NHGRI Institutional Review Board
Personal Financial Holdings
**** 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 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" 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.
Policies and Forms
- HRPP Standard Operating Procedure/Policy Approval & Implementation (SOP Number: 21)
Conflict of Interest Requirements for Researchers and Research Staff
- SOP 21 Appendix A: A Guide to Avoiding Financial and Non-Financial Conflicts or Perceived Conflicts of Interest in clinical Research at NIH
- SOP 21 Appendix C: Algorithm for Decisions Regarding Financial Disclosure
Flow chart: Algorithms for decisions regarding financial disclosure.
- SOP 21 Appendix D: Clearance of NIH Investigator Personal Financial Holdings by IC Ethics Office
- SOP 21 Attachment E: Conflict of Interest (COI) Certification for NIH Employees Who Do Not File Financial Disclosure Forms 717 or 450
- SOP 21 Attachment F: Conflict of Interest (COI) Certification for Non-Federal Employees
- HHS 717-1 Guidance, Form and Instructions [ethics.od.nih.gov]
Appendix C: 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)).
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:
- 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.
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: April 12, 2016