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Conflict of Interest and Financial Disclosure

The ³Ô¹ÏÍø and its employees are committed to conducting all UM-work related activities in accordance with the highest integrity standards and in full compliance with all ethical and conflict of interest legal requirements applicable to the University and its employees.  Such ethical conduct standards are detailed in UM Policy 703 – Conflict of Interest and Financial Disclosure and include state, federal, and University policies regarding conflict of commitment, conflict of interest, nepotism, and business participation.

Section of this website

1. DISCLOSURE REQUIREMENTS

The key mechanism for implementation of this Policy is disclosure. Disclosure allows the campus and the employee to evaluate personal interests to determine if they present a conflict of interest and to take appropriate action based on the evaluation. All full-time faculty and other employees must annually complete and submit a Conflict of Interest Disclosure (“Disclosure”) as noted below.  Faculty members or other employees working less than half-time are exempt from submitting the annual Disclosure, but nonetheless are required to comply with UM Policy 703 – Conflict of Interest and Financial Disclosure and to make disclosures of any potential Conflict of Interest whenever they occur.

A. Circumstances Requiring Conflict of Interest Disclosure

All employees must disclose the following whenever they occur. These situations apply to the employee and their relatives and as directly related to the employee’s University responsibilities:

1. Related Outside Interest - The acquisition of any personal or financial interest in an entity engaged in University commercial or research activities that may create a conflict of interest. This includes but is not limited to consulting arrangements, research activities, University contracts and agreements, or other business relationships.

2. Related Purchase/Sale Interest - Any financial interest of the employee or an Immediate Family Member in an entity involved in a University purchase or sale whenever the employee is in a position to recommend or approve the purchase or sale. Such interests must be disclosed to Procurement Services for purchases and to the Property Management Department for sales. NOTE: This disclosure requirement does not include textbook adoptions when the employee is clearly identified as an author, contributor, or editor of the textbook or course material under consideration.  However, faculty members should not receive a profit as a result of recommending a specific vendor for the purchase of textbooks or course materials by their students, whether online or from other sources.

3. Related Sponsored Research Interest - In Sponsored Research, the acquisition of a Significant Financial Interest.  (See Section VI: Sponsored Research below)

4. Related Interest by Outside Position - The holding of an executive or officer position in or serving as a member of the board of directors of an entity engaged in University commercial or research activities.

5. Employee Inventor Equity Interest and/or Business Participation - Participation as an employee, officer, board member, or owner in an entity which has, or wishes to have, rights to intellectual property invented or created during the course of UM employment per .

6. Favoritism in the Workplace - The planned direct participation in a University decision which would or could appear to involve favoritism or a direct benefit or detriment to a relative by blood or marriage, a person in whom or with whom the employee has a financial interest, or a person with whom the employee has a consensual romantic relationship.

7. Outside Supervisory Interest - Faculty or Faculty member’s immediate family employing students or employees outside the University. Such arrangements must be approved through the appropriate University channels to avoid supervisory conflicts.

8. Use of Personal Funds to Support Employee’s Own Work - Arrangements by the employee to provide personal funds to support the employee’s UM work, laboratory, and payment of lab staff and students.

B. Circumstances Requiring Conflict of Commitment Disclosure

All employees must disclose the following whenever they occur. These situations apply to the employee and members of his/her family and as directly related to the employee’s University responsibilities:

1. Outside Professional or Commercial Commitments - Outside professional or commercial commitments, whether paid or unpaid, that interfere or have the potential to interfere with the employee’s University responsibilities. NOTE: This disclosure requirement does not include traditional academic responsibilities such as oral presentations, peer review, books and graphic works for publication, articles, for which royalties, honoraria, are considered a part of an employee’s University responsibilities. See .

2. Consulting - Consulting of services for which remuneration in any form is received by the employee from a person, firm or corporation other than the University.

3. Outside Academic Appointments - Visiting appointments during an approved leave of absence or brief transitional appointments. NOTE: Employees may not have an academic appointment at another institution unless approved by the Provost.

4. Foreign Government or Entity Affiliations - Funding received from any foreign government or entity, any courtesy or honorary appointments that are held at other institutions and any participation with any foreign talent program and any research collaborations, affiliations, or partnerships with institutions, organizations, or individual researchers outside the U.S.

C. Annual Disclosure

Annually, all employees (.5 FTE or greater) must complete a Disclosure Form as follows:

1. Disclosure must be completed and filed by September 30^th of each year AND any time a new potential conflict of interest arises.
2. Conflict of Interest Disclosure is done through Cyberbear:
   1. Sign into Cyberbear with your NetID and password;
   2. Click on “Employee”
   3. Then “annual Renewal Forms”
   4. Click on “Conflict of Interest”, and follow instructions.
3. The employee’s submission of the Disclosure certifies that the employee has read and understands this policy, and that:
   1. The employee does not have any interests or outside commitments which require disclosure;
   2. The employee has a potential conflict of interest or conflict of commitment which has been duly disclosed previously and there has been no change which requires an updated disclosure; or
   3. The employee has new interests which may create a conflict of interest or conflict of commitment and has disclosed them.
4. UM will submit an annual written report to the Board of Regents per BOR §770.
5. All annual and new circumstantial disclosures shall be submitted to the Institutional Official or designee. Records will be made available to the employee’s Upon request, records are also available to the appropriate Department Head, Dean or Director, and any other supervisor in the line of authority when applicable.

2. DISCLOSURE REVIEW AND DISPOSITION

A. Initial Review

The Institutional Official or designee shall review all disclosures and determine whether a conflict of interest exists. 

B. Submission to President

All disclosures of executive employees reporting directly to the president shall be forwarded to the President following review by the Institutional Official.

C. Determination of Conflict/Commitment

After the initial review, the Institutional Official or designee, along with Legal Counsel, if necessary, will provide a written resolution to determine the nature of the conflict:

1. The disclosure does not represent a conflict or outside commitment that is prohibited by statute or regulation nor is it likely to influence the actions of the employee and, therefore, requires no further action;
2. The disclosure represents a conflict or outside commitment that requires management; or
3. The disclosure represents a conflict or outside commitment that must be eliminated. 

D. Waiver of Conflict

For disclosures made under Section II.B above, the Institutional Official, in consultation with the responsible Vice President or President, may waive the conflict and the need for a conflict management plan if they make the following written determination:

1. The conflict of interest is so remote that there is no probability for bias in the overall conduct of the sponsored activity;
2. Any resolution of the conflicts other than by disclosure and waiver would be ineffective or inequitable; or
3. Any bias reasonably expected is outweighed by the interests of scientific progress, technology transfer, or the public health and welfare.

E. Conflicts Management Plan

If a conflict of interest exists and is deemed manageable, the Institutional Official or designee, the employee, Conflict of Interest Committee, and any others deemed helpful in assessing the situation, will develop a written Conflicts Management Plan to manage, reduce, or eliminate the inappropriate influence or bias, or the appearance thereof. The purpose of the plan is to:

1. Accurately describe the potential conflicts in writing
2. Create explicit agreements to protect against inappropriate influence or bias
3. Facilitate oversight

3. APPEAL/RECONSIDERATION PROCEDURE

A. Appeal to President

If an employee believes the conditions or restrictions in the Conflict Management Plan or the determinations of the Institutional Official are ineffective and unduly burdensome, the employee may appeal the decision to the President.  The President’s decision on the appeal shall be the final decision of the University whether or not the President was involved in the decision appealed. 

B. Conflict Review Committee (CRC)

If the President wishes to have the benefit of advice from a Conflict Review Committee, the President shall appoint a three-member committee.  The members shall include employees or community members who have had no involvement in the decision being appealed and who have relevant experience or training to assess the conflict.

C. ³Ô¹ÏÍø University System Appeal

An employee who disagrees with the President’s decision may appeal further as provided in the and exercise any applicable rights permitted by Article 19 of the UM University Faculty Association Collective Bargaining Agreement.  No grant will be accepted by UM while any appeal is pending.

4. RECORD MAINTENANCE

The Institutional Official or designee shall maintain all disclosure and conflict management records (both general and Sponsored Research records) for the period of time required by state and federal laws and regulations. Records will be maintained in a manner to protect sensitive and confidential information.  See also Section 6.I below.

5. NONCOMPLIANCE

A. Breach of Policy

The University expects all employees to comply fully and promptly with all requirements of this Policy. Breaches of this Policy include, but are not limited to:

1. intentionally filing an incomplete, erroneous, or misleading disclosure form;
2. failure to provide additional information as required;
3. failure to provide a disclosure as required by this policy;
4. failure to comply with University requirements concerning the Conflict of Interest; or
5. failure to follow a Conflicts Management Plan.

B. Disciplinary Action

A violation of this policy may be the basis for discipline of an employee and result in potential sanctions. Such discipline will be in accordance with the policies and procedures and collective bargaining agreements applicable to the particular employee. Potential sanctions may include, but are not limited to, the following:

1. Letter of admonition;
2. Suspension or termination of participation in a Sponsored Research grant;
3. Removal or suspension of privileges related to the violation, such as suspension of the privilege to apply for Sponsored Research grants or contracts, to supervise graduate students, or to perform research which requires approval of any UM Compliance or Institutional Review Board;
4. Suspension;
5. Non-renewal of probationary appointment; or
6. Termination

6. SPONSORED RESEARCH

The Institutional Official or designee and the University office overseeing federal grant management are responsible for compliance duties related to conflicts of interest in Sponsored Research.  As a University that received U.S. Public Health Service (PHS) funding, including National Institutes of Health (NIH), the University has adopted PHS terminology and perspective for reviewing sponsored research conflicts related to any funding agency.  For reporting purposes, the interest threshold at which the University must disclose varies by agency.

While acting within the law, the intent of this policy is to identify conflicts and manage them by defining the boundaries within which conflicts occur while allowing investigators to proceed with their research.  The primary goal is to maintain objectivity in research by establishing standards to ensure that there is no reasonable expectation that the design, conduct, or reporting of research will be biased by a Financial Conflict of Interest of an Investigator.

A. Sponsored Research Definitions

Financial Conflict of Interest (FCOI): A significant financial interest that could directly and significantly affect the design, conduct, or reporting of research.

Financial Interest: Anything of monetary value, whether or not the value is readily ascertainable.

Institution: Any domestic or foreign, public or private, entity or organization (excluding a federal agency) that is applying for, or that receives, PHS/NIH funding.

Institutional Responsibilities: Specific responsibilities or particular professional activities performed on behalf of UM that directly establish the substantive basis for supervisory assessment of an individual’s University job performance.  For faculty, this includes activities such as research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as an Institutional Review Board. For non-faculty, this includes the particular duties and responsibilities assigned to one’s position or appointment as expressed in one’s job description. 

Investigator: The Principal Investigator (PI) and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by an award or proposed for such funding, which may include collaborators or consultants. 

Manage: Taking action to address a FCOI, which can include reducing or eliminating the FCOI, to ensure, to the extent possible, that the design, conduct, and reporting of research will be free from bias,

Senior/Key Personnel: The PI and any other person  senior/key personnel by UM in the grant application, progress report, or any other report submitted to the funding agency by UM.

Significant Financial Interest (SFI):  means:

1. A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigator’s spouse and dependent children) that reasonably appear to be related to the Investigator’s Institutional Responsibilities performed on behalf of UM:
   1. With regard to any foreign or domestic Publicly Traded Entity: A  significant financial interest exists if the value of any remuneration received from the entity in the twelve 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. 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 foreign or domestic Non-Publicly Traded Entity: A  significant financial interest exists if the value of any remuneration received from the entity in the twelve 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., 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. (See Section 6.B below)

2. The term ‘Significant Financial Interest’ does not include, and therefore, Investigators are not required to disclose, the following types of financial interests:
   1. Salary, royalties, or other remuneration paid by the University to the Investigator if the Investigator is currently employed or otherwise appointed by the University.
   2. Intellectual property rights assigned to UM, and agreements to share in royalties related to such rights.
   3. 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.
   4. Income from seminars, lectures, or teaching engagements sponsored by a federal, state, or local government agency located in the United States, a United States Institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with a United States Institution of higher education.
   5. Income from service on advisory committees or review panels a federal, state, or local government agency located in the United States, a United States Institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with a United States Institution of higher education.
   6. Travel that is reimbursed or sponsored by a federal, state, or local government agency located in the United States, a United States Institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with a United States Institution of higher education.

* NOTE: Exclusions above do not apply to Foreign Financial Interests: Investigators must disclose all foreign financial interests (including income from seminars, lectures or teaching agreements, income from service on advisory committees or review panels, and reimbursed or sponsored travel) received from any foreign entity, including foreign Institutions of higher education or a foreign government (which includes local, provincial, or equivalent governments of another country).

Sponsored Research: Research, creative activities, scholarship, training and instructional projects involving funds, materials, or other compensation from outside sources under agreement. Research in this context means a systematic investigation, study or experiment designed to develop or contribute to generalizable knowledge. The term encompasses basic and applied research (e.g., a published article, book or book chapter) and product development (e.g., a diagnostic test or drug). This may also include a research grant, career development award, center grant, individual fellowship award, infrastructure award, institutional training grant, program project, or research resources award.

B. Sponsored Research Disclosures and Review

Sponsored Research Disclosure Requirements

All Investigators must disclose any SFIs and PHS Sponsored Travel prior to the University expenditure of funds. Investigators will disclose their SFIs that are related to their “ institutional responsibilities” at the following times:

1. Disclosure Prior to Proposal Submission: Disclosure to the University shall be made before submitting a proposal for funding. UM employees will use the FCOI Research Disclosure Form (FRDF) included with the Cayuse Sponsored Programs proposal submission platform via the Office of Sponsored Programs (OSP), covering the previous 12 months of activity. The questions contained in the FRDF shall provide the vehicle to inform Investigators of this Policy, their disclosure responsibilities, and federal regulation.
2. Disclosure During Sponsored Research: For as long as the Sponsored Research continues, new Investigators and existing Investigators acquiring new interests shall disclose SFI and/or PHS Sponsored Travel to the University that would reasonably appear to be related to the Investigator’s Institutional Responsibilities within 30 days of discovering or acquiring (e.g., through purchase, marriage, or inheritance). All disclosures must be also updated on the Annual Report per Section 1.C. of these procedures during the period of the award. 

PHS Sponsored Travel Disclosure

Investigators also must disclose the occurrence of any reimbursed or sponsored travel (i.e., 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 a federal, state, or local government agency located in the United States, a United States Institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with a United States Institution of higher education.   The disclosure should include reimbursed or sponsored travel received over the previous twelve months. The disclosure must include:

• the purpose of the travel;
• the identity of the sponsor;
• the destination;
• the duration of the travel; and
• any additional information requested by the University, including monetary value, in order to determine whether the travel constitutes an FCOI

Disclosure Review

The Institutional Official will determine whether an Investigator’s SFI is related to the NIH-funded research and, if so, whether the SFI is a financial conflict of interest.

• Relatedness Test: An Investigator’s significant financial interest is related to the NIH-funded research when the Institutional Official reasonably determines that the significant financial interest either could be affected by the NIH-funded research, or is in an entity whose financial interest could be affected by the research.  The Institutional Official may involve the Investigator in this step.
• FCOI Determination: A financial conflict of interest exists when the Institutional Official reasonably determines that the SFI could directly and significantly affect the design, conduct, or reporting of the NIH-funded research.

If a FCOI exists, appropriate action to manage the conflict will be taken as provided in Section 6.C below.

C. Sponsored Research Conflicts Management

Sponsored Research Conflict Management Plans

Whenever, in the course of an ongoing PHS/NIH funded research project, an Investigator who is new to participating in the research project discloses a SFI or an existing Investigator discloses a new SFI, the IO will, within 60 days: review the disclosure of SFI, determine whether the SFI is related to the NIH-funded research, determine whether an FCOI exists, and, if so, implement, on at least an interim basis, a management plan that shall specify the actions that have been, and will be, taken to manage the FCOI.

Examples of conditions that might be imposed to manage a financial conflict of interest include, but are not limited to:

1. Public disclosure of FCOI (e.g., when presenting or publishing the research);
2. For research projects involving human subjects research, disclosure of financial conflicts of interest directly to human participants;
3. Appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of the research against bias resulting from the financial conflict of interest;
4. Modification of the research plan;
5. Change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or a portion of the research;
6. Reduction or elimination of the financial interest (e.g., sale of an equity interest);
7. Severance of relationships that create financial conflicts.

If the IO determines that a conflict exists, it will communicate its determination and the means developed for managing the FCOI in writing to the individual.

No expenditures on an NIH award will be permitted until the Investigator has complied with the Disclosure requirements of this Policy and has agreed, in writing, to comply with any plans determined by the Institutional Official(s) necessary to manage the Financial Conflict of Interest. The FCOI Institutional Official(s) of the University will submit the FCOI report to NIH.

Monitoring Investigator Compliance

The University will monitor Investigator compliance with the management plan for the duration of the award term or until the FCOI no longer exists. Monitoring of public disclosure requirements will include reviewing publications and presentations to confirm that the Investigator disclosed the FCOI in such communications. To facilitate additional monitoring, Investigators will be required to disclose the FCOI in writing to research personnel in the study and send a copy of the communication to the IO which will serve as documentation for compliance with the management plan.

D. Sponsored Research Reporting and Records

FCOI Reporting

As applicable by agency, the University will provide the Investigator’s FCOI and implemented management reports to the funding agency. PHS FCOI Reports shall contain all the agency designated elements and will be submitted:

1. Initial Reports: Prior to the expenditure of funds;
2. Ad Hoc Reports: Within 60 days of discovering or acquiring a new FCOI of an Investigator on any ongoing NSF-funded research;
3. Annual Reports: Annually for ongoing, managed FCOI cases; and
4. After a retrospective review to update a previously submitted report, if new information is discovered following completion of the review. See Section 6.E for discussion of retrospective reviews.

The Annual FCOI report will be submitted at the same time as when the Research Performance Progress Report or multi-year progress report is due and at the time of grant extension, if applicable. The NIH will send an annual report email notification to the University when an annual report is due.  

The University will submit FCOI to the NIH through the eRA Commons FCOI Module only when a grant or cooperative agreement is active and an FCOI is identified. 

No Reporting for Elimination of Conflict

In cases in which the University identifies a FCOI and eliminates it prior to the expenditure of awarded funds, the University shall not submit an FCOI report to the awarding agency.

Sponsored Research Public Reporting Requirements

FCOI Policy: UM will ensure public accessibility of its FCOI policy by posting the FCOI policy on its public website (www.umt.edu).

Identified FCOIs held by Senior/Key Personnel: Prior to the expenditure of any funds under an NIH award, the University will ensure public accessibility by providing a written response to any requestor within five business days of a request for information concerning any SFI disclosed that meets the following three criteria: 

1. The SFI was disclosed and is still held by the senior/key personnel;
2. UM has determined that the SFI is related to the research funded through an award; and
3. UM has determined that the SFI is a financial conflict of

The information made available in a written response will include, at a minimum:

1. The Investigator’s name;
2. The Investigator’s title and role with respect to the research project;
3. The name of the entity in which the Significant Financial Interest is held;
4. The nature of the Significant Financial Interest; and
5. The approximate dollar value of the Significant Financial Interest in the following ranges:
   • $0-$4,999; $5,000- $9,999; $10,000-$19,999;
   • amounts between $20,000-$100,000 by increments of $20,000;
   • amounts above $100,000 by increments of $50,000,
   • or a statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value. 

The written response will note that the information provided is current as of the date of the correspondence and is subject to updates on at least an annual basis and within 60 days of the Institution’s identification of a new FCOI which should be requested subsequently by the requestor.

Information on SFIs subject to the public accessibility requirement will remain available for at least three years from the most recent update.

E. Sponsored Research Noncompliance 

Enforcement Mechanisms

The provisions of Section V: Noncompliance will also apply to sponsored research noncompliance.

Retrospective Review

1. Whenever a Financial Conflict of Interest is not identified or managed in a timely manner, including:
   • Failure by the Investigator to disclose a Significant Financial Interest that is determined by the University to constitute a Financial Conflict of Interest;
   • Failure by the University to review or manage such a Financial Conflict of Interest; or
   • Failure by the Investigator to comply with a Financial Conflict of Interest management plan;
   the University shall, within 120 days of UM’s determination of noncompliance, complete a “retrospective review” of the Investigator’s activities and the NIH-funded research project to determine whether any NIH-funded research, or portion thereof, conducted during the time period of the noncompliance was biased in the design, conduct, or reporting of such research.
   
   
2. The University shall document the retrospective review which must include at least the following key elements: 
   • Project number;
   • Project title;
   • PD/PI or contact PD/PI if a multiple PD/PI model is used;
   • Name of the Investigator with the FCOI;
   • Name of the entity with which the Investigator has a financial conflict of interest
   • Reason(s) for the retrospective review;
   • Detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documents reviewed, etc.);
   • Findings of the review; and
   • Conclusions of the review.

Bias Determined

If bias is found, the University shall notify NIH promptly and submit a mitigation report per the NIH  FCOI regulation at   that must include, at a minimum, the key elements documented in the retrospective review above and a description of the impact of the bias on the research project and the University’s plan of action or actions taken to eliminate or mitigate the effect of the bias (i.e., impact on the research project, extent of harm done, including any qualitative and quantitative data to support any actual or future harm; analysis of whether the research project is salvageable). 

No Bias Determined

If bias is not found, no further action will be taken unless new information is discovered that needs to be reported to the NIH.

F. Training Requirements

Investigators must complete Conflict of Interest Training prior to engaging in research related to any funded research, at least every four years, and immediately when any of the following circumstances apply  ()):

1. UM revises this Policy, or procedures related to this Policy, in any manner that affects the requirements of Investigators.
2. An Investigator is new to UM research under an NIH award (training is to be completed prior to his/her participation in the research).
3. UM finds that an Investigator is not in compliance with this Policy or a management plan issued under this Policy (training is to be completed within 30 days in the manner specified by the Institutional Official(s)).

Online training for UM Investigators is available at CITI Collaborative Institutional Training Initiative.

Additional training regarding the Investigator’s responsibilities for disclosure of Significant Financial Interests and of UM Policy #703 can be found in the NeoEd Learning Platform (coming soon).

G. Subrecipients

When the University carries out PHS-funded research through a subrecipient (e.g. subcontractors or consortium members), the (prime awardee) institution’s  office overseeing federal grant management will take reasonable steps to ensure that any subrecipient Investigator complies by written agreement with the subrecipient terms that establish whether the FCOI policy of the awardee institution or that of the subrecipient will apply to the subrecipient’s Investigators in accordance with PHS regulations.

Awardee institutions must also incorporate as part of a written agreement with a subrecipient terms that establish time periods to meet disclosure and/or Financial Conflict of Interest reporting requirements. 

Subrecipient Institutions who rely on their Financial Conflict of Interest policy must report identified financial conflicts of interests to the awardee Institution in sufficient time to allow the awardee Institution to report the Financial Conflict of Interest to the NIH to meet its reporting obligations. 

Subrecipient institutions that must comply with the awardee Institution’s policy must submit all Investigator disclosures of Significant Financial Interests to the awardee in sufficient time to allow the awardee to review, manage and report identified FCOIs to the NIH.

Awardee Institutions are responsible for monitoring subrecipient’s compliance with the Financial Conflict of Interest regulation, management plans, and for reporting all identified financial conflicts of interest to the NIH.

H. Clinical Research Requirements

If the Department of Health and Human Services determines that one of its funded clinical research projects, 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 a FCOI that was not managed or reported by UM, UM shall require the Investigator involved to disclose the FCOI in each public presentation of the results of the research and to request an addendum to previously published presentations.

I. Sponsored Research Record Maintenance

The University will keep all records of all Investigator disclosures of financial interests and the University’s review of, or response to, such disclosures (whether or not a disclosure resulted in the determination of an FCOI), and all actions under this policy or retrospective review, if applicable.  Records of financial disclosures and any resulting action will be maintained for at least three years from the date of submission of the final expenditures report or, where applicable, from other dates  specified in for different situations.  UM will retain records for each competitive segment as provided in the regulation. Management plans will be retained as part of the UM records.

In addition, UM will make information available, promptly upon request, to the HHS relating to any Investigator disclosure of financial interests and the University’s review of, and response to such disclosures whether or not the disclosure resulted in the University’s determination of FCOI per the regulation.

Point of Contact

For questions related to UM’s Financial Conflict of Interest Policy or to disclose an SFI or potential FCOI, please contact Claudia Eccles, AVP for Research Compliance and Tech Transfer.