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NIH Prior Approval and Notification

Background: In 2012, NIH issued new notices that advised investigators that in certain circumstances NIH prior approval must be obtained before spending NIH research funds on a new or modified research protocol involving human subjects. The full notices are available at:

Dr. Thomas Insel, Director of the National Center for Advancing Translational Sciences (NCATS), also issued an agency memorandum (5/25/2012) addressing the new requirements. As a scholar or trainee provided with pilot funding through the NIH/NCATS-funded Clinical and Translational Science Institute (CTSI), these polices apply to you.

The notices define 'delayed onset' human subjects research and 'change in scope' as situations requiring NIH prior approval. 'Delayed onset' applies whenever a trainee submits a new, non-exempt human subjects research protocol to the Institutional Review Board (IRB) for the first time. 'Change in scope' applies when a trainee seeks IRB approval for a protocol modification that is deemed to increase risks to human subjects. In either scenario, NIH prior approval must be obtained before you can spend any of your CTSI research funds toward the aims of new protocol. Human subjects protocols that qualify for an exemption (categories 1-6), and animal studies entailing IACUC approval, require formal NIH notification but not prior approval.

To comply with these requirements, KL2-CTS scholars are required to notify ICRE Administrator Patrick Reitz ( / 692-2018) in advance whenever planning to submit a new or modified protocol to the IRB. Patrick will assist you in applying NIH guidance to your specific protocol, and with whatever additional administrative steps (e.g., form, submission to NIH) are required to comply with the rules.