|Policy & Guidance|
|Compliance & Oversight|
|Research Involving Human Subjects|
|Regulations, Policies & Guidance|
|Research w/Vulnerable Populations|
|Research Using Human Specimens, Cell Lines or Data|
|Human Subjects Protections Training|
|NIH Inclusion Policies and Procedures|
|Frequently Asked Questions|
|Office of Laboratory Animal Welfare (OLAW)|
|Animals in Research|
|Peer Review Policies & Practices|
|Intellectual Property Policy|
|Acknowledging NIH Funding|
|Invention Reporting (iEdison)|
|NIH Public Access|
Research Involving Human Subjects
This site provides, HHS and NIH requirements and resources for the extramural community involved in human subjects research in their roles as: Applicants/Grantees, Offerors/Contractors, Peer Reviewers, Institutional Officials.
HHS and NIH take steps to Enhance Transparency of Clinical Trial ResultsNovember 24, 2014
The U.S. Department of Health and Human Services has issued a Notice of Proposed Rulemaking (NPRM), which proposes regulations to implement reporting requirements for clinical trials that are subject to Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA).
NOT-OD-15-015 Notice of Revised NIH Definition of Clinical TrialOctober 29, 2014
NOT-OD-15-015 The revised definition clarifies the distinction between clinical trials and clinical research studies and is designed to enhance the precision of the information NIH collects, tracks, and reports on clinical trials.
Starting March 3, 2014, Continuing Medical Education (CME) credit will be availableFebruary 27, 2014
Starting March 3, 2014, Continuing Medical Education (CME) credit will be available for successfully completing OER’s Protecting Human Research Participants on-line tutorial. For more information visit the CME Info page.
The Bioethics Commission Released its ethical analysis and recommendationsJanuary 23, 2014
The Bioethics Commission released its ethical analysis and recommendations on incidental and secondary findings on December 12, 2013.
Regulations, Policies & Guidance
Research with Vulnerable Populations
Research Using Human Specimens, Cell Lines, or Data
Human Subjects Protections Training
NIH Inclusion Policies and Procedures
Frequently Asked Questions
|For questions or comments regarding this site, contact Human Subjects Mailbox.|
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