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Conflict of Interest Review by IC Deputy Ethics Counselors (DECs)

IC DEC Submission Checklist for Study Teams


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If you are new to the DEC Submission Process please use the checklist above to get started.

It is the Federal Government’s policy to eliminate or minimize actual or perceived conflict of interest (COI) in the conduct of clinical research, which is intended to promote objectivity and to maintain the public’s trust. The NIH requires that actual or apparent COI be considered for all investigators working on a covered research protocol1 (CRP).  To explain these requirements, all investigators working on a CRP must be provided the COI Guide (please see below). In addition, the names of all investigators working on a CRP must be submitted to the IC Deputy Ethics Counselor at specified time points (initial and continuing review and when a new investigator is added to the study team), using the DEC Submission form in iRIS. Once the IC DEC has completed the review of the protocol, the COI outcome letter can be provided to the reviewing IRB, assuring the IRB that NIH COI requirements have been met. This is page provides tools for investigators to aid them in complying with these requirements, as specified in Policy 3014-102 - Investigator Conflict of Interest and Government Royalties:

  1. Covered Research Protocol – Covered research protocols (and covered substudies) include: (1) studies of investigational drugs and devices, (2) studies with a research question about a commercially available drug or device, and (3) studies involving collaborations with a substantially affected organization (SAO) or another for-profit entity when the entity is receiving data or specimens from the NIH for the purpose of developing a product. Most interventional protocols will be Covered Research Protocols unless the intervention does not involve the criteria listed above (e.g., a behavioral intervention might not meet the criteria for a covered research protocol or use of a device for physiological exploration where there is no intent to develop a commercial application).