Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries. Executive Summary; Volume 1. Report and Recommendations of the National Bioethics Advisory Commission; and Volume 2. Commissioned Papers and Staff Analysis.

摘要

This report discusses the ethical issues that arise when research that is subject to U.S. regulation is sponsored or conducted in developing countries, where local technical skills and other key resources are in relatively scarce supply. Within this context, the Commission's attention was focused on the conduct of clinical trials involving competent adults, in particular those trials such as Phase III drug studies that can lead to the development of effective new treatments. Complex and important ethical concerns are likely to be more pressing in clinical trials than in many other types of research investigations; thus, the focus of this report has been limited accordingly. Although much of the discussion in this report is relevant to other types of research. The report centers on the principal ethical requirements surrounding the conduct of clinical trials conducted by U.S. interest abroad, and in particular the need for such trials to be directly relevant to the health needs of the host country.