The following definitions apply to this policy.
A potential conflict of interest occurs when there is a divergence between an individual’s private interests and his or her professional obligations to the APA such that an independent observer might reasonably question whether the individual's professional actions or decisions are determined by considerations of personal gain, financial or otherwise.
Equity interest
is a financial interest that includes, but is not limited to, stock, stock option, and other ownership interest.
Financial interest
means anything of monetary value, whether or not the value is readily ascertainable.
A Financial Conflict of Interest (FCOI) exists, for the purposes of this policy, when the APA, through procedures described herein, reasonably determines that a significant financial interest could directly and significantly affect the design, conduct, or reporting of PHS-funded research.
FCOI Report
means the APA’s report of a financial conflict of interest to a PHS Awarding Component.
Investigator
means the project director or principal investigator (“PD/PI”), any other person identified as senior/key personnel by the APA in the grant application, and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by the PHS, or proposed for such funding, which may include, for example, collaborators or consultants.
Institutional Official
means the individual within the APA who is responsible for the solicitation and review of disclosures of significant financial interests (including those of the Investigator’s family) related to the Investigator’s institutional responsibilities. For the purposes of this policy the Institutional Official is the Director of Grants & Contracts.
Institutional Responsibilities
means the Investigator’s responsibilities on behalf of the APA, which are defined by the APA as research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as institutional review boards.
Payment for services
is a financial interest that includes, but is not limited to salary, consulting fees, honoraria, and paid authorship.
PHS
means the Public Health Service of the U.S. Department of Health and Human Services, and any components of the PHS to which the authority involved may be delegated, including the National Institutes of Health.
PHS Awarding Component
means the organizational unit of the PHS that funds the research that is subject to this subpart.
Significant Financial Interest
means a financial interest consisting of one or more of the following of the Investigator or an Investigator’s spouse or dependent children that reasonably appears to be related to the Investigator's institutional responsibilities:
- Any intellectual property rights and interest (e.g., patents, trademarks, service marks, and copyrights), upon receipt of royalties or other income related to such intellectual property rights and interests.
- For any publicly traded entity, if the value of the following when aggregated, exceeds $5,000:
- Any payment for services received from the entity in the twelve months preceding the disclosure, and
- The value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000.
- For any non-publicly traded entity, if either of the following conditions exist:
- The value of any payment for services received from the entity in the twelve months preceding the disclosure exceeds $5,000, or
- The Investigator’s spouse or dependent children hold any amount of equity in the entity as of the date of disclosure.
The term Significant Financial Interest does not include:
- Salary, royalties, or other remuneration from the APA to the Investigator if the Investigator is currently employed by the APA;
- Income from investment vehicle, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles;
- Salary, royalties or other payments that when aggregated for the Investigator and the Investigator's spouse or domestic partner and dependent children over the next twelve months, are not expected to exceed $5,000;
- Income from seminars, lectures, or teaching engagements sponsored by a federal, state, or local government agency, an institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education; or
- Income from service on advisory committees or review panels for a federal, state, or local government agency, an institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education.
Provided, however, that the exclusions above shall not apply if the compensation or transfer of an equity interest is conditioned upon a particular outcome in a sponsored research project.