45 CFR 46 - PROTECTION OF HUMAN SUBJECTS

Title 45 published on 2011-10-01

no entries appear in the Federal Register after this date.

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.

United States Code

42 USC 289 - Institutional review boards; ethics guidance program

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 45 CFR 46

2011-09-01; vol. 76 # 170 - Thursday, September 1, 2011

76 FR 54408 - Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators; Extension of Comment Period

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2011-22341
RIN

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Office of the Secretary, Food and Drug Administration

Advance notice of proposed rulemaking; extension of comment period.

The comment period for the proposed rule published July 26, 2011, at 76 FR 44512 is extended. Comments will be received through October 26, 2011.

45 CFR Parts 46, 160, and 164

Summary

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 extending the comment period for an advance notice of proposed rulemaking (ANPRM) requesting comment on how current regulations for protecting human subjects who participate in research might be modernized and revised to be more effective. That ANPRM was published in the Federal Register on July 26, 2011.

2011-07-26; vol. 76 # 143 - Tuesday, July 26, 2011

76 FR 44512 - Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2011-18792
RIN

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Office of the Secretary, Food and Drug Administration

Advance notice of proposed rulemaking.

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.

45 CFR Parts 46, 160, and 164

Summary

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.

45 CFR 46 - PROTECTION OF HUMAN SUBJECTS

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