Biomedical Research Ethics : Updating International Guidelines, a Consultation

This text records the papers and commentaries, with an edited discussion, presented at an international consultation convened by the Council for International Organizations of Medical Sciences (CIOMS) to guide revision of the CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects.

The Guidelines, first issued in 1982 and then revised in 1993, are being updated and expanded to address a number of challenging ethical issues.

These include issues raised by international collaborative trials of drugs in developing countries, especially expensive drugs, and the use of placebo controls in randomized clinical trials.

Others arise from the complexity of research in human genetics, including stem-cell research, and in reproductive biology.

Throughout, particular attention is given to the difficult questions that arose during the heated debate over trials, in developing countries, of short-duration zidovudine (AZT) therapy to reduce perinatal transmission of HIV.