chapter  17
16 Pages

Institutional Review Board/Independent Ethics Committee and Informed Consent: Protecting Research Subjects in the U.S. and Foreign Clinical Trials

WithTrials Rochelle L. Goodson

INTRODUCTION The increasing globalization of human subjects’ research over the last few years has resulted in a corresponding need to develop initiatives that ensure the protection of research subjects on a worldwide basis. The regulatory requirements promulgated by the FDA for U.S.-based trials, as well as foreign trials [including Health and Human Services (HHS) funded research that is subject to FDA regulations], underscores the concept that fostering research standards that reflect international cooperation and harmonizing efforts has become an imperative for sponsors and institutions that conduct clinical research in foreign countries.