Federal Register Notice: FDA is making available a draft guidance entitled Informed Consent Information Sheet: Guidance for IRBs, Clinical Investigators, and Sponsors. It 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. It 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. To download this guidance, click here. To view this notice, click here.