{"abstract":"The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft guidance for industry, clinical investigators, and institutional review boards entitled \"Use of Electronic Informed Consent in Clinical Investigations: Questions and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.","action":"Notice.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2015/03/09/2015-05377.html","cfr_references":[],"citation":"80 FR 12496","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by May 8, 2015.","disposition_notes":null,"docket_ids":["Docket No. FDA-2015-D-0390"],"dockets":[],"document_number":"2015-05377","effective_on":null,"end_page":12497,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2015/03/09/2015-05377.xml","html_url":"https://www.federalregister.gov/documents/2015/03/09/2015-05377/use-of-an-electronic-informed-consent-in-clinical-investigations-questions-and-answers-draft","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2015-05377?publication_date=2015-03-09","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2015-03-09/2015-05377/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":2778,"last_updated":"2026-10-24 00:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2015-03-09/pdf/2015-05377.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2015-05377.pdf?1425649580","publication_date":"2015-03-09","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2015/03/09/2015-05377.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2015-D-0390","supporting_documents_count":0,"docket_id":"FDA-2015-D-0390","regulation_id_number":null,"title":"Clinical Investigators, and Institutional Review Boards – Use of an Electronic Informed Consent in Clinical Investigations – Questions and Answers","checked_regulationsdotgov_at":"2015-05-09T05:00:35Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":12496,"subtype":null,"title":"Use of an Electronic Informed Consent in Clinical Investigations: Questions and Answers; Draft Guidance for Industry, Clinical Investigators, and Institutional Review Boards; Availability","toc_doc":"Use of an Electronic Informed Consent in Clinical InvestigationsQuestions and Answers","toc_subject":"Guidance for Industry and Staff:","topics":[],"type":"Notice","volume":80}