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Medical School Policy on Conflict of Interest

Part I

Adopted by the Executive Faculty June 9, 1993, and amended July, 1996.

The faculty and administrators at Washington University School of Medicine share with the University common goals of teaching, research and service. All recognize a shared responsibility to ensure that their efforts in the School of Medicine are conducted in an unbiased manner that serves all three of these essential goals. It is thus the responsibility of the School of Medicine and its employees to guard against conflicts of interest that might compromise the integrity and objectivity of the University community.

It is understood that faculty members, as developers of new knowledge, have a unique opportunity and responsibility to disseminate that knowledge to the public. By adopting this Conflict of Interest Policy, the School of Medicine reaffirms the value of collaboration with industry as a means of fostering public access to the practical benefits of University research. By adopting this Conflict of Interest Policy, the School of Medicine also (i) demonstrates its commitment to the ethical principles that guide University research and (ii) establishes a mechanism to safeguard University and faculty integrity and objectivity so that University/industry interactions can optimally benefit society.

This statement of the School of Medicine policy has been prepared to outline the School of Medicine's approach to identifying and evaluating potential conflict of interest among administrators, faculty and staff, and to assist its employees in carrying out the shared responsibility to address conflict of interest issues. It has been and shall continue to be the policy of the Washington University School of Medicine that all School of Medicine employees take steps to avoid conflict of interest or the appearance of conflict of interest between their financial or other personal interests and the goals and policies of the School of Medicine. This policy statement, effective June 9, 1993, replaces previously unwritten or uncollected conflict of interest policies, and incorporates governmental requirements

  1. Applicability of Policy

    This policy is applicable to:
    1. All School of Medicine faculty members.
    2. All School of Medicine staff members.
  2. Definitions

    1. Employee - Any person covered by this policy as provided in Section A.
    2. Dean - Principal academic officer of the School of Medicine.
    3. Conflict of interest - Many employees either have positions that allow them to influence University decisions, or they have been entrusted with the authority to make decisions for the University. Conflict of interest exists if an employee's position or authority may be used to influence or make decisions that lead to any form of financial or personal gain for that employee or for his or her family. A conflict of interest is material if an ordinary person would take it into account in making a decision. Material conflicts of interest are within the scope of this policy.

      In academic research, the term conflict of interest refers especially to situations in which financial or other personal considerations may compromise, or may have the appearance of compromising, an investigator's professional judgement in conducting or reporting research. The bias such conflicts may conceivably impart not only affects collection, analysis and interpretation of data, but also the hiring of staff, procurement of materials, sharing of results, choice of protocol, and the use of statistical methods. Conflicts of interest can affect other scholarly duties as well, but are particularly important to consider in biomedical and behavioral research because of the impact such conflicts can have on human health.1 It is acknowledged that, in their wider roles as academicians and professionals, the faculty may be subject to conflicts of interest that are not necessarily financial, and that are not within the scope of a policy that is designed to address conflicts of interest in the employer-employee setting. For example, the policy is not designed to address conflicts that may be encountered in service to a professional society, or in community service. Academic and professional activities not covered by this policy are best handled within the ethical guidelines established by the University Policy on Academic Freedom, Responsibility and Tenure, by various professional organizations, or by governmental policies.

      In academic administration, the term conflict of interest refers especially to situations in which financial or other personal considerations may compromise, or appear to compromise, decisions made by administrators.
    4. Family - For purposes of this policy, family is defined as the employee's spouse and minor children.
    5. Financial interest - Any relationship, including a consulting relationship, entered into by the employee or his or her family, other than employment by the University, that could result in financial gain for the employee or his or her family.
    6. Equity or debt instrument - This term includes, but it is not limited to, preferred and common stock, stock options, warrants, bonds and notes. For purposes of this policy, investments in mutual funds or other investments in which an independent party has primary decision-making control regarding stocks selected or shares held are not included in the definition of equity.
    7. Research performed under contract to a company - Any research, including clinical trials, materials evaluations, or general research projects, performed under a University contract with a company in which the company provides full or partial funding of the project.
    8. Clinical trial - Any study, regardless of funding source, involving the evaluation of a diagnostic or therapeutic drug, a vaccine, or a medical device in preparation for a regulatory evaluation or within a regulatory evaluation process, when the protocol requires approval by the Institutional Review Board of the Washington University School of Medicine.
  3. Principles

    1. General Principles
      As a natural outgrowth of personal commitment to academic principles, School of Medicine employees must ensure the integrity of their pursuits by taking steps to avoid conflict of interest, or even the appearance of conflict of interest. Because the complexity and diversity of personal relationships is extensive, and the perception of conflict of interest may vary from one individual to another, the most effective means to address conflict of interest is to establish a system under which employees disclose and obtain evaluation of potential conflict. Thus, School of Medicine employees shall disclose any potential conflict of interest that is or may be material.
    2. Identification of Conflict of Interest
      Identifying conflict of interest is not a simple task. A School of Medicine employee has a potential conflict of interest if his or her judgment and discretion in research or in other matters affecting the University is or may be influenced by considerations either of personal gain or financial benefit.

      The following is a partial list of activities or actions that merit case-by-case examination to determine whether they create a material conflict of interest that should either be managed appropriately or eliminated.
      1. Consulting activities.
      2. The purchase of goods or services for the School of Medicine from businesses in which the employee, or his or her family, has a financial interest or, as a result of such purchase, may directly benefit.
      3. Receipt of gifts, gratuities, loans or special favors (including trips or speaker's fees) from research sponsors or vendors.
      4. Holding of an ownership interest by the employee or the employee's family in any real or personal property leased or purchased by the University.
      5. Holding of an equity, royalty or debt instrument interest by the employee or the employee's family in any entity providing to the University financial support, including research or other support or services, when such support will benefit the employee or persons supervised, directly or indirectly, by the employee.
      6. Receipt, directly to the employee from non-University sources, of cash, services or equipment provided in support of the employee's University activities.
      7. Some memberships on boards of directors, committees, advisory groups (or similar bodies) of governmental, for-profit or not-forprofit entity.
      8. Use of information received as a University employee for personal purposes.
    3. Review of Ongoing Activities
      Increased research support from the private sector, changes in federal law and regulations encouraging technology transfer, and the continued need of the University and its employees to demonstrate public accountability have necessitated some new approaches in the management of conflict of interest. Some previously acceptable activities may now require reevaluation, and ongoing activities that involve potential conflict of interest should be disclosed and reevaluated at the time this policy becomes effective. If reevaluation indicates that changes are required, provision will be made to achieve them in an orderly and reasonable fashion.
    4. Protection of Students and of Academic Freedom
      Special care should be exercised in the involvement of students, including fellows at the postdoctoral level, in the evaluation of commercial products or in research supported by industrial sponsors, and such activities should be evaluated with attention to avoidance of detrimental effects on the student's academic program. For the protection of academic freedom and integrity, restrictions on publication except for limited periods to permit filing of applications for protection of intellectual property, or restrictions on the dissemination of research data, should be avoided.
    5. Research Performed Under Contract to a Company
      1. Research performed under contract to companies is desirable in order to promote the advancement of research and to benefit the public by bringing the results of research more rapidly into public use. To preserve the integrity of research information arising from company-funded projects it is necessary to take particular care to manage conflict of interest. Clinical trials research is an area in which it is particularly important to avoid conflict of interest because of the immediacy of impact of this kind of research on patient care and the general public welfare. Financial interests of the employee or the employee's family must not influence, or appear to influence, the design, conduct or reporting of company funded research or any clinical trials involving the evaluation of commercial products such as drugs, vaccines and medical devices.
      2. Prior to engaging in research funded by a company, or in a clinical trial funded either by a company or non-company sponsor, both the employee serving as the principal investigator and any person subject to this policy who has responsibility for the design, conduct or reporting of the project shall disclose, via the mechanisms developed under Section D, any material interest, including consulting or other financial interest or family financial interest in any entity that manufactures, sells or otherwise has property rights in the type of product to be studied.
      3. When no material financial interest is involved, the disclosure requirement may be satisfied by certifying to that fact.
      4. If a financial interest is disclosed, it will be determined whether it is likely that this interest will compromise, or appear to compromise, the design, conduct, or reporting of the study. Recommendations for resolution will be provided as described in Part I, Section D. The activity creating the possible conflict of interest shall not be initiated unless authorized through the mechanisms provided in Part I, Section D.
      5. In accordance with University Conflict of Interest Policy, disclosures by employees who are involved in collaborative projects that cross School boundaries shall be reviewed by the Disclosure Review Committee (DRC, as defined in Part I, Section D) of the School in which the employee has his or her prime appointment. The DRCs shall develop mechanisms for coordination of any federal reporting that may be required on such collaborative projects. If disputes arise in the management of conflict of interest in collaborative projects, the case will be referred to the University's Conflict of Interest Review Committee (CIRC) as provided in Part I, Section D.7.
  4. Implementation

    1. Authority
      The Dean and the Executive Faculty shall develop and administer procedures to implement this policy that shall include all the elements required by Washington University policy. These procedures shall be placed on file in the Office of the University General Counsel.
    2. Disclosure Submission
      1. Faculty disclosures shall be referred to a standing committee appointed by the Dean, the Disclosure Review Committee (DRC), which shall include representation from the faculty and the office of the University's General Counsel. It shall be the responsibility of the DRC to keep and maintain in a secure manner files that may be required to satisfy compliance with federal regulations on conflict of interest.

        Initial disclosures by the faculty of financial interests, either as required by this policy or by government regulations or policy, shall be made, using a standard format developed by the DRC, to the faculty member's department head. The review by the department head shall consist of an evaluation of each situation on its own merits and a written recommendation to be forwarded to the Disclosure Review Committee (DRC) as provided in Part I, Section D.6. Disclosures made by the members of the Executive Faculty shall be submitted to the Dean for review. The Dean shall forward such disclosures to the DRC with a written recommendation.
      2. The Dean's disclosure shall be made to the Chancellor, who shall report on management of any conflict of interest to the Audit Committee of the Board of Trustees of the University.
      3. Disclosures by non-faculty employees of the School of Medicine shall be provided to their immediate supervisors for review and management.
    3. Materiality
      The Medical School may adopt guidelines providing, on a categorical basis, that certain types of potential conflicts of interest, are, or will not be, regarded as material for purposes of this policy. Such guidelines shall be consistent with the provisions of University and medical school policy and with federal law and regulations regarding conflict of interest.
    4. Timing of Disclosures
      Faculty disclosures may occur annually, and also at the time of proposal of company-funded research or clinical trials, as provided in Part I, Section C.5, and will occur at such other times as may be required by law or federal regulation (e.g. disclosures that may be required at the time of grant application submission) or when the employee's financial interest, as previously disclosed, materially changes in a manner that is relevant to the concerns of this policy. Non-faculty disclosures shall occur upon request of the relevant supervisors.
    5. Conflict and Confidentiality in Review
      Coinvestigators or persons with a material financial interest in any entity named in the employee's disclosure shall not participate in the review of the disclosure. Persons to whom disclosures are made shall take steps to ensure the confidentiality of the disclosure.
    6. Review and Management of Conflict of Interest by the DRC
      The DRC shall develop procedures to evaluate faculty conflict of interest, and shall promptly review disclosures transmitted by departmental chairpersons, and provide its written conclusions and recommendations to the faculty member and his or her immediate supervisor.

      Whenever appropriate the DRC, or when necessary, the Dean or his or her designee, shall attempt to resolve or manage the conflict situation in a manner appropriate and reasonable to the individual situation by obtaining employee cooperation in the implementation of the recommendations. The outcome will be recorded by the DRC. To the extent required by law, the Dean or his or her designee shall report conflict disclosures and their resolution to appropriate governmental agencies.
    7. Appeals Process
      Unresolved disagreements between faculty employees and the DRC or the Dean concerning the application of this policy shall be referred for final resolution to a Conflict of Interest Review Committee (CIRC) established by the Chancellor. As provided in the University Conflict of Interest Policy, the CIRC also serves as a review body for questions concerning conflict of interest management involving projects that cross School boundaries.
    8. Amendments to the Policy
      This policy will be amended to conform with University Conflict of Interest Policy whenever changes of substance or procedure are required to comply with governmental requirements. The Dean shall inform the faculty of any such required change and arrange for the dissemination of information concerning amendments made to the policy.
  5. Accessibility of Information

    To allow the implementation of this policy, the Dean or his or her designees may seek from employees subject to this policy any information relevant to insuring compliance with this policy. Because the credibility and academic integrity of the research is enhanced by disclosure, it is expected that employees will provide any relevant information requested. The information received shall be handled confidentially unless public disclosure is part of the conflict of interest management plan, or unless such disclosure is required by law.
  6. Non-compliance with Policy

    Violations of the requirements of this policy by any employee shall, if not resolved, subject the employee to sanctions or other actions permitted by University policy, which shall be applied according to the provisions of the University Policy on Academic Freedom, Responsibility, and Tenure.
  7. Prohibition of Corruption

    As required by Federal law, the offering or acceptance of a bribe or kickback is strictly prohibited.
  8. Interpretation

    Questions concerning the interpretation or applicability of this policy should be directed to the Office of the General Counsel, the Office of the Vice Chancellor for Research, or the Chair of the Disclosure Review Committee.

Part II

Guidelines on Disclosure and Management of Conflicts of Interest in Academic-Industrial Relationships

Approved by the Executive Faculty May 4, 1994.
  1. Introduction

    The Disclosure Review Committee (DRC) at the School of Medicine is charged with responsibilities described in Part I, Section D., IMPLEMENTATION, of the Washington University Conflict of Interest Policy (the "Policy").

    In general, it is the DRC's responsibility to:
    1. Formulate guidelines, applicable to faculty, that identify the types of potential conflicts of interest in academic-industrial relationships that will be considered material;
    2. Prepare a faculty annual disclosure review form;
    3. Develop procedures to obtain and review information supplied by faculty on the annual disclosure review form;
    4. Develop procedures to manage or eliminate material conflict of interest;
    5. Maintain records necessary for reporting to the federal government on management of conflict of interest; and
    6. Assure confidentiality of the disclosure, review and management of the conflict of interest, to the extent possible.
    For purposes of this document, 'faculty' shall be defined to include University employees with an academic appointment of instructor or higher on all three tracks.
  2. Policy Statement

    The growing involvement of academic investigators with industrial organizations has raised concerns about potential conflicts of interest in these interactions. The DRC acknowledges that conflicts of interest are neither inherently wrong nor avoidable in all cases. The term conflict of interest indicates that a conflict-containing situation exists and does not presume that undesirable actions have, or will, occur.

    Situations in which real or perceived conflicts of interest may exist cannot be completely avoided without severely impairing the many desirable consequences of academic-industrial interactions. Therefore, it is not the intention of the DRC to ban all conflicts. Rather, the DRC's responsibility is to develop the means to manage material conflicts of interest. The goal is to ensure that the integrity of the investigator, the institution, and the academic research, training or clinical activities are not compromised or perceived to be compromised by considerations of personal gain or financial benefit.
  3. Guidelines for Identifying Material Conflicts of Interest

    The following statements identify factors that increase the risk that a situation will have inherent potential for conflict of interest and that the conflict of interest will be material. The policy defines a conflict of interest as 'material' if "an ordinary person would take it into account in making a decision." As a general rule, if a situation poses a higher degree of risk or has greater potential for adverse consequences, it is more likely that aggressive management oversight will be necessary.

    In assessing the risk that a conflict of interest may be created by the relationship of a faculty member with a company, the DRC agrees that, in general:
    1. The risk of conflict of interest increases with the magnitude of the personal compensation received or expected.
    2. A critical threshold is crossed when an investigator's relationships with a company enlarge to include an academic research program. A conflict of interest is then possible at the most fundamental levels of research, including design of experiments and data collection. Additional possible conflicts may arise with respect to the faculty member's obligations to the University or to other research sponsors. The University must also consider its responsibilities to ensure appropriate use of University resources, protection of ownership rights and compliance with requirements of research sponsors.
    3. The risk of conflict of interest is inherently greater when an investigator holds equity rather than receiving personal cash compensation from a company. To the extent that the research outcome can influence equity value, and to the extent that the investigator can profit thereby, holding of equity may jeopardize research integrity.
    4. The involvement of trainees in research supported by a company creates risk that academic training will be compromised. The primary goal of training must be to further academic development, and the trainee must have the freedom to publish in a timely fashion and to pursue academic goals upon leaving the program.
    5. The use of human subjects in work by an investigator who has compensation from a company creates for the human subjects additional risk for adverse consequences. Patients must be recruited and treated with full protection of their personal rights and their right to ethical and impartial clinical management.
    6. Investigators in positions of leadership in the institution have a greater risk of conflict of interest. Adverse consequences are magnified when decisions are made by those with a high level of responsibility.
    With these guidelines in mind, the following sections describe the management procedures that may be cumulatively applied in situations that present increasing risk of material conflict of interest.
  4. Management Procedures

    A set of procedures shall be utilized for the management of situations that present material conflicts of interest. The management tool chosen will depend on the DRC's assessment of the degree of risk in the situation and the appearance that the integrity of the investigator, the research, or the institution may be compromised by considerations of personal gain or financial benefit.

    The procedures for management fall into general categories of increasing levels of oversight and may be cumulatively applied. The major categories are outlined below, with selected examples of situations in which use of the management procedure would be appropriate. In the examples, holding of equity or a financial interest by either a faculty member or his or her family are equivalent. The policy defines 'family' to include the faculty member's spouse and minor children. The description below is not meant to be all-inclusive, and additional procedures may be required in particular circumstances.

    1. Management Level One: Disclosure
      A potential material conflict of interest must always be disclosed. Initially, a Financial Disclosure Statement (See https://research.wustl.edu/Pages/ResearchGateway.aspx ) will be filled out. These forms are provided to all new faculty members in the faculty packet. After completing the form, it is sent to the appropriate department chairperson for signature and then forwarded to the DRC office for review and approval. Faculty are required, at a minimum, to make an annual disclosure . If a research agreement is completed with a research sponsor in which the faculty member has a consulting, licensing or equity relationship, it is likely that the Financial Disclosure Statement will need to be updated.
      1. In most situations, annual disclosure to the DRC will be the only management required. Examples requiring only this level of management include:
        • Holding of equity in a company involved in biomedical research that does not directly involve the faculty member's academic program.
        • Serving as an executive or advisor to a nonprofit organization supporting research activities at the University.
        • Receipt by a faculty member of cash royalties for published work.
        • Cash compensation from a for-profit company for services, such as consulting or speaking, when there is no other relationship between the company and the faculty member.
      2. In many situations, annual disclosure to the DRC and disclosure to others as specified may be required.

        Examples requiring only this level of management include:
        • Receipt of equity compensation for services as a consultant to a for-profit company, when there is no other relationship between the company and the faculty member. Public disclosure of the relationship in publications in the scientific areas that are the subject of company business will be necessary.
        • Assignment of a trainee to work on a project sponsored by a forprofit company, when no personal (e.g. consulting) relationship exists between the faculty member and the company. Disclosure of the conditions of the sponsored research agreement will be made to the trainee and to the thesis advisory committee (for students in the Division of Biology and Biomedical Sciences) or to the department chair (for postdoctoral fellows and residents).
        • Potential receipt of cash royalty or other cash licensing income for technology developed in the course of research on the technology. Public disclosure of the relationship in publications on the technology may be necessary.
    2. Management Level Two: Review and Approval of Contemporaneous Research and Consulting
      A situation may exist in which a faculty member doing research sponsored by a company also has another relationship with the company, such as consulting. Existence of multiple relationships with a company can create a material conflict of interest. These situations will be managed by disclosure of the relationships during the negotiation and approval of the terms for the sponsored research agreement.

      (A 'sponsored research agreement' is one in which a company provides financial support for research in exchange for certain rights in the resultant technology, and includes contracts, grants and clinical trials or other service agreements.) Management of a conflict of interest arising after a sponsored research agreement is already in place also will require review and possible negotiation of any proposed consulting agreements. In addition, public disclosure of the relationship with the company upon publication of results shall always be necessary. If a material conflict of interest cannot be otherwise managed, the University may decline to enter into a research agreement.

      Examples requiring this level of management include:
      • Receipt of cash or equity compensation for consulting services to a for-profit company that has proposed a sponsored research agreement involving the faculty member's academic program. Review of the proposed sponsored research agreement and the extant consulting agreement by the appropriate University office may be required. The sponsored research agreement will be modified when necessary to avoid conflict-creating provisions relating to publication rights, confidentiality and ownership of the resultant technology.
      • Support of a faculty member's academic program by a sponsored research agreement with a for-profit company that has proposed a consulting relationship with the faculty member. Review of the proposed consulting agreement by the University office that established the sponsored research agreement may be required. Provisions relating to publication rights, confidentiality and ownership of resultant technology are to be identified and adjusted.
      • Both consulting and sponsored research agreements exist, as above, but in addition trainees are involved in the sponsored research. Review of the consulting and the sponsored research agreements may be necessary, following disclosure of the involvement of trainees to the University office that established the sponsored research agreement. The existence of the consulting relationship must be disclosed to the trainee, to the thesis advisory committee and/or to the chair of the department, as appropriate.
      • Participation in a clinical trial supported by a company for which the faculty member also is being paid for services, such as consulting or speaking. The faculty member's financial involvement with the company must be disclosed to the IRB prior to approval of the protocols. The IRB may require further disclosure to the participants in the trial. Disclosure of the consulting relationship to the appropriate University office will be necessary during review of the research agreement.
    3. Management Level Three: Equity
      Additional management procedures will likely be required when a faculty member's ownership of equity creates a material conflict of interest. These situations will always require a careful review of any agreements by the appropriate University office, as well as public disclosure of the relationship with the company upon publication of results. Management may also involve sequestration of the equity pursuant to an agreement between the faculty member and the University or placing the equity in escrow or trust. Equity will remain sequestered during the period of research support or until such time as the research results can no longer cause a substantial change in the value of the equity. The limits of the sequestration will be agreed upon prior to the acceptance of a sponsored research agreement. (Specific questions about escrow accounts may be directed to the Office of General Counsel.)

      Procedures for management other than escrow may include divestiture of the equity, waiver of the faculty member's rights to equity through licensing, transfer of the research project to another investigator without a conflict, or the University may decline to enter into a sponsored research agreement.

      Examples requiring this level of management include:
      • Having an equity-compensated position with, or holding equity in, a company that has proposed a research agreement to support the faculty member's academic program. The faculty member's financial interest in the company must be disclosed on the annual disclosure, and to the appropriate University office during review of the research agreement. The DRC may stipulate that if the sponsored project is to be accepted by the University, the faculty member's equity holding must be placed in escrow.
      • Entering into an equity-compensated consulting position for a company already supporting research. In addition to full disclosure and review of the consulting agreement, the DRC may stipulate that if the equity is to be accepted by the faculty member for consulting, conflict of interest must be managed by placing the equity in escrow.
      • Participation in research on a technology owned or controlled by a company in which a faculty member has a substantial financial interest. The circumstances must be fully disclosed at the annual disclosure and to the appropriate University office during review of the research agreement. In general, equity will be placed in escrow during the period of, and perhaps for a period subsequent to, the research support.
      • Equity compensation by, or holding of equity in, a company that is sponsoring a phase II, or beyond, clinical trial in which the faculty member is involved. The equity will be disclosed to the department chair, the appropriate University office and to the IRB before any research support agreement or research protocols are approved. In general, holding of equity in these circumstances will be extremely difficult to justify and effectively manage due to the potential adverse consequences of such a conflict of interest.
  5. Disclosure and Review Process

    The disclosure and review process is described in Part I of this booklet, "Policy on Conflict of Interest," Section D. In general, faculty are required to complete a confidential Financial Disclosure Statement annually. The Financial Disclosure Statement will be reviewed initially by the faculty member's department chairperson (or his or her designee). Following the chairperson's review, the form will be sent to the DRC for evaluation. The DRC will report its conclusions and recommendations for management, if any, to the faculty member and the department chairperson (or his or her designee). Any unresolved situations will be referred to the Dean or the Conflict of Interest Review Committee (CIRC) as provided in Part I, Section D.7. The DRC shall take steps to ensure the confidentiality of the disclosure and review process.