Grants and Funding
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.

News Flash:

HHS and NIH take steps to Enhance Transparency of Clinical Trial Results
November 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).         
You can read a summary of the proposed changes :

NOT-OD-15-015 Notice of Revised NIH Definition of Clinical Trial
October 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 available
February 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 recommendations
January 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
Additional Resources
For questions or comments regarding this site, contact Human Subjects Mailbox.

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This page last updated on April 18, 2013
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