{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled \"Informed Consent Information Sheet: Guidance for IRBs, Clinical Investigators, and Sponsors.\" The draft guidance announced in this notice is intended to assist institutional review boards (IRBs), clinical investigators, and sponsors involved in clinical investigations of FDA-regulated products in carrying out their responsibilities related to informed consent. The draft guidance provides the Agency's recommendations and requirements for informed consent to assure the protection of the rights and welfare of human subjects in clinical investigations.","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/2014/07/15/2014-16492.html","cfr_references":[],"citation":"79 FR 41291","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Although comments on any guidance can be submitted at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers a comment on this draft guidance before it begins work on the final version of the guidance, electronic or written comments on the draft guidance should be submitted by September 15, 2014.","disposition_notes":null,"docket_ids":["Docket No. FDA-2006-D-0031"],"dockets":[],"document_number":"2014-16492","effective_on":null,"end_page":41292,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2014/07/15/2014-16492.xml","html_url":"https://www.federalregister.gov/documents/2014/07/15/2014-16492/draft-informed-consent-information-sheet-guidance-for-institutional-review-boards-clinical","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2014-16492?publication_date=2014-07-15","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2014-07-15/2014-16492/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":4205,"last_updated":"2026-09-22 16:15:06 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2014-07-15/pdf/2014-16492.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2014-16492.pdf?1405342227","publication_date":"2014-07-15","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2014/07/15/2014-16492.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Waiver of IRB Requirements for Drug and Biological Products Stuides","document_id":"FDA-2006-D-0031-0004"},{"title":"FDA Institutional Review Board Inspections","document_id":"FDA-2006-D-0031-0003"},{"title":"Information Sheet Guidance For IRBs,Clinical Investigators, and Sponsors","document_id":"FDA-2006-D-0031-0002"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2006-D-0031","supporting_documents_count":3,"docket_id":"FDA-2006-D-0031","regulation_id_number":null,"title":"Human Subject Protection--Information for Institutional Review Boards, Clinical Investigators, and Sponsors; Rescission, Reissuance, and Development of FDA Guidance Documents","checked_regulationsdotgov_at":"2014-09-16T05:01:07Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":41291,"subtype":null,"title":"Draft Informed Consent Information Sheet: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Availability","toc_doc":"Informed Consent Information Sheets","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":79}