Conflict of Interest Policy and Procedures Pertaining to Sponsored Projects

On August 24, 2011, the Department of Health and Human Services published in the federal register a revised rule regarding financial conflicts of interest.  The text, in its entirety, can be found here:  http://www.gpo.gov/fdsys/pkg/FR-2011-08-25/pdf/2011-21633.pdf.  The University of Detroit Mercy has revised its policy on Financial Conflicts of Interest in accordance with the new regulations set out by the DHHS. 

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 and service on advisory or review panels for a federal, state, or local government agency, an Institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education.

3.    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 $5,000 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

4.    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 $5,000

5.    Income from investment vehicles, such as mutual funds and retirement accounts, so long as the Investigator does not directly control the investment decisions made in these vehicles

6.    Reimbursed or sponsored travel if the sponsoring agency is a federal, state, or local government agency, an Institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education.

The Conflict of Interest Review Committee (CIRC) is the committee appointed by the Provost and Vice President for Academic Affairs to implement this policy. It shall be made up of the Director for Sponsored Projects and Research Activities 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 gain 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 than $5,000 per year, exclusive of dividends and interest.

4.    The Investigator has received travel funds in any amount related to Institutional responsibilities from such organization or corporation. 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 1-4 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 all Significant Financial Interests related to the Investigators’ institutional responsibilities, including reimbursed travel or sponsored travel related to Institutional responsibilities (including purpose of trip, sponsor/organizer, destination, and duration).  The Investigator is NOT required to disclose travel that is reimbursed or sponsored by a federal, state, or local government agency, an Institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education.

As required by Federal regulation, all significant financial interests must be disclosed prior 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 is to be sent to the Office for Sponsored Projects and Research Activities (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 Provost and Vice President for Academic Affairs, and others who have a legal right to review the records.

4.    The Director for Sponsored Projects and Research Activities, 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.

4.1. If the Director for Sponsored Projects and Research Activities, 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.

4.2.  If the Director for Sponsored Projects and Research Activities, 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 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.

5.1  If the CIRC reaches the first conclusion, it shall document its determination and no further action shall be required.

5.2  If the CIRC reaches the second conclusion, it shall discuss with the Investigator possible ways of reducing, managing or eliminating the potential conflict of interest. The Investigator shall be informed that a Resolution Plan (RP) will need to be developed and approved prior to the expenditure of any award funds.

6.    The OSPRA will work with the Investigator to develop and present 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 Provost and Vice President for Academic Affairs who will consult with the Investigator and CIRC as the Provost and Vice President for Academic Affairs deems necessary and appropriate to the particular circumstance. The decision of the Provost and Vice President for Academic Affairs 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 Dean or Director. 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 sponsor prior to expenditure of any funds under an award, or within 60 days (for new FCOIs, or for an investigator newly participating in the project).

The PHS requires the University to report to the PHS Awarding Component the following:

  • Grant/Contract number
  • Project Director/Principal Investigator
  • Name of Investigator with the Financial Conflict of Interest (FCOI)
  • Whether the FCOI was managed, reduced, or eliminated
  • Name of the entity with which the investigator has a FCOI
  • Nature of FCOI (e.g. equity, consulting fees, travel reimbursement, honoraria
  • Value of the financial interest
  • A description how the financial interest relates to PHS-funded research and the basis for the institution’s determination that the financial interest conflicts with such research

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 Activities 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 Provost and Vice President for Academic Affairs. The decision of the Provost and Vice President for Academic Affairs 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. Retrospective reviews will be completed and documented within 120 days. 

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.

PHS requires that the institution notify the PHS Awarding Component promptly and submit a report to the PHS Awarding Component in cases where bias is found.  The report will address the impact of the bias on the research project and the actions the Institution has taken, or will take, to eliminate or mitigate the effect of the bias.

In any case in which the Department of Health and Human Services determines that a PHS-funded research project of clinical research whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment has been designed, conducted, or reported by an Investigator with an FCOI that was not managed or reported as required by the regulation, the Investigator involved will be required to:

  • Disclose the FCOI in each public presentation of the results of the research, and
  • Request an addendum to previously published presentations.

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. The formal written agreement must include terms that establish whether the FCOI policy of the awardee institution or that of the subrecipient will apply to subrecipient investigators and include time periods to meet disclosure and/or FCOI reporting requirements.  Subrecipient institutions which rely on their FCOI policy must report identified FCOIs to the awardee institution in sufficient time to allow the awardee institution to report the FCOI to the granting organization.  Subcontractors from commercial firms need not make a certification, except when the prime award is from the Public Health Service. PHS requires that all subcontractors, including commercial firms, follow the above guidelines. 

13.  The University of Detroit Mercy is required to make certain information available concerning identified FCOIs held by senior/key personnel by a written response to any requestor within five business days of a request.

14.  Each Investigator must complete training prior to engaging in research related to any PHS-funded grant or contract and at least every four years, and immediately when a PHS-funded investigator is new to UDM.

UDM uses CITI program for its FCOI training.  Any investigator applying for PHS funding must complete the training prior to award acceptance.  Please click here for further instructions: