Financial Conflict of Interest in Research Policy
Fenway Health Standard Operating Procedure for Financial Conflict of Interest in Research
Version 3.0, Effective April 30, 2013
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:
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.
For purposes of this policy, the following definitions shall apply:
The following are not required to be disclosed:
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.
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.
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.
Administrative Structure of Committee:
Committee Procedures for Determination and Management of FCOI:
Management strategies may include, but are not limited to:
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.
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.
Any Investigator may appeal management of a financial conflict of interest in writing to the Vice President of Fenway Health.
In addition to the requirements of this policy outlined above, the Institute will apply the following specific provisions to research funded by PHS:
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.
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.
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 policy:
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:
Manager of Research Integrity and Compliance
The Fenway Institute, Fenway Health
Boston, MA 02215
NIH Public Health Service:
National Science Foundation:
Food and Drug Administration: