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2011-07-26
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Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators
Proposed Rules
D09002ee1bdcff091
D09002ee1bdcff153
United States
Department of Health and Human Services
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United States Government Agency or Subagency
United States
Office of the Secretary
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United States Government Agency or Subagency
United States
Food and Drug Administration
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United States Government Agency or Subagency
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.
76 FR 44512
https://www.govinfo.gov/app/details/FR-2011-07-26/2011-18792
2011-18792
fr26jy11-23
4150-28-P
https://www.govinfo.gov/app/details/FR-2011-07-26/2011-18792
https://www.govinfo.gov/content/pkg/FR-2011-07-26/html/2011-18792.htm
https://www.govinfo.gov/content/pkg/FR-2011-07-26/pdf/2011-18792.pdf
20 p.
44512
44531
76 FR 44512
Code of Federal Regulations
Title 21 Part 50
21 CFR Part 50
Code of Federal Regulations
Title 21 Part 56
21 CFR Part 56
Code of Federal Regulations
Title 45 Part 160
45 CFR Part 160
Code of Federal Regulations
Title 45 Part 164
45 CFR Part 164
Code of Federal Regulations
Title 45 Part 46
45 CFR Part 46
Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators; Federal Register Vol. 76, Issue
PRORULE
2011-18792
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Food and Drug Administration
2011-09-26
4150-28-P
2011-18792
Advance notice of proposed rulemaking.
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.
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.
Jerry Menikoff, M.D., J.D., Office for Human Research Protections (OHRP), Department of Health and Human Services, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852; telephone: 240-453-6900 or 1-866-447-4777; facsimile: 301-402-2071; e- mail: jerry.menikoff@hhs.gov.
Human Subjects Research Protections:
Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators
,
jerry.menikoff@hhs.gov
ClinicalTrials.gov
http://answers.hhs.gov/ohrp/categories/1564
http://www.dhhs.gov/ohrp/sachrp/sachrpletter013108.html
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM127013.pdf
http://www.hhs.gov/ocr/privacy/hipaa/understanding/coveredentities/nprmhitech.pdf
http://www.hhs.gov/ohrp/newsroom/rfc/com030509.html
http://www.hhs.gov/ohrp/policy/belmont.html
http://www.hhs.gov/ohrp/policy/expedited98.html
http://www.iom.edu/∼/media/Files/Activity%20Files/Research/HIPAAandResearch/PrittsPrivacyFinalDraftweb.ashx
http://www.justice.gov/opcl/1974privacyact-overview.htm
http://www.justice.gov/opcl/privstat.htm
http://www.regulations.gov
http://www.whitehouse.gov/sites/default/files/omb/assets/omb/fedreg/2007/061507_cipsea_guidance.pdf
http://www.whitehouse.gov/sites/default/files/omb/assets/omb/inforeg/cipsea/cipsea_statute.pdf
https://www.aamc.org/initiatives/clinicalresearch/irbreview/
Federal Register
Vol. 76, no. 143
Office of the Federal Register, National Archives and Records Administration
2011-07-26
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311 p.
Table of Contents:
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GS 4.107:
AE 2.106:
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