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Statement of policy

Summary of contents/major changes

1. Purpose of the Policy

   This policy establishes the duties and responsibilities of ɫɫ�� Michigan University’s Research Investigators to promote objectivity in research and to ensure that the design, conduct, and reporting of funded research and grants and cooperative agreements will not be biased by any conflict of interest, Financial Conflict of Interest, or Conflict of Commitment of the Investigator and/or the Investigator’s Family.  

   This policy informs Investigators about situations that generate conflicts of interest related to research, provides mechanisms for Investigators and the Institution to manage those conflicts of interest that arise, and describes situations that are prohibited. 

2. Stakeholders Impacted by the Policy

   This Policy applies to all sponsored Investigators of the Institution. 

3. Key Definitions

   2. Institutional Official

      the individual within the Institution who is responsible for the solicitation and review of disclosures of significant financial interests including those of the Investigator’s Family related to the Investigator’s institutional responsibilities.  For the purposes of this policy, the Institutional Official is designated as the Vice President, Office of Research and Innovation.

   3. Institutional responsibilities

      the Investigator’s professional responsibilities associated with their Institutional appointment or position, such as research, teaching, clinical activities, administration, and institutional, internal and external professional committee service.

   4. Investigator

      any individual who is responsible for the design, conduct, or reporting of sponsored research, or proposals for such funding.  This definition is not limited to those titled or budgeted as principal investigator or co-investigator on a particular proposal, and may include postdoctoral associates, senior scientists, or graduate students.  The definition may also include collaborators or consultants as appropriate.

   5. Family

      a spouse, domestic partner, dependent child, or anyone else with whom a University Employee has a close, continuing personal or business relationship.  Siblings, parents and non-dependent children (including step- and in-law variants of those relationships) are included in this definition in circumstances where the University Employee has actual knowledge that such relative is likely to, or will, benefit from a particular University transaction.

   6. Conflict of Commitment (COC)

      when a University Employee’s external relationships or activities may, in actuality or in appearance, interfere or compete with the University Employee’s commitment to ɫɫ��'s mission to provide leadership in teaching, research, learning, and service, or with that individual’s ability or willingness to perform the full range of responsibilities associated with their position.

   7. Conflict of Interest (COI)

      personal, professional, commercial, or financial interests or activities outside of the University that may, either in actuality or in appearance: 1) compromise a University Employee’s judgment; 2) bias the nature or direction of their scholarly research; 3) influence a University Employee’s decision or behavior with respect to teaching and student affairs, appointments and promotions, uses of University resources, contracting, or other matters of interest to the University; or 4) result in a personal or Family Member’s gain or advancement arising out of University business. Unless specifically stated, for purposes of this Policy, the phrase Conflict of Interest will also include COC and FCOI.

   8. Financial Interest

      2. anything of monetary value, received or held by an Investigator or an Investigator’s Family, whether or not the value is readily ascertainable, including, but not limited to: salary or other payments for services (e.g., consulting fees, honoraria, or paid authorships for other than scholarly works); any equity interests (e.g., stocks, stock options, or other ownership interests); or intellectual property rights and interests (e.g., patents, trademarks, service marks, and copyrights), upon receipt of royalties or other income related to such intellectual property rights and interests. For Investigators, Financial Interest also includes any reimbursed or sponsored travel undertaken by the Investigator and related to his/her institutional responsibilities.  This includes travel that is paid on behalf of the Investigator as well as travel that is reimbursed, even if the exact monetary value is not readily available.  It excludes travel reimbursed or sponsored by U.S. Federal, state or local governmental agencies, U.S. institutions of higher education, research institutes affiliated with institutions of higher education, academic teaching hospitals, and medical centers.

      3. Financial Interest does NOT include:

         2. salary, royalties, or other remuneration from ɫɫ�� Michigan University;

         3. income from the authorship of academic or scholarly works;

         4. income from seminars, lectures, or teaching engagements sponsored by or from advisory committees or review panels for U.S. Federal, state or local governmental agencies; U.S. institutions of higher education; research institutes affiliated with institutions of higher education, academic teaching hospitals, and medical centers; or

         5. equity interests or 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.

   9. Significant Financial Interest

      a Financial Interest that reasonably appears to be related to the Investigator’s Institutional Responsibilities, and:

      2. if with a publicly traded entity, the aggregate value of any salary or other payments for services received during the 12-month period preceding the disclosure, and the value of any equity interest during the 12-month period preceding or as of the date of disclosure, exceeds $5,000; or

      3. if with a non-publicly traded entity, the aggregate value of any salary or other payments for services received during the 12-month period preceding the disclosure exceeds $5,000; or

      4. if with a non-publicly-traded company, is an equity interest of any value during the 12-month period preceding or as of the date of disclosure; or

      5. is income exceeding $5,000 related to intellectual property rights and interests not reimbursed through the Institution, or

      6. is reimbursed or sponsored travel related to their institutional responsibilities.

   10. Financial Conflict of Interest (FCOI)

       a Significant Financial Interest (or other required Financial Interest disclosure) of an Investigator or Investigator’s Family that the Institution reasonably determines could directly and significantly affect the design, conduct, or reporting of sponsored research.

   11. Renumeration

       includes salary and payments for services, such as consulting fees, honoraria or paid authorship; cash or in-kind gifts from entities for which you provide services.

   12. Equity Interest

       stock, stock option, or other ownership interest, the value of which is determined through reference to public prices or other reasonable measures of fair market value.

   13. Conflict of Interest Committee (COI Committee)

       the Institution’s committee or individual that advises the Institutional Official on conflict of interest matters.

   14. Research

       a systematic investigation, study, or experiment designed to contribute to generalizable knowledge relating broadly to public health, including behavioral and social-sciences research. The term encompasses basic and applied research (e.g., published articles, books, or book chapters) and product development (e.g., a diagnostic test or drug).

4. Full Policy Details

   2. Every Investigator has an obligation to become familiar with, and abide by, the provisions of this policy.

   3. Investigators should conduct their affairs so as to avoid or minimize COI, and must respond appropriately when COI arise. ɫɫ�� encourages employees to patent and license inventions arising from their research, develop partnerships with industry to market new technology, apply for industry-sponsored research funds, and serve as consultants for industry. The Federal government also encourages universities to commercialize the results of federally supported research for the public good (Bayh‐Dole Act). However, these activities could potentially divert university employees from their primary mission of education, research, and service and are one possible source of COI.

   4. Disclosures

      All Investigators are required to disclose their outside Financial Interests to the Institutional Official annually and on an ad hoc basis, as described below.  The Institutional Official is responsible for the distribution, receipt, processing, review and retention of disclosure forms.

      2. Annual Disclosures

         All Investigators must disclose their Financial Interests that are related to the investigator’s institutional responsibilities annually.  All forms should be submitted to the Institutional Official or designee by October 15 for the previous calendar year or as determined by the subrecipient.

      3. Ad Hoc Disclosures

         In addition to annual disclosure, Investigators must disclose Significant Financial Interests to the Institutional Official within thirty days of their initial appointment or employment, or acquisition or discovery of the Significant Financial Interest. 

      4. Prior to entering into Public Health Service (PHS)-sponsored projects or applications for PHS-sponsored projects, where the Investigator has a Significant Financial Interest, the Investigator must confirm that their most recent annual disclosure is accurate or submit an updated Significant Financial Interest disclosure.  The Institution will not submit a research proposal unless the Investigator(s) have submitted such ad hoc disclosures.

      5. All Investigators must submit an ad hoc disclosure of any Significant Financial Interest they acquire or discover during the course of the year within thirty days of discovering or acquiring the Significant Financial Interest.

      6. Travel

         Investigators must disclose reimbursed or sponsored travel related to their Institutional Responsibilities.  Such disclosures must include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, the duration, and, if known, the monetary value.  The Institutional Official will evaluate whether additional information is needed (e.g., the monetary value if not already disclosed) to determine if the travel constitutes a FCOI with the Investigator’s research. Note that, as public employees, ɫɫ�� Investigators may be subject to restrictions on reimbursed travel that colleagues from private institutions do not have.

   5. Review and Decision of Institutional Official

      2. If the disclosure form reveals a Significant Financial Interest, it will be reviewed promptly by the Institutional Official or designee for a determination of whether it constitutes a FCOI.  If a FCOI exists, the Institutional Official will take action to manage the FCOI including reducing or eliminating the conflict, as appropriate.  The Institutional Official may consult a COI Committee for guidance in specific cases, or in the application of the Policy to particular situations.

      3. If the Institutional Official determines that there is a FCOI that can be managed, the Official must develop and implement a written management plan.  The affected Investigator must formally agree to the proposed management strategies and sign the written management plan before any related sponsored research goes forward.

      4. The Institutional Official will periodically review the ongoing activity disclosed as a FCOI, monitor the conduct of the activity (including use of students and postdoctoral appointees), to ensure open and timely dissemination of the research results, and to otherwise oversee compliance with the management plan.

   6. Managing Conflicts

      2. For cases that require management, the Investigator and the Institutional Official or designee will develop a Management Plan collaboratively with the supervisor of the Investigator.  Examples of conditions or restrictions that may be employed to manage conflicts include:

         2. Public disclosure of significant financial interests (e.g., when presenting or publishing the research); 

         3. Disclosure of significant financial interests directly to subjects involved in human research; 

         4. Appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of research; 

         5. Modification of research plan;

         6. Change of personnel or personnel responsibilities;

         7. Disqualification from participation in all or a portion of the research; 

         8. Reduction or elimination of the financial interest (e.g., sale of an equity interest); 

         9. Severance of relationships that create the actual or potential conflict of interest;

      3. If it proves impossible to reach an acceptable Management Plan, funds will be returned to the sponsor. 

   7. Subrecipient Requirements

      For sponsor funded research that involves subcontractors, subgrantees or subawardees (collectively, subrecipients) at other Institutions, ɫɫ�� Michigan University requires a written agreement that includes terms that establish whether the FCOI policy of the awardee Institution or that of the subrecipient Institution will apply to subrecipient Investigators. Subrecipient Institutions who rely on their FCOI policy must report identified financial conflicts of interests to the awardee Institution in sufficient time to allow the awardee Institution to report the FCOI to the sponsor awarding component. Subrecipients who do not have a Research COI Policy will be required to follow the ɫɫ�� Michigan University COI Research Policy. A subrecipient’s failure to promptly comply with the ɫɫ�� Policy will be considered grounds for immediate termination of any applicable award.

   8. Monitoring

      The Institutional Official and designees will monitor Investigator compliance with Management Plans. The frequency of monitoring will be dictated by sponsor/agency requirements and Management Plan provisions.

   9. Record Retention

      The Institutional Official will retain all disclosure forms, conflict management plans, and related documents for five years from the date the final expenditure report is submitted to the sponsor or to the prime sponsor awardee. If any litigation, claim, financial management review, or audit is started before the expiration of the five-year period, the records shall be retained until all litigation, claims or audit findings involving the records have been resolved and final action taken.

   10. Confidentiality

       The Institutional Official will maintain records of disclosed potential COIs.  To the extent permitted by law, all disclosure forms, conflict management plans, and related information will be confidential. This information will remain confidential within ɫɫ�� Michigan University unless disclosure is requested by a funding agency, if required pursuant to a governmental authority having jurisdiction by a demand or regulation, or if otherwise legally required. If the Institution is requested to provide disclosure forms, conflict management plans, and related information to an outside entity, the Investigator will be informed of this disclosure.

   11. Reporting to Sponsors

       When applicable, the Institutional Official will report financial conflicts of interest or non-compliance to a sponsor in accordance with sponsor regulations.  If the funding for the Research is made available from a prime sponsor-awardee, such reports shall be made to the prime awardee prior to the expenditure of any funds and within 60 days of any subsequently identified FCOI such that the prime awardee may fulfill their reporting obligations to the sponsor.

   12. Enforcement and Noncompliance

       2. The Institutional Official is responsible for ensuring implementation of this Policy and may suspend all relevant activities until the FCOI is resolved or other action deemed appropriate by the Institutional official is implemented.  Violation of any part of these policies may also constitute cause for disciplinary or other administrative action pursuant to Institutional policy.  

       3. Disciplinary Action

          Failure to comply with this Policy will result in disciplinary action and/or sanctions which may include formal reprimand, non-renewal/termination of appointment or affiliation, additional training requirements, additional supervision, closing existing research or denying future research by the Investigator, and/or any other enforcement action mandated by the applicable funding agency or ɫɫ�� Michigan University. Any ɫɫ�� disciplinary procedures will be consistent with applicable Collective Bargaining Agreements as appropriate.

       4. Retrospective Review

          If the Institutional Official determines that a FCOI was not identified or managed in a timely manner, including but not limited to an Investigator’s failure to disclose a Significant Financial Interest that is determined to be a FCOI, or failure by an Investigator to materially comply with a management plan for a FCOI, a committee appointed by the Institutional Official will complete a retrospective review of the Investigator’s activities and the sponsored research project to determine whether research conducted during the period of non-compliance was biased in design, conduct or reporting.

           This retrospective review will be completed in the manner and within the time frame established in sponsor regulations. If bias is found, the institution will promptly notify the sponsor awarding component and submit a mitigation report in accordance with the sponsor regulations.

5. Training

   Each Investigator must complete COI training on this Policy, the Investigator’s responsibilities regarding disclosure, sponsor COI regulations prior to engaging in externally funded research, and at least every four years thereafter while funded or as otherwise required by the Institutional Official.

6. Public Accessibility

   2. Institutions are required by federal regulations to ensure public accessibility to information concerning any significant financial interest disclosed to the Institution that meets the following criteria:

      2. The significant financial interest was disclosed and is still held by senior/key personnel involved in the research;

      3. The Institution has determined that the significant financial interest is related to funded research; and

      4. The Institution has determined that the significant financial interest is a FCOI.

   3. When a financial conflict of interest in funded research has been identified, the following will be made available within 5 business days of a request for information:

      2. The investigator’s name; The investigator’s title and role with respect to the research;

      3. The name of the entity in which the financial interest is held;

      4. The nature of the financial interest that constitutes a financial conflict of interest; and

      5. The approximate value of the financial interest by range or, if the dollar value cannot be determined by reference to public prices or other reasonable measures of fair market value, a statement to that effect.

7. Related Procedures and Guidelines

   The Significant Financial Interest Disclosure Form and the Conflict Avoidance Statement Form can be found in the Attachments portion of this page.

8. FAQs

   2. Where do I go to find out if I have a FCOI?

      Contact the Vice President, Office of Research and Innovation 269‐387‐8270.

   3. Where do I go to find out more information about COI as it pertains to the protection of human subjects?

      Contact the research compliance coordinator at 269‐387‐8293.