Policy documents

  • NIH-funded Studies Involving Human Subjects
    NIH made a number of policy changes to improve the stewardship of clinical trials across the life cycle of the trial. Learn more on the Human Subject and Clinical Trial Information form. A new Clinical Trial Requirements for NIH Grantees and Contractors web page has been developed to bring together all the information you need to know. A 15 minute video, Overview of New NIH Policies on Human Subjects Research and Clinical Trials, provides a succint explanation of the various policy changes and what they mean.

  • NIH Resources:
    - Training Resources: includes summary presentations, videos, FAQs, and upcoming webinars.
    - Clinical Trial Requirements for Grants and Contracts: includes the details of all the policy changes, including a decision tree for dtermining if your study is a clinical trial.
    - Case Studies: examples of studies to help you decide if your study meets the definition of a clinical trial. This list is constantly being updated.
    - Continuing to Clarify the NIH Definition of a Clinical Trial - blog from Dr. Mike Lauer, NIH's Deputy Director for Extramural Research

  • New NIH "FORMS-E" Grant Application Instructions
    NIH has updated their application guide for use with grant application due dates on or after January 25, 2018
    Focus of changes:

  • New PHS Human Subjects & Clinical Trials Information Form
    • Consolidates human subjects, inclusion enrollment, and clinical trial information into one form
    • Collects information at the study-level
    • Uses discrete form fields to capture clinical trial information and provide the level of detail needed for peer review
    • Presents key information to reviewers and staff in a consistent format
    • Aligns with ClinicalTrials.gov (where possible) for future data exchange with ClinicalTrials.gov
    • Includes attachment to comply with NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research (see NIH-OD-17-076)
  • Clarification that the Research Strategy attachment should be used to discuss the overall strategy, methodology, and analyses of the proposed research, but applicants should not duplicate information collected in the new PHS Human Subjects and Clinical Trials Information form
  • Incorporation of updated appendix policy (see NOT-OD-17-098)
  • Incorporation of recent Grants.gov changes to R&R Budget and SBIR/STTR Information forms
  • Discontinue use of supplemental instructions for all competing applications and progress reports
    • All information has been folded into the application guide form instructions and/or is contained in the appropriate policy website (e.g., NIH Grants Policy Statement)

All updates to form instructions are listed here