Conflict of Interest Policy and Procedures for Sponsored Projects

The Department of Health and Human Services published Subpart F—Promoting Objectivity in Research to establish standards that provide a reasonable expectation that the design, conduct and reporting of research funded under Public Health Service (PHS) grants or cooperative agreements will be free from bias resulting from investigator financial conflicts of interest (FCOI) or significant financial interests (SFI). University of Detroit Mercy has revised its policy on financial conflicts of interest in accordance with the new regulations as of December 1, 2020. Detroit Mercy’s policy will be extended to all externally sponsored projects. The full notice can be found by visiting the Electronic Code of Federal Regulations' webpage.

While the investigators of University of Detroit Mercy recognize that their primary professional obligation is to University of Detroit Mercy, they must be alert to the possibility that outside arrangements, whether they be financial interests or employment relationships, may compromise their objectivity as teachers, researchers, clinicians and administrators. This rule 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.

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 family 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.

What is required?

Federal regulations require institutions to have policies and procedures in place to ensure that investigators disclose any significant financial interest that may present a conflict of interest in relationship to externally sponsored projects. Such disclosures must be made prior to the submission of a proposal for funding, and institutions must develop specific mechanisms by which conflicts of interest will be satisfactorily managed, reduced or eliminated prior to award or acceptance of an award. The director of the Office for Sponsored Programs and Research Activities (OSPRA) will manage this process, assure adherence to the policy and act as a liaison between federal agencies and the PI(s).

NOTE: If a new reportable significant conflict of interest arises at any time during the period after the submission of the proposal through the dates of the award, the filing of a disclosure is required to be submitted to OSPRA within 30 days and reported to the federal agency within 60 days with plan for management of any conflicts.

Who is covered?

"Investigator" means the principal investigator/project director, co-principal investigators 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. This includes subrecipient Investigator(s), students and consultants, if applicable. In this context, the term "investigator" extends to the investigator's spouse and dependent children as well.

What must be disclosed?

Each investigator shall disclose all significant financial interests:

1. That would reasonably appear to be affected by the research or educational activities funded, or proposed for funding, by an external sponsor; or

2. In entities whose financial interests would reasonably appear to affected by such activities.

What is covered?

"Significant financial interests" means anything of monetary value, including but not limited to:

1. With regard to any publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the 12 months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000. For purposes of this definition, remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship); Equity interest includes any stock, stock option or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value.

2. With regard to any non-publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the 12 months preceding the disclosure, when aggregated, exceeds $5,000, or when the investigator (or the investigator’s spouse or dependent children) holds any equity interest (e.g., stock, stock option or other ownership interest).

3. Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.

4. Investigators also must disclose the occurrence of any reimbursed or sponsored travel (i.e., that which is paid on behalf of the investigator and not reimbursed to the investigator so that the exact monetary value may not be readily available), related to their institutional responsibilities, provided, however, that this disclosure requirement does not apply to travel that is reimbursed or sponsored by excluded sources provided in regulation. 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.

5. 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.

The term does not include:

1. Salary, royalties or other remuneration from University of Detroit Mercy; Intellectual property rights assigned to the Institution and agreements to share in royalties related to such rights. Any ownership interest in the Institution held by the investigator, if the Institution is a commercial or for-profit organization.

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

3. Income from seminars, lectures or teaching engagements sponsored by a federal, state or local government agency, an institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center or a research institute that is affiliated with an institution of higher education.

4. Income from service on advisory committees or review panels for a federal, state or local government agency, institution of higher education as defied at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center or a research institute that is affiliated with an institution of higher education.

How do I disclosure my interests?

1. All investigators must disclose their significant financial interests utilizing the Internal Summary Form and by attaching all required supporting documentation. The completed form and packet are to be submitted with the proposal to the Office for Sponsored Programs and Research Activities (OSPRA). Supporting documentation of a conflict of interest should be submitted in a sealed envelope marked "Confidential."

2. In accordance with federal regulations, a complete disclosure must be made by investigator(s) prior to the submission of the proposal.

3. Management Plans for potential conflicts of interest will be incorporated into a signed agreement that is executed between the investigator(s), provost and vice president of Academic Affairs, director of OSPRA, dean or unit leader and vice president for Finance (CFO) prior to making any expenditures of sponsored project funds.

4. NSF only requires the University to report conflicts which cannot be satisfactorily managed or eliminated.

What if a bias is discovered in the design, conduct or reporting of funded research?

1. Contact the director of OSPRA, who will promptly notify the federal agency (NIH, HHS, DoE, NSF, etc.) of the nature of the bias and its impact on funded research.

2. A mitigation report will be submitted to the federal agency within 120 days of notification to be signed by the provost and vice president of Academic Affairs, director of OSPRA, dean or unit leader and vice president for Finance (CFO) prior to making any expenditures of sponsored project funds.

3. The Conflict of Financial Interest Committee will meet within 60 days to determine if any disciplinary action is necessary, establish a ruling and set forth a corrective action plan which will then be reported to the sponsor within 120 days, in accordance with policy 42 CFR 50.605(a)(3).

4. Any researcher involved in a finding of non-compliance with the FCOI policy, especially where it involves evaluation of the safety of a drug, medical device or treatment; the PI will retroactively request an addendum to any published research or presentations on such research. The PI must also make the FCOI clear in any dissemination of research findings going forward.

5. 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 of the Office for Sponsored Projects and Research Activities and three to five members of Detroit Mercy 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 and be the body which investigates any suspected FCOI of SFI and/or deliberates on whether such a conflicts exists. Its findings are final.

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

  • Project director/Principal investigator
  • Grant/Contract number
  • 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)

7. 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.

8. 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.

What is the role of the Conflict of Interest Review Committee (CIRC) and when are they involved?

If the director of the Office 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 OSPRA.

In its review, the CIRC will reach one of two conclusions:

  • That the potential conflict of interest is not proximate or significant enough to cause a concern for objectivity or integrity; or
  • 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.

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

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 Management Plan will need to be developed and approved prior to the expenditure of any award funds.

3. OSPRA will work with the investigator to develop and present to the CIRC a Management Plan that details proposed steps that will be taken to reduce or eliminate the potential conflict of interest. Methods adopted in the plan may include one or more of the following:

  • Public disclosure of significant financial interests
  • Review of research protocol by independent reviewers
  • Monitoring of research by independent reviewers
  • Modification of the research plan
  • Disqualification from participation in all or a portion of the research funded
  • Divestiture of significant financial interests
  • Severance of relationships that create actual or potential conflicts of interest

4. The CIRC shall review the resolution plan. The CIRC may modify the plan, including adding conditions or restrictions, before it approves the plan.

5. 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.

6. Violations of this policy or the terms of the Management Plan, 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 Detroit Mercy-UDMPU Collective Bargaining Agreement. Retrospective reviews will be completed and documented within 120 days. 

How are records maintained, publicized and for how long?

1. OSPRA will maintain all records regarding FCOI for federal and State of Michigan grants for a period of seven years past the end date of any award in a secure file backed up on Detroit Mercy’s server daily.

2. This includes other dates as specified in 45 CFR 75.361, where applicable.

3. Reports will also be kept for a period of 10 years past the submission of a final expenditure report of any NIH-funded project, or upon the resolution of any government action involving those records, whichever comes first.

4. Information on the policy and Management Plans enacted as a result of a finding of an FCOI will be publicly available on the website and via request within five-days.

5. OSPRA will also submit annual reports to NIH and request annual disclosures from faculty and subrecipients to be included in these reports.

What if a subrecipient is included in my grant budget?

1. All subrecipients are required to submit their institution’s policy on FCOI at the time an application is submitted, providing it meets the NIH standard. If it does not fully comply, Detroit Mercy’s form may be used.

2. A memorandum signed by the institution’s AOR will be submitted as a cover letter to the policy describing which policy shall be followed and why.

3. All subrecipients must report discovery of a FCOI to Detroit Mercy as the prime within 30 days. PHS requires that all subcontractors, including commercial firms, follow the above guidelines. 

What do I need to fill out prior to submitting my grant?

1. The Internal Summary Form for Proposals with all corresponding documentation must be filled out, signed and submitted to OSPRA. The FCOI and SFI agreement is embedded in this form for your convenience.

2. 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 Detroit Mercy.

3. Detroit Mercy uses CITI program for its FCOI training. Any investigator applying for PHS funding must complete the training prior to award acceptance. Please visit Detroit Mercy's Office of Academic Affairs webpage for further instructions.

NIH policies related to SFI and FCOI can be found at https://grants.nih.gov/grants/policy/coi/index.htm.