INTRODUCTION AND PURPOSE:

The purpose of this policy is to: a) ensure compliance with all regulations; b) describe the process for disclosure of any potential financial or non-financial conflict of interest (COI) related to research, educational or service activities; and c) identify processes that will be used to manage, reduce or mitigate significant COIs.  COIs are broadly defined as relationships that may lead someone to: a) compromise or lose their independence, impartiality or judgment in connection with an arrangement with Oakland University (the University); b) propose or support an arrangement with the University that is not in the University’s best interest; c) gain personally or financially from an arrangement; d) gain preferential treatment for the individual or their immediate family; or e) damage the University’s reputation or public confidence in the University. 

Oakland University William Beaumont School of Medicine (OUWB) is committed to maintaining integrity and protecting the safety and welfare of participants in all areas of academia: teaching, research and service. OUWB faculty, administration and staff have a professional obligation to act in the best interest of OUWB and the University; principled collaboration and collegiality among OUWB faculty and staff, other academic institutions, sponsors and industry is vital to preserving public trust.

POLICY STATEMENT:

All OUWB faculty, administration and staff employed by the University and as a precondition of being permitted to engage in OUWB educational programs, community service, and/or the design, conduct or reporting of OUWB research, must disclose financial or other personal interests that may be, or may appear to be, COIs. Disclosure requirements are broad and cover anything related to an individual's responsibilities at OUWB, including but not limited to clinical, administrative, research, service and/or educational activities.

Individuals not employed by OUWB who serve as faculty, volunteers, advisors, consultants or board members must disclose financial and/or non-financial interests that may conflict with their role in OUWB’s programs. Disclosures required by this policy are in addition to any disclosures required by the University or Beaumont Health.

RESPONSIBILITY:

The OUWB Conflict of Interest Workgroup (COIWG) will provide guidelines and actively participate in the review of all COI disclosures by OUWB faculty, administration, staff and volunteers.  In addition, the COIWG will work with the OUWB Dean to establish and monitor management plans, as appropriate.  The Dean, or COIWG as delegated, will report all OUWB COIs and any proposed COI mitigation plans to the University’s Conflict Review Committee for its independent review and approval.

DEFINITIONS:

1. Covered Individuals: All OUWB faculty, administrators, and staff employed by the University, and all individuals not employed by OUWB who serve as faculty, volunteers. advisors, consultants and board members.
2. Immediate Family Members of Covered Individuals: Includes faculty or staff member's spouse or domestic partner, and dependent children.
3. Individual Financial Conflict of Interest: Any financial interest of a covered individual or their Immediate Family Members, or of any foundation or entity controlled or directed by the covered individual or their Immediate Family Members, which appears to affect educational programs, service programs or the design, conduct or reporting of research at OUWB, must be disclosed for review as a potential COI. Disclosures will be reviewed by the COIWG to determine: 1) if the interest is related to any OUWB programs – academic or otherwise; and 2) whether it results in a financial COI. Examples of things that may be considered a COI include but are not limited to:
   • Monies received for lecturing or developing educational materials for competing persons, entities or interests.
   • Consulting or serving in any position in an entity.
   • Non-monetary gifts, such as travel.
   • Holding of stock, stock options, partnerships, equity or any other ownership interests.
   • Ownership of intellectual property (e.g., patent or copyright).
   • Potential future personal income from licensing.
   • Financial COIs do not include: Salary from the University; Interest of any amount in publicly traded, diversified mutual funds; Payments made to the University or OUWB for the covered individual that are directly related to reasonable costs incurred in the conduct of research, service or educational programs; Income from or reimbursement of expenses for seminars, lectures, or service on advisory committees or review panels sponsored by government agencies, institutions of higher education, academic health systems or medical centers, or research institutes affiliated with institutions of higher education when approved by the faculty or staff’s immediate supervisor, department/unit head and/or the Dean; Intellectual property rights assigned to the University; Textbook and publishing royalties, unless the text or published work is recommended or required for use by OUWB trainees, faculty or staff.
4. Non-Financial Conflicts of Interest: Any condition other than financial that can generate, or be perceived as generating, bias in terms of an individual’s OUWB responsibilities.  This may include personal or political relationships, membership or unpaid relationships with organizations or industry, or inappropriate utilization of students, faculty, administration or staff in programs or projects.
5. Outside Professional Activity: Any activity undertaken by faculty, administration or staff outside their employment at OUWB. These activities may include consulting, participation in civic or charitable organizations, working as a technical or professional advisor or practitioner, or holding a part-time job with another employer.  These activities may not be identified as COIs by the COIWG.
6. Conflict of Commitment: As determined by full time equivalent employment, faculty, administration and staff are required to commit their employed time, effort and intellectual energies to education, research and other services supporting the OUWB mission. A Conflict of Commitment occurs when a faculty member’s, administrator’s or staff member’s time is devoted to outside activities that diminish their capacity to meet OUWB responsibilities, or otherwise adversely impacts the University.  If intending to engage in any external activity that exceeds limits established by OUWB, faculty and staff must have written approval from their immediate supervisor, department/unit head and/or the Dean.  Individuals may be required to take a leave of absence or reduced employment status to proceed with an external activity.
7. Institutional Conflict of Interest: Any financial interest of the institution (e.g., stock holdings, royalties, etc.) or financial or business interests of an individual who makes or participates in committees that make institutional decisions affecting purchasing, educational programs, research or technology transfer must be reviewed by the COIWG as a potential institutional COI.
8. OUWB Research: For purposes of this policy, OUWB Research refers to all types of research, including but not limited to clinical, outcomes, population health, behavioral, social, animal, basic science or educational. Any research review, such as that by the Institutional Review Board (IRB) or Institutional Animal Care and Use Committee (IACUC), must include an understanding of existing COIs.
9. Individuals Responsible for Design, Conduct or Reporting of Research: Those individuals participating in research, including but not limited to participation in: study design; project direction/management (e.g., principal investigator (PI), co-investigator, sub-investigator, technical staff); screening for and enrolling research participants; administering informed consent; administering or providing test articles; analyzing or reporting research data; or preparation of abstracts, manuscripts or presentations. For human subject research, this includes everyone listed as key personnel with the IRB. For federally funded projects this also includes outside independent consultants and collaborators.
10. OUWB Educational Programs: For the purposes of this policy, the term Educational Programs refers to instructional activities involved in degree granting programs or in programs of continuing education or career advancement.
11. Disclosure: The process of reporting relationships or interests in outside organizations to the COIWG.
12. Management Plan for COI: A plan developed to manage, reduce or eliminate an identified COI (including Institutional COI or Conflict of Commitment). This plan will be developed based on the outcome of the COI disclosure review process, as described below.

DISCLOSURE OF POTENTIAL CONFLICTS OF INTEREST:

1. Public Health Service (PHS) regulations require each individual involved in the design, conduct or reporting of PHS funded research to submit a COI disclosure at least annually. If a current disclosure is not on file, one must be submitted: 1) at the time of new grant applications; 2) when an individual is newly assigned to a project; or 3) within 30 calendar days after developing a new relationship or obtaining a new interest. At OUWB, these requirements apply to all research, regardless of type or funding, and to educational initiatives. OUWB administration, faculty and staff (who may not be involved in research or education) are required to submit a COI disclosure at least annually and within 30 calendar days after developing a new relationship or obtaining a new interest related to their employment.  The attached disclosure form will be utilized for all disclosures.
2. Individuals must disclose any financial or relational interests, regardless of actual and perceived value, which appear to affect the individual's institutional responsibilities at OUWB, including clinical, educational, administrative, service or research. These include, but are not limited to, payments or salaries received from non-University sources; and interests in companies who sponsor or fund, or whose products may be used in, research or educational programs being conducted or proposed by OUWB. Disclosure must also include any reimbursed or sponsored travel, including the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration.
3. In the event a new potential COI arises, a new relationship is developed, or a new interest is obtained during the year, the individual must complete an updated disclosure 30 calendar days prior to finalizing the commitment in order to provide adequate time for review.

COI DISCLOSURE REVIEW PROCESS:

1. Review for All Grants and Contracts: When a new grant is submitted or accepted, a new sub-contract is executed, or a new contract/agreement is reviewed, key personnel listed for the project will be compared to the list of current disclosures. Positive disclosures will be identified and pulled for review according to the process below. Any key personnel who do not have a COI disclosure on file will be required to submit a disclosure prior to grant submission, acceptance or contract execution.
2. OUWB Conflict of Interest Workgroup: The OUWB Conflict of Interest Workgroup (COIWG) will be appointed annually by the Dean. The Workgroup will be composed of at least seven members, including the Associate Dean of Research, Associate Deans of Medical Education, Associate Dean for Faculty Affairs, Chair of Foundational Medical Studies, Vice Dean for Business and Administration, and one OUWB-employed faculty member at large. The Dean will appoint the chair of the COIWG annually; the chair will be a voting member.
3. Review Process for all COI Disclosures: To determine whether a COI exists, the COIWG will: 1) apply the principles and definitions in MCL 15.301 and other applicable state and federal COI statutes as adopted and amended; 2) apply the current COI policy statements, principles and guidelines published by the Association of Governing Boards of Universities and Colleges; 3) apply definitions commonly used to define and interpret the terms direct, indirect, apparent, actual and possible in the context of COI; and 4) apply the following definitions as defined in the University’s Board of Trustee COI Policy:
   1. Arrangements: Includes the purchase of any good/service, gifts and nepotism in any aspect of University employment, research, teaching and service.
   2. Immediate Family: Includes faculty or staff member’s spouse or domestic partner, and dependent children.
   3. Gift: Anything of value in any form including money, goods, entertainment, services, use of property or facilities, loans and price concessions. 
   4. Nepotism: The bestowal of patronage to family members through initiation, participation or influence of arrangements.
4. The OUWB COIWG will be responsible for initial and continuing review of all disclosures from OUWB faculty, administration and staff that identify potential COI, including individual or institutional conflict, as well as Conflict of Commitment. Decisions will be made by majority vote of disinterested members. COIWG members must recuse themselves from decisions regarding personal disclosures and COIs. Questions regarding a disclosure will be directed to the disclosing individual.  The COIWG will determine whether a disclosure: 1) is related to any current or proposed research, educational initiative or contract/agreement; and 2) represents a COI based on one or more of the following:
   1. Any equity interest which directly affects, or could reasonably appear to affect, OUWB educational or service programs; research being conducted, reviewed, funded or proposed for funding; or OUWB business (e.g., purchased products and services). This includes investments in a sponsor or its parent company (if publicly or non-publicly traded), such as ownership interest or stock options.
   2. Payments from a sponsor, its parent company or subsidiary, or the producer/distributor of a product being tested or utilized in educational, service or research programs, which in total exceeded $5,000 in the prior year or are expected to exceed $5,000 in the next year. This includes any and all types of income including consulting fees, royalties, honoraria, gifts, or payments for consulting, lecturing, travel or service on an advisory board.
   3. Financial arrangements where the value of the compensation could be influenced by the outcome of a study or educational initiative. Examples include:
      • Compensation explicitly for a favorable outcome.
      • Equity interest in the sponsor.
      • Royalty rights.
      • Holding or the promise of a fiduciary role with the sponsor.
      • Any payments in connection to research or educational programs that are not specified in the agreement between the sponsor and the institution.
      • A proprietary or financial interest in a product such as a patent, trademark, copyright or licensing agreement.
      • Serving as an officer, director or employee, or functioning in any other fiduciary role for a sponsor, sponsor parent company or sponsor subsidiary, regardless of whether compensation for the service is provided.
5. If the COIWG determines that a conflict exists, the Dean or OUWB COIWG as designated by the Dean, will contact the University’s Conflict Review Committee for its review and decision. The University’s Conflict Review Committee will work with the Dean and COIWG to determine whether the conflict can be managed to eliminate the introduction of bias to the research, service or educational program, and take steps necessary to manage, reduce or eliminate the conflict. If the University COI Committee decides the COI cannot be managed or is not in the University’s best interest, the COI will be disallowed.
6. COIWG meetings, deliberations and decisions will be documented to confirm the integrity of the process and the propriety of decisions by confidential, written minutes that include the nature of the conflict, the names of all individuals involved, the due diligence conducted, the vote (roll call if necessary) and any management plans considered.
7. The Office of the Associate Dean of Research will maintain records of all disclosures, decisions, and subsequent actions.

REVIEW AND APPROVAL PROCESS FOR UTILIZATION OF FACULTY/EMPLOYEE-AUTHORED PUBLISHED WORKS BY OUWB TRAINEES, FACULTY OR STAFF:

The following procedure will be utilized to review potential conflicts that may arise when an OUWB employee has authored a text, chapter or other published work and wishes to recommend or require its utilization by OUWB faculty, students and/or staff. The purpose is to: 1) ensure that OUWB employees and trainees have access to the best learning resources, regardless of authorship; and 2) provide a process for OUWB faculty and staff to recommend or require utilization of their authored and published works at OUWB. In some cases, such utilization may result in the author receiving royalty payments or other forms of compensation. 

Procedures:

1. Authorship activity is disclosed on the annual OUWB Conflict of Interest Disclosure form.
2. The COIWG determines if the authored work has the potential to be required or recommended for use by OUWB students, faculty and/or staff, and, if so, refers the disclosure to the Published Works Task Force, which is composed of the Chair of Foundational Medical Studies (FMS), Associate Dean of Research and two faculty members, one from FMS and one a physician in an OUWB clinical department. 
3. The Published Works Task Force:
   1. may request more information from the author, up to and including interviewing the individual,
   2. determines if the author is in a position to recommend utilization of the authored work,
   3. determines if the author stands to receive compensation for OUWB use of the authored work,
   4. makes a determination on whether the potential compensation is significant enough to influence the choice of resources by the author, and
   5. makes a recommendation to the COIWG regarding whether the authored work could be required or recommended for use by OUWB students, faculty or staff.
4. The COI Workgroup makes a determination on OUWB’s utilization of the published work and any potential management requirements, and notifies the author.

SUPERVISOR APPROVAL OF EXTERNAL ACTIVITIES: 

As indicated above by the Definition of Conflict of Commitment, faculty, administration and staff employed full time by OUWB are required to commit their employed time, effort and intellectual energies to education, research and other services supporting OUWB. A Conflict of Commitment occurs when an individual’s time is devoted to outside activities that diminish their capacity to meet OUWB responsibilities or otherwise adversely impact the University.  If planning to engage in any external activity, full time employees must discuss the activity and receive approval from their immediate supervisor, department/unit head and/or dean.  Individuals may be required to take a leave of absence or reduced employment status to proceed with an external activity.

Faculty, staff and administration are required to disclose any outside activity that may affect, or be perceived as affecting, their commitment to OUWB responsibilities.  During COIWG review of annual or updated disclosures, the individual’s supervisor will be contacted to ensure they are aware of and approve of any activity that may be, or may be perceived as, a Conflict of Commitment.  

MANAGEMENT PLANS:

1. If it is determined there is a COI or the appearance of a conflict, the OUWB COIWG will prepare a Management Plan (MP) recommendation for the Dean to be submitted by the Dean to the University’s Conflict Review Committee for its independent review and approval. Depending on the nature of the interest and the type of OUWB activity (e.g., research, education, service), MPs may be developed at the individual or project/program level. Individual MPs will be designed to cover all academic activities of the individual.  Study/program specific MPs will address the conflict specific to the individual’s role in the study/program.  MPs will reflect the extent of the conflict and the level of risk to the University or OUWB, its programs, students, and human participants. MP requirements may include, but are not limited to:
   • A disclosure of the relationship or interest in Informed Consent and Authorization documents so prospective research participants may make an informed decision about participation in a related study.
   • A disclosure of the relationship or interest in public releases of information about the study or program (e.g., advertising, press releases, abstracts, presentations, publications).
   • Limits on the conflicted individual's role in the study or program (e.g., may not serve as PI or lead, or be involved in administering informed consent or analyzing data, etc.).
   • Placement of the investment in escrow for the duration of the study/program, and for a suitable period after completion.
   • Divestiture of the interest.
   • Severance of the relationship that caused the conflict or perceived conflict.
   • Disqualification of the covered individual from conducting the research or participating in the program, in part or in its entirety.
   • Oversight by a non-conflicted individual who is not in a subordinate role to the conflicted individual.
   • Audits (e.g., patient eligibility, data integrity, program outcomes).
   • Non-approval of the study or program.
2. The proposed MP will be submitted to the Dean, who will approve or amend the recommendation before forwarding the MP to the University’s Conflict Review Committee for its independent review and approval. If approved by the University’s Conflict Review Committee, the COIWG may not remove any components of the approved MP but may add additional safeguards they deem appropriate if approved by the Dean and the University’s Conflict Review Committee. For research involving human participants or animals, the IRB or IACUC, respectively, has the final authority to determine whether the research may be approved, given the interests disclosed and the MP developed to manage those interests.
3. COI Disclosures, COIWG minutes, approved MPs and associated communications will be retained in confidence in the Office of the Associate Dean of Research.
4. Processing Management Plans: The MP approved by the Dean and the University’s Conflict Review Committee will be returned to the COIWG for implementation and monitoring via the Associate Dean of Research. Initially, the MP will be shared with the conflicted individual with a signature obtained to attest to his/her understanding of the requirements. The chair of the individual’s primary department (or next higher non-conflicted individual on the applicable organization chart) must also sign the MP acknowledging its requirements and return it to the Associate Dean of Research. Upon approval and implementation of the fully signed MP, the research, educational or service initiative may be approved.
5. Institutional Conflict and Approval of Research or Program: When an individual with a conflict of interest provides University or OUWB signature approval for applications, projects, amendments, contracts, purchases, programs or other agreements, an institutional COI review will be conducted with a MP established as appropriate. Signatures may be required from the individual directly above the conflicted individual based on the applicable organizational chart. Members of approval committees with COIs may not engage in research approval activities related to identified conflicts.
6. Institutional Conflict Arising from OUWB/University Interests: If aware of Institutional Interests (e.g., University ownership or income resulting from intellectual property) related to educational, research or service programs within OUWB, the COIWG shall review the interests for perceived or real conflicts, and recommend appropriate MPs to the Dean for subsequent review by the University’s Conflict Review Committee.  Implementation and monitoring will be conducted by the Associate Dean for Research and will be reviewed by the COIWG.
7. Conflict of Commitment: If the COIWG identifies a disclosed activity as being a Conflict of Commitment with University or OUWB responsibilities, the COIWG will develop a MP for review by the Dean and the University’s Conflict Review Committee. This MP may require reduction in the individual’s University effort to ensure that the University and/or OUWB resources are not provided as resources to the non-University commitment. 

PHS NOTIFICATION:

Potential COI on Federal and/or State funded grants will be reported to Office of Research Administration to ensure compliance with respective COI guidelines.  Consistent with Federal regulations, if it is determined that a significant financial COI exists related to a PHS funded project, the identified conflict and MP details will be reported by the Office of Research Administration to PHS when the MP is instituted and annually thereafter. If OUWB is participating as a sub-contractee, the Office of Research Administration will report the required information to the sub-contractor for subsequent reporting to PHS.

NON-COMPLIANCE AND CORRECTIVE ACTION:

1. Failure to disclose a COI or potential COI, or non-compliance with a MP will result in corrective action as determined by the Dean. Corrective actions may include, but are not limited to:
   • Completion of additional education as determined by the Dean.
   • Restrictions on the use of data derived from the research.
   • Suspension or termination of the project or program.
   • Withdrawal of funding.
   • Formal corrective actions.
   • Report of actions to external regulatory agencies.
2. When non-compliance with a MP related to a PHS funded project occurs, a retrospective review will be conducted by the COIWG. If bias in the research is found, a mitigation report will be filed with PHS by the Office of Research Administration, which may include:
   • Key elements documented in the retrospective review.
   • A description of the bias identified.
   • The plan of action to eliminate or mitigate the effect of the bias.

MONITORING AND AUDITING:

The OUWB COIWG will conduct periodic audits to ensure compliance with each MP. Audit results will be provided to the Dean and faculty member/administrator/staff member.

EDUCATION AND TRAINING:

1. All individuals responsible for the conduct of research, education or service programs must be knowledgeable about this policy and the University’s COI policy. COI policies and procedures will be reviewed with existing faculty, administration and staff once approved, and with new faculty, administration and staff as part of the onboarding process. Education regarding changes or new procedures will be distributed to all faculty, administration and staff within 30 business days.
2. Consistent with Federal regulations, researchers involved in PHS funded research will be required to complete a training course specific to PHS requirements. The training must be completed prior to engaging in PHS funded research and at least every four years thereafter.

PUBLIC ACCESS TO COI INFORMATION:

As required by Federal regulation, this policy will be made available to the public. Additionally, within five days of a request, information on COIs for individuals involved in PHS funded research will be provided to the agency.

RECORD RETENTION:

All records relating to COI disclosures, review, and MPs will be retained in the Office of the Associate Dean for Research for a minimum of 11 years past completion of the research, project or program.

CONFIDENTIALITY and APPROPRIATION of UNIVERSITY OPPORTUNITIES:

No one may use confidential information acquired in service to the University for any purpose other than University business or give confidential information to any person or entity without the prior written consent of the University. 

ACTIONS NOT VOID or VOIDABLE:

No arrangement undertaken by the University is void or voidable, or may be challenged by a third party under this policy.

SCOPE:

This policy supplements but does not replace any applicable state or federal law, or University policy.  In cases of federally sponsored grants and contracts, the Federal regulations and procedures necessary to meet federal agency COI requirements will control.