China has become one of the main fields for international drug and device trials in the last twenty years. Although China has greatly strengthened the protection of human research participants over this time, there is still room for improvement. In order for Chinese investigators to participate in international clinical trials, compliance with internationally recognized ethical regulations is essential. In the United States (U.S.), research involving human subjects is reviewed by an ethics committee called the Institutional Review Board (IRB). In this article, we briefly introduce the background, composition, and function of the IRB in the U.S. to our Chinese investigators.
© 2018 Chinese Medical Association. Pediatric Investigation published by John Wiley & Sons Australia, Ltd on behalf of Futang Research Center of Pediatric Development.