**** Important Note: If the Protocol is not considered "covered", then investigators do not need to fill out the Conflict of Interest Form. No further action is necessary.****
All "covered" protocols 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 to the NHGRI DEC at least two months ahead of the anticipated IRB review date.
You will need to download Conflict of Interest form, fill it out and submit it to "Ethics".
Send it to: 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. Covered individuals include:
Who is not a "Covered Individual"?
To view the files on this page, you will need Adobe Acrobat Reader.
NHGRI DEC Contact:
Leonard Ross, J.D., M.S.A.
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.
Top of page
Last Updated: November 25, 2015