Some clauses will hinder development of new drugs and vaccines

摘要

The Declaration of Helsinki has provided widely accepted ethical principles for medical research involving human subjects since its adoption in 1964. All recent Merck protocols for such research include the 1996 declaration. Independent institutional review boards or ethical review committees review and approve all Merck trials in accordance with ethical guidelines and applicable national and international regulations. The 2000 revisions to the declaration, however, include several provisions that we believe do not provide better protection for participants in clinical trials and could inadvertently hamper the development of safe and effective new drugs and vaccines.