NCATS PRIOR APPROVAL
Investigators who are nominated for or awarded a CTSI Pilot award may be required to submit documentation for NCATS Prior Approval for human subjects research.
NCATS is the NIH National Center for Advancing Translational Sciences which holds the parent award supporting CTSI. As such, CTSI and all pilot awardees supported by the CTSI are subject to the NCATS requirement for Prior Approval of human subjects research.
The following is an except from the NCATS Prior Approval FAQs page.
Prior approval is required for human subjects research with all pilot projects funded by NCATS, in full or partially, and for any pilot projects using institutional commitment specifically mentioned in the grant application.
CTSI has developed a REDCap repository into which PIs will upload documents and which includes detailed instructions and templates to facilitate this process. PIs of projects that are subject to this requirement will be sent a link to this REDCap survey as soon as notification of recommendation for funding is issued.
Important Notes
- NCATS requires IRB approval at the time of submission for Prior Approval.
- NCATS requires receipt of documents at least 30 days before the project start date.
- As such, PIs must adhere to given timelines and submission deadlines to avoid rescission of funding recommendation.
The current version of the NCATS Prior Approval Checklist is provided below as a reference only, since it is subject to change. The CTSI REDCap repository will include the most up-to-date version and will be made available to all eligible PIs at the time of notification of recommendation for funding.