Informed consent procedures: Responsibilities of researchers in developingcountries

We describe the informed consent procedures in a research. clinic in Santia go, Chile, and a qualitative study that evaluated these procedures. The rec ruitment process involves information, counseling and screening of voluntee rs, and three or four visits to the clinic. The study explored the decision -making process of women participating in contraceptive trials through 36 i nterviews. Women understood the research as experimentation or progress. Th e decision to participate was facilitated by the information provided; time to consider it and to discuss it with partners or relatives; and perceived benefits such as quality of care, non-cost provision of methods and medica l care. For some women, participation was an opportunity to express altruis m. The main obstacles for participation were perceived side effects or risk s. The final risk-benefit balance was strongly influenced by women's needs. Women perceived that the consent form benefited the clinic, proving that p articipants had made a free decision, and benefited the volunteers by warra nting their right to free medical care. The most important problem detected was occasional misunderstanding of the information given on the form. We c oncluded that a full decisionmaking process enhances women's ability to exe rcise their right to choose, and assures research institutions that trials are conducted without coercion and that the participants are committed to t he study. Researchers have the responsibility of conducting this process.