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HHS/OASH | RIN: 0937-AA02 | Publication ID: Fall 2011 |
Title: ●Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators | |
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) issued an 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 solicited 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. Revisions to the current human subjects regulations are being considered because OSTP and HHS believe these changes would strengthen protections for research subjects. | |
Agency: Department of Health and Human Services(HHS) | Priority: Other Significant |
RIN Status: First time published in the Unified Agenda | Agenda Stage of Rulemaking: Proposed Rule Stage |
Major: No | Unfunded Mandates: No |
CFR Citation: 45 CFR 160 45 CFR 164 21 CFR 56 21 CFR 50 | |
Legal Authority: 21 USC 321p 21 USC 331 21 USC 351 to 353 21 USC 355 21 USC 360 21 USC 371 |
Legal Deadline:
None |
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Timetable:
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Regulatory Flexibility Analysis Required: Undetermined | Government Levels Affected: Undetermined |
Federalism: No | |
Included in the Regulatory Plan: No | |
RIN Data Printed in the FR: No | |
Agency Contact: Jerry Menikoff Director, Office for Human Research Protections Department of Health and Human Services Office of Assistant Secretary for Health 1101 Wootton Parkway, Suite 200, Rockville, MD 20852 Phone:240 453-6900 Email: jerry.menikoff@hhs.gov |