Disease control has increasingly shifted towards large scale, disease specific, public health interventions. The emerging problems of HIV, hepatitis, malaria, typhoid, tuberculosis, childhood pneumonia, and meningitis have made community based trials of interventions a cost effective long term investment for the health of a population. The authors conducted this study to explore the complexities involved in obtaining informed consent to participation in rural north India, and how people there make decisions related to participation in clinical research.

Background: Establishment of Sri Lankan Twin Registry demanded development of ethical guidelines, as an effective ethical framework was not available in Sri Lanka. Design: Objectives were to find out whether the ombudsman concept exists in current informed consent practices and to investigate opinion about ombudsmen. We searched Pub Med, conducted a postal survey, and monitored Internet discussion. Results: The responses were categorized into current practices and existing models in informed consent process, reservations expressed about current practices, arguments supporting the concept, (...) concerns and issues, alternatives, and how to implement the proposal. The concept of a third person is not entirely novel. How to find a truly independent person, the financial implication, confidentiality, obligations, and liabilities of ombudsmen, also emerged. Conclusions: The concept of an ombudsman is conceptually and ethically sound and acceptable but the challenges posed by this very same solution to creating a better process of informed consent will have to be faced. (shrink)

Researchers, scientists, and physicians in Uganda have become increasingly aware of the need to develop a systematic approach to reviewing bio-medical research conducted in their country. Much of this awareness and their concern stems from Uganda's high seroprevalence of human immunodeficiency virus and the consequent large influx of research monies and HIV researchers from developed countries, including the United States and Great Britain.We report on the proceedings of a five-day symposium on bioethical principles governing clinical trials, which convened in Jinja, (...) Uganda in September 1994. The thirteen male and female workshop participants included representatives from the Uganda Ministry of Health, Makerere University, the Uganda AIDS Commission, Uganda's National Council of Science and Technology, and the National Chemotherapeutic Laboratory. These representatives included ethicists, physicians, researchers, and pharmacists, all of whom have conducted research themselves. Initial workshop sessions focused on the history of human experimentation and the development of protections for human participants in medical research, both in the United States and internationally. (shrink)

The concept of reproductive health promises to play a crucial role in improving health care provision and legal protection for women around the world. This is an authoritative and much-needed introduction to and defence of the concept of reproductive health, which though internationally endorsed, is still contested. The authors are leading authorities on reproductive medicine, women's health, human rights, medical law, and bioethics. They integrate their disciplines to provide an accessible but comprehensive picture. They analyse 15 cases from different countries (...) and cultures, and explore options for resolution. The aim is to equip readers to fashion solutions in their own health care circumstances, compatibly with ethical, legal and human rights principles. (shrink)