Who Must Disclose Conflicts of Interest?
According to the 2011 Final Rule issued by the U.S. Department of Health and Human Services, all applicants to Public Health Service (PHS) funding opportunities must complete a disclosure statement.
- All investigators on the research team must file a disclosure with the Office of Research Administration.
- An investigator is anyone who is responsible for the design, conduct, or reporting of findings for the research project. This includes (but it not limited to) faculty, staff, and students.
When Must an Investigator Disclose Conflicts of Interest?
An Investigator is required to submit a disclosure statement:
- At the time of application for funding
- Within 30 day of discovering or acquiring a new significant financial interest
What Financial Interests Need to be Disclosed?
- A financial interest consisting of one or more of the following interests of the investigator
(and those of the Investigator’s spouse and dependent children) that reasonably appears
to be related to the Investigator’s institutional responsibilities:
a. With regard to any publically traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000. For purposes of this definition remuneration includes salary and any payment for service not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship); equity interest includes any stock, stock option, or other ownership interests, as determined through reference to public prices and other reasonable measures of fair market value.
b. With regard to any non-publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve preceding months the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or the Investigator’s spouse or dependent children) holds any equity interests (e.g., stock, stock option, or other ownership interest).
c. Intellectual property rights and interest (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
- Investigator’s must also disclose the occurrence 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), related to their institutional responsibilities. This does not include travel reimbursed or sponsored by a federal, state, or local government agency, and Institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education.
As required by the 2011 revised regulation, Western Carolina University shall ensure
Western Carolina University shall provide a written response within 5 calendar days of receiving a request for information concerning any Significant Financial Interest (SFI) disclosed to the Institution that meets the following three criteria:
- The SFI was disclosed and is still held by the senior/key personnel for the NIH-funded research project identified by the Institution in the grant application, progress report, or any other required report submitted to the NIH;
- The Institution determines that the SFI is related to the NIH-funded research; and
- The Institution determines that the SFI is a Financial Conflict of Interest
Official requests for public disclosure must be submitted to:
Research Compliance Officer
Western Carolina University
110 Cordelia Camp Building
Cullowhee, North Carolina 28723