Conflict of Interest Policy
Adopted October 20, 1993 by the University Faculty Senate Council, and accepted as
amended on December 17, 1993 by the University Faculty Senate.
The faculty and administrators at Washington University recognize a shared
responsibility to ensure that they conduct themselves in an unbiased manner and serve the
goals of the University. It is thus the responsibility of the University and its employees
to guard against conflicts of interest which might compromise the integrity and
objectivity of the University community.
It is understood that the faculty, as developers of knowledge, have a unique
opportunity and responsibility to disseminate that knowledge to the public. By adopting
this Conflict of Interest Policy, the University 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 University 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 University policy has been prepared to outline the University's
approach to identifying and evaluating potential conflicts of interest and assisting its
employees in addressing conflict of interest issues. It has been, and shall continue to
be, the policy of Washington University that all University 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 University. This policy builds
on the principles established by the 1964 Statement of the Council of the American
Association of University Professors and the American Council on Education, incorporated
into University policy in 1977, and on the 1978 Report of the Committee on Confidentiality
Agreements and Externally Sponsored Activities (the "Niland Report"), and
incorporates governmental requirements. This policy statement, effective October 20 1993,
replaces all previous written, unwritten, or uncollected University conflict of interest
- Application of Policy
This policy is applicable to:
- All University faculty members.
- All University staff members.
- Employee. Any person covered by this policy as provided in Section A.
- Dean. Principal academic officer of a School of the University.
- 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.
- 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 judgment in conducting or reporting research. The bias can affect collection, analysis, and interpretation of data, hiring of staff, procurement of materials, sharing of results, choice of protocol, and the use of statistical methods. Conflicts of interest can affect all scholarly fields.
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 may have the appearance of compromising, decisions made by administrators.
- A conflict of interest is material if an ordinary person would take it into account in making a decision. Only material conflicts of interest are within the scope of this policy.
- Family. For purposes of this policy, family is defined as the employee's spouse and minor children.
- Financial Interest. Any relationship, including a consulting relationship, entered into by the employee or his or her family, other than employment by the University, which could result in financial gain for the employee or his or her family.
- 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.
- 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.
- 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 an Institutional Review Board of Washington University.
- General Principles. As a natural outgrowth of personal commitment to academic principles, University employees must ensure the integrity of their academic 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, University employees shall disclose any potential conflict of interest that is or may be material.
- Identification of Conflict of Interest. Identifying conflict of interest is not a simple task. A University employee has a 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.
- Consulting activities.
- The purchase of goods or services for the University 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.
- Receipt of gifts, gratuities, loans, or special favors (including trips or speaker's fees) from research sponsors or vendors.
- 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.
- Holding of an equity, royalty, or debt instrument interest by the employee or the employee's family in an 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.
- Receipt, directly to the employee from non-University sources, of cash, services, or equipment provided in support of the employee's University activities.
- Some memberships on board of directors, committees, advisory groups (or similar bodies) of governmental, for-profit or not-for-profit entity.
- Use of information received as a University employee for personal purposes.
- 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 problems exist, provision will be made to correct them in an orderly and reasonable fashion.
- Protection of Academic Freedom and Integrity
- 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) and/or restrictions on the dissemination of research data should not be permitted.
- Special care should be exercised in the involvement of students, including fellows at the post-doctoral 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.
- Research Performed Under Contract to a Company.
- 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.
- 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 under Section D any consulting or other financial interest as defined by this policy, in any entity that manufactures, sells, or otherwise has property rights in the type of product to be studied.
- When no financial interest is involved, the disclosure requirement may be satisfied by certifying to that fact.
- 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, and recommendations for resolution will be provided as described in Section D. The activity creating the possible conflict of interest shall not be initiated unless authorized through the mechanisms provided in Section D.
- Disclosures by employees who are involved in collaborative projects that cross school boundaries shall be reviewed by the Disclosure Review Committee (DRC, defined in Section D of this policy) of the school in which the employee has his/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 as a result of decisions of several DRCs that relate to the same project, such disputes shall be referred to the Conflict of Interest Review Committee (CIRC, see D.3.c) for resolution.
- Authority. Each school shall develop and administer procedures to implement this policy that include at least the elements outlined in this Section D, and shall place a copy of the procedures on file with the University's General Counsel.
- Disclosure Review.
- Faculty disclosures shall be referred to a standing committee(s), the Disclosure Review Committee (DRC), which shall include representation from the faculty and the office of the University's General Counsel. The deans of the school are each responsible for the establishment of appropriate DRCs, and each school must either have its own DRC, or may participate in a joint DRC established for a subset of the schools. It shall be the responsibility of each DRC to keep and maintain in a secure manner such files that may be required to comply with federal regulations on conflict of interest.
- Disclosures by non-faculty employees who are subject to this policy shall be provided to their immediate supervisors for review and management. Disclosures by Officers of the University shall be made to the chancellor, who shall, with the advice of the University's General Counsel, resolve any conflicts of interest and who shall report any such resolution annually to the Audit Committee of the Board of Trustees.
- Faculty Disclosures
- All faculty members subject to this policy shall disclose, using a standard format developed by the relevant Disclosure Review Committee (DRC), financial interests, either as required by this policy or by government regulations or policy. Disclosures either shall be made directly to the DRC or, alternatively, to the department head for referral to the DRC, according to the implementation mechanism established by the school. Heads of department shall make initial disclosures to the relevant dean, for transmittal to the DRC. The review of the disclosures shall include an evaluation of each situation on its own merits, and, if potential conflict is noted, will include a written recommendation for its management. The evaluations of disclosures of the faculty shall either be generated by the relevant DRC, or be reviewed and approved by the relevant DRC.
- A school may adopt guidelines providing 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 this policy and with federal law and regulations regarding conflict of interest.
- The provost, or any other representative appointed by the chancellor, shall establish a Conflict of Interest Review Committee (CIRC) for the University, which shall include the University's General Counsel, and which shall (a) review and manage any unresolved conflicts of interest that may be referred to the CIRC from a school (see Section D.7) and (b) resolve questions arising from conflicts of interest in projects that cross school boundaries and are not satisfactorily resolved by the relevant DRCs (see Section C.5.e).
- The deans shall provide personal disclosures to the chancellor, who shall, with the advice of the University's General Counsel, resolve any conflicts of interest, and who shall report on such resolution annually to the Audit Committee of the Board of Trustees. The chancellor's disclosure shall be made to the Audit Committee of the University Board of Trustees.
- Timing of Disclosures. Faculty disclosures shall occur upon the request of the dean of a school and may be required on an annual basis. Disclosure by staff shall occur upon request of the relevant supervisor and may occur on an annual basis. Faculty disclosures shall also be required at the time of proposal of company-funded research or clinical trials, as provided in 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 previous disclosed, changes in a manner that is relevant to the concerns of this policy.
- 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.
- Identification and Management of Conflict of Interest. The DRC shall develop procedures to promptly evaluate faculty conflict of interest and shall share its written conclusions and recommendations with the faculty member and his/her immediate supervisor. Whenever appropriate the DRC, or when necessary, the dean or his/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/her designee shall report conflict disclosures and their resolution to appropriate governmental agencies.
- 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 the Conflict of Interest Review Committee (CIRC) established by the provost, or any other representative appointed by the chancellor.
- Amendments to the Policy. This policy may be amended by the chancellor, or the chancellor's designee, with the concurrence of the Faculty Senate whenever changes of substance or procedures are required, and in particular to comply with governmental requirements. The deans shall inform the faculty of any such required change and arrange for the dissemination of information concerning amendments made to the policy.
- Accessibility of Information
To allow the implementation of this policy, the dean or his/her designees, may seek from employees subject to this policy any information relevant to ensuring compliance with this policy. Because the integrity and, therefore the credibility of scholarly activity 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 is required by law.
- Noncompliance 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 in particular the University Policy on Academic Freedom, Responsibility, and Tenure.
- Prohibition of Illegal Activity and Corruption
Activities which are in violation of federal, state, or local law, including the offering or acceptance of a bribe or kickback, are strictly prohibited.
Questions concerning the interpretation or applicability of this policy should be directed to the chair of the relevant Disclosure Review Committee.
Guidelines on Disclosure and Management of Conflicts of Interest in Academic-Industrial Relationships
Approved by the Danforth Disclosure Review Committee April 14, 1999
The Danforth Disclosure Review Committee (DRC) is charged with responsibilities described in Section D., IMPLEMENTATION, of the Washington University Conflict of Interest Policy (the "Policy").
In general, it is the DRC's responsibility to:
- Formulate guidelines, applicable to faculty, that identify the types of potential conflicts of interest in academic-industrial relationships that will be considered material;
- Prepare a faculty annual disclosure review form;
- Develop procedures to obtain and review information supplied by faculty on the annual disclosure review form;
- Develop procedures to manage or eliminate material conflicts of interest;
- Maintain records necessary for reporting to the federal government on management of the conflict of interest, to the extent possible.
For purposes of this document, "faculty" is defined to include full-time University employees with an academic appointment of instructor or higher on the tenure track, the research-professor track, or the clinician track.
- 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.
- Guidelines for Identifying Material Conflicts of Interest
Identifying conflict of interest is not a simple task. 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. The policy defines a conflict of interest as "material" if "an ordinary person would take it into account in making a decision."
- Consulting activities.
- The purchase of goods or services 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.
- Receipt of gifts, gratuities, loans or special favors (including trips or speaker's fees) from research sponsor or vendors.
- Receipt of significant compensation for a position in a company or for consulting with a company, or holding significant equity in a company, that supports research of the faculty member.
- Receipt of significant compensation for a position in a company or for consulting with a company, or holding significant equity in a company if that company operates in the field of research of the faculty member
- 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.
- Holding of a significant 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.
- Receipt, directly to the employee from non-University sources, of cash, services or equipment provided in support of the employee's University activities.
- Some membership on boards of directors, committees, advisory groups (or similar bodies) of governmental, for-profit or not-for-profit entity.
- Use of information received as a University employee for personal purposes.
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. 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 risk of conflict of interest increases with the magnitude of the personal compensation received or expected.
- 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.
- The risk of conflict of interest is inherently great 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.
- The involvement of trainees/students 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.
- 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 or professional management.
- 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.
- 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, 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.
- Management Level One: Disclosure
A potential material conflict of interest must always be disclosed. Initially, a Financial Disclosure Statement will be filled out. These forms are provided to all new faculty members. After completing the form, it is sent to the DRC 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.
- 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 research that does not directly involve the faculty member's academic program.
- Serving in a compensated position or as advisor to a nonprofit organization supporting research activities at the University.
- Receipt by a faculty member of honoraria for publications or lectures.
- 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.
- 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 for-profit company, when there is no other relationship between the company and the faculty member. Public disclosures of the relationship in publications in the scientific areas that are the subject of company business will be necessary.
- Assignment of a trainee/student to work on a project sponsored by a for-profit 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/student and to the thesis/dissertation advisory committee or to the department chair as appropriate.
- 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.
- 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 may, in some cases, require review of proposed consulting agreements. In addition, public disclosure of the relationship with the company upon publication of results is always 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. Provisions relating to publication rights, confidentiality, and ownership of resultant technology are to be identified and adjusted. In some cases, review of the proposed consulting agreement may be required.
- Both consulting and sponsored research agreements exist, as above, but in addition trainees/students are involved in the sponsored research. The existence of the consulting relationship must be disclosed to the trainee/student, to the thesis/dissertation advisory committee and/or to the chair of the department, as appropriate.
- Both consulting and sponsored research agreements exist, but in addition, human subjects are involved in the sponsored research. The relationship with the company must be disclosed to the Human Studies Committee prior to approval of the protocols. The Human Studies Committee 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.
- 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 Human Studies Committee 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.
Disclosure and Review Process
The disclosure and review process is described in the Policy on Conflict of Interest. In general, faculty are required to complete a confidential Financial Disclosure Statement annually. The Financial Disclosure Statement will be sent to the Disclosure Review Committee (DRC) for evaluation. The DRC will report its conclusions and recommendations for management, if any, to the faculty member and if appropriate to the department chair or equivalent position. Any unresolved situations will be referred to the Vice Chancellor for Research or the Conflict of Interest Review Committee (CIRC). The DRC shall take steps to ensure the confidentiality of the disclosure and review process.