STANDARD OPERATING PROCEDURE FOR FINANCIAL CONFLICT OF INTEREST IN RESEARCH
Version 3.0, Effective April 30, 2013
The purpose of this policy is to ensure the objectivity of research and to avoid actual or perceived conflict, by defining the process for identifying, reporting and managing conflict of interest.
This policy applies to all persons at The Fenway Institute who meet the definition of Investigator and applies to all activities meeting the definition of research. Designated provisions of this policy apply only to Investigator’s applying for or conducting research funded by the Public Health Service (including the National Institutes of Health).
Oversight of policy:
- This policy is overseen by the Vice President, Primary Care, Behavioral Health and Institute Operations, of Fenway Health (hereafter referred to as “Vice President”).
- The Vice President appoints the Manager of Research Compliance (hereafter as “Compliance Manager”) to implement and enforce disclosure procedures outlined in section B. The Compliance Manager will review all financial disclosure forms to identify real and perceived financial conflicts of interests.
The Vice President will appoint a Conflict of Interest in Research Committee (hereafter referred to as “Committee”) to review and recommend research management plans for disclosed financial conflicts of interest to TFI.
There are no allowable exceptions.
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For purposes of this policy, the following definitions shall apply:
- Disclosure means an Investigator’s disclosure of financial interests to the Institution related to his or her institutional responsibilities.
- Entity means an organization other than the Institution, whether public or private. Examples include the following: a company, partnership, professional associations, voluntary health organizations, etc.
- Financial Conflict Of Interest means a significant financial interest that is related to proposed Institution research (i.e., the interest reasonably appears to be affected by the research or is in an entity whose financial interest reasonably appears to be affected by the research) and that could directly and significantly affect the design, conduct, or reporting of research.
- Financial Interest means anything of monetary value, whether or not the value is readily ascertainable, in any one of the following categories: compensation; equity (stock, stock options or other ownership interest) in a public or private company; royalty/licensing income; a position in a non‐Institute entity giving rise to a fiduciary duty such as Vice President, officer, partner, trustee, employee or any position of management; or, or researchers with funding from the Public Health Service, any reimbursed or sponsored travel.
- Human Subject means a living individual about whom an Investigator (whether professional or student) conducting research obtains (1) Data through intervention or interaction with the individual, or (2) Identifiable private information.
- Institution: The Fenway Institute.
- Institutional Responsibilities means an Investigator’s professional responsibilities on behalf of the Institute, including, but not limited to, activities such as research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels.
- Institution Review Board means the Fenway Community Health IRB.
- Investigator means any person responsible for the design, conduct, or reporting of research. It includes but is not limited to a principal Investigator and a co-principal Investigator.
- Manage means to take action to address a financial conflict of interest, which includes reducing or eliminating the financial conflict of interest, to ensure that the design, conduct, and reporting of research are free from bias or the appearance of bias.
- Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
- Significant Financial Interest for the purpose of this policy significant financial interest means anything of monetary value or potential monetary value held by an Investigator (and by the Investigator’s spouse and dependent children), and that reasonably appears to be related to the Investigator’s institutional responsibilities, as follows:
- Outside payments such as consulting fees, honoraria, and travel reimbursements from companies and organizations outside the investigator’s current institution (TFI or Fenway Health) if the value within the past 12 months as of the date of disclosure exceeds $5,000.
- Equity such as stock or stock options in companies and organizations, excluding the investigator’s current institution.
- Royalties related to intellectual property rights paid by any source other than the investigator’s current institution.
- Any reimbursed or sponsored travel (e.g. air and taxi fare, car rentals, etc.) paid by an entity, including non-profit organizations, but not including travel sponsored by or reimbursed by:
- a government agency,
- a U.S. institution of higher education or
- a research institute affiliated with such,
- a medical center or an academic teaching hospital.
The following are not required to be disclosed:
- Salary, royalties, or other remuneration paid to the investigator from the institution that currently employs the investigator (Fenway Health).
- Income from investments in mutual funds or retirement accounts, as long as the Investigator does not make the investment decisions.
Payment for services (honoraria, advisory committees, review panels, etc.) or travel expenses paid by a U.S. federal, state, or local government agency, a U.S. institution of higher education or a research institute affiliated with such, a U.S. medical center or academic teaching hospital.
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FINANCIAL DISCLOSURE PROCEDURES
Investigators are required to disclose significant financial interest (defined above) related to their institutional responsibilities on an annual basis and an event-required basis. All disclosures must be made no later than the time of applying for research funding. The mechanism for SFI disclosure is the Financial Disclosure Form which is distributed to investigators by the Compliance Manager.
- Required Reporting: Investigator must update their report of significant financial interests related to their Institutional responsibilities annually.
- New Hire: All new investigators are required to complete a Financial Disclosure Form within 30 days of hire.
- Newly Assigned Responsibilities: Individuals who become newly responsible for the design, conduct, reporting, or direct administration of research are required to complete a Financial Disclosure Form within 30 days of their assumption of such responsibilities.
- Material Change in Circumstances: Investigators must amend their Financial Disclosure Form within 30 days of any material changes to their responses. Material changes include but are not limited to the initiation or elimination of a reportable external commitment or financial interest for the reporter and family, a change in, or the initiation of, a sponsor.
The Compliance Manager is responsible for soliciting and reviewing all Financial Disclosure Forms. These forms are maintained by the Compliance department for at least three years from the date the final expenditure report is submitted for a research project and/or at least three years from the date the final report is submitted for a research project.
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REVIEW OF FCOI DISCLOSURE BY COMPLIANCE MANAGER
- The Compliance Manager reviews all Financial Disclosure Forms and determines whether an investigator’s significant financial interests:
The Vice President is notified of all significant financial interests held by Investigators.
When the Compliance Manager determines a FCOI exists, the issue is referred to the Committee for appropriate management.
- could directly and significantly affect the research, or
- is in an entity whose financial interest could be affected by the research
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DETERMINATION AND MANAGEMENT OF FCOI
Administrative Structure of Committee:
- The Committee will be appointed by the Vice President.
- No member of the Committee who holds a significant financial interest in a project may participate in the review of interest or the development of a management plan for that project.
- Committee meetings are closed to the public.
Committee Procedures for Determination and Management of FCOI:
- Where the Compliance Manager has determined that a financial conflict of interest exists, the Committee will develop and recommend for implementation to the Vice President a management plan that specifies the actions that have been and/or will be taken to manage the financial conflict of interest.
- In so doing, the Committee will consider the nature of the research, the nature and size of the interest, the degree to which the conflict is related to the research, the extent to which the interest could be affected by the research, and any management strategies that would mitigate or eliminate the conflict.
Management strategies may include, but are not limited to:
- Public disclosure of financial conflicts of interest (e.g., when presenting or publishing the research);
- For research projects involving human subjects research, disclosure of financial conflicts of interest directly to participants;
- Appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of the research against bias, or the appearance of bias, resulting from the financial conflict of interest;
- Modification of the research plan;
- Change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or a portion of the research;
- Reduction or elimination of the financial interest (e.g., sale of an equity interest); and
- Severance of relationships that create actual or potential financial conflicts.
- Specific Provisions Applicable to Human Subjects Research
The Institution will not allow an Investigator with a financial conflict of interest to conduct a clinical research protocol whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment.
In such cases, disclosure or standard conflict management strategies may be inadequate and adequate monitoring plans may be difficult or impossible to implement. It is noted that this prohibition applies not only to the principal investigator of a clinical research project, but also to any investigator involved in the design, conduct, or reporting of the research. A principal investigator would thus be prohibited not only from serving in that role, but in any role in which he/she is responsible for the design, conduct or reporting of the study.
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IMPLEMENTATION BY THE VICE PRESIDENT
The Vice President will review the recommendation of the Committee and determine the final management plan to be implemented for the research. This determination will be provided to the Investigator, who must accept the requirements of the management plan in writing before beginning work on the project. Copies of the signed management plan will also be provided to relevant Fenway Health officials and to the Institutional Review Board.
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Any Investigator may appeal management of a financial conflict of interest in writing to the Vice President of Fenway Health.
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- Failure to file a complete and truthful disclosure as required by this policy or to comply with the management plan constitutes a violation of Institution policy and may violate state and/or federal law.
- Non-compliance by an Investigator in human subject research project will be promptly reported to the IRB.
- In such cases, the Investigator will be subject to appropriate sanctions consistent with Fenway Health policies relating to disciplinary policies. In addition, the Institute may suspend an ongoing research project or halt the expenditure of funds.
- In any case in which the Investigator does not comply with any applicable conditions or restrictions imposed pursuant to this policy, the Institute will withdraw any affected applications for funding if the project cannot otherwise be completed without the services of the Investigator.
- In the event the Institute discovers that a failure to comply with this policy has biased the design, conduct, or reporting of the research, the Institution will promptly notify the sponsor of the research as required by applicable law and describe the corrective action(s) taken or to be taken.
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SPECIFIC PROVISIONS APPLICABLE TO PHS-FUNDED RESEARCH
In addition to the requirements of this policy outlined above, the Institute will apply the following specific provisions to research funded by PHS:
- Disclosure Upon Application: Any investigators planning to participate in PHS-Funded Research must disclose any significant financial interests to the Compliance Manager no later than the time of application or submission of a formal proposal for the PHS-Funded Research.
- Monitoring: For PHS‐funded research, the Investigator’s management plan will be monitored by the Committee on an ongoing basis until the completion of the research project.
- If the Institution carries out the PHS‐funded research through a subrecipient, the Institution will incorporate as part of a written agreement with the subrecipient terms that establish whether the Institution’s or the subrecipient’s policy on conflict of interest in research will apply to the subrecipient Investigators.
- If the subrecipient’s policy will apply, the subrecipient will certify as part of the agreement that its policy complies with the PHS regulations on Objectivity in Research. Additionally, the agreement shall specify time period(s) for the subrecipient to report all identified financial conflicts of interest to the Institution to enable the Institution to provide timely reports to PHS.
- Alternatively, if the Institution’s policy on conflict of interest will apply, the agreement shall specify time period(s) for the subrecipient to submit all subrecipient Investigator disclosures of significant financial interests to the Institution. Such time periods shall be sufficient to enable the Institution to comply with timely review, management, and reporting obligations under the PHS regulations.
- In the event the Institution identifies a significant financial interest that was not disclosed in a timely manner by an Investigator or, for whatever reason, was not previously reviewed by the Institution during an ongoing research project, and where the Compliance Manager has determined that the undisclosed significant financial interest constitutes a financial conflict of interest related to a PHS‐funded research project, the Committee will review the financial conflict of interest and the Institution will implement a management plan for the project within 60 days of identification of that interest.
- In addition, the Committee will, within 120 days of its determination of noncompliance, complete a retrospective review of the Investigator's research activities associated with the project to determine whether the research conducted during the period of the noncompliance was biased in the design, conduct, or reporting of such research.
- If the Committee determines in the conduct of its retrospective review of PHS‐funded research that the research or any part of it was biased, the Committee will recommend a mitigation plan to the Vice President and the IRB to address any such issues. The Institution will notify the PHS Awarding Component of its determination and subsequently follow up with the mitigation report for the project.
Public Access of Disclosed Significant Financial Interest:
- The Institution will make available to the public upon request information concerning any significant financial interest disclosed to the Institution that meets the following three criteria:
- The disclosed significant financial interest is still held by the senior/key personnel of the active PHS project;
- The Institution determines that the significant financial interest is related to the PHS‐funded research; and
- The Institution determines that the significant financial interest is a financial conflict of interest.
- The information request must be made to the Compliance Manager who will respond within five (5) business days of receipt of the request. Disclosed information will be provided to the extent required by applicable PHS regulations and state law.
- When in the course of an ongoing research project an Investigator new to the project discloses a significant financial interest or an existing Investigator discloses a new or changed significant financial interest, and where the Compliance Manager has determined that the disclosed significant financial interest constitutes a financial conflict of interest subject to management under this policy, the Committee will review the disclosure and the Institution will implement a management plan for the project within 60 days of the submission of the disclosure to the Institution.
- Depending on the nature of the financial conflict of interest, the Institution may determine that additional interim measures are necessary with regard to the Investigator’s participation in the research project between the date of disclosure and the implementation of the Institution’s management plan.
- The IRB will address and implement any interim measures as necessary for the protection of human participants in any ongoing research.
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The Institution will provide initial and ongoing reports of its management of financial conflicts of interest to external sponsors of Institution research as required by law and in accordance with this policy.
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Records relating to all Investigators disclosures of significant financial interests and the Institution’s review and management of such disclosures, will be maintained by research for three years from the date of submission of the final expenditures report (in the case of grants and cooperative agreements) or three years from the final payment (in the case of research contracts), or as otherwise required by law.
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Prior to engaging in
any research project, all Investigators must complete training on the Investigators
obligations under this policy.
This training must be
repeated at least every four years and must be completed immediately if this
- Is revised so as to
affect the Investigator’s obligations,
- If an Investigator is
new to the Institution,
- Or if the Institution
finds an Investigator to have violated this policy or any applicable management
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All inquires related to
Fenway’s FCOI policy or to obtain information on the significant financial
interests of senior/key personnel should be made to:
Jessica Ripton, MPH
Manager of Research Compliance
The Fenway Institute, Fenway Health
Boston, MA 02215
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FEDERAL CONFLICT OF INTEREST REGULATIONS
NIH Public Health
Food and Drug
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