Ethics in Biomedical Research

There has been a sharp increase in the number of clinical trials in India. The number of countries in which clinical investigators conduct drug research that is tracked by FDA increased from 28 in 1990 to 79 in 1999. Among the countries that have experienced the largest growth in clinical investigators are Russia and countries in Eastern Europe, India and Latin America. Sponsors explain thisgrowth by pointing to readily accessible human subjects, potential new markets for approved drugs and recent international agreements that ease FDA acceptance of foreign research data. Contract research organizations are also moving into these areas. The pharmaceutical industry, National Regulatory agencies, the National Bioethics Advisory Commission, and the World Health Organization have allraised concerns about some of the institutional review boards that review research at foreign sites. Their concerns tend to focus on the boards’ lack of experience and insufficient monitoringpractices.