Zdrowie i gospodarka · 15.07.2014
Draft Informed Consent Information Sheet: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled "Informed Consent Information Sheet: Guidance for IRBs, Clinical Investigators, and Sponsors." The draft guidance announced in this notice is intended to assist institutional review boards (IRBs), clinical investigators, and sponsors involved in clinical investigations of FDA-regulated products in carrying out their responsibilities related to informed consent. The draft guidance provides the Agency's recommendations and requirements for informed consent to assure the protection of the rights and welfare of human subjects in clinical investigations.