What You Need to Know About the National Institutes of Health (NIH) FCOI Policy
By Amy Baugh
The significant change to Financial Conflict of Interest (FCOI) policy of the National Institutes of Health (NIH) and other Public Health Service (PHS) departments has raised numerous questions. In an attempt to provide answers and clarification, the Office of the Vice President for Research (OVPR) has compiled a list of frequently asked questions we’ve received since the change took effect Aug. 24. The source for most of these questions is the NIH FAQ
website and Texas Tech Operating Policy 70.37
What do I need to do prior to submitting a proposal to NIH or to any other PHS funding component?
1) Complete one of the two FCOI training options. These can be found on the OVPR Investigator Financial Disclosure website
under “PHS Investigator Requirements.”
2) Complete your annual financial interest disclosure by selecting “Electronic Financial Disclosure” on the OVPR Investigator Financial Disclosure website
. Select “Yes” when asked if you are participating in a PHS/NIH research project. Contact Amy Baugh
by email or by phone at (806) 834-2139 if you need assistance.
Who needs to complete training and submit financial interest disclosure documents?
All investigators must complete the training and PHS-specific disclosure forms either in hard copy or via the online system. The following question outlines the definition of investigator.
Who is considered an “Investigator” for the purpose of this regulation?
“Investigator” means the project director or principal investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by the NIH or other PHS department, or proposed for such funding, which may include, for example, collaborators or consultants. Institutions should consider the role, rather than the title, of those involved in research and the degree of independence with which those individuals work. When the definition of investigator is limited to titles or designations (e.g., to principal investigators, key personnel, faculty) the risk is that an unidentified FCOI may compromise the research enterprise increases.
Does the regulation apply to subrecipients, subgrantees, and collaborators (e.g., subcontractors or consortium members)?
Yes. The 2011 revised regulation is applicable to each institution that applies for or receives NIH funding for research through grants or cooperative agreements and, through the implementation of the regulation by each institution, to each investigator who is planning to participate, or is participating in, such research. A subrecipient relationship is established when federal funds flow down from or through an awardee institution to another individual or entity and the subrecipient will be conducting a substantive portion of the NIH-funded research project and is accountable to the awardee institution for programmatic outcomes and compliance matters. Accordingly, as a recipient of federal funds from an awardee institution, the FCOI regulation applies to subrecipients (e.g., subcontractors or consortium members). See 42 CFR 50.604 (c)
I am a collaborator/consultant/subgrantee/subcontractor/subrecipient performing research funded by the NIH but am not employed directly by the Institution that received the award. Does this regulation apply to me?
Yes. If you meet the definition of an “investigator,” the PHS regulation applies to you.
I am a post-doctoral fellow receiving funding from the NIH. Does this regulation apply to me?
Yes. If you meet the definition of an “Investigator,” the PHS regulation applies to you. The regulation is applicable to each institution that applies for or receives NIH grant awards or cooperative agreements for research and, through the implementation of the regulation by each institution, to each investigator who is planning to participate, or is participating in such research. As noted above, an investigator is defined as the project director or principal investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by the NIH, or proposed for such funding. Thus, if a post-doctoral fellow meets the definition of an investigator, he or she is subject to the regulation if the NIH funding is for research.
I am a graduate student working on research funded by the NIH. Am I subject to the requirements of the Financial Conflict of Interest regulation?
Yes. If you meet the definition of an “investigator,” the PHS regulation applies to you. As stated above, the term "Investigator" is defined to encompass individuals "responsible for the design, conduct or reporting" of research funded by the NIH or other PHS funding entity.
Does the 2011 revised FCOI regulation apply to foreign institutions and international organizations?
Yes. The regulation applies to any institution, foreign or domestic, that applies for or receives NIH research funding by means of a grant or cooperative agreement as either a prime awardee institution or a subrecipient institution.
Must Investigators disclose their reimbursed or sponsored travel for the previous 12-month period?
Yes. Investigators who are planning to participate in PHS-funded research must disclose their reimbursed or sponsored travel related to their institutional responsibilities over the previous twelve-month period no later than at the time of application for PHS-funded research. Investigators must submit an updated disclosure of reimbursed or sponsored travel within 30 days of each occurrence.
The initial disclosure of any reimbursed or sponsored travel (i.e., that which is paid on behalf of the Investigator and not reimbursed to the investigator so that the exact monetary value may not be readily available) is included with the detailed disclosure forms. Instructions regarding updating travel disclosures are below.
How do I disclose reimbursed or sponsored travel after I have submitted my initial disclosure?
Once investigators have made their initial disclosure, they are required to update their disclosures within 30 days of discovering or acquiring a new Significant Financial interest (SFI), and annually during the period of award. Investigators may report reimbursed or sponsored travel here
. Investigators may access the system at any time and as often as necessary throughout the proposal and award process to provide details of each occurrence of sponsored/reimbursed travel.
Travel paid by your NIH funds is not required to be reported. The reported travel is sponsored or reimbursed travel that is paid to you or for you by an entity. The disclosure requirement does not apply to travel that is reimbursed or sponsored by the following: a federal, state, or local government agency, an institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education.
How do non-TTU employees complete their disclosure forms?
Non-Texas Tech University employees may access the electronic disclosure system here
. If hard copy forms are preferred, the forms may be accessed on the OVPR Investigator Financial Disclosure website
Amy Baugh is the administrator for financial disclosure in the Office of the Vice President for Research.