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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:

August 1, 2012

New Guide Notices related to NIH funded human subjects research: OER has issued two related guide notices that describe when an awardee institution must seek prior NIH approval for new human subjects research that is proposed after an award has been made:

  • Changes proposed for awarded projects that would increase risk to subjects will now require prior NIH approval; please see Guide Notice OD-12-129 for more details.
  • The prior approval process for awards originally submitted without definitive plans for human subjects research (delayed onset awards) is described in Guide Notice OD-12-130.

May 10, 2012

OHRP has launched an educational webinar series! Kristina Borror, Ph.D., Director of the Division of Compliance Oversight, recently presented "When the Feds Come A-Knockin': How to Prepare for an OHRP Evaluation of Your Program." It is now available on the OHRP YouTube playlist. You may view supporting materials at

Regulations, Policies & Guidance
Research with Vulnerable Populations
Research Using Human Specimens, Cell Lines, or Data
Human Subjects Protections Training
Frequently Asked Questions
Additional Resources
For questions or comments regarding this site, contact Human Subjects Mailbox.

Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.

This page last updated on July 31, 2012
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