US ethics guidelines for trials in the developing world

The US should not sponsor or conduct trials in the developing world unless participants are provided with basic ethical protections including minimization of risks adequate care and compensation for injuries sustained during the research and voluntary informed consent.

Abstract

Clinical trials in developing countries done by US researchers or sponsored by US agencies should be limited to research that is “responsive to the needs” of the host country, the US National Bioethics Advisory Commission (NBAC) says in a new report. In addition, the USA should not sponsor or conduct trials in the developing world unless participants are provided with basic ethical protections, including the minimisation of risks, adequate care and compensation for injuries sustained during the research, and voluntary informed consent, the commission says. Data collected by studies that do not meet the minimum ethical standards laid out in the report should not be accepted by the US Food and Drug Administration, NBAC says (see www.nbac.org).