...

• IC Deputy Ethics Counselor (DEC) clearance for "covered research protocols", as applicable.
  • "Covered research protocols" include the following and need clearance by the IC Ethics Office (also referred to as "DEC Clearance"):
    • studies of investigational drugs and devices
    • studies with a research question about a commercially available drug or device
    • studies involving collaborations with a substantially affected organization (SAO) or another for-profit entity when the entity is receiving specimens and/or data 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).
  • Non-covered research protocols include NIH research protocols that are categorized as Natural History studies, unless these studies meet the criteria for covered research protocols listed above.
  • When the PI determines that the protocol meets the definition of a covered research protocol, the following steps occur. (See Policy 102, Investigator Conflict of Interest and Government Royalties for more detailed information on this process.)
    1. For covered research protocols, the PI must provide all investigators and individuals (including NIH employees, non-NIH federal employees, and individuals who are not federal employees) who will be engaged in activities as well as those involve in statistical analysis of primary endpoint data whose role has the potential to bias the research results, even if they are not otherwise engaged in human subjects research, with a copy of the Guide to Avoiding Financial and Non-Financial Conflicts or Perceived Conflicts of Interest in Clinical Research at the NIH found in the Reference section at the end of Policy 102, Investigator Conflict of Interest and Government Royalties.
    2. Relevant NIH federal employees and other federal employees within the Executive Branch must complete any public, confidential, or supplemental financial disclosure reports required by their employing agency.
    3. Investigators  NIH investigators who do not file public or confidential financial disclosure reports and non-NIH federal employees must sign a Conflict of Interest (COI) Certification Form. Most commonly, in the context of a NIH study teamteams, it is the study statistician who is not otherwise required to file a financial disclosure report who needs to complete the COI Certification. 
    4. The PI must collect and submit the relevant COI Certification Forms in the eIRB system.
    5. The PI initiates DEC review in the eIRB system by going to the tab labeled Manage Ancillary Reviews.  Additional information can be found in the NIH DEC Researcher's Guide.  
    6. The PI's Ethics Office conducts an assessment of actual and apparent conflicts of interest for all investigators listed on the protocol and, if any federal employees have actual or apparent conflict of interest, the Ethics Office works with the employee, the NIH PI, NIH Ethics Official(s) and, as needed or appropriate, the NEO Director and/or the Office of the General Counsel, Ethics Division, to identify an appropriate remedy under applicable law.
    7. Upon completion of the COI review, approval of the IC DEC is noted in the eIRB system (also known as the DEC Clearance).

...