Scientific Review
Clinical protocols in the NIH Intramural Research Program that require IRB approval must undergo scientific review at the Institute/Center (IC) level, with concurrence by the Chief Scientific Officer (CSO) for some reviews. All waivers of Scientific Review must be approved by the CSO.
Clinical protocols in the NIH Intramural Research Program that require IRB approval must undergo scientific review at the Institute/Center (IC) level, with concurrence by the Chief Scientific Officer (CSO) for some reviews. All waivers of Scientific Review must be approved by the CSO.
Scientific Review in the Intramural Research Program
Scientific review timepoints include initial protocol review and quadrennial review for ongoing protocols, and at the time of any substantive modification to the protocol that poses new scientific questions or substantially alters the scientific approach. For a further details and exceptions to when quadrennial review is not required, see the policy and process links below.
For further information about scientific review requirements, you may contact: ccScientificReview@cc.nih.gov
NIH Intramural Research Program Guidance on Updated BESH Policy
Below is updated guidance from the Office of the Chief Scientific Officer (OCSO) on implementation of NIH policy NOT-OD-26-032 for Basic Experimental Studies Involving Humans (BESH) within the IRP.
Key Change:
BESH studies are no longer considered NIH clinical trials and are not subject to NIH clinical trial reporting requirements. However, FDAAA requirements remain unchanged; studies that meet Applicable Clinical Trial (ACT) criteria must still report results on ClinicalTrials.gov (CTG).
Bottom Line:
BESH designation does not determine reporting obligations; ACT status does.