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Office of Research & Sponsored Programs


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Compliance - Conflict of Interest

IMPORTANT

Effective November 1, 2013, Proposal Automated Routing System (PARS) privileges will be suspended or denied, respectively, to any current or new Investigator or Approver who has not submitted to the Office of Research and Sponsored Programs (ORSP) a certificate showing satisfactory completion of the UMS Financial Conflict of Interest (FCOI) training.

Overview

The U.S. Department of Health and Human Services (HHS) issued a final rule on August 25, 2011 amending 1995 Public Health Service (PHS) regulations on the Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought.  The new rule, which went into effect August 24, 2012, seeks to strengthen accountability, transparency, compliance, and oversight of government, institutional, and private sector participants in PHS-sponsored research,

Since the promulgation of the regulations in 1995, biomedical and behavioral research and the resulting interactions among government, research Institutions, and the private sector have become increasingly complex. This complexity, as well as a need to strengthen accountability, led to changes that expand and add transparency to Investigators’ disclosure of Significant Financial Interests (SFIs), enhance regulatory compliance and effective institutional oversight and management of Investigators’ financial conflicts of interests, as well as increase the Department of Health and Human Services’ (HHS) compliance oversight. [1]

Important revisions to to the regulations include:

Definitions

A Conflict of Interest (COI) is a divergence between an individual’s private interests and his or her professional obligations to the University such that an independent observer might reasonably question whether the individual’s professional actions or decisions are determined by considerations of personal gain, financial or otherwise.

Investigator refers to the Project Director/Principal Investigator, any other person identified as Senior/Key personnel in a grant application, progress report, or other report submitted to an external sponsor, and others who direct or can materially influence the research, or who are responsible for the design, conduct, and reporting of such research.

Significant Financial Interest means anything of monetary value, including but not limited to salary or other payments for services (e.g., consulting fees or honoraria); equity interests (e.g., stocks, stock options, or ownership interests); and intellectual property rights (e.g., patents, copyrights, and royalties from such rights).

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UMaine Policy & Procedures

The University of Maine’s revised Policies and Procedures for Financial Disclosures and Conflicts of Interest in Extramurally Sponsored Activities (PDF), applies to all University employees and students who serve as investigators on proposals submitted to external sponsors on or after April 1, 2013, and to all University investigators applying for or receiving PHS funding from a grant, cooperative agreement, or contract on or after August 24, 2012.

In brief, UMaine’s FCOI policy requires that prior to submitting a request for extramural funding each Investigator named in a proposal successfully complete the Collaborative Institutional Training Initiative (CITI) FCOI training and certify whether s/he has a significant financial interest related to the proposed activity.  Any investigator having such an interest must complete a Significant Financial Interest Disclosure Form (PDF) and in certain circumstances follow an approved Conflict Resolution Plan. Individuals not listed as investigators in proposals who later assume such roles through hiring, promotion, or other means are required to complete CITI FCOI training, certify their financial interests and make any applicable disclosures prior to commencing work on the project.

COI Resources


[1]  42 C.F.R. Subpart F §50.

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Contact Information

Office of Research & Sponsored Programs
5717 Corbett Hall
Orono, Maine 04469-5717
Phone: 207-581-1484 | Fax: 207-581-1446
The University of Maine
Orono, Maine 04469
207.581.1110
A Member of the University of Maine System