{"abstract":"The Food and Drug Administration (FDA or we) is proposing to replace current requirements for FDA-regulated cooperative research with new requirements that would require any institution located in the United States participating in FDA-regulated cooperative research to rely on review and approval by a single institutional review board (IRB) for that portion of the research that is conducted in the United States, with some exceptions. FDA is also proposing an IRB recordkeeping requirement for research that takes place at an institution in which IRB oversight is conducted by an IRB that is not operated by the institution. FDA is proposing these revisions to streamline the IRB review process and decrease administrative burdens and inefficiencies for investigators and IRBs without compromising human subject protections. This proposed rule would harmonize FDA's requirements for cooperative research and IRB records, to the extent practicable and consistent with statutory provisions, with the \"Federal Policy for the Protection of Human Subjects\" (revised Common Rule) and is being issued in accordance with a provision of the 21st Century Cures Act (Cures Act).","action":"Proposed 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/2022/09/28/2022-21089.html","cfr_references":[{"chapter":null,"citation_url":null,"part":56,"title":21}],"citation":"87 FR 58752","comment_url":null,"comments_close_on":"2022-11-28","correction_of":null,"corrections":[],"dates":"Either electronic or written comments on the proposed rule must be submitted by November 28, 2022. Submit written comments (including recommendations) on the collection of information under the Paperwork Reduction Act of 1995 (PRA) by October 28, 2022.","disposition_notes":null,"docket_ids":["Docket No. FDA-2019-N-2175"],"dockets":[{"supporting_documents":[{"title":"TAB C 2017-1110 Cooperative Research PRIA as Cleared by OMB RE Memorandum to FDA DMS on Cooperative Research Proposed Rule","document_id":"FDA-2019-N-2175-0031"},{"title":"TAB C 2017-1110 Cooperative Research NPRM as Cleared by OMB RE Memorandum to FDA DMS on Cooperative Research Proposed Rule","document_id":"FDA-2019-N-2175-0030"},{"title":"TAB A 2017-1110 Cooperative Research NPRM as Submitted to OMB RE Memorandum to FDA DMS on Cooperative Research Proposed Rule","document_id":"FDA-2019-N-2175-0026"},{"title":"PRIA Reference 16 - U.S. Small Business Administration, Size Standards, https://www.sba.gov/sites/default/files/files/Size_Standards_Table.pdf, accessed on May 1, 2018. RE Institutional Review Boards; Cooperative Research","document_id":"FDA-2019-N-2175-0023"},{"title":"PRIA Reference 15 - North American Industry Classification System (NAICS), U.S. Census Bureau Data, “General Medical and Surgical Hospitals NAICs Code 622110” available at https://www.census.gov/naics/? input=622110&year=2017&details=622110, accessed on June 2, 2022 RE Institutional Review Boards; Cooperative Research","document_id":"FDA-2019-N-2175-0022"},{"title":"PRIA Reference 14 - Clinical Trials Transformation Initiative (CTTI). Use of Central IRBs for Multicenter Clinical Trials: Final Report. Available at: https://ctti-clinicaltrials.org/our-work/ethics-and-human-research-protection/single-irb, accessed June 7, 2022. RE Institutional Review Boards; Cooperative Research","document_id":"FDA-2019-N-2175-0021"},{"title":"PRIA Reference 13 - Sugarman, Jeremy, et al., (2005) “The Cost of Institutional Review Boards in Academics Medical Centers,” New England Journal of Medicine 352;17 April 28, 2005 pages 1825 to 1827. RE Institutional Review Boards; Cooperative Research","document_id":"FDA-2019-N-2175-0020"},{"title":"PRIA Reference 12 - Memorandum to File, FDA summary of data analysis; HHS, “Office for Human Research Protections (OHRP) Database for Registered IORGs & IRBs, Approved FWAs, and Documents Received in Last 60 Days,” prepared by Christian Brown, FDA, March 28, 2019. RE Institutional Review Boards; Cooperative Research","document_id":"FDA-2019-N-2175-0019"},{"title":"PRIA Reference 11 - Department of Health and Human Services, Valuing Time in U.S. Department of Health and Human Services Regulatory Impact Analyses: Conceptual Framework and Best Practices, 2017, available at https://aspe.hhs.gov/reports/valuing-time-us-department-health-human-services-regulatory-impact-analyses-conceptual-framework, accessed December 10, 2021.","document_id":"FDA-2019-N-2175-0018"},{"title":"PRIA Reference 10 - Bureau of Labor Statistics, Occupational Employment and Wages, May 2017, 43-0000 Office and Administrative Support Occupations (Major Group), available at: https://www.bls.gov/oes/current/oes430000.htm, accessed on February 26, 2019.RE Institutional Review Boards; Cooperative Research","document_id":"FDA-2019-N-2175-0017"}],"agency_name":"FDA","documents":[{"comment_count":38,"comment_start_date":"2022-11-28","updated_at":"2023-02-27T20:15:17.919-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2019-N-2175-0001","allow_late_comments":null,"id":"FDA-2019-N-2175-0001","comment_end_date":"2022-12-29","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":28,"id":"FDA-2019-N-2175","title":"Institutional Review Boards; Cooperative Research"}],"document_number":"2022-21089","effective_on":null,"end_page":58763,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2022/09/28/2022-21089.xml","html_url":"https://www.federalregister.gov/documents/2022/09/28/2022-21089/institutional-review-boards-cooperative-research","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2022-21089?publication_date=2022-09-28","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2022-09-28/2022-21089/mods.xml","not_received_for_publication":null,"page_length":12,"page_views":{"count":7513,"last_updated":"2026-04-05 00:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2022-09-28/pdf/2022-21089.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2022-21089.pdf?1664282733","publication_date":"2022-09-28","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2022/09/28/2022-21089.txt","regulation_id_number_info":{"0910-AI08":{"issue":"202404","html_url":"https://www.federalregister.gov/regulations/0910-AI08/institutional-review-boards-cooperative-research","title":"Institutional Review Boards; Cooperative Research","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202404&RIN=0910-AI08&operation=OPERATION_EXPORT_XML","priority_category":"Section 3(f)(1) Significant"}},"regulation_id_numbers":["0910-AI08"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"TAB C 2017-1110 Cooperative Research PRIA as Cleared by OMB RE Memorandum to FDA DMS on Cooperative Research Proposed Rule","document_id":"FDA-2019-N-2175-0031"},{"title":"TAB C 2017-1110 Cooperative Research NPRM as Cleared by OMB RE Memorandum to FDA DMS on Cooperative Research Proposed Rule","document_id":"FDA-2019-N-2175-0030"},{"title":"TAB A 2017-1110 Cooperative Research NPRM as Submitted to OMB RE Memorandum to FDA DMS on Cooperative Research Proposed Rule","document_id":"FDA-2019-N-2175-0026"},{"title":"PRIA Reference 16 - U.S. Small Business Administration, Size Standards, https://www.sba.gov/sites/default/files/files/Size_Standards_Table.pdf, accessed on May 1, 2018. RE Institutional Review Boards; Cooperative Research","document_id":"FDA-2019-N-2175-0023"},{"title":"PRIA Reference 15 - North American Industry Classification System (NAICS), U.S. Census Bureau Data, “General Medical and Surgical Hospitals NAICs Code 622110” available at https://www.census.gov/naics/? input=622110&year=2017&details=622110, accessed on June 2, 2022 RE Institutional Review Boards; Cooperative Research","document_id":"FDA-2019-N-2175-0022"},{"title":"PRIA Reference 14 - Clinical Trials Transformation Initiative (CTTI). Use of Central IRBs for Multicenter Clinical Trials: Final Report. Available at: https://ctti-clinicaltrials.org/our-work/ethics-and-human-research-protection/single-irb, accessed June 7, 2022. RE Institutional Review Boards; Cooperative Research","document_id":"FDA-2019-N-2175-0021"},{"title":"PRIA Reference 13 - Sugarman, Jeremy, et al., (2005) “The Cost of Institutional Review Boards in Academics Medical Centers,” New England Journal of Medicine 352;17 April 28, 2005 pages 1825 to 1827. RE Institutional Review Boards; Cooperative Research","document_id":"FDA-2019-N-2175-0020"},{"title":"PRIA Reference 12 - Memorandum to File, FDA summary of data analysis; HHS, “Office for Human Research Protections (OHRP) Database for Registered IORGs & IRBs, Approved FWAs, and Documents Received in Last 60 Days,” prepared by Christian Brown, FDA, March 28, 2019. RE Institutional Review Boards; Cooperative Research","document_id":"FDA-2019-N-2175-0019"},{"title":"PRIA Reference 11 - Department of Health and Human Services, Valuing Time in U.S. Department of Health and Human Services Regulatory Impact Analyses: Conceptual Framework and Best Practices, 2017, available at https://aspe.hhs.gov/reports/valuing-time-us-department-health-human-services-regulatory-impact-analyses-conceptual-framework, accessed December 10, 2021.","document_id":"FDA-2019-N-2175-0018"},{"title":"PRIA Reference 10 - Bureau of Labor Statistics, Occupational Employment and Wages, May 2017, 43-0000 Office and Administrative Support Occupations (Major Group), available at: https://www.bls.gov/oes/current/oes430000.htm, accessed on February 26, 2019.RE Institutional Review Boards; Cooperative Research","document_id":"FDA-2019-N-2175-0017"}],"regulatory_plan":{"html_url":"https://www.federalregister.gov/regulations/0910-AI08/institutional-review-boards-cooperative-research","title":"Institutional Review Boards; Cooperative Research"},"comments_count":38,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2019-N-2175","supporting_documents_count":28,"docket_id":"FDA-2019-N-2175","document_id":"FDA-2019-N-2175-0001","regulation_id_number":"0910-AI08","title":"Institutional Review Boards; Cooperative Research","checked_regulationsdotgov_at":"2023-02-28T01:15:17Z"},"regulations_dot_gov_url":null,"significant":false,"signing_date":null,"start_page":58752,"subtype":null,"title":"Institutional Review Boards; Cooperative Research","toc_doc":"Institutional Review Boards; Cooperative Research","toc_subject":null,"topics":["Human research subjects","Reporting and recordkeeping requirements","Safety"],"type":"Proposed Rule","volume":87}