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Please discuss this at the IC level. There is an NIH requirement that the IC hold the IND. Usually there is a regulatory expert that can assist with this. If your IC does not have this expertise, please contact Dr. Gini Guptill in the ORSC: orscprotocolsupport@nih.gov

Protocol templates can be found on the Templates & Forms page.

Consent templates can be found on the Templates & Forms page.

The Clinical Center has Recruitment Services available: Recruitment Services.

Please email: IRB@od.nih.gov or call 301-402-3713.