NCATS Prior Approval for Human Subjects Research

Effective January 2018, all CTSI-Pilot Award funded studies that involve human subjects research deemed greater than minimal risk by the IRB or meet the NIH definition of a Clinical Trial must receive prior approval before beginning research activities. Starting in 2020, studies that are minimal risk or exempt are no longer required to receive prior approval, but must still provide some documentation before beginning research activities.

Prior Approval Process

You are responsible for preparing the Human Subjects and Clinical Trials Information form, HSS Addendum, and accompanying documents for submission to NIH. You will submit the complete documents in a zipped folder to the CTSI-Pilot Awards program manager ([email protected]) who will compile and verify them for submission to NIH.

IRB Approval must be obtained before submission to NIH for prior approval. Submission of incomplete documentation may result in delays to your research. It may take up to 6 weeks after submission of a complete packet to receive notice of approval, and failure to receive NCATS Prior Approval will result in cancellation of award.

Follow the instructions on the HSS Addendum to determine

a) Which documents are required, and 

b) How to fill out the Human Subjects and Clinical Trial Information form

Prior Approval Document Checklist

1) Completed HSS Addendum (Abstract <500 words with budget)

  • PI and co-investigator names as listed in the RAP grant application
  • Study information (title, investigators) match IRB Approval Letter

2) Completed Human Subjects and Clinical Trials Information form

  • Use Annotated Form Sets for as a quick reference
  • Follow all Application Instructions carefully
  • PI and co-investigator names as listed in the RAP grant application
  • Study information (title, investigators) match IRB Approval Letter
  • NCATS Required Documents (see HSS Addendum)

          - IRB letter, or exemption determination

          - CITI certificates for key personnel

          - Biosketches for all key personnel (≤5 pages)

          - IRB-approved protocol and consent documents, if a clinical trial

  • Inclusion Enrollment Form

Take a video tour of the form.Link to Non-U.S. Government Site - Click for Disclaimer

Click here for more guidance from NIH on most common submission errors