University of Rhode Island
Financial Conflict of Interest Policy
for
Investigators Funded by the U.S. Public Health Service
The Public Health Service (PHS), a component of the U.S. Department of Health and Human Services (DHHS), issued a Revised Financial Conflict of Interest Regulation in 2011. The goal of the regulation is to promote objectivity in research by setting standards that will promote the design, conduct and reporting of funded research that is free from bias due to an investigator’s financial conflict of interest (FCOI). The National Institutes of Health (NIH) are a component of the PHS. Other components are listed here:
It is the University of Rhode Island’s policy to comply with all Federal applicable laws and regulations. This policy sets forth the manner in which it will comply with the new PHS regulation as set forth at 42 CFR Part 50 Subpart F. The full text of the regulation is available here; The definitions of the terms used in this policy are the definitions used in the regulation. This policy becomes effective when it is made publicly available. It must be made available by August 24, 2012.
The University’s Designated Conflict of Interest Official is the Director, Office of Research Compliance.
DEFINITIONS
What financial interests are covered by the regulation and what is a Significant Financial Interest? (Institution and Investigator)
The regulation covers all financial interests that have monetary value, whether or not the value is readily ascertainable.
The 2011 revised regulation defines a “Significant Financial Interest” as follows:
“(1) 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:
(i) With regard to any publicly traded entity, a significant financial interest exists if the value of 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 $5,000. For purposes of this definition, remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, 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;
(ii) 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 months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or the Investigator’s spouse or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest); or
(iii) Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
(2) Investigators also must 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; provided, however, that this disclosure requirement does not apply to travel that is reimbursed or sponsored by 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. The Institution’s FCOI policy will specify the details of this disclosure, which will include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration. In accordance with the Institution’s FCOI policy, the institutional official(s) will determine if further information is needed, including a determination or disclosure of monetary value, in order to determine whether the travel constitutes an FCOI with the PHS-funded research.
(3) The term significant financial interest does not include the following types of financial interests: salary, royalties, or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution, including intellectual property rights assigned to the Institution and agreements to share in royalties related to such rights; any ownership interest in the Institution held by the Investigator, if the Institution is a commercial or for-profit organization; 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; income from seminars, lectures, or teaching engagements sponsored by 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; or income from service on advisory committees or review panels for 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.”
Training
Who must receive training?
All investigators applying for or receiving a PHS grant or cooperative agreement must receive training before funds can be dispersed. The regulation defines investigator as “any person, regardless of title or position, who is responsible for the design, conduct or reporting of research funded by the PHS (e.g., NIH) or proposed for such funding.” It is not limited to the principal investigator. Collaborators, consultants graduate students and postdoctoral fellows are included. These regulations do not, however, cover those submitting Phase I Small Business Innovative Research (SBIR) applications.
When training must be obtained
Each investigator, as defined by the regulation, must complete training before engaging in research funded by the PHS and at least every four years after that. In addition, an investigator must complete training immediately if the institution’s FCOI policy changes in a manner that affects the investigator, if an investigator is new to the institution, and if an investigator is not in compliance with the policy or management plan.
How to receive training
Investigators may use the NIH conflict of interest training module at and must successfully pass the training module. A training certification will be issued if the model is passed and must be submitted to the Office of Research Compliance. Alternatively, an investigator could successfully pass the CITI training program for Research with Human Subjects (completed after 1/1/2012.)
The Office of Research Compliance will also provide training sessions about investigator responsibilities and the institution’s policy. Training workshops will be offered at the start of each semester. Investigators who need immediate training can contact the Office of Research Compliance.
All training certificates and disclosures will be stored in a database accessible to the Office of Research Compliance and the Office of Sponsored Projects, which submits and receives grants on behalf of the University.
Disclosure, Review and Monitoring
The University will require investigators, Co-Investigators and Key Personnel to disclose significant financial conflicts of interest when applying for research funding from PHS, at least annually during the award period and within 30 days of acquiring or discovering a new significant financial conflict of interest. The URI, NIH SFCOI Disclosure Form can be found on the Compliance Office website.
The Designated Conflict of Interest Official will solicit and review disclosures of financial interest to determine whether an investigator, Co-Investigator, or Key Personnel has a significant financial interest related to PHS-funded research and, if so related, whether the interest represents a FCOI. In instances where a FCOI may exist, the Conflict of Interest Officer may seek the assistance of a conflict of interest committee to make a determination and develop a management plan.
Reporting to NIH
The Designated Conflict of Interest Officer will send initial, annual and revised FCOI reports as required to the PHS for the University and its sub-recipients when applicable, in conformance with the regulation. As required, reports will be sent prior to the expenditure of funds, within 60 days of identification of an investigator who is newly participating in a project, and at least annually to provide the status of the FCOI and any changes to the management plan, if applicable, until the project is completed. The Official will, when appropriate submit a report following a retrospective review to update a previously submitted report.
The Designated Conflict of Interest Officer will notify NIH promptly if bias is found with the design, conduct or reporting of NIH-funded research. The Director will submit a Mitigation Report in accordance with the regulation. This procedure will include all reporting elements as required by the regulation.
The Designated Conflict of Interest Officer will notify NIH promptly if an investigator fails to comply with the University’s FCOI policy or if an FCOI management plan appears to have biased the design, conduct or reporting of the NIH-funded research. The Officer will take corrective action for noncompliance with the University’s policy or the management plan.
Record Maintenance
The Office of Research Compliance will maintain FCOI-related records for at least three years from the date the final expenditure report is submitted. When applicable, it will maintain these records in compliance with 45 CFR 74.53(b) (OMB Circular A-110) and 92.42(b) (OMB Circular A-102).
Non-Compliance
In the event that an individual is non-compliant, all grant funds on which the individual is listed will be immediately frozen until the individual is found to be compliant.
The Designated Conflict of Interest Officer will complete and document retrospective reviews within 120 days of the University’s determination of noncompliance for significant financial interests not disclosed in a timely manner. It also will conduct such a review if it determines such noncompliance in a PHS-funded research project that, for whatever reason, was not previously reviewed. The reviews will be documented consistent with the regulation.
The University will take specific action in any case in which the DHHS determines that the University failed to manage or report an investigator FCOI in PHS-funded clinical research project that evaluates the safety or effectiveness of a drug, medical device or treatment. The Designated Conflict of Interest Officer will require the investigator to disclose the FCOI in each public presentation of the results of the research, and will request an addendum to previously published presentations.
Subrecipients
The University will, at the time of proposal submission, determine whether subrecipient investigators have received appropriate FCOI training. When applicable, it will determine whether a subrecipient has a satisfactory FCOI policy or whether the subrecipient will follow the University’s policy.
Public Accessibility
Information about identified financial conflicts of interest will be available from the Office of Research Compliance only upon request. The information as required under the FCOI rule will be provided within the five calendar days required by the federal regulation. The information will include the minimum elements as provided by the regulation. It will be updated annually and within 60 days of a newly identified FCOI. The information will remain available for three years from the date that it was most recently updated.
The University’s FCOI Policy for PHS funded research is available on the University’s Web site.
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