federal_register: 2022-21089
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
This data as json
| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2022-21089 | Institutional Review Boards; Cooperative Research | Proposed Rule | 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). | 2022-09-28 | 2022 | 9 | https://www.federalregister.gov/documents/2022/09/28/2022-21089/institutional-review-boards-cooperative-research | https://www.govinfo.gov/content/pkg/FR-2022-09-28/pdf/2022-21089.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | 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... |