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Research Involving Human Subjects

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I am an Investigator

Those in the process of applying for a grant, cooperative agreement or R&D contract. This includes those submitting an SBIR/STTR application. Those who have submitted an application. Those who have been funded. 

I am at an Institution

Institutional officials and administrators, IRB administrators and members.

About Peer Review

Learn about the review of human subjects during the peer review process. Applicants can get a better idea of what peer reviewers look for in the application and Protection of Human Subjects section. Peer Reviewers can find guidance for reviewing the human subjects research plan.

I have a Special Award

Human Subjects information for specific NIH award types.

Recent news

**Starting with NIH applications due on January 25, 2018 and after Human Subjects and Clinical Trial information has changed (see Forms E). Depending on the due date of your NIH application there are specific Human Subjects instructions. Please see the Application Guide Instructions for the correct package.**

 

A brief summary of the proposed changes can be accessed at the following HHS website: http://www.hhs.gov/ohrp/humansubjects/regulations/nprm2015summary.html

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

Implementation questions should be directed to Dr. Tina Urv and NICHD.

New Human Subjects Tools

  • 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 (http://grants.nih.gov/grants/funding/424/SupplementalInstructions.pdf). Find the scenario that best describes your research to determine what supplemental information needs to be submitted with your NIH application.
  • Exemptions Infographic - This one-page infographic is a guide to simplify the 3 human subjects research exemptions most commonly used at the NIH. It summarizes Exemptions 1, 2 and 4 providing basic definitions, examples of studies that meet and do not meet the criteria of the exemption, and things one must consider when engaged in exempt human subjects research. 
     

    Am I doing Human Subjects Research? Questionnaire

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