National Institutes of Health U.S. Department of Health and Human Services
NHGRI Institutional Review Board
Personal Financial Holdings
All initial and continuing protocols (as well as amendments that involve adding new investigators) are subject to conflict-of-interest review by the NHGRI Deputy Ethics Counselor (DEC). 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.
Effective for the DEC submissions as of October 27, 2014:
Please see the revised and streamlined SOP 21 "Conflict of Interest Requirements for Researchers and Research Staff", and the revised "A Guide to Avoiding Financial and Non-financial Conflicts or Perceived Conflicts of Interest in Clinical Research at NIH (October 2014)". If you have any questions please contact the Ethics Office at NHGRIEthics@mail.nih.gov and use the following template:
Protocol Review - PI Last Name, First Name (Protocol Number) - Type of Protocol - Review
Appendix B: Algorithm 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:
of investigational drugs and devices
whose research question involves a commercially available drug or device
involving a CRADA or Clinical Trials Agreement
involving collaboration with a substantially affected organization, or
involving intellectual property
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)).
**** Important Note: If the Protocol is not considered "covered" then you do not need to fill out the Conflict of Interest Form. You don't need to go any further.****
COI Assessment ONLY for "Covered Individuals"
"Covered" individuals are persons that may realize financial benefit or loss as a result of participation in the protocol. Covered individuals include:
Personnel who have independent decisional roles in conducting a covered research protocol. These individuals are influential in the design, direction, or conduct of a covered research protocol, or engaged in the analysis or interpretation of data.
The principal investigator, personnel whose resume or CV is provided to a sponsor, personnel listed on an FDA 1572 Form, and personnel who obtain informed consent or who make decisions about research eligibility.
Others who have decisional responsibilities as above, e.g. as co-investigator, research nurse, associate investigators, or an individual who interprets or analyzes research data.
Who is not a "Covered Individual"
Individuals who participate only through isolated tasks that are incidental to the research (for example, scheduling patient tests), and those individuals who support research of many protocols through the performance of routine patient care tasks are not covered individuals
E.g. Technicians, phlebotomists, Office of Patient Recruitment and Public Liaison (PRPL), or those screening for multiple protocols
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 Sara Hull with any questions about the Conflict-of-Interest Review policy.