Conflict of Interest Policy and Procedures Pertaining to Sponsored Projects

In recent years both the frequency and complexity of the relationships of the University and its Investigators with industry, government, and other entities have increased dramatically. While the Investigators of the University of Detroit Mercy recognize that their primary professional obligation is to the University of Detroit Mercy, they must be alert in this changing environment to the possibility that outside obligations, financial interests, or employment relationships may compromise their objectivity as teachers, researchers, clinicians, and administrators. This obligation pertains to both full-time and part-time Investigators. To avoid any such possible conflict of interest, or the appearance of a conflict of interest, in the conduct of grant or contract activities, the safeguards outlined in this document are hereby established, as mandated by federal law.

Definitions

A potential Conflict of Interest occurs when there 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 means the principal investigator/project director, co-principal investigators, and any other person 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.

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 other ownership interests); and intellectual property rights (e.g., patents, copyrights and royalties from such rights). The term does not include:

1. Salary, royalties, or other remuneration from the University;

2. Income from seminars, lectures, or teaching engagements sponsored by public or nonprofit entities;

3. Income from service on advisory committees or review panels for public or nonprofit entities; or

4. An equity interest that when aggregated for the Investigator and the Investigator's spouse and dependent children, meets both of the following tests: does not exceed $10,000 in value as determined through reference to public prices or other reasonable measures of fair market value, or, constitute more than five percent ownership interest in any single entity; or

5. Salary, royalties or other payments that when aggregated for the Investigator and the Investigator's spouse and dependent children over the next twelve months, are not expected to exceed $10,000.

The Conflict of Interest Review Committee (CIRC) is the committee appointed by the Vice President for Academic Affairs and Provost to implement this policy. It shall be made up of the Director for Sponsored Research Administration and three to five members of the UDM faculty, from different disciplines, who are experienced in conducting sponsored research (at least one of whom has been a principal investigator involved in a sponsored project in the last five years) or in managing potential conflicts of interest. The committee shall select its own chairperson.

Areas of Potential Conflict

The areas of potential conflict may be divided into two categories. Conflicts of Interest are defined as situations in which Investigators may have the opportunity to influence the University's business decisions in ways that could lead to personal again or give improper advantage to the Investigator or members of their families or to associates. Conflicts of Commitment are defined as situations in which Investigators' external activities interfere, or appear to interfere, with their paramount obligations to their students, colleagues, and the University.

In those circumstances in which the University is engaged in, or intends to engage in, a sponsored project with a commercial organization, or has subcontracted or intends to subcontract to an external organization under one of the University's sponsored projects, a conflict of interest may occur when an Investigator's affiliation with the external organization meets any one of the following criteria:

1. The Investigator is an officer, director, partner, trustee, employee, advisory board member, or agent of an external organization or corporation either funding a sponsored project or providing goods and services under a sponsored project on which the Investigator is participating in any capacity.

2. The Investigator is the actual or beneficial owner of more than five percent (5%) of the voting stock or controlling interest of such organization or corporation.

3. The Investigator has dealings with such organization or corporation from which he or she derives income of more that $10,000 per year, exclusive of dividends and interest.

4. The Investigator's immediate family (spouse, parents, parents-in-law, siblings, children, or other relatives living at the same address as the faculty member) meet any of the criteria stated in 1-3 above.

Investigators are encouraged to consult with their Department Chair, Dean, or Director for advice prior to initiating a sponsored research proposal when they believe a potential conflict of interest may exist.

Procedures and Guidelines

The following procedures and guidelines are to be followed in resolving Investigator conflicts of interest and commitment pertaining to sponsored projects. They apply to all sponsored projects irrespective of the source of the funds.

1. Each Investigator is required to disclose the following Significant Financial Interests: (i) Any Significant Financial Interest of the Investigator that would reasonably appear to be affected by the research or educational activities funded, or proposed for funding, by an external sponsor; or (ii) Any Significant Financial Interests of the Investigator in an entity whose financial interest would reasonably appear to be affected by the research or educational activities funded, or proposed for funding, by an external sponsor. These are considered to be the minimum requirements.

   An Investigator, in his or her best interest, may choose to disclose any other financial or related interest that could present an actual, or perceived, conflict of interest. As required by Federal regulation, all significant financial interests must be disclosedprior to the time a proposal is submitted. All financial disclosures must be updated by Investigators during the period of the award as new reportable Significant Financial Interests are obtained.

2. The Significant Financial Interest Disclosure portion of the Internal Summary Form for Proposal Review and Approval (Attachment 1) is to be sent to the Office for Sponsored Projects and Research Administration (OSPRA ) accompanied by all required supporting documentation. Supporting documentation that identifies the business enterprise or entity involved and the nature and amount of the interest should be submitted in a sealed envelope marked confidential.

3. The OSPRA shall maintain the records pertaining to each disclosure in strict confidence. Access to such records will be limited to the Investigator, the Conflict of Interest Review Committee, the Vice President for Academic Affairs and Provost, and others who have a legal right to review the records

4. The Director for Sponsored Research Administration, or his/her official designee, shall conduct an initial review of the financial interest disclosures to determine if the CIRC needs to review the project.

   3.1

   If the Director for Sponsored Research Administration, or his/her designee, determines that any potential for a conflict of interest is remote or minimal, the CIRC does not need to review the proposal.  The Director or designee shall then file a report stipulating that the project proposal and financial disclosures have been reviewed and that the determination has been made that the potential for a conflict of interest is not enough to warrant a review by the Committee.

   3.2

   If the Director for Sponsored Research Administration, or his/her designee, determines that the potential for more than a remote or minimal conflict of interest may exist, he or she shall schedule a meeting of the CIRC to review the proposal and the disclosures. The Investigator shall be informed that the CIRC will review the proposal and will be invited to attend the meeting for the purpose of presenting his or her position and answering any questions the Committee may have. A potential conflict of interest will not delay processing of the proposal or its submission to the sponsoring agency. The Significant Financial Interest Disclosure and supporting documentation will not be conveyed beyond the OSPRA.

5. In its review, the CIRC will reach one of two conclusions: i) that the potential conflict of interest is not proximate 4.  In its review, the CIRC will reach one of two conclusions: i) that the potential conflict of interest is not proximate or significant enough to cause a concern for objectivity or integrity; or ii) that the potential conflict of interest is such that a Significant Financial Interest could directly and significantly affect the design, conduct, or reporting of the proposed project.  In reviewing these disclosures, the Conflict of Interest Review Committee will act in a timely manner so as not to delay unduly the conduct of the project.

   4.1	If the CIRC reaches the first conclusion, it shall document its determination and no further action shall be required.
   4.2	If the CIRC reaches the second conclusion, it shall discuss with the Investigator possible ways of reducing or eliminating the potential conflict of interest. The Investigator shall be informed that a Resolution Plan (RP) will need to be developed and approvedprior to the expenditure of any award funds.
   4.3	If the CIRC determines that imposing the above referenced conditions or restrictions would be inequitable, or that the potential negative impacts that may arise from a significant financial interest are outweighed by interests of scientific progress, technology transfer, or the public health and welfare, then the CIRC may recommend, to the extent permitted by Federal regulations [Public Health Services (PHS) policy, for instance, does not permit such an action], that the research go forward without imposing such conditions or restrictions. In these cases, the Vice President for Academic Affairs and Provost shall make the final decision regarding resolution.

6. The Investigator is responsible for developing and presenting to the CIRC an RP that details proposed steps that will be taken to reduce or eliminate the potential conflict of interest. Methods adopted in the RP might include one or more of the following:

   (a)	Public disclosure of significant financial interests;
   (b)	Review of research protocol by independent reviewers;
   (c)	Monitoring of research by independent reviewers;
   (d)	Modification of the research plan;
   (e)	Disqualification from participation in all or a portion of the research funded;
   (f)	Divestiture of significant financial interests; or
   (g)	Severance of relationships that create actual or potential conflicts of interest.

7. The CIRC shall review the Resolution Plan. The CIRC may modify the Plan, including adding conditions or restrictions, before it approves the Plan.
8. If the Investigator is dissatisfied with the CIRC'S conclusion, the Investigator may appeal to the Vice President for Academic Affairs and Provost who will consult with the Investigator and CIRC as the Vice President for Academic Affairs and Provost deems necessary and appropriate to the particular circumstance. The decision of the Vice President for Academic Affairs and Provost shall be final.
9. The approved Resolution Plan shall be incorporated into a Memorandum of Understanding (MOU) between the University of Detroit Mercy and the faculty member that details the conditions or restrictions imposed upon the Investigator in the conduct of the project or in the relationship with the Business Enterprise or Entity. The MOU shall be signed by the Investigator and the Investigator's responsible Vice President. Actual or potential conflicts of interest will be satisfactorily managed, reduced, or eliminated in accordance with these Guidelines and all required reports regarding the conflict of interest submitted to the sponsorprior to expenditure of any funds under an award. [For example, the PHS requires the University to report to the PHS Awarding Component the existence of a conflict of interest (but not the nature of the interest or other details) found by the University and assure that the interest has been managed, reduced, or eliminated. NSF only requires the University to report conflicts which cannot be satisfactorily managed, or eliminated.]
10. Records of Investigator financial disclosures and of actions taken to manage actual or potential conflicts of interest, shall be retained by the Office for Sponsored Projects and Research Administration until three (3) years after the termination or completion of the award to which they relate, or the resolution of any government action involving those records.
11. Violations of this policy or the terms of the Memorandum of Understanding, such as willful concealment of financial interests, may result in sanctions being imposed upon the violating individual. If the violation results in a collateral proceeding under the Institution's policies regarding misconduct in science, then the CIRC shall defer a decision on sanctions until the misconduct in science process is completed. The CIRC will review allegations of violations and will make recommendations regarding the imposition of sanctions to the Vice President for Academic Affairs and Provost. The decision of the Vice President for Academic Affairs and Provost with regard to the imposition of sanctions shall be final subject to any rights the Investigator may have under the grievance procedure contained in the UDM - UDMPU Collective Bargaining Agreement.

    In addition, the University shall follow Federal regulations regarding the notification of the sponsoring agency in the event an Investigator has failed to comply with this policy. The sponsor may take its own action as it deems appropriate, including the suspension of funding for the Investigator until the matter is resolved.

12. Collaborators/subrecipients/subcontractors from other academic or not-for-profit institutions must either comply with this policy or provide a certification from their institutions that they are in compliance with Federal policies regarding investigator significant financial interest disclosure and that their portion of the project is in compliance with their institutional policies. Subcontractors from commercial firms need not make a certification, except when the prime award is from the Public Health Service. The PHS requires a certification from any subcontractor, including commercial firms, stating that it is in compliance with federal policies regarding investigator significant financial interest disclosure and that portion of the project is in compliance with company policies.