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

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 This guidance finalizes the draft guidance entitled ``Use of Electronic Informed Consent in Clinical Investigations--Questions and Answers'' issued in March 2015.