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# Guidance on Electronic Informed Consent Q&A
- URL: https://www.fdaweb.com/guidance-on-electronic-informed-consent-q-a/
- Published: 2016-12-15T12:00:00.000Z
- Updated: 2026-09-14T21:55:35.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5137586

*Federal Register* Notice: FDA and HHS’s Office for Human Research Protections are making available a guidance entitled “Use of Electronic Informed Consent — Questions and Answers.” The document 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. To view the guidance, click [here](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM436811.pdf?ref=fdaweb.com). To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-12-15/pdf/2016-30146.pdf?ref=fdaweb.com).