Business Office Resources
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.
All units of the university
Responsible Executive: Associate Vice President
Responsible Offices: Office of Sponsored Projects
Contact: Your college or unit administrative office or the Office of Sponsored Projects
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.
The objectivity of research is of paramount importance and the basis for obtaining and maintaining public trust. To address the increasing complexities of the financial interests
held by biomedical and behavioral researchers and the resulting interactions among Government, research Institutions, and the private sector, the Public Health Service (PHS) and the Office of the Secretary of the U.S. Department of Health and Human Services (HHS) published revised regulations on the Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought and Responsible Prospective Contractors (commonly known as the Financial Conflict of Interest (FCOI) regulations). These regulations establish new standards and clarify previously established standards to be followed by Institutions that apply for or receive research funding from PHS Awarding Components, including the National Institutes of Health (NIH), for grants, cooperative agreements, and research contracts. The 2011 revised regulations were written to increase
accountability, add transparency, enhance regulatory compliance and effective Institutional management of Investigators’ financial conflicts of interest, and strengthen NIH’s compliance oversight. The primary goal is to promote objectivity by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research funded under PHS grants, cooperative agreements and contracts will be free from bias resulting from Investigator financial conflicts of interest.
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.
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.
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.
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:
All FCOI reports must include sufficient information to enable the NIH to understand the nature and extent of the Financial Conflict of Interest and to assess the appropriateness of the Institution’s management plan. The regulation provides key elements that must be included in the FCOI report to NIH. These include but are not necessarily limited to the following:
See the “Management” section for the questions for guidance on the minimum requirements for the management plan.
NIH grant and cooperative agreement award recipients should continue to submit FCOI reports using the electronic Research Administration (eRA) Commons FCOI Module. Once the institution is required to be in full compliance with the regulatory requirements, the additional reporting requirements must be met. Therefore, if the eRA Commons FCOI Module is not updated by the time this occurs, the FCOI report should include an attachment that addresses the minimum elements of the FCOI report as stated above and provided in 42 CFR 50.605(b)(3)
Whenever a Financial Conflict of Interest is not identified or managed in a timely manner, including:
the Institution shall, within 120 days of the Institution’s determination of noncompliance, complete a “retrospective review” of the Investigator’s activities and the NIH-funded research project to determine whether any NIH-funded research, or portion thereof, conducted during the time period of the noncompliance was biased in the design, conduct, or reporting of such research.
The institution shall document the retrospective review which must include at least the following key elements;
If bias is found, the Institution must notify NIH promptly and submit a mitigation report. If the FCOI was previously reported to the NIH, the mitigation report is submitted as a “Revised FCOI Report.” (see FAQ H.2.). The mitigation report must include, at a minimum, the key elements documented in the retrospective review above and a description of the impact of the bias on the research project and the Institution’s plan of action or actions taken to eliminate or mitigate the effect of the bias (i.e., impact on the research project, extent of harm done, including any qualitative and quantitative data to support any actual or future harm; analysis of whether the research project is salvageable). Thereafter, the Institution will submit FCOI reports annually as prescribed by the regulation.
No. When bias is not found following the completion of a Retrospective Review, the grantee should not submit a “Revised” FCOI report to notify NIH that either the Retrospective Review has been completed or that bias is not found. See FAQ H.22. for more information about when it is appropriate to submit a “Revised” FCOI report following the completion of a Retrospective Review.
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.
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:
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.
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