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.


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.