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:

  • Preliminary Guidance Related to Informed Consent for Research on Dried Blood Spots Obtained Through Newborn Screening

    NIH has published a Guide Notice (NOT-OD-15-127) describing the implementation of new research requirements contained in the Newborn Screening Saves Lives Reauthorization Act.  This legislation designates federally funded research using newborn dried blood spots collected on or after March 18, 2015  as non-exempt human subjects research for which parental permission must have been obtained.

    Implementation questions should be directed to Dr. Tiina Urv at NICHD.

New Content

  • Human Subjects Infographic -  This one-page infographic is a guide to defining human subjects research at the NIH. It summarizes human subjects research, what you will need for your NIH application and what you will need if you are funded.
  • Preparing the Human Subjects Section - Are you working on human subjects research or human specimens or data? Should you submit a Data and Safety Monitoring Plan? This 15-slide presentation simplifies the human subjects scenarios found in the Supplemental Grant Application Instructions for NIH applications ( Find the scenario that best describes your research to determine what supplemental information needs to be submitted with your NIH application.

News Flash Archive


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.