Ethical and Policy Issues in International Research. Clinical Trials inDeveloping Countries. Volume I. Report and Recommendations of the National Bioethics Advisory Commission

摘要

The report discusses the ethical issues that arise when research that is subjectto 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, our attention is focused on the conduct of clinical trials; in particular those trials-such as Phase III drug studies-that can lead to the development of effective new treatments. because complex and important ethical concerns are likely to be more pressing in clinical trails than in many other types of research investigations, the focus of this report has been limited accordingly.