GOVERNANCE & GUIDELINES

Prior Approval of Planned Research Involving Human Subjects

Date: January 10, 2018
Last Revision: June 15, 2018

Requests for prior approval of planned research involving human subjects conducted through NCATS UL1 pilot projects and KL2 scholar projects must be submitted in writing to NCATS no later than 30 days before the proposed implementation of research involving human subjects. The NCATS Human Subjects Prior Approval Checklist provides a suggested form to submit materials for the review of delayed-onset research involving human subjects. This form is expected to assist with streamlining NCATS’ review of the materials.

NCATS Human Subjects Prior Approval Checklist New – 4.4.2018

NCATS Human Subjects Prior Approval Decision Tree

FAQs have been posted here: CTSA Program Prior Approval Frequently Asked Questions

March 28 CTSA PI Webinar about the NCATS Human Subjects Prior Approval Checklist here

Comments and questions about this process? Email: NCATSDOPAinquiry@mail.nih.gov