**** Important Note: If the Protocol is not considered "covered" then investigators do not need to fill out the Conflict of Interest Form. However, there is a requirement for all FTEs on protocols to have at least an HHS Form 717-1 on file. PIs are encouraged to contact the NHGRI Ethics Branch directly when adding AIs to their protocols to confirm that AIs who are FTEs have completed required disclosure forms. ****
All covered research protocols, as defined by OHSRP SOP 21.3D, are subject to conflict-of-interest review by the NHGRI Deputy Ethics Counselor (DEC), both at the time of initial review and for amendments that involve adding new investigators. To obtain review and clearance, PIs should complete and send the "Clearance of NIH Investigator Personal Financial Holdings by IC Ethics Office" form (SOP 21 Appendix D) to the NHGRI DEC at least two months ahead of the anticipated IRB review date. SOP 21 Appendix E and F may also need to be filed, if applicable. Clearance of these forms from the DEC office will be needed to upload with your NIH IRB submission action.
You will need to download Conflict of Interest form, fill it out and submit it to "Ethics" at NHGRIEthics@mail.nih.gov and type in the Subject Line:
Protocol Review - PI Last Name, First Name, (Protocol Number), Type of Protocol -Review (i.e. IR, CR, or Amendment).
If you have any questions you can also contact OHSRP at OHSR_nih_ddir@od.nih.gov.
Flow chart: Algorithms for decisions regarding financial disclosure.
COI Assessment ONLY for "Covered Protocols"
"Covered" protocols involve interests that may lead to the financial benefit or loss to any individual or entity. This includes studies:
Substantially Affected Organization (SAO): A biotechnology or pharmaceutical company, a medical device manufacturer; or a corporation, partnership, or other enterprise or entity significantly involved, directly or through subsidiaries, in the research, development, or manufacture of biotechnological, biostatistical, pharmaceutical, or medical devices, equipment, preparations, treatments, or products (5 CFR § 5501.109(b)(10)).
COI Assessment is for "Covered Individuals" ONLY.
"Covered" individuals are persons that may realize financial benefit or loss as a result of participation in the protocol. The PI is responsible for deciding who on their covered protocol is identified as a covered individual and, therefore, needs to have COI clearance. Covered individuals include:
Who is not a "Covered Individual"?
NHGRI Ethics Branch Contact:
Leonard Ross, J.D., M.S.A.
Chief, Ethics Branch
National Human Genome Research Institute, NIH
Building 31, Room B1B55
31 Center Drive
Bethesda, MD 20814
Phone: (301) 594-5957
Fax: (301) 594-5501
Please contact Leonard Ross or Office of Human Subjects Research Protection (OHSRP) with any questions about the Conflict-of-Interest Review policy.
Last Updated: June 19, 2018