FCOI

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FINANCIAL CONFLICT OF INTEREST POLICY

1. Background

MNI is committed to ensuring that MNI staff and others with designated research related responsibilities at MNI are provided an open and productive environment in which to conduct research. Conflict of interest, which arises when a secondary objective could affect the performance of a person's primary mission, is a normal part of human existence. The potential for financial gain is one of many potential incentives that can lead to bias in a subjective activity. While MNI encourages interaction with outside institutions and persons, MNI also defines clear boundaries within which to operate to ensure that MNI research and participant care are performed in a manner that maintains the utmost in integrity and objectivity. 

This policy is intended to be consistent with federal and state laws and regulations. Where there is a discrepancy, the applicable federal or state law or regulation will take precedence.

2. Scope

This policy applies to MNI, whereas MNI is an Institution having responsibilities under 42_CFR_50_Subpart_F. 

This policy also applies to Investigators employed or otherwise contracted through MNI; whereas such Investigators have responsibilities under 42_CFR_50_Subpart_F.

3. Definitions

Financial Interest: Anything of monetary value or potential monetary value that reasonably appears to be related to the MNI Individual's duties and responsibilities, including, but not limited to:

 

  • Payment for service (e.g., a consulting fee, reimbursed travel, lecture payment, or honorarium), except as otherwise excluded by this policy
  • A gift (e.g., money, hospitality, or a physical item);
  • An equity interest (e.g., stock, stock option, security, or other ownership interest);
  • An intellectual property right (e.g., a patent, copyright, or royalty from such right); and
  • Other interests as determined by MNI. For example, a financial interest may only have potential to be of value, like an option in a non-publicly traded company. Because this potential value may be an economic incentive, a situation like this is considered a financial interest.

The term does not include:

  • Ownership of a share in a mutual fund;
  • Salary or other remuneration from MNI or an accredited institution of higher education; and
  • Salary or other remuneration from the U.S. Department of Veterans Affairs or another federal, state, or local government entity.

 

Financial Conflict of Interest ("FCOI"): A financial interest that could directly and significantly affect the design, conduct or reporting of PHS funded research.

A significant FCOI can exist in a variety of situations, including the following example: 

FCOI is present in a situation in which a primary interest or responsibility is affected, perhaps unduly, by a secondary interest or responsibility. This means that a subjective component of a primary interest (e.g. research) is affected, or potentially affected, by a financial secondary interest, either ongoing (e.g. consulting) or where there is the potential for increased valuation (of stock or an option). Financial COI is present when the outcome of the research could affect future income or the value of an asset (including an option for equity).

Institution: Any domestic or foreign, public or private, entity or organization (excluding a Federal agency) that is applying for, or that receives, PHS research funding.

Investigator: Any person who is independently responsible for making decisions regarding PHS funded research. This would include both the Principal Investigator on a research study, and anyone else, regardless of title, who is responsible for the design, conduct, or reporting (i.e. key personnel) of research funded by the PHS. For any one individual, the policy includes a financial interest of any immediate family member (spouse or spousal equivalent, and dependent children) as if any financial interest of that family member were one of the individual. Investigators include both those currently working on PHS projects, and those who may in the future become associated with PHS projects.

PHS: Public Health Service of the U.S. Department of Health and Human Services, including the National Institutes of Health (NIH).

4. Policy and Process

Statement of Policy

It is the policy of MNI that an Investigator is obligated to appropriately disclose any financial interest to MNI, and if after review it is determined necessary by MNI's FCOI committee, MNI is obligated to ensure the establishment of a management plan which has been developed, approved and implemented by MNI, with commitment of compliance by the Investigator and all other involved parties per MNI procedures.

Identification of Potential Financial Conflicts of Interest

An Investigator will be required to report to MNI her/his financial interests on an annual basis and at the time of a reportable change. MNI reserves the right to request additional information, as deemed necessary.

Establishment of Financial Conflict of Interest Committee

A financial conflict of interest committee will be appointed by the General Partners of MNI and the committee will report to the General Partners.

Procedures for Evaluation of Potential Financial Conflicts of Interest

The FCOI committee will determine who is classified as an Investigator. Training on this policy and the annual disclosure requirements will be held annually. 
Disclosure statements will be required of all Investigators of MNI annually (prospective, for the upcoming year) and when an Investigator identifies a new financial interest during the year. The committee will review all disclosure statements, and determine if a significant FCOI exists. If the committee determines that a significant FCOI exists, the committee will develop a management plan for the FCOI, meet with the Investigator to review the plan and obtain the Investigator's acceptance of the plan. Annually, the FCOI committee will present the status of disclosures and management plans to MNI's General Partners. The FCOI committee will also be responsible for all required reporting of significant FCOI to NIH as required by the regulation.

Management of Financial Conflicts of Interest

The FCOI committee will oversee the implementation of the management plan, which may include the elimination of the financial conflict of interest, approval of a management plan, or adoption of an alternative course of action