{"abstract":"The Office of the Secretary of the Department of Health and Human Services (HHS) in coordination with the Office of Science and Technology Policy (OSTP) is issuing this advance notice of proposed rulemaking (ANPRM) to request comment on how current regulations for protecting human subjects who participate in research might be modernized and revised to be more effective. This ANPRM seeks comment on how to better protect human subjects who are involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. The current regulations governing human subjects research were developed years ago when research was predominantly conducted at universities, colleges, and medical institutions, and each study generally took place at only a single site. Although the regulations have been amended over the years, they have not kept pace with the evolving human research enterprise, the proliferation of multi-site clinical trials and observational studies, the expansion of health services research, research in the social and behavioral sciences, and research involving databases, the Internet, and biological specimen repositories, and the use of advanced technologies, such as genomics. Revisions to the current human subjects regulations are being considered because OSTP and HHS believe these changes would strengthen protections for research subjects.","action":"Advance notice of proposed rulemaking.","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":"Office of the Secretary"},{"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/2011/07/26/2011-18792.html","cfr_references":[{"chapter":null,"citation_url":null,"part":50,"title":21},{"chapter":null,"citation_url":null,"part":56,"title":21},{"chapter":null,"citation_url":null,"part":46,"title":45},{"chapter":null,"citation_url":null,"part":160,"title":45},{"chapter":null,"citation_url":null,"part":164,"title":45}],"citation":"76 FR 44512","comment_url":null,"comments_close_on":"2011-09-26","correction_of":null,"corrections":[],"dates":"To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on September 26, 2011.","disposition_notes":null,"docket_ids":[],"dockets":[],"document_number":"2011-18792","effective_on":null,"end_page":44531,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2011/07/26/2011-18792.xml","html_url":"https://www.federalregister.gov/documents/2011/07/26/2011-18792/human-subjects-research-protections-enhancing-protections-for-research-subjects-and-reducing-burden","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2011-18792?publication_date=2011-07-26","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2011-07-26/2011-18792/mods.xml","not_received_for_publication":null,"page_length":20,"page_views":{"count":7252,"last_updated":"2026-04-04 16:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2011-07-26/pdf/2011-18792.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2011-07-26","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2011/07/26/2011-18792.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2011-08-13T08:08:09Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":44512,"subtype":null,"title":"Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators","toc_doc":"Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators","toc_subject":"Human Subjects Research Protections:","topics":[],"type":"Proposed Rule","volume":76}