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
5	Submission and Review of Disclosures
RFMH will designate an Institutional Official(s) to solicit and review disclosures of Financial Interests that reasonably appear to be related to the Investigator’s Institutional Responsibilities from each Investigator who is planning to participate in or is participating in research funded through RFMH. The Director of each Research Institute (NYSPI, NKI and IBR) shall designate an appropriate person or committee to be the Institutional Official responsible for ensuring that disclosures are obtained from each such Investigator and for the review of such disclosures. The responsible Institutional Official for all other locations shall be appointed by the Managing Director of RFMH. Investigators who are planning to participate in research funded through RFMH must disclose to the applicable Institutional Official their Financial Interests (and those of their spouse and dependent children) related to the Investigator’s Institutional Responsibilities. Financial Interests are considered related to the Investigator’s Institutional Responsibilities when those Financial Interests are derived from or associated with an external entity engaged in activities that: relate even broadly to the same or reasonably similar subject matter as the Investigator’s Institutional Responsibilities, AND/OR include activities that the Investigator knows or should have known involve the same patients, clients or research subjects that the Investigator interacts with as part of Institutional Responsibilities. All Financial Interests involving pharmaceutical companies, biotechnology companies, medical equipment or supplies manufacturers and distributors and all intellectual property rights, including patents, royalties and licensing agreements are considered to be related to RFMH/DMH employment and must be disclosed under this policy.
	5.1 Submission Prior to Application for Funding or Negotiation of an Agreement
	Each Investigator must disclose to the appropriate Institutional Official the Financial Interests of the Investigator, the Investigator’s spouse and the Investigator’s dependent children related to the Investigator’s Institutional Responsibilities no later than the time an application is submitted for research funding. The disclosure should include any Financial Interests existing during the prior 12 months and, for Financial Interests related to the application or agreement, those that existed from the time study planning began and any Financial Interests that are reasonably anticipated to arise in the future, including subsequent to the current research.
	5.2 Submission of Updated Reports
	At least annually each Investigator must submit an updated disclosure of Financial Interests (including those of the spouse or dependent children). Such disclosure shall include any information that was not previously disclosed and any updated information, e.g. an updated value of equity interest. In addition, each Investigator must submit an updated disclosure of Financial Interest (including those of the spouse or dependent children) within 30 days of discovering or acquiring such an interest. The Institutional Official for the Investigator’s location will determine the schedule for submitting updated annual reports which may be based on the anniversary of the original submission date, a fixed date for all investigators at the location or other schedule.
	5.3 New Investigators and New Disclosures
	In the course of an ongoing research project if an Investigator is added to the project and discloses a Financial Interest or an existing Investigator discloses a new Financial Interest the designated Institutional Official must review the disclosure within 60 days, make the determinations described in “Review of Disclosures” below and, if a FCOI is found to exist implement, on at least an interim basis, a management plan that specifies the actions that have been and will be taken to manage the FCOI. Interim measures may be taken as necessary during the period of review.
	5.4 Review of Disclosures
	The Institutional Official shall determine for each Financial Interest : Whether the Financial Interest is related to a specific funded project or application for funding. A Financial Interest is related when the Financial Interest: could be affected by the research or related activity; or is in or derived from an entity whose Financial Interest could be affected by the research or related activity; and If related, whether the Financial Interest poses a conflict of interest or a potential conflict of interest; and Whether the Financial Interest is a Significant Financial Interest. If the Financial Interest is related, poses a conflict or potential conflict of interest and is a Significant Financial Interest, it is a Financial Conflict of Interest (FCOI). A Financial Conflict of Interest (FCOI) exists when the appropriate Institutional Official reasonably determines that the Financial Interest is a Significant Financial Interest and could directly and significantly affect the design, conduct, including data analysis, or reporting of the research. FCOI’s are not ordinarily allowable and in most cases will be eliminated rather than managed before the research or related activity is permitted to commence. Note: If the Financial Interest is related and poses a conflict or potential conflict of interest but is not a Significant Financial Interest, the appropriate Institutional Official will take actions as appropriate to manage or eliminate the Financial Interest. Such conflicts are not ordinarily allowable and in most cases will be eliminated rather than managed before the research or related activity is permitted to commence.

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