Clinical Trials Guidelines At Odds With U.s. Policy

摘要

Aiming for consensus on some long-debated issues in clinical research, the World Medical Association (WMA) adopted a revised ethics manifesto at its meeting last week in Seoul, South Korea. WMA's guidelines, known as the Declaration of Helsinki, have long been used by regulatory agencies around the world as the basis of rules governing the conduct of clinical trials, although the U.S. Food and Drug Administration (FDA) is in the process of moving to a different-some say less demanding-set of ethical standards.