Eastern Michigan University: Board Policy Manual

Conflict of Interest: Federally-Sponsored Projects

Effective Date:	01.23.1996	Revision Date:
Chapter Name:	Academic Programs and Requirements		Policy Number:	6.4.1
Policy Name:	Conflict of Interest: Federally-Sponsored Projects
*A PDF version of this policy is available via this link.*

UNIVERSITY POLICY STATEMENT:

In accordance with federal regulations, Eastern Michigan University has a responsibility to manage, reduce, or eliminate any conflicts of interest that may be presented by a financial interest of an investigator. Thus, it is the policy of the University to require investigators to disclose any significant financial interest that may present a conflict of interest in connection with federally sponsored projects.

Definitions

The term investigator refers to the principal investigator/project director, co-principal investigator(s), and any other person at the University who is responsible for the design, conduct, or reporting of research or educational activities funded or proposed for funding by an external sponsor. In this context, the term investigator includes the investigator's spouse and dependent children.
A conflict of interest may take many forms, but arises when a principal investigator is or may be in a position to influence University business, research, or other decisions in ways that could lead to any form of personal gain for the principal investigator (including his/her spouse and/or dependent children) or give improper advantage to others to the University's detriment.
A potential conflict of interest occurs when there is a divergence between an individual' s private interests and his or her other professional obligations to the institution 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. An actual conflict of interest depends on the situation, and not on the character or actions of the individual.
An actual or potential conflict of interest exists when the reviewers of disclosures deten11ine that a significant financial interest could reasonably appear to affect the design, conduct, or reporting of the research or educational activities funded or proposed for funding by an external sponsor.
Significant financial interest means anything of monetary value, including, but not limited to, salary or other payment for services ( e.g., consulting fees or honoraria); equity interests ( e.g., stocks, stock options, or other ownership interests); and intellectual property rights (e.g., patents, copyrights, and royalties from such rights).

The term significant financial interest does not include:

Salary, royalties, or other remuneration from Eastern Michigan University.
Income from seminars, lectures, or teaching engagements sponsored by public or nonprofit entities.
Income from service on advisory committees or review panels for public or nonprofit entities; or
Financial interests in business enterprises or entities if the value of such interests does not exceed $10,000 or $10,000 per annum if such interests represent salary, fees, or other continuing payments) or represent more than 5% ownership interest for any one enterprise or entity when aggregated for the investigator and the investigator's spouse and dependent children.

Significant financial interests that may be disclosed are: (a) any financial interests of the investigator (including the investigator's spouse and dependent children) that would reasonably appear to be directly and significantly affected by the research or educational activities funded or proposed for funding by the external sponsor; or (b ) entities whose financial interests would reasonably appear to be directly and significantly affected by the sponsored activities.

UNIVERSITY PRACTICE:

Federal regulations require institutions to have policies and procedures in place that ensure that investigators disclose any significant financial interest that may present a conflict of interest in relationship to federally sponsored projects. Such disclosures must be made prior to the submission of a proposal for funding; and institutions must certify compliance on each proposal, as well as develop specific mechanisms by which conflicts of interest will be satisfactorily managed, reduced, or eliminated, prior to the University's expenditure of any funds under an award. The institution must also maintain appropriate records. If a new or reportable conflict of interest arises at any time during the period after submission of the proposal through the period of the award, the filing of a disclosure is also required.

Effective October 1 , 1995, Eastern Michigan University requires each investigator submitting a proposal for funding by a federal agency to submit all required financial disclosures at the time of proposal submission and to update this information annually, or as new reportable interests are obtained, during the life of the award.
Disclosure of financial interests shall be made to the Director of the Office of Research Development ( or official designee ) by means of a packet of information consisting of the Conflict of Interest Disclosure Form for Federally Sponsored Projects, all required supporting documentation (in a sealed envelope marked confidential), the proposal, and the proposal transmittal form.
In accordance with federal regulations, a complete disclosure must be made by the investigator(s) prior to the submission of the proposal. At the time a proposal is submitted to a federal funding agency, the Director of the Office of Research Development shall certify that the University has implemented a written and enforced conflict of interest policy that is consistent with current federal guidelines.
The procedure to review disclosures, assess their potential for conflicts of interest, and develop strategies to "manage, reduce, or eliminate" such conflicts shall be incorporated with the standard internal university review process and integrated into the normal submission process.
A Conflict of Interest Review Committee shall be charged with the responsibility for review of financial disclosure to determine whether an actual or potential conflict of interest exists; to determine what conditions or restrictions, if any, should be imposed by the institution to manage, reduce, or eliminate such conflicts of interest; and, as necessary, to recommend sanctions.

In the event that a conflict of interest cannot be resolved to the satisfaction of the committee, the administrative officer of the committee shall direct the Director of the Office of Research Development to inform the funding agency of the unresolved issues prior to the University's expenditure of any funds under the award.

The Office of Research Development shall be responsible for appropriate follow-up reporting and records management procedures. Records of investigator financial disclosures and actions taken to manage actual or potential conflicts of interest shall be retained for at least three years beyond the termination or completion of the grant to which they relate, or until the resolution of any government action involving those records, whichever is longer. All records shall be maintained in a manner to protect confidentiality.

RESPONSIBILITY FOR IMPLEMENTATION:

The President of the University has the overall responsibility for implementation of this policy. The Director of Research Development is responsible for the daily administration of the policy.

SCOPE OF POLICY COVERAGE:

This policy requires the principal investigator/project director, co-principal investigator(s) and any other person at the University who is responsible for the design, conduct, or reporting of research or educational activities funded or proposed for funding by an external sponsor to disclose any significant financial interest that may present a conflict of interest in connection with federally sponsored projects.

EASTERN MICHIGAN UNIVERSITY

CONFLICT OF INTEREST DISCLOSURE FORM

FOR FEDERALLY SPONSORED PROJECTS

Name ___________________________________ Title and/or Rank ____________________________

College Department/Unit ____________________Department/Unit _______________________

Do you have a consulting or other financial relationship with a sponsor of your research?

_____yes (If so, please list and explain in an attached statement.)

_____no

Do you have a managerial role or a significant financial relationship with a company in a field of your research or a company that does business with the University?

_____ yes (If so, please list and explain in an attached statement.)

______no

Are you engaged in non-University professional or income-producing activities involving either Eastern Michigan University students or other staff?

_____ yes (If So, please list and explain in an attached statement.)

_____ no

Do you or any members of your immediate family have any other relationships, commitments, or activities that might present or appear to present a conflict of interest or commitment related to this grant or grant proposal?

_____ yes(If so, please list and explain in an attached statement.)

_____ no

I have read and understand Eastern Michigan University's Investigator Significant Financial Disclosure Policy for Federal1y Funded Projects and have made all financial disclosures required by that policy, if any, in an attached statement. I will comply with any conditions or restrictions imposed by the University to manage, reduce, or eliminate actual or potential conflicts of interest.

Name _________________________________________ Date __________________________

Authority for Creation or Revision:

Minutes of the Board of Regents, January 23, 1996

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