From: Barry W. Stevens,
Director, Research Policy Development
Subject: University Policy on Financial Conflicts of Interest in Federally- Funded Research
This memorandum transmits for your review a proposed revised university policy on financial conflicts of interest in Federally-funded research. By consensus, the committee that developed this policy endorses its contents and recommends that it be adopted by the university. The members of the policy development committee were the following:
Danny Menasce, Associate Dean, Volgenau School of Information
Technology and Engineering
Keith Howell, Associate Dean, College of Health and Human Services
Peter Barcher, Associate Dean, College of Education and Human Development
Linda Samuels, Professor, Management
Jane Flinn, Associate Professor, Psychology
Matt Kluger, Vice President for Research and Economic Development
Jennifer Murphy, Director, Office of Technology Transfer
Mike Laskofski, Director, Office of Sponsored Programs
Tom Moncure, University Counsel
I chaired the committee and served as facilitator, researcher, and drafter.
A revised policy on financial conflicts of interest in Federally-funded research is needed to update the university’s current policy, which was adopted on October 1995 and is not fully consistent with current university practice. Federal oversight of financial conflicts of interest has recently become more focused. A revision of the policy presents opportunities not only to ensure that the university meets the requirements of Federal regulations but to strengthen standards to ensure that the design, conduct, and reporting of Federally-funded research is not biased by any conflicting financial interest of an investigator.
The principal features of the revised policy are the following:
1. The policy updates and streamlines the process for the required disclosure and review of “significant financial interests” that could give rise to a conflict of interest. Investigators may make required certifications online. If they believe they have such an interest, they disclose it to their Dean or Institute Director, or that officer’s designee, who evaluates it to determine whether a conflict of interest may exist. If that initial determination is in the affirmative, the matter is referred to a university-wide conflict of interest committee that reviews the disclosure and, if the Vice President for Research agrees that a conflict exists, works with the investigator to develop a management plan to ensure that the conflict is managed, reduced, or eliminated. The Dean or Director, or that officer’s designee, monitors the investigator’s compliance with the terms of the agreed-upon management plan.
2. While it applies to investigators engaged in any Federally-funded research, the policy provides that disclosures must be made prior to the university’s submission of an application for funds only where expressly required by the funding agency (the Public Health Service and the National Science Foundation). For funding from all other Federal agencies, disclosures are due 30 days after the submission of the application.
3. Its provisions are intended to be user-friendly. For example, the policy provides guidance to investigators on what interests are covered by Federal disclosure requirements and incorporates university commitments required by Federal law in ways that do not create unnecessary administrative burdens.
The full-text document:Proposed Federal Financial Conflict of Interest Policy
http://www.gmu.edu/facstaff/senate/COI-proposed.pdf
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