Use of an Electronic Informed Consent in Clinical Investigations: Questions and Answers; Draft Guidance for Industry, Clinical Investigators, and Institutional Review Boards; Availability

摘要

The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft guidance for industry, clinical investigators, and institutional review boards entitled "Use of Electronic Informed Consent in Clinical Investigations: Questions and Answers." The guidance provides recommendations for clinical investigators, sponsors, and institutional review boards (IRBs) on the use of electronic media and processes to obtain informed consent for FDA-regulated clinical investigations of medical products, including human drug and biological products, medical devices, and combinations thereof.