Approvals Required Prior to Funding Start Date Prior to receiving funds, research involving human subjects must have appropriate approvals from the Duke and/or NC State IRB. If the research includes animals, the appropriate IACUC animal research forms must also be approved before the project’s start date. Either an IRB approval letter or an IRB response to a “Determination Whether Research or Similar Activities Require IRB Approval” must be submitted to Duke CTSI prior to funds being released. Human subjects or animal research must be reviewed in accordance with the university’s general assurances and HIPAA. In addition, if the research involves human subjects, all personnel named on the budget page must have certification of training in the protection of human subjects prior to the start of the grant period. Research involving human subjects must also be approved by the National Center for Advancing Translational Sciences (NCATS) prior to receiving funds. The Duke CTSI will request required documents from the Duke PIs and submit a regulatory package to NCATS for review and approval. Failure to submit documents in the requested timeframe may result in cancellation of funding.
Approvals Required Prior to Funding Start Date Prior to receiving funds, research involving human subjects must have appropriate approvals from the Duke IRB and NCATS. The Duke CTSI will request required documents from the PI and submit a regulatory package to NCATS for review and approval prior to the funding start date. If the research includes animals, the appropriate IACUC animal research forms must also be approved before the project’s start date. Failure to submit documents in the requested timeframe may result in cancellation of funding.
