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HHS/OPHS | RIN: 0940-AA06 | Publication ID: Fall 2008 |
Title: Human Subjects Protection Regulations: Institutional Review Boards Registration Requirements | |
Abstract: This notice of proposed rulemaking proposes to add subpart F to Department of Health and Human Services (HHS) regulations for protection of human subjects, 45 CFR part 46, to require registration of institutional review boards (IRBs) with HHS. The registration information would include contact information, approximate numbers of active protocols involving research conducted or supported by HHS, accreditation status, IRB membership, and staffing for the IRB. The proposed registration requirements will make it easier for the Office for Human Research Protections (OHRP) to convey information to IRBs, and will support the current IRB registration operated by OHRP. Under the current OHRP IRB registration system, the submission of certain registration information is required by human subjects protection regulations, and certain other information may be submitted voluntarily. This proposed information collection was submitted to the Office of Management and Budget under the Paperwork Reduction Act. Under the proposed rule, all registration information will be required, making the IRB registration system uniform with IRB registration requirements of the Food and Drug Administration (FDA), and creating a single HHS IRB Registration system. FDA simultaneously published a proposed rule regarding FDA IRB registration requirements. | |
Agency: Department of Health and Human Services(HHS) | Priority: Substantive, Nonsignificant |
RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Final Rule Stage |
Major: No | Unfunded Mandates: No |
CFR Citation: 45 CFR 46 | |
Legal Authority: 5 USC 301 42 USC 289 |
Legal Deadline:
None |
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Timetable:
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Regulatory Flexibility Analysis Required: No | Government Levels Affected: None |
Small Entities Affected: No | Federalism: No |
Included in the Regulatory Plan: No | |
RIN Data Printed in the FR: No | |
Agency Contact: Irene Stith-Coleman Ph.D Department of Health and Human Services Office of Public Health and Science Suite 200, The Tower Building, 1101 Wootten Parkway, Rockville, MD 20852 Phone:240 453-6900 Fax:301 402-2071 Email: irene.stith-coleman@hhs.gov |