Investigator Resources

Prior Approval

Certain research applications may be submitted to a sponsoring agency with the knowledge that human subjects will be involved during the period of support, but definite plans for this involvement cannot be described in the application (45 CRF 46.118). This situation is referred to as "delayed onset human subjects research." As noted in the NIH Grants Policy Statement (GPS), after award and prior to the involvement of human subjects, the grantee must submit to the NIH awarding Institute/Center (IC) for approval, a detailed human subjects section that follows the NIH Supplemental Grant Application Instructions that are part of the NIH competing application guide as well as the terms of award.

Therefore, grantees must receive approval from NCATS for all pilots and K scholar projects involving human subjects, including pilot projects funded through institutional funds identified as voluntary cost share in the Notice of Award. Pilot and K Scholar CTSA projects will be reviewed and approved by NCATS staff to ensure protection of human subjects, appropriate data and safety monitoring, and scientific integrity.

For more detailed information about Prior Approval, review the following resources: