judgement based upon neither science nor logic. To support his argument, the author points to a difference between HRP guidelines and those of the WHO Special Program for Research and Training in Tropical Disease (TDR). TDR, unlike HRP, favors a risk-benefit guideline which takes account of the circumstances in which research is conducted. Although both programs follow accepted procedures for phase I, II, and III clinical studies, TDR is more likely to encourage these to proceed concurrently when the benefits seem to outweigh the risks of the trial. Feminist concerns discussed in Geneva, the self-imposed regulations of donor agencies such as the US Agency for International Development, the use of quinacrine as an anti-malarial drug, and North-South differences in contraception research are discussed.

作者：E, Kessel

来源：Lancet (London, England) 1994 年 344卷 8924期