Original Effective Date 10/20/1993
Last Revised Date 8/24/2012
The Washington University Research Conflicts of Interest Program is implemented based on the Policy outlined below. Guidance and processes may be revised from time to time based on the requirements of research sponsors and/or government regulations.
WASHINGTON UNIVERSITY RESEARCH CONFLICTS OF INTEREST POLICY
Washington University seeks to employ faculty and staff of exceptional knowledge, experience, and competence in their respective fields of endeavor. Such individuals have opportunities to share and apply their expertise outside of the University, which also serves as a mechanism of knowledge dissemination. Washington University also has the opportunity and responsibility to disseminate and promote the application of new discoveries and knowledge which its faculty, staff, and students create and seeks to maximize the public benefit from its research as rapidly as possible. An integral component of this process involves moving promising research results and technologies to entities that can develop and commercialize successfully. Principled partnerships with new and existing companies are an effective mechanism for fostering commercial translation and public access to the practical benefits of university research as well as a means of advancing knowledge towards the greatest societal benefit. It is through a confluence of interest and principled collaboration that academia and industry can have a confluence of impact.
Washington University is firmly committed to the responsible and ethical conduct of research. Members of the Washington University community, including faculty, staff, students, and other trainees, are obligated with a shared responsibility to conduct themselves in a responsible, ethical, and unbiased manner while serving the research goals of the University. Moreover, these same individuals have a shared and equal responsibility with those external partners with whom they engage, to act with the same integrity, objectivity and ethical principles. The University must also discharge the responsible stewardship of its resources, compliance with requirements of research sponsors and applicable local, state, and federal statutes, and protection of intellectual property ownership rights. Such are the foundational elements of University/industry interactions, by which society can optimally benefit, and safeguard the public trust in research and the investment therein.
The goal of this policy is to assure that the objectivity and integrity of the researcher, the University, and academic research, training, or other activities are not compromised or perceived to be compromised by considerations of personal gain or financial benefit. It is not the intention of this policy to ban all potential financial conflicts of interest, but rather to develop strategies to effectively and successfully manage financial conflicts of interest to assure the objectivity and integrity of research. The essential components of a conflict of interest program are disclosure, review, assessment and determination, and management. This policy establishes these principles and a mechanism to safeguard the University and its members’ integrity and objectivity so that University/industry interactions can optimally benefit society while establishing that those intersecting interests are not de facto a conflict of interest.
This policy outlines the University’s approach to identifying the personal financial relationships of individuals, evaluating and determining the existence of financial conflicts of interest related to research activities, and developing strategies to manage those conflicts. This policy assists faculty, staff, and students in meeting their obligations to conduct research ethically and objectively and to comply with applicable federal, state, and local regulations and University policies.
This policy applies to “covered individuals,” who are defined as:
a. All University faculty, which for purposes of this policy, shall be defined to include individuals with an academic appointment of Instructor or higher on tenure or non-tenure tracks; and
b. Any other individual who, regardless of title or position, is independently responsible for the design, conduct, or reporting of research at WUSTL, which includes, but may not be limited to, a principal investigator, project director, co-investigator and key personnel. The principal investigator/project director is responsible for making the determination of any other individuals who meet this definition.
5. Definitions – For the Purposes of This Policy
a. Conflict of Interest Review Committee (CIRC): refer to Section 7.a.i.
b. Covered Individual: refer to Section 4.
c. Entity: includes public or non-publicly traded companies and non-profit organizations.
d. Equity or Debt Instrument: includes, but is not limited to, preferred and common stock, stock options, warrants, bonds, and notes.
e. Faculty: refer to Section 4.a.
f. Family: a covered individual’s spouse and/or dependent children.
g. Financial Conflict of Interest (FCOI): a financial conflict of interest exists when it is reasonably determined that a personal financial interest could directly and significantly affect the design, conduct, or reporting of research.
h. Financial Interest: anything of monetary value, whether or not the value is readily ascertainable.
i. Human Subjects Research: any investigation or organized activity, regardless of funding source, involving patient oriented research, behavioral research, or epidemiological, outcomes, or health services research, which requires approval by an Institutional Review Board of Washington University.
j. Institutional responsibilities: an individual’s professional duties and responsibilities on behalf of the University. These may include, but are not limited to activities such as research or other scholarly inquiry, education, professional practices, clinical activities, administration, institutional committee membership, and service on panels such as internal review boards and data and safety monitoring boards.
k. Manage: taking action(s) to address a FCOI, to ensure, that the design, conduct, and reporting of research will be free from bias.
l. Office of Research Integrity & Ethics (ORIE): refer to Section 7.a.ii.
m. Research: a systematic investigation, study, or experiment designed to develop or contribute to generalizable knowledge. This includes basic, behavioral, and social sciences research and encompasses basic and applied research (e.g. a published article, book or book chapter) and product development research (e.g. diagnostic test or drug).
n. Research Activities: any research, including clinical research, materials evaluations, or general research projects that may be unfunded or performed under an agreement or grant with an entity in which the entity provides full or partial funding of the project.
a. Completion of a financial disclosure statement
A covered individual shall complete or update a financial disclosure statement that:
i. identifies all research in which the covered individual is engaged at the time of the disclosure; and
ii. discloses all personal financial interests and those of their family, regardless of value, that appear to be related to the covered individual’s institutional responsibilities.
The covered individual should resolve any doubt about whether research or a personal financial interest should be disclosed, in favor of disclosure. Covered individuals will provide any additional information, as requested by the designated official(s), relevant to ensuring compliance with this policy.
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 financial conflicts of interest and who shall report any such resolution annually to the Audit Committee of the Board of Trustees.
b. Timing of disclosures
Disclosures shall occur upon the request of the designated official(s) and are, at a minimum, required annually. Disclosures may also be required at the time of submitting a research proposal, establishing the research fund, or prior to engaging in research, and will occur at such other times as may be required by law or federal regulations or when the covered individual’s personal financial interest, as previously disclosed, changes in a manner that is relevant to the concerns of this policy.
c. Access to disclosure information
Financial disclosures will primarily be viewed by the designated officials and may include other University officials as appropriate. Financial disclosure may also be made available to the deans, department chair, or equivalent positions as appropriate.
7. Disclosure Review
i. The Conflicts of Interest Review Committee(s) (CIRC) is the designated official(s) responsible for evaluating financial disclosures. The CIRC is a standing faculty committee, designated with the responsibility to provide an independent peer-reviewed assessment of personal financial interests reported by covered individuals. Membership will be appointed in accordance with the CIRC Member Appointment Procedures.
ii. The Office of Research Integrity & Ethics (ORIE): refer to Section 7.a.ii., an administrative unit under the Office of the Vice Chancellor for Research, is designated with managing the administration of the University’s research conflicts of interest program and provides support to the CIRC.
i. The CIRC’s responsibilities include, but may not be limited to:
- Overseeing the development of procedures and forms to obtain and review information supplied by covered individuals;
- Formulating standards that are used to identify financial conflicts of interest and management plans;
- Establishing procedures to determine when a personal financial interest is material; evaluating its relatedness to research and risks in determining whether a financial conflict of interest exists;
- Determining appropriate management of FCOIs;
- Overseeing the development of education for covered individuals;
- Developing mechanisms for coordination of any reporting that may be required;
ii. Members of the CIRC who are co-investigators or persons with a material personal financial interest in any entity named in an individual’s disclosure shall recuse themselves from reviewing the disclosure.
iii. The ORIE’s responsibilities include, but may not be limited to:
- Completing preliminary assessments of the financial disclosures to determine whether further review is required, in accordance with CIRC processes;
- Documenting the review and outcome of the financial disclosure reviews; keep and maintain records, in a secure manner, necessary for compliance with applicable policies and federal regulations, to the extent possible;
- Developing procedures and forms to obtain and review financial disclosure information;
- Monitoring compliance with management plans and applicable policies and processes, evaluates potential non-compliance, initiates investigations, and oversees implementation of corrective actions;
- Submitting appropriate reports to federal, state, sponsor, or regulatory agencies;
- Assuring the delivery of education for covered individuals.
8. Determination of a Conflict of Interest
a. Material Financial Interests
Personal financial interests, defined as anything of monetary value, regardless of whether the value is readily ascertainable, must be disclosed as outlined in Section 6.a. above. However, only certain personal financial interests will be deemed material in determining whether a FCOI exists. The standards for defining a material financial interest shall be established by the CIRC in accordance with applicable federal, state, sponsor, or regulatory agencies, as appropriate.
b. Financial Conflicts of Interest
For the purposes of this policy, a FCOI refers to situations in which it is reasonably determined a personal financial interest could directly and significantly affect the design, conduct, or reporting of research. The bias can affect all aspects of the research, which may include, but not be limited to, collection, analysis, and interpretation of data, hiring of staff, obtaining materials or tissues, sharing of results, choice of protocol, or the use of statistical methods.
Only FCOIs are within the scope of this policy. In their wider roles as academicians and professionals, covered individuals may be subject to conflicts of interest that are not necessarily financial and that are not within the scope of this policy.
The CIRC evaluates individuals’ personal financial interests and assesses its relatedness and risks in determining whether a conflict of interest exists and, when applicable, in determining the appropriate management plan. The research creating the financial conflict of interest shall not be initiated unless authorized by the CIRC.
c. Assessment of Risks
In assessing a FCOI, the CIRC shall consider such elements, that may include, but are not necessarily limited to, the nature of the research, the magnitude of the personal financial interest, the degree to which the interest is related to the research, the extent to which the research performance, outcome, or both could affect the value of the interest, the potential to introduce bias by study design, performance, or interpretation, and/or the degree of risk to the human subjects involved. The following statements identify factors that increase the risks associated with a FCOI and shape the management plan. The risk of a FCOI increases:
i. With the magnitude of the material financial interest.
ii. With the extent of the individual’s ability to directly influence the design, conduct, or reporting of the research.
iii. With the involvement of trainees/students in research supported by an entity with which the individual has a material financial interest. 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.
iv. When the individual holds equity in an entity and the extent to which the research outcome can influence equity value (e.g. the individual can materially benefit).
v. When the individual is in a position of leadership in the University. Adverse consequences are magnified when decisions are made by those with a high level of responsibility.
vi. When the individual has a material financial interest with an entity and there is research performed under an agreement with that entity or involving the evaluation of technology owned or licensed by that entity. To preserve the integrity of research arising from these arrangements it is necessary to take particular care to manage the financial conflict of interest.
vii. When the research is directly evaluating or developing intellectual property/technology owned or controlled by the entity in which the individual has an ownership interest and/or fiduciary responsibilities, there is greater concern regarding the objectivity of the research.
viii. When the research involves human subjects and the individual has a material financial interest in the entity sponsoring the research or owns or licenses the technology being studied, which may include an entity that manufactures, sells, or otherwise has property rights in the type of product to be studied. Such cases will be held to a higher standard of assessment, adjudication, and management.
9. Management of Material Conflicts of Interest
a. If the CIRC determines a covered individual has a FCOI related to his/her research, it shall develop a management plan governing the FCOI, in accordance with the Procedures for Determining and Managing FCOIS. A management plan will impose conditions and prescribe actions necessary to manage a FCOI.
b. For situations in which the FCOI is not manageable, covered individuals will choose to remove themselves from having a role in the design, conduct, or reporting of the research or chose to divest or decrease their personal financial interest.
c. The management tool chosen will depend on the CIRC’s assessment of the relatedness and risk of the FCOI based on the provisions outlined in Section 8.
d. The CIRC shall provide its written conclusions and management plan to the covered individual and his/her dean, department chair or equivalent position. The management plan will provide that the covered individual acknowledges receipt of the plan, understands the requirements, and agrees to comply with the required action(s) or other terms of the plan.
10. Dispute Resolution [additional guidance]
Unresolved disagreements concerning the application of this policy shall ultimately be referred for final resolution to a committee established by the chancellor or representative appointed by the chancellor.
11. Monitoring for Compliance [additional guidance]
The University will provide regular monitoring of financial disclosure statements and management plans to determine compliance with this policy, and applicable federal regulations or sponsoring agency requirements.
12. Education Requirements [additional guidance]
A covered individual must complete training in regard to this policy and applicable federal regulations as established by the University and/or applicable federal regulations.
The information received to comply with this policy shall be handled confidentially, to the extent possible and/or as described in this policy, unless public disclosure is part of the management plan or such disclosure is required by the University, federal regulations or sponsoring agencies.
14. External Reporting Requirements [additional guidance]
To the extent required, the dean or his/her designee shall report applicable information to appropriate governmental or sponsoring agencies or others as required.
Violations of this policy may subject the covered individual to corrective actions or other sanctions as deemed appropriate by the vice chancellor for research in consultation with the dean of the appropriate school.
16. Policy Approval
Modifications to this policy must be approved by the Executive Committee on Research and communicated to the WUSTL community as appropriate.
Questions concerning the interpretation or applicability of this policy should be directed to the Chair of the Conflict of Interest Review Committee(s), Office of Research Integrity and Ethics, or the Vice Chancellor for Research.