FREQUENTLY ASKED QUESTIONS
- Who is covered by the FCOI policy?
- What do I have to do in order to comply with the policy?
- What happens if my financial interests change during the period of the research award or during the annual disclosure?
- What must be disclosed?
- What are Institutional responsibilities?
- Do I need to disclose all reimbursed or sponsored travel?
- Do I have to disclose stock holdings such as my retirement account or my mutual funds?
- I am involved in a research project that receives sub-recipient funding (for example, funding from the National Institutes of Health (NIH) to a university, then to HHC). Does this policy apply to me?
- If I do disclose an actual conflict of interest, what happens then?
1. Who is covered by the FCOI policy?
Anyone responsible for the design, review, conduct or reporting of research (internally and externally funded), regardless of title or position. These people are defined as Investigators under the HHC policy.
Investigators, including non-employees, collaborators and consultants, must complete FCOI disclose forms and obtain training in accordance with the HHC policy.
2. What do I have to do in order to comply with the policy?
At a minimum, you’ll have to file an annual Financial Conflict of Interest Disclosure form every January 1st before initiating any internally and externally funded research activity. You do not have to update the disclosure more than once a year unless you have any changes to your financial interests that present a conflict or potential conflict with a new or current funding source.
3. What happens if my financial interests change during the period of the research award or during the annual disclosure?
You have an ongoing obligation to disclose financial interests throughout the year. You must update your disclosure form within thirty (30) days of a change in previously-disclosed financial interests or the event resulting in a new financial interest.
4. What must be disclosed?
You must disclose anything of monetary value that belongs to you, your spouse and/or your dependent children that is related to your Institutional responsibilities – not just your research-related activities.
5. What are Institutional responsibilities?
- Stock or other equity interest in a publicly-traded company in which you directly control the investment decisions
- Income from a publicly-traded company
- Stock or other equity/ownership interest in a private company
- Income from a private company
- Licensing or royalty income related to your inventions or copyrights that is paid to you by an entity other than HHC
- Certain reimbursed or sponsored travel (see FAQ #6)
Institutional responsibilities are your professional obligations carried out on behalf of HHC, involving your expertise. Examples include activities such as research, research consultation, teaching, professional practice (e.g., providing patient care, accounting services, legal counsel), participation in purchasing decisions, evaluating products or services on behalf of HHC, committee memberships, and service on panels such as an Institutional Review Board or Data and Safety Monitoring Board.
6. Do I need to disclose all reimbursed or sponsored travel?
Maybe. If you are involved in PHS funded research, you are required to disclose the occurrence of any
travel where your expenses are either reimbursed or paid directly by a sponsor to the airline, hotel, etc. This includes travel reimbursed or sponsored by a non-profit entity such as a professional association. However, disclosure does not apply to travel that is reimbursed or sponsored by the following types of organizations:
- a federal, state or local government agency
- an outside institution of higher education
- an outside academic teaching hospital
- an outside medical center
- a research institute that is affiliated with an institution of higher education
Finally, travel that is required as a part of a research project, such as to attend an Investigators’ meeting, is not required to be disclosed.
7. Do I have to disclose stock holdings such as my retirement account or my mutual funds?
No. You don’t have to disclose your investments, such as retirement accounts or mutual funds, as long as you do not directly control the investment decisions.
8. I am involved in a research project that receives sub-recipient funding (for example, funding from the National Institutes of Health (NIH) to a university, then to HHC). Does this policy apply to me?
Yes, in this scenario you are considered to be involved in PHS funded research and are required to complete a FCOI disclosure form in accordance with HHC policy.
9. If I do disclose an actual conflict of interest, what happens then?
Your disclosure form will be shared with the Research Conflict of Interest committee. The committee may request that you submit a management plan to mitigate or manage the conflict so that you can conduct your research as planned.
HHC/HH Research Institute FCOI Policy
NIH Grants Policy Statement – effective 10/1/11
NIH Summary of Major COI Changes
NIH – FCOI Web Page
NIH FAQs to 2011 Revised FCOI Regulations
NIH FCOI Training Tutorial