Brazil The System for the Protection of Voluntary Participants in Research推荐.pdfVIP

Chapter 6 Brazil: The System for the Protection of Voluntary Participants in Research Corina Bontempo Duca de Freitas, William Saad Hossne, and Susie Dutra 6.1 First Steps in Research Involving Humans Discussions on the establishment of ethical parameters and the regulation of clinical trials with human participants began in Europe and the United States in the 1950s, gaining increasing emphasis during the 1970s and 1980s. In Brazil, clinical research grew during the 1980s, when investigators from Europe and the USA invited major Brazilian centers – public hospitals and academic centers – to take part in clinical trials. As a result, the first centers for research were established, and, as in other parts of the world, some incidents happened which caused concern and illustrated the need for regulations to protect study subjects. The Norplant study was a major case in point. Norplant, a long-term (five years) contraceptive, developed by the Population Council of the United States, consists of six capsules of levonorgestrel inserted beneath the skin (Israel and Dacach 1993). Norplant began to be used in Brazil in the mid-1970s, but was not reviewed by the health authorities until 1984. At that time the country had a military government, many universities had links with population centers, and ethical standards were lowered. For example, when the University of Campinas presented the Norplant project to the health authorities in 1984, the President of the University was a member of the advisory committee of the Population Council, and the study was approved without fulfilling fundamental ethical standards. The study did not require women to give informed consent, the C.B.D. de Freitas (*) ˜ ˜ ´ ˜ Coordenac¸ao de Pesquisa e Comunicac¸ao Cientıfica, Fundac¸ao de Ensino e Pesquisa em ˆ ´ Ciencias da