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University of Guam is committed to overseeing the conduct of research in a manner that ensures the integrity of the research process and maintains the public trust and that of sponsors in the integrity and credibility of its faculty, its staff, and its research programs. This commitment requires the university to ensure that there is no reasonable expectation that research results are biased by the external commitments and financial interests of persons who are responsible for the design, conduct, reporting, or direct administration of university research. Such individuals are, for the purposes of this policy, referred to as "research personnel." Research, for the purpose of this policy, includes all sponsored projects, including research and extension, and all non- sponsored university research.

The University’s policy on financial conflict of interest (FCOI) identifies and addresses the real or apparent financial conflicts of interest presented by the intersection of research activities and personal financial interests, and defines the requirements of all research personnel to ensure that those activities are conducted objectively and without consideration of personal financial gain.

Entities Affected by this Policy

All units of the university

Policy Information

• Responsible Executive: Associate Vice President

• Responsible Offices: Office of Sponsored Projects

• Contact: Your college or unit administrative office or the Office of Sponsored Projects

Violations of Finance Policy

Violation of a financial policy should be reported to your supervisor, your human resource representative, unit manager, and/or the office responsible for the policy. Where these resources are inadequate, you may choose to make an anonymous report through the Comptroller’s Office.

What is the purpose of this regulation? (Institution and Investigator)

The 2011 revised regulation promotes objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research performed under NIH grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest. This regulation is commonly referred to as the Financial Conflict of Interest (FCOI) regulation.

Who is required to disclose financial interests? (Institution and Investigator)

Under the 2011 revised regulation, Investigators (as defined by the regulation) who are planning to participate in, or are participating in, NIH-funded research, with the exception of Phase I SBIR/STTR applications, are required to disclose to the designated official(s) of the Institution a listing of Significant Financial Interests (and those of his/her spouse and dependent children) that reasonably appear to be related to the Investigator’s institutional responsibilities.

Who is covered by the regulation? (Institution and Investigator)

The regulation is applicable to each Institution that is applying for, or that receives, NIH research funding by means of a grant or cooperative agreement and, through the implementation of the regulation by the Institution, to each Investigator who is planning to participate in, or is participating in, such research. The regulation, however, does not apply to Phase I Small Business Innovative Research or Small Business Technology Transfer applications. For purposes of financial disclosure only, the regulation covers the Investigator’s spouse and dependent children. The regulation also applies to those few cases where an individual, rather than an Institution, is applying for or receives NIH research funding. However, in those cases, the NIH will make case-by-case determinations on the steps an Institution or an Investigator must take, consistent with the regulation, to provide a reasonable expectation that the design, conduct, and reporting of the research will be free from bias resulting from a Financial Conflict of Interest of the individual.

Financial Conflict of Interest FAQ

FCOI Management

How can an Institution manage conflicting financial interests? (Institution and Investigator)

How an Institution manages an Investigator’s conflicting financial interest is left to the Institution’s policies and procedures. Examples of conditions or restrictions that might be imposed to manage an Investigator’s Financial Conflict of Interest include, but are not limited to:

• Public disclosure of financial conflicts of interests (e.g., when presenting or publishing the research; to staff members working on the project; to the Institution’s Institutional Review Board(s), Institutional Animal Care and Use Committee(s), etc;
• 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 resulting from the Financial Conflict of Interest;
• Modification of the research plan;
• Change of personnel or personnel responsibilities, or disqualifications 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); or
• Severance of relationships that create financial conflicts

FCOI Training

Institutions are required to train Investigators “immediately” upon certain situations. How is “immediately” defined in this context? (Institution)

NIH expects Institutions to define “immediately” in the Institution’s Financial Conflict of Interest policy, which would establish a reasonable timeframe when Investigators must complete training under the prescribed circumstances. Although the regulation does not define a precise timeline, the expectation is that Institutions will make it a priority to ensure Investigators understand and comply with the requirements of the regulation and the Institution’s Financial Conflict of Interest policy, which reinforces the need for training to be handled expeditiously.

Does the regulation require Investigator training? (Institution and Investigator)

Yes. Each Investigator (as defined by the regulation), including sub-recipient Investigator(s), must complete training and be made aware of University’s FCOI Policy Statement prior to engaging in NIH-funded research and at least every four years, and immediately under the designated circumstances:

• Institutional Financial Conflict of Interest policies change in a manner that affects Investigator requirements
• An Investigator is new to an Institution
• An Institution finds that an Investigator is not in compliance with the Institution’s Financial Conflict of Interest policy or management plan.

Institutions may utilize resources available on NIH’s Office of Extramural Research Financial Conflict of Interest Web page found at https://grants.nih.gov/grants/policy/coi/ to satisfy some of the training requirements. However, Institutions must also provide additional training regarding Investigator’s responsibilities for disclosure of Significant Financial Interests and of the Institution’s specific policy on financial conflicts of interests.