Research Foundation for Mental Hygiene

RFMH Financial Conflict of Interest Policy

Effective Date 8-24-2012, revised 12-14-2012
Research Foundation for Mental Hygiene, Inc. (RFMH) Financial Conflict of Interest Policy
2	Definitions
Contractor means an entity that provides property or services under contract for the direct benefit or use of the Federal Government.
Disclosure of Significant Financial Interests means an Investigator’s disclosure of Significant Financial Interests to RFMH.
Financial Conflict of Interest (FCOI) means a Significant Financial Interest that could directly and significantly affect the design, conduct (including data collection and analysis), or reporting of research.
FCOI report means RFMH’s report of a Financial Conflict of Interest to a PHS Awarding Component.
Financial Interest means anything of monetary value, whether or not the value is readily ascertainable and would include an intellectual property right or interest, whether or not any income has yet been received in respect of that right or interest. Financial Interest does not include the following: 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.
Institutional Responsibilities means an Investigator’s professional responsibilities on behalf of RFMH an associated state agency (OMH, OPWDD, OASAS) and any affiliated academic institution. Professional responsibilities include all clinical, administrative, research and academic activities such as research, research consultation, teaching, professional practice, institutional committee membership, and service on panels such as an Institutional Review Board or Data and Safety Monitoring Board.
Institutional Official for the purposes of this policy means the persons or committees appointed by the Directors of the New York State Psychiatric Institute (NYSPI), Nathan Kline Institute (NKI) and Institute for Basic Research (IBR) to ensure disclosure and review of disclosures under this policy at each location and the person appointed by the Managing Director of RFMH to ensure disclosure and review of disclosures under this policy for Central Office and all locations other than NYSPI, NKI and IBR.
Investigator means the project director or principal investigator and any other person, regardless of title or position and including key personnel, who is responsible for the design, conduct (including data collection and analysis), or reporting of research which may include collaborators or consultants.
Manage means taking action to address a Financial Conflict of Interest, which can include reducing or eliminating the financial conflict of interest, to ensure, to the extent possible, that the design, conduct, and reporting of research will be free from bias.
Research means a systematic investigation, study or experiment designed to develop or contribute to generalizable knowledge relating broadly to public health, including behavioral and social-sciences research and encompassing basic and applied science and product development.
Senior/key personnel means the Project Director/Principal Investigator and any other person identified as senior/key personnel in a grant application, progress report or other report submitted to PHS or other Sponsor and any person identified as key personnel in a contract proposal and contract.
Significant Financial Interest (SFI) means
	(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 appear 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, directorships, executive roles and other special relationships with business having the potential for personal financial gains); 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. This disclosure will include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration. 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. Travel reimbursed by RFMH or DMH is not required to be disclosed.
	(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.
	Previous Section	Next Section