Use of Electronic Informed Consent in Clinical Investigations, Guidance

December 15, 2016

Today the Office for Human Research Protections (OHRP) and Food and Drug Administration (FDA) published final guidance aimed at providing answers to commonly asked questions about using 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  This guidance finalizes the draft guidance entitled “Use of Electronic Informed Consent in Clinical Investigations--Questions and Answers” issued in March 2015. The final guidance was developed in collaboration with FDA and OHRP and is issued as a joint final guidance. To access the Federal Register notice announcing the availability of the final guidance document go to: https://www.gpo.gov/fdsys/pkg/FR-2016-12-15/pdf/2016-30146.pdf  or  https://www.gpo.gov/fdsys/pkg/FR-2016-12-15/html/2016-30146.htm To access a copy of the final guidance document go to: https://www.hhs.gov/ohrp/regulations-and-policy/guidance/use-electronic-informed-consent-questions-and-answers/index.html