Policies, Procedures and Guidelines

Determining and Managing Research FCOIs Procedures

1. Introduction

The following describes the Conflicts of Interest Review Committee’s (CIRC) procedures and considerations for a) reviewing individuals’ personal financial interests, b) determining whether there is a material financial interest, c) evaluating its relatedness to the research and risks, to determine if a financial conflict of interest exists. It also provides guidelines and examples for managing financial conflicts of interest.

2. Determination of a Material Financial Interest

The CIRC will review an individual’s personal financial interests and those of their spouse and/or dependent child(ren), and determine whether it is material based on the Disclosure Review and Management Thresholds.

3. Determination of Relatedness

Once a material financial interest with an entity is identified, the CIRC will consider, for example, the following questions to assess its relatedness to the research:

  • Are the activities of the entity related to the subject of the research?
  • Could the research directly benefit the entity?
  • Does the entity support or sponsor the research?
  • Does the entity own or license intellectual property studied in the research?

4. Determination of a Financial Conflict of Interest

The determination of a financial conflict of interest is based on:

  • The determination of relatedness; then
  • The degree of risk associated with the situation;
  • Whether the situation meets the definition of a financial conflict of interest.

The WUSTL Research Conflicts of Interest Policy defines a financial conflict of interest as: “A situation in which it is reasonably determined that a material financial interest could directly and significantly affect the design, conduct, or reporting of research.” In assessing the extent of a financial conflict of interest, the CIRC considers such factors as the nature of the research, the magnitude of the 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 in the design, performance, or interpretation of the study, and/or the degree of risk to any human subjects involved.

As a general principle, the higher the degree of risk for adverse consequences of a financial conflict of interest, the higher the standards of management that will be necessary to address the situation. According to the WUSTL Research Conflicts of Interest Policy, the following factors identify the increased risks associated with a financial conflict of interest and affect the management plan. The risk of a financial conflict of interest 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 information 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.

viii. When the research involves human subjects and the individual has a material financial interest in the entity supporting 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 in order to assure the objectivity and integrity of the research and protection of the research participants.

Examples of situations that would not typically be determined to be a financial conflict of interest and therefore, not require management

  • Consulting for or advising a non-profit entity
  • Receipt of cash royalties for published work (e.g. books) or other paid authorships (that are allowable under WUSTL policies)
  • Travel to meetings for professional societies or travel directly related to sponsored research activities

5. Management Guidelines

When the CIRC determines a covered individual has a financial conflict of interest, a management plan is developed to address the financial conflict of interest. The following are management options commonly employed:

a. The individual discloses his/her material financial interests and, when deemed appropriate, the details of the management plan:

  • In presentations and publications
  • To the Principal Investigator (PI)/Project Director (PD) and other individuals involved in the design, conduct or reporting of the research
  • To trainees, which includes disclosure to the thesis advisory committee
  • To the research participants, for human subjects research

b. When trainees are involved in the research, appointment of a co-advisor or removal of the conflicted individual as the chair or member of the thesis advisory committee

c. Modification of the conflicted individual’s role in the research to minimize the individual’s influence over the design, conduct, or reporting of the research

d. Additional oversight:

  • Independent data analysis;
  • Independent review of publications; and/or
  • Appointment of an independent monitor(s) capable of taking measures to protect the design, conduct, and reporting of the research against bias resulting from the financial conflict of interest

e. Removal of the conflicted individual from participation in all or a portion of the research

f. Divestiture or reduction of the financial interest/severance of the relationship that creates the financial conflict of interest

6. Management Examples

Management Level One (non-clinical research)
This degree of management is typically applied in situations in which an individual has a material financial interest, such as cash compensation or royalties, from an entity whose interests are directly related to the research being performed, but that does not sponsor the research. Management options include:

  • Disclosure of the financial relationship (e.g. in publications and presentations related to the research, and to the PI/PD and others as appropriate). The requirement for disclosure will depend upon how related the research is to the entity’s activities and the degree of risk related to the financial conflict of interest.
  • For receipt of cash royalties:
    • When directly evaluating licensed IP, disclosure is required. Depending upon how directly the research could affect the value of the IP, additional management may be needed to protect the objectivity of the research.
    • When using but not evaluating licensed IP in research, disclosure may be required, depending on the extent of its use in the research or relatedness to the research.
    • When the royalties resulting from the licensed IP are from fixed/flat fee agreements, disclosure is not necessary.

Management Level Two (non-clinical research)
This degree of management is typically applied when an individual has material financial interests with an entity, excluding ownership interests in non-publicly traded entity, and the entity is supporting the research. Management options include:

  • Disclosure of the financial relationship (e.g. in publications and presentations related to the research, and to the PI/PD and others as appropriate) shall always be necessary.
  • When trainees are involved in the above research, the financial relationship must be disclosed to the trainee, to the thesis advisory committee and/or to the chair of the department/division chief, as appropriate.
  • When there is a high level of risk and a financial conflict of interest cannot be otherwise managed to adequately protect the objectivity of the research, the University may decline to enter into a sponsored research agreement or the individual may choose to reduce his/her personal financial interest to below the threshold for a material financial interest.
  • For receipt of cash royalties:
    • When directly evaluating licensed IP, disclosure is required. Depending upon how directly the research could affect the value of the IP, additional management may be needed to protect the objectivity of the research.
    • When using but not evaluating licensed IP in research, disclosure may be required, depending on the extent of its use in the research or relatedness to the research.
    • When the royalties resulting from the licensed IP are from fixed/flat fee agreements, disclosure is not typically required.

Management Level Three (non-clinical research)
This degree of management typically applies when the individual has ownership of equity in a non-publicly traded entity and the entity is supporting the research or when the individual’s 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. In these situations, there is a greater concern regarding the objectivity of the research. Management options include:

  • Disclosure of the relationship (e.g. in publications and presentations related to the research, and to the PI/PD and others as appropriate) shall always be necessary
  • For trainees involved in the above research, the financial relationship must be disclosed to the trainee, to the thesis advisory committee and/or to the chair of the department/division chief, as appropriate
  • In instances where there is a high level of risk and a financial conflict of interest cannot be otherwise managed to protect the objectivity of the research, the individual may choose either to reduce his/her personal financial interest or discontinue all involvement in the design, conduct, and reporting of the research.
  • Additional management options may include:
    • Modification of the individual’s role within the study (e.g. removal from collecting data, analyzing data, and/or role as PI);
    • Requirement for independent data analysis;
    • Monitoring of publications by the CIRC (may include submission to the CIRC in parallel to submission to the journal or pre-review by the CIRC or others as delegated);
    • Oversight of the research (e.g. oversight committee)— typically used when there are no other means of satisfactorily managing the financial conflict of interest;
    • Prohibition of work by the individual at both the company and the University on the same research project; and/or
    • For research, such as SBIR/STTR Phase II funding, the PD/PI for the small business and the PD/PI for the subagreement to the University must be different individuals.

Management Level Four (clinical research)
The highest level of review and management is applied when an individual is involved in the design, conduct, or reporting of research involving human subjects and has a financial relationship in the entity that is supporting the research or that owns or licenses the technology being studied. Level four management is required when the individual’s financial relationship with the entity exceeds $10,000 in a twelve month period, is greater than or equal to 5% ownership interest in a publicly traded entity or when the individual has any ownership interest in a non-publicly traded entity.

In many instances, it may be possible for an individual to be involved in such research projects despite the presence of the above financial relationship if adequate safeguards are in place to ensure the integrity and objectivity of the research and the protection of the participants. The CIRC utilizes the following primary criteria in evaluating situations that fall into this category:

  • Research is in its early stages and the potential for bias is negligible.
  • Individual is uniquely qualified by virtue of his/her expertise and experience. Additionally, as determined by the CIRC, the research could not otherwise be conducted as safely, effectively, and/or as quickly without that individual’s involvement.
  • Research is to develop an early stage discovery that may require the insights, knowledge, perseverance, laboratory resources, or special patient populations of the individual.
  • Research is not designed to support a new indication or application of the licensed technology.
  • Research presents little or no risk to the human participants.
  • The outcome of the research cannot affect the value of the financial interest and/or the value of the entity.
  • Research is in the best interests of the patients who would have direct benefit from their involvement in the research.
  • Financial interest/relationship is unrelated to the research.
  • Sufficient mechanisms exist in the study design that the conflicted individual’s influence over the design, conduct, and reporting of the research is sufficiently low, for instance:
    • The study is multi-centered, randomized, double-blinded
    • The individual is adequately separated from significantly influencing and/or not involved in one or more of the following:
      • study design
      • consenting process
      • determining eligibility criteria of the participants
      • collecting the data
      • analyzing the data
      • reporting the results

The CIRC’s determination that there are adequate safeguards in place to ensure the integrity and objectivity of the research and the protection of the participants must be approved by the Vice Chancellor for Research and applicable Dean, given the high level of concern for these types of situations.

For the situations that fall into this category, the following management must always occur:

a. Disclosure of the material financial interest in publications and presentations related to the research, to the research team (PI/PD and others as appropriate)and to research participants shall always be necessary; when trainees are involved in the above research, the financial relationship must be disclosed to the trainee, to the thesis advisory committee and/or to the chair of the department/division chief, as appropriate

Additional management strategies, dependent upon relatedness and risk, may commonly include:

b. When trainees are involved in the research, appointment of a co-advisor or removal of the conflicted individual as the chair or member of the thesis advisory committee

c. Modifying the individual’s role within the study (e.g. removal of the individual from obtaining informed consent, determining enrollment criteria, collecting data, analyzing data, and/or serving as PI)

d. Requiring independent data analysis

e. Monitoring by the CIRC of publications (may include submission to the CIRC in parallel to  submission to the journal or pre-review by the CIRC or others as delegated)

f. Monitoring adherence to the human studies protocol (referral to the HR QA/QI committee)

g. Oversight of the research (e.g. oversight committee)— typically used when there are no other means of satisfactorily managing the financial conflict of interest.

In instances when the CIRC determines there are not adequate protections in place to ensure the objectivity of the research and protection of the participants, and the management options outlined above will not adequately address the financial conflict of interest, the following management must occur:

h. The individual’s personal financial interest must remain under the threshold for a material financial interest for the duration of the study through first publication of the study results.

or

i. The individual must discontinue any involvement with the design, conduct, and reporting of the research. This includes, but is not limited to, discontinuing involvement with all activities related to enrolling subjects, collecting and/or reviewing research data, authorship of manuscripts, and supervising individuals involved with the research. Furthermore, the individual must not serve as the PI, Co-PI, collaborator, or a member of the research team.

Originally effective October, 20, 1993 and amended December 17, 1993 for the University
Originally effective June 9, 1993 and amended February 2, 1994, for the School of Medicine