UNIVERSITY-WIDE RESEARCH FINANCIAL CONFLICT OF INTEREST POLICY
Mercer University’s Research Financial Conflict of Interest Policy is a university-wide program. It is comprised of multiple components, which covers the disclosure process, training, and a management plan. Federal regulations 42 CER Part 50 and 45 CFR Part 94 and Mercer University Policy require that all PHS, NSF, and NIH funded research by a grant or cooperative agreement and investigators who are planning to participate in such research adhere to the revised regulatory requirements as of August 24, 2012. The SBIR Program Phase I applications are excluded from the revised regulatory requirement.
WHAT MUST BE REPORTED
Significant Financial Interest (SFI)
All investigators are required to disclose their outside financial interest to Mercer University. An investigator must report any Significant Financial Interest (SFI) that may reasonably appear to affect or be affected by the actual research project on which the investigator is working.
Significant Financial Interests that would reasonably appear to affect or be affected by the research on which the investigator is working or that are held in any entity whose financial interests would reasonably appear to affect or be affected by the research.
The revised regulations emphasize three important disclosures areas.
- The Investigator must report any remuneration 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 $5000.00. Remuneration includes salary and any payment for services not otherwise identified as salary. For example, consulting fees, honoraria, or paid authorship. Equity interest includes any stock, stock option, or other ownership interest as determined through reference to public prices or other reasonable measures of fair market value.
2. The Investigator must report Significant Financial Interests (SFI) that are related to the research both for himself/herself and for his/her spouse, domestic partner, and/or dependent children. In determining whether or not an interest must be reported, the Investigator must aggregate the amount or percentage of his/her interest with those interests, if any, of the Investigator’s spouse, domestic partner or dependent children. Federal regulations and University Policy require that Investigators disclose the existence and nature of the Significant Financial Interests related to the research BEFORE submitting a grant or contract application.
3. At a minimum, a Disclosure of Financial Interests in Research must be provided for:
a) Any person whose biographical sketch is included in the proposal or budget; and/or
b) Any person responsible for the design, conduct, or reporting of the project
c) Any person identified as senior or key personnel by the Institution in the grant application, progress report, or any other report submitted to PHS, NIH, or NSF by the Institution.
d) Any sub-awardees or sub-contractors
RESEARCH FINANCIAL CONFLICT OF INTEREST TRAINING
Effective August 24, 2012, each investigator must complete training prior to engaging in research related to any PHS-funded grant or contract and at least every four years. The online web-based training web address is: https://www.citiprogram.org
INVESTIGATORS SHOULD NOT REPORT THE FOLLOWING
(1) Any salary, royalties, or other remuneration paid by Mercer University to the Investigator if the currently employed or appointed by Mercer.
(2) Any gifts to Mercer University, so long as the Investigator does not have signing authority on the Mercer account into which the gift is placed.
(3) Any payments the Investigator receives from non-promotional educational seminars, lectures or teaching engagements that are sponsored and paid for by a governmental entity or by a non-profit entity that is not controlled by or under contract to a commercial entity. For example, income from a non-profit speakers’ bureau that is paying a speaking fee pursuant to a contract with a for-profit company would have to be reported.
(4) Any income for serving 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 research institute that is affiliated with an Institution of higher education.
(5) Any income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles.
(6) Any 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 research institute that is affiliated with an Institution of higher education.
(7) Funding from the Small Business Innovation Research (SBIR) or the Small Business Technology Transfer (STTR) programs whose primary purpose is to provide competitive awards for small businesses to discover their technology capability
A Designated Institutional Official has been delegated the authority and responsibility for administrating the FCOI Program at Mercer University. The Designated Institutional Official is to solicit and ensure review of disclosures of significant financial interest from each investigator who participates in PHS-funded research. The staff in the Office of Research Compliance will provide administrative support to the disclosure process. A Campus Official will be identified by each Dean at Mercer University. The Campus official(s) to whom a disclosure of significant financial conflict of interest is made, shall review, along with the school’s or college’s Conflict of Interest Committee (CIC), such disclosures and make a determination as to whether or not a significant financial conflict of interest exists. The information provided will be used by the CIC to conduct a review in order to reasonably determine whether any of an investigator’s Financial Interests could be affected by the funded research, or is in an entity whose financial interest could be affected by the research. A conflict of interest will exist whenever a determination is made that a significant financial interest exists which could directly and significantly affect the design, conduct or reporting of the research or scholarly activities funded by a sponsor. Should a significant financial conflict of interest exist, the Campus Official and the CIC shall determine what restrictions, if any, should be imposed by Mercer University to manage, reduce, or eliminate such financial conflict as appropriate and report the results of their determinations to the Designated Institutional Official. The Designated Institutional Official may provide assistance and guidance in the resolution and management of any significant financial conflicts.
Direct questions about the Research Financial Conflict of Interest Policy or about the annual disclosure process to: Ms. Ajuania White (478) 301-5646 or White_AG@Mercer.edu.
Send completed forms to: FCOI Form
Attention: Ms. Ajuania White
Office of Research Compliance
1400 College Street
Macon, GA 31207
To Fax Use: 1-478-301-2329
PHS Conflict of Interest Policy
Mercer University Research Financial Conflict of Interest Policy