{"abstract":"The Food and Drug Administration (FDA) is amending its current informed consent regulations to permit harmonization of the Department of Health and Human Services' (DHHS) policies on emergency research and to reduce confusion on when such research can proceed without obtaining an individual subject's informed consent. This regulation provides a narrow exception to the requirement for obtaining and documenting informed consent from each human subject, or his or her legally authorized representative, prior to initiation of an experimental intervention. The exception would apply to a limited class of research activities involving human subjects who are in need of emergency medical intervention but who cannot give informed consent because of their life-threatening medical condition, and who do not have a legally authorized person to represent them. FDA is taking this action in response to growing concerns that current rules are making high quality acute care research activities difficult or impossible to carry out at a time when the need for such research is increasingly recognized.","action":"Final rule.","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/1996/10/02/96-24967.html","cfr_references":[{"chapter":null,"citation_url":null,"part":null,"title":21},{"chapter":null,"citation_url":null,"part":"50","title":21},{"chapter":null,"citation_url":null,"part":"56","title":21},{"chapter":null,"citation_url":null,"part":"312","title":21},{"chapter":null,"citation_url":null,"part":"314","title":21},{"chapter":null,"citation_url":null,"part":"601","title":21},{"chapter":null,"citation_url":null,"part":"812","title":21},{"chapter":null,"citation_url":null,"part":"814","title":21},{"chapter":null,"citation_url":null,"part":"46","title":45}],"citation":"61 FR 51498","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"These regulations are effective November 1, 1996.","disposition_notes":null,"docket_ids":["Docket No. 95N-0158"],"dockets":[{"supporting_documents":[{"title":"Re: Prehospital Airway Control Trial (PACT)","document_id":"FDA-1995-S-0036-0190"},{"title":"Attachment - Community Consultantion for ResQPRO Clinical Trial (Advanced Circulatory Systems, Inc., to the Division of Dockets Management re: IDE G080169, ResQpro Clinical Trial, Community Consultation Plan - Report) re FDA-1995-S-0036-0112","document_id":"FDA-1995-S-0036-0121"},{"title":"Report 17 - \"Lehigh Valley Hospital\" - [Northfield Laboratories, Inc. - Public Disclosure Information]","document_id":"FDA-1995-S-0036-0105"},{"title":"Northfield Laboratories Inc BB IND 10719","document_id":"FDA-1995-S-0036-0099"},{"title":"Northfield Laboratories Inc BB IND 10719","document_id":"FDA-1995-S-0036-0098"},{"title":"Northfield Laboratories Inc BB IND 10719","document_id":"FDA-1995-S-0036-0097"},{"title":"Northfield Laboratories Inc BB IND 10719","document_id":"FDA-1995-S-0036-0096"},{"title":"Northfield Laboratories Inc BB IND 10719","document_id":"FDA-1995-S-0036-0093"},{"title":"Northfield Laboratories Inc BB IND 10719","document_id":"FDA-1995-S-0036-0092"},{"title":"Northfield Laboratories Inc BB IND 10719","document_id":"FDA-1995-S-0036-0091"}],"agency_name":"FDA","documents":[{"comment_count":8,"comment_start_date":"1996-07-17","updated_at":"2023-04-19T21:56:07.012-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-1995-S-0036-0001","allow_late_comments":null,"id":"FDA-1995-S-0036-0001","comment_end_date":"2021-05-04","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":29,"id":"FDA-1995-S-0036","title":"Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24"}],"document_number":"96-24967","effective_on":"1996-11-01","end_page":51531,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":null,"html_url":"https://www.federalregister.gov/documents/1996/10/02/96-24967/protection-of-human-subjects-informed-consent","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/96-24967?publication_date=1996-10-02","mods_url":"https://www.govinfo.gov/metadata/granule/FR-1996-10-02/96-24967/mods.xml","not_received_for_publication":null,"page_length":34,"page_views":{"count":731,"last_updated":"2026-10-25 00:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-1996-10-02/pdf/96-24967.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"1996-10-02","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/1996/10/02/96-24967.txt","regulation_id_number_info":{"0910-AA60":{"issue":"199604","html_url":"https://www.federalregister.gov/regulations/0910-AA60/protection-of-human-subjects-informed-consent","title":"Protection of Human Subjects; Informed Consent","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=199604&RIN=0910-AA60&operation=OPERATION_EXPORT_XML","priority_category":"Other Significant"}},"regulation_id_numbers":["0910-AA60"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Re: Prehospital Airway Control Trial (PACT)","document_id":"FDA-1995-S-0036-0190"},{"title":"Attachment - Community Consultantion for ResQPRO Clinical Trial (Advanced Circulatory Systems, Inc., to the Division of Dockets Management re: IDE G080169, ResQpro Clinical Trial, Community Consultation Plan - Report) re FDA-1995-S-0036-0112","document_id":"FDA-1995-S-0036-0121"},{"title":"Report 17 - \"Lehigh Valley Hospital\" - [Northfield Laboratories, Inc. - Public Disclosure Information]","document_id":"FDA-1995-S-0036-0105"},{"title":"Northfield Laboratories Inc BB IND 10719","document_id":"FDA-1995-S-0036-0099"},{"title":"Northfield Laboratories Inc BB IND 10719","document_id":"FDA-1995-S-0036-0098"},{"title":"Northfield Laboratories Inc BB IND 10719","document_id":"FDA-1995-S-0036-0097"},{"title":"Northfield Laboratories Inc BB IND 10719","document_id":"FDA-1995-S-0036-0096"},{"title":"Northfield Laboratories Inc BB IND 10719","document_id":"FDA-1995-S-0036-0093"},{"title":"Northfield Laboratories Inc BB IND 10719","document_id":"FDA-1995-S-0036-0092"},{"title":"Northfield Laboratories Inc BB IND 10719","document_id":"FDA-1995-S-0036-0091"}],"regulatory_plan":{"html_url":"https://www.federalregister.gov/regulations/0910-AA60/protection-of-human-subjects-informed-consent","title":"Protection of Human Subjects; 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