Use of Electronic Informed Consent-Questions and Answers; Guidance for Institutional Review Boards, Investigators, and Sponsors; Availability

摘要

The Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP), Department of Health and Human Services (HHS), are announcing the availability of a guidance entitled "Use of Electronic Informed Consent--Questions and Answers." The guidance is intended for institutional review boards (IRBs), investigators, and sponsors engaged in or responsible for oversight of human subject research under HHS and/or FDA regulations. The guidance provides recommendations on the use of electronic systems and processes that may employ multiple electronic media to obtain informed consent for both HHS-regulated human subject research and FDA-regulated clinical investigations of medical products, including human drug and biological products, medical devices, and combinations thereof. This guidance finalizes the draft guidance entitled "Use of Electronic Informed Consent in Clinical Investigations--Questions and Answers" issued in March 2015.