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imageWASHINGTON UNIVERSITY RESEARCH CONFLICTS OF INTEREST POLICY AND GUIDELINES

The Washington University Research Conflicts of Interest Program is implemented based on the Policy, Guidelines and Procedures outlined below. Guidance and processes may be revised from time to time based on the requirements of research sponsors and/or government regulations. 

 Research Conflicts of Interest Policy Research Conflicts of Interest Guidance and Procedures
  1. Preamble
  2. Mission
  3. Purpose
  4. Applicability
  5. Definitions
  6. Disclosure
  7. Disclosure Review
  8. Determination of a Conflict of Interest
  9. Management of Material Conflicts of Interest
  10. Dispute Resolution
  11. Monitoring for Compliance
  12. Education Requirements
  13. Confidentiality
  14. External Reporting Requirements
  15. Sanctions
  16. Policy Approval
  1. Covered Individuals
  2. Financial Interests to Disclose
  3. Travel Procedures and Guidance
  4. Timing of Disclosures
  5. Procedures for Determining and Managing Research FCOIs
  6. Dispute Resolution/Appeals Procedures
  7. FCOI Education Requirements
  8. Material Financial Interests
  9. Information Available to the Public
  10. Monitoring Procedures
  11. Non-Compliance
  12. How to Disclose
 

 

 

imageWASHINGTON UNIVERSITY RESEARCH CONFLICTS OF INTEREST POLICY

1. PREAMBLE
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.

2. MISSION
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.

3. PURPOSE
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.

image4. APPLICABILITY
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. 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). 

m. Research Ethics and Compliance Office (RECO): refer to Section 7.a.ii.

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.

6. DISCLOSURE
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.

image7. DISCLOSURE REVIEW
a. Authority

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 Research Ethics and Compliance Office (RECO), 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.

b. Responsibilities

i. The CIRC’s responsibilities include, but may not be limited to:

    1. Overseeing the development of procedures and forms to obtain and review information supplied by covered individuals; 
    2. Formulating standards that are used to identify financial  conflicts of interest and management plans;
    3. 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; 
    4. Determining appropriate management of FCOIs; 
    5. Overseeing the development of education for covered individuals;
    6. 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 RECO’s responsibilities include, but may not be limited to:

    1. Completing preliminary assessments of the financial disclosures to determine whether further review is required, in accordance with CIRC processes; 
    2. 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; 
    3. Developing procedures and forms to obtain and review financial disclosure information; 
    4. Monitoring compliance with management plans and applicable policies and processes, evaluates potential non-compliance, initiates investigations, and oversees implementation of corrective actions;
    5. Submitting appropriate reports to federal, state, sponsor, or regulatory agencies; 
    6. 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 g​uidance]
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 guidan​ce]
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 [addition​al 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.  
 
13. CONFIDENTIALITY
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 gu​idance]
To the extent required, the dean or his/her designee shall report applicable information to appropriate governmental or sponsoring agencies or others as required.

15. SANCTIONS [additional guid​ance]
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.

Policy Revised:        August 24, 2012
Approved by Executive Committee on Research:     July 9, 2012

Questions concerning the interpretation or applicability of this policy should be directed to the Chair of the Conflict of Interest Review Committee(s), Research Ethics and Compliance Office, or the Vice Chancellor for Research.

Originally effective October, 20, 1993 and amended December 17, 1993 for the University
Originally effective June 9, 1993 and amended February 2, 1994 and July 1996 for the School of Medicine

 

imageWASHINGTON UNIVERSITY RESEARCH CONFLICTS OF INTEREST GUIDANCE AND PROCEDURES

  1. Covered Individuals
  2. Financial Interests to Disclose
  3. Travel Procedures and Guidance
  4. Timing of Disclosures
  5. Procedures for Determining and Managing Research FCOIs
  6. Dispute Resolution/Appeals Procedures
  7. FCOI Education Requirements
  8. Material Financial Interests
  9. Information Available to the Public
  10. Monitoring Procedures
  11. Non-Compliance
  12. How to Disclose
1. COVERED INDIVIDUALS - Who is Required to Submit a Disclosure Statement       [back t​o policy]

 a. All faculty with an academic appointment of instructor or higher on tenure or non-tenure tracks.

  • Includes: Tenure-track faculty, Non-tenure-track faculty (Research, Clinical, Practice, Visiting appointments).
  • May include: Adjunct or Emeritus if they have effort and are involved in research.
  • Does not typically include: Lecturers or Courtesy appointments

b. Individuals, who by definition have independent responsibility for the design, conduct, or reporting of research at WUSTL, which includes:

  • Principal Investigator/Project Director
  • Co-investigator
  • Key personnel
  • Mentors and fellows on individual fellowship grants
  • Mentors identified on institutional training grants

c. Any other individual, who regardless of title or position, has or may have independent responsibility for the design, conduct, or reporting of the research. The Principal Investigator (PI)/Project Director (PD) is responsible for making the determination of who meets this definition, which may include: 

  • Collaborators/consultants
  • Research/Staff Scientists
  • Trainees/Students
  • Individuals who do not have an appointment at WUSTL, but have the above role/designation related to research being conducted at WUSTL

d. Subrecipients  
As part of WUSTL’s assurance of compliance with federal regulations related to financial conflicts of interest, WUSTL is required to incorporate as part of a written agreement with the subrecipient, terms that establish whether the financial conflict of interest policy of WUSTL or that of the subrecipient will apply. This standard is applicable to PHS and NSF sponsored research or any other sponsoring agency that has COI requirements for subrecipients. If a subrecipient defers to WUSTL’s policies and process, the individuals involved in the design, conduct, or reporting of the research are considered covered individuals. 

2. FINANCIAL INTERESTS TO DISCLOSE                                                              [back to​ policy]

 All personal financial interests, and those of the individual's spouse and dependent child(ren), that appear to be related to a covered individual’s institutional responsibilities at WUSTL must be reported, regardless of value. Institutional responsibilities are defined as 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. Examples of financial interests:

   Required to be disclosed  Not required to be disclosed

 

 

Compensatio​n
for

 

 

 

  • Consulting activities
  • Service on an advisory board or board of directors
  • Product evaluation payments
  • Legal consulting activities (such as expert witness testimony)
  • Service to a non-profit organization (such as service on a board or consulting)
  • Employment (other than WUSTL)
  • Publishing agreements, 
  • Royalties for books, or
  • Authorship
  • Honoraria or other compensation for activities such as talks or educational activities
  • Salary or other remuneration paid by WUSTL
  • Income or financial benefit from U.S. government agencies (e.g. service on advisory committees or rev​iew panels)
    • U.S. federal, state, or local government agency, or 
    • U.S. institutions ​of higher education, academic teaching hospitals, medical centers, or research institutes affiliated with an institution of higher education​


 
 Royalties
  • Receipt of any income related to intellectual property rights (e.g. cash royalty payments), and includes:
    • Royalties from other academic institutions
    • Royalties paid through WUSTL for  intellectual property rights assigned to WUSTL
  • An agreement with an entity, including WUSTL, that entitles an individual to future royalties but no income has been received
  • Invention disclosures or patents

Equity/
Ownership Interests
  • Ownership interest in an entity (stocks, stock options, warrants, or other ownership interest) 
  • Income from investment vehicles (such as mutual funds, retirement accounts, and blind trusts) as long as the individual does not have direct control over the investment decisions


Travel 

Only applicable to PHS funded investigators:

  • Travel for which the individual is either reimbursed for or paid for on the individual’s behalf and includes registration fees, accommodation, transportation costs, etc.

Travel paid for by:

  • WUSTL
    ​​
  • U.S. federal, state, or local  government agencies
  • Other U.S. institutions of higher education, academic teaching hospitals, medical centers, or research institutes affiliated with an institution of higher education

Other
  • Gifts or other personal finan​cial benefit


3. TRAVEL PROCEDURES AND GUIDANCE                                                                     

Washington University has developed the following procedures and guidelines regarding the requirements to disclose travel by individuals involved in the design, conduct, or reporting of Public Health Services (PHS)-funded research, as required by the PHS regulations governing financial conflicts of interest (42 C.F.R. Part 50 and 45 C.F.R. Part 94).

Procedures

1. Applicability

WUSTL shall require individuals who meet the definition of a cover​ed individual and are involved in design, conduct, or reporting of PHS (e.g. National Institutes of Health)-funded research to disclose information about certain travel activities. 

2. Disclosure Requirements

Individuals must disclose the occurrence of any reimbursed or sponsored travel that appear to be related to their institutional responsibilities and are paid for by an entity other than WUSTL, U.S. federal, state, or local government agencies, or other U.S. institutions of higher education, academic teaching hospitals, medical centers, or research institutes affiliated with an institution of higher education. 

Disclosure is required regardless of value for travel in which the individual is reimbursed by an outside entity and/or travel that is paid for on the individual’s behalf by an outside entity. Travel includes, for instance, registration fees, accommodations, transportation costs, and meals. Outside entities may include, but are not necessarily limited to, professional societies, foreign institutions of higher education, for-profit entities, and non-profit entities.

3. Frequency

Travel must be disclosed within 30 days after the travel activity.

4. Disclosure Process

Individuals will disclose travel using a disclosure form specifically designed for travel, and will not use the annual Financial Disclosure Statement. The disclosure form shall be submitted to the CIRC for review, either via email, fax, or campus mail. 

The individual shall disclose:

• The dates of travel
• Destination
• Entity that paid for the travel
• Purpose of the trip
• Travel paid for the individual’s spouse and/or dependent child(ren) by the entity

In order to remind individuals to disclose, an email will be sent on a monthly basis prompting the individual to disclose travel using the disclosure form included in the email. 

5. Review
Review of travel disclosure forms will be handled in accordance with the Procedures for Determining and Managing FCOIs.

Guidance

a. Who must disclose travel?

Only those individuals who meet the definition of a covered​ individual and are involved in PHS/NIH funded research need to disclose travel.

b. What must be disclosed?

• Travel for which the individual is reimbursed for by an outside entity
• Travel that is paid for on the individual’s behalf by an outside entity
• Includes any registration fees, accommodations, transportation costs, etc.
• Disclosure is required regardless of value

Examples of outside entities:

• Professional societies
• Foreign institutions of higher education
• For-profit entities
• Non-profit entities

c. What information needs to be disclosed?

• The dates of travel
• Destination
• Entity that paid for the travel
• Purpose of the trip
• Was travel paid for your spouse and/or dependent child(ren) by the entity?

d. What does not need to be disclosed?

Travel paid for by:

• WUSTL (regardless of whether WUSTL is reimbursed for the travel by a third party),
• U.S. federal, state, or local government agencies,
• Other U.S. institutions of higher education, academic teaching hospitals, medical centers, or research institutes affiliated with an institution of higher education

e. When must travel be disclosed?

Within 30 days after the travel activity.

f. Why is the amount/cost of the travel not needed?

The regulations do not require the University to ask for this information. In addition, if the entity paid for the travel directly, the individual may not know the amount or be able to easily obtain the amount.

g. How will travel be disclosed?

For those individuals required to disclose travel, they will be emailed each month and prompted to disclose any material travel using a disclosure form that will be included in the email. Then the individuals may email, fax, or send via campus mail to the CIRC for review. 

h. When will travel be considered a conflict of interest?

Travel will be assessed on a case by case basis. In general, reimbursement for the actual cost of travel to meetings for professional societies/other non-profits or travel directly related to sponsored research activities will not be considered a financial conflict of interest.

4. TIMING OF DISCLOSURES                                                                              [bac​k to policy]

Covered individuals should update their Financial Disclosure Statement:

  • at least annually; 
  • within 30 days of acquiring a new financial interest (which includes travel for individuals involved in PHS funded research – see above); or
  • when they initiate new research projects.

a. Sponsored Research Projects (e.g. grants or contacts)
For Proposals: Annual Financial Disclosure Statements (FDS) or COI Certification (see How to Disclose) for all covered individuals must be received by the Conflict of Interest Review Committee (CIRC) prior to the submission of an application to the Public Health Services, the National Science Foundation, the American Heart Association, or any other agency requiring disclosure. 

For Award Acceptance/Set-up: For all other research funding sources, the FDS or COI Certification (see How to Disclose) for covered individuals must be received by the CIRC prior to acceptance/set-up of an award. Regardless of research funding source, the FDS must be reviewed by the CIRC and any necessary management plans implemented prior to any expenditures under the award (e.g. acceptance/award set-up).

b. Subrecipients
Typically, subrecipients will provide, when required, appropriate assurances and certifications to WUSTL regarding COI at the time of submission of the grant/contract. For example, for PHS grant applications, the subrecipient will provide, at the time of submission, a signed face page, letter of intent, or consortium letter providing the appropriate assurances and certifications regarding federal regulations, which includes conflicts of interest. However, if the subrecipient cannot provide the appropriate assurances that it has COI policies and process that comply with 42 CFR Part 50 or 45 CFR part 94, then the covered individuals under the subagreement will be required to comply with WUSTL’s COI policies and process.

c. Human Subjects Research
Any individual engaged in the design, conduct, or reporting of human subjects research (anything needing the Institutional Review Board (IRB) approval) must report in each protocol application, any personal financial interests related to the research. For example, an individual should disclose any financial interests with the sponsor of the study, the supporting organization, or the company that owns or licenses the technology/drug being studied. It is the PI/PD’s responsibility to ensure that the protocol application reflects the appropriate disclosures for all study team members.

 

image5. PROCEDURES FOR DETERMINING AND MANAGING RESEARCH FCOIs                [back​ to policy]

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

5MANAGEMENT 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

6. DISPUTE RESOLUTION/APPEALS PROCEDURE                                                  [back to​ policy]

INTRODUCTION
The WUSTL Research Conflicts of Interest Policy states “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.” This procedure outlines the necessary steps individuals shall take to resolve disagreements and, if needed, seek an appeal regarding the Conflict of Interest Review Committee’s (CIRC) determination and management plan to address the financial conflicts of interest (FCOI).

INITIAL PROCESS

  1. Once the individual receives the CIRC’s management plan, s/he must respond within the specified period of time by signing and returning the letter. If the individual has questions or concerns regarding the CIRCs management plan, s/he should contact the CIRC Chair or the Research Ethics and Compliance Office (RECO), within the same specified timeframe.  
  2. a. The individual will be invited to attend the subcommittee or full committee to present his/her concerns.
    b. The individual will be provided with the written conclusions of the CIRC’s decision, in the form of a management plan. S/he must respond within the specified period of time by signing and returning the letter or pursue set number 3 in that same time period.
If the CIRC’s determination does not resolve the issue, the individual should contact the vice chancellor for research (VCR). The VCR may discuss the situation with the CIRC Chair as well as the applicable dean to try to reach a resolution. 
a. Dependent upon the resolution, the VCR or CIRC Chair will communicate with the individual in writing with the proposed resolution.
b. If the individual still disagrees with the decision, s/he may submit to the VCR a written request for appeal.  
  1. Should the situation not be resolved, the VCR, in consultation with the applicable dean, will determine if there are grounds for an appeal.
    a. The VCR will send a written determination to the individual, with copies to the CIRC and the relevant department chair and dean, as appropriate.

INTERIM MANAGEMENT PROCEDURES
If the dispute cannot be resolved within 30 days from the date of the CIRC’s management plan, the VCR may implement an interim management plan as needed. The interim management plan will be determined in consultation with the CIRC chair, the applicable dean, and the Executive Chair of the Institutional Review Board, as appropriate. Interim management plans may consist of, but are not limited to:

  • Modifying the role of the conflicted individual;
  • Requiring independent data analysis and/or additional oversight of the research;
  • Placing a temporary hold on the human studies protocol(s) or subject accrual; and/or
  • Temporarily delaying dissemination of the research results.

The interim management plan will remain in effect until such time as, in the opinion of the VCR, the situation is resolved.  Interim management strategies cannot be appealed.

APPEALS COMMITTEE
Charge
The COI Appeals Committee is responsible for reviewing appeals from individuals who disagree with the CIRC’s determination and/or management plan for addressing an individual’s financial conflict of interest.

Organizational Structure of the Appeals Committee
The VCR will coordinate the appointment of the Committee, with the approval of the chancellor. For more information regarding the Appeals Committee, please contact the Research Ethics and Compliance Office.

7. FCOI EDUCATION REQUIREMENTS                                                                  [back to polic​y]

Introduction
The WUSTL Research COI Policy states “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.” Central to Washington University's mission of fostering excellence in research is a commitment to ensure that individuals responsible for the design, conduct, or reporting of research receive education regarding financial conflicts of interest (FCOI) that is appropriate to help assure the ethical and objective conduct of research. FCOI education includes information regarding WUSTL’s policy on financial conflicts of interest, an individual’s responsibilities regarding disclosure of financial interests, and federal regulations governing financial conflicts of interest. 

Procedures
This document further defines the procedures governing the FCOI education requirements as addressed in the Research Conflicts of Interest Policy.

Applicability
Educational requirements apply to all "covered individuals," those individuals required to submit a Financial Disclosure Statement, examples include:

  1. All faculty with an academic appointment of instructor or higher on tenure or non-tenure tracks, and
  2. Any other individual who, regardless of title or position, is independently responsible for the design, conduct, or reporting of research at WUSTL.

Requirements/Frequency
Completion of the education is required within the next 12 months or prior to the start date of any new, competitive, or non-competitive awards supporting research activities, whichever occurs first. For example, if your research funding is due to start September 1, 2012, the education must be completed prior to September 1, 2012, to prevent delays in the award set-up.

  1. Renewal of the education will be required every four years.
  2. Education will also be required in WUSTL revises its FCOI policy that affects the requirements of covered individuals and/or when an investigator is not compliant with a FCOI management plan.

Process
Education shall be provided through a web-based education module available via the Research Gateway and can be accessed by logging-in using a WUSTL key, click on "FCOI Education Module" in the Education and Featured Programs box. The module should take approximately 15 minutes to complete. 

Roles and Responsibilities
Principal Investigator/Project Director
The PI/PD is responsible for assuring that covered individuals involved with their research projects complete the appropriate education requirements.

School, Department, or Program Administration
Schools, departments, and programs should monitor compliance with FCOI education requirements by:

  1. Working with the PI/PD to help inform appropriate individuals of their need to comply with this requirement; 
  2. Verifying appropriate individuals have complied with this requirement within the applicable timeline for completion. The completion data is available via the Compliance Module; and
  3. Implementing necessary internal procedures to assure that issues of noncompliance are identified and resolved.

Office of Sponsored Research Services (OSRS)
The OSRS is responsible for providing institutional assurance of compliance with the education requirements for all applicable research sponsors. Should the necessary education not be completed by the covered individuals, OSRS may delay the set-up of the award in accordance with federal regulations and/or institutional policies or processes.

Research Ethics and Compliance Office (RECO)
The RECO is responsible for working with the Conflict of Interest Review Committee (CIRC) to develop and deliver education that complies with institutional policies and federal regulations. The RECO may also monitor for compliance.

Monitoring
As outlined here or as required, compliance with the educational requirements will be monitored.

Compliance
Issues of non-compliance with the educational requirements that are identified through ongoing monitoring activities will be forwarded to the vice chancellor for research who, as institutional official, is responsible for imposing sanctions.

Failure to gain compliance within a specified timeline and/or circumstances of repeated or egregious noncompliance may result in corrective actions or sanctions, which may include the restriction of access to all project funds until compliance is obtained and/or removal of allocated salaries for the non-compliant individual from the research funds.

8. MATERIAL FINANCIAL INTEREST                                                                    [back​ to policy]

Type of Research Funding: 

PHS/NIH

All Non PHS (e.g. NSF, industry, etc.)

Financial Interests Required to be Disclosed
  • All financial interests related to an individual's institutional responsibilities
  • Travel reimbursed or paid for on behalf of an investigator other than by government agency or institution of higher education
  • All financial interest related to an individual's institutional responsibilities
CIRC Threshold for Reviewing Financial Interests

Includes:

  •  ≥$5,000 in remuneration from an entity  (includes non-profits), in aggregate
  •  ≥$5,000 equity in publicly traded entity
  • Holding of any ownership interest or equity in a non-publicly traded entity (includes non-profits)
  • Travel reimbursed or paid for on behalf of an investigator other than by government agency or institution of higher education
  • ≥$10,000 in remuneration from an entity, in aggregate
  • ≥$10,000 equity or >5% ownership in publicly traded entity
  • Holding of any ownership interest or equity in a non-publicly traded entity
  • Receipt of royalties/compensation related to intellectual property rights and interests
  • An agreement with an entity that entitles an individual to future royalties related to intellectual property (IP) rights and the IP is used or evaluated in human studies research

 Excludes:

  • Income from seminars, lectures, teaching engagements, service on advisory committees or panels paid by federal/state/local government agency, or institutions of higher education
  • Income from investment vehicles, such as mutual funds and retirement accounts, as long as the individual does not directly control the investment decisions
  • Invention disclosures or patented intellectual property (unrelated to a licensing agreement)

 

9. Information Available to the Public                                                               [back to p​olicy]Washington University (WUSTL) shall provide to any requestor written information about Financial Conflicts of Interest, which were determined to be a Financial Conflict of Interest related to Public Health Services (PHS)-funded research on or after August 24, 2012, in accordance with 42 CFR Part 50 and 45 CFR Part 90 and this procedure. Information concerning Financial Conflicts of Interests of an individual subject to these requirements shall remain available upon written request for at least three years from the date the information was most recently updated.

Procedures

1. Requests must be in writing and received either through the US mail or via email.

  • Mailing address: Research Ethics and Compliance Office, Campus Box 1054, One Brookings Drive, St. Louis MO, 63130
  • Email address: coi@wustl.edu

2. The request must include the following:

  • PHS project number (e.g., 1R01CA12345-06)
  • Name of the senior/key personnel about whom information is being requested. 
  • First and last name of the requestor and a return email address or physical street address, P.O. Boxes are not acceptable.  

3. WUSTL’s response will be postmarked or dated (if replying by electronic means) within 5 business days of the receipt of the request.

4. Information concerning an individual will be provided if the following criteria are met:

  • The individual is identified as senior/key personnel by WUSTL in the grant application, progress report, or any other required report submitted to PHS;
  • The personal financial interest was disclosed and is still held by the individual; and
  • WUSTL determines the personal financial interest is related to the PHS-funded project and is a Financial Conflict of Interest.

5.  If all the criteria set forth in Section 4 above are met, the following information will be provided to the requestor:

    • Project Number;
    • Name of the individual;
    • Individual’s title and role with respect to the research project;
    • The name of the entity in which the financial interest is held;
    • Nature of the financial interest (e.g. equity, consulting fee, travel reimbursement, honorarium);
    • Approximate value of the financial interest (in ranges), or a statement that the interest is one whose valued cannot be readily determined through reference to public prices or other reasonable measure of fair market value; and
    • A statement that the information is accurate as of the date of the response and that it is subject to updates in accordance with applicable law.

6. If the request does not meet the requirements of Section 4 above, WUSTL will so inform the requestor within the timeframe indicated in Section 3.  

10. Monitoring Procedures                                                                               [back to​ policy]Washington University (WUSTL) shall monitor compliance with FCOI management plans related to Public Health Services (PHS)-funded research on an ongoing basis until the completion of the PHS-funded research project, in accordance to PHS regulations, 42 CFR Part 50 and 45 CFR part 94. Monitoring of management plans for PHS-funded research will occur as prescribed below.
 
1. Monitoring for compliance with FCOI management plans
For PHS funded research, monitoring will include, when applicable, but may not be limited to the following activities:

a. Verifying appropriate disclosure

i.   In publications
ii.  In presentations
iii. In consent forms
iv. To all individuals involved in the research

b. Confirming/Verifying:

i.  For students/trainees, a co-advisor is appointed
ii. The financial interest remains under the appropriate threshold for the duration of the study and through the first publication
iii. HR QA/QI monitoring was completed
iv. Oversight of the research was performed
v.  Independent data analysis was performed

c. Confirming/Verifying the conflicted individual’s role has been modified

i.   For students/trainees, removal of the conflicted individual from the thesis advisory committee
ii.  Removal from the informed consent process
iii. Removal from determining enrollment criteria
iv. Removal from analyzing data and/or obtaining data
v.  Removal from serving as the PI/PD
vi. Removal of the conflicted individual from the design, conduct, and reporting of the research

 2. Roles and Responsibilities

a. The Research Ethics and Compliance Office will monitor for compliance and document the activity

b. The covered individual and/or principal investigator, as appropriate, will respond to requests related to monitoring for compliance

c. The CIRC Chair(s) will review the monitoring reports provided by RECO and determine if the individual is compliant with WUSTL’s policies and processes governing research conflicts of interests 

3. Potential non-compliance
If there is potential non-compliance with a management plan, the Procedures for Assessing Non-Compliance and Sanctions for Non-Compliance will be followed.

image11. Non-Compliance                                                                                     [back to​ policy]1. Assessing non-compliance
When the results of monitoring (or other instances) identify a potential failure to comply with WUSTL’s policies and processes governing research conflicts of interests:

a. The CIRC Chair will conduct an assessment of the situation and make a determination as to whether the individual failed to comply and the extent of the non-compliance. The Chair may involve/discuss the potential compliance failure with the covered individual and/or others as necessary to make a determination. If needed, the Chair may involve CIRC members in the assessment.

b. A covered individual is non-compliant when, for example, s/he fails to:

i. submit a Financial Disclosure Statement, as required;
ii. disclose his/her personal financial interests to the CIRC;
iii. cooperate or respond to the CIRC’s/RECO’s requests for additional information;
iv. agree to manage his or her financial conflict of interest; and/or
v. take the necessary steps to manage his or her conflict of interest as agreed to in the applicable management plan.

c. If the CIRC Chair determines non-compliance occurred:

i. A written assessment will be submitted to the vice chancellor for research;
ii. Corrective actions or other sanctions as deemed appropriate will be determined by the vice chancellor for research in consultation with the dean of the appropriate school. Examples of potential sanctions/corrective actions are outlined in Section 3; 
iii. If the compliance failure involves Public Health Services’ research funding (e.g National Institutes of Health funding), WUSTL will also complete a retrospective review as prescribed in 42 C.F.R. Part 50 and 45 C.F.R. Part 94, which is outlined below in section 2. 

• When a retrospective review is initiated, depending on the nature of the financial conflict of interest, the vice chancellor for research may determine additional interim measures are necessary with regard to the covered individual’s participation in the PHS-funded research project between the date the financial conflict of interest or the individual’s noncompliance is determined and the completion of the retrospective review. 

2. Retrospective Review for PHS funded research:
If a compliance failure is identified involving PHS-funded research:

a. A retrospective review will be completed in the following instances: 

i.  whenever a financial conflict of interest is not identified or managed in a timely manner including failure by the covered individual to disclose a significant financial interest that is determined by WUSTL to constitute a financial conflict of interest;
ii.  failure by WUSTL to review or manage such a financial conflict of interest; or
iii. failure by the covered individual to comply with a financial conflict of interest management plan.

b. WUSTL shall, within 120 days of its determination of noncompliance, complete the review of the covered individual's activities and the PHS-funded research project to determine whether any PHS-funded research, or portion thereof, conducted during the time period of the noncompliance, was biased in the design, conduct, or reporting of such research. 

c. The vice chancellor for research will designate the individual(s) who will complete the retrospective review.

d. The retrospective review will be documented; such documentation shall include, but not necessarily be limited to, all of the following key elements:

i.     Project number;
ii.    Project title;
iii.   PD/PI or contact PD/PI if a multiple PD/PI model is used;
iv.   Name of the covered individual with the FCOI;
v.    Name of the entity with which the covered individual has a financial conflict of interest;
vi.   Reason(s) for the retrospective review;
vii.  Detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documents reviewed);
viii. Findings of the review; and
ix.   Conclusions of the review.

e. The outcome of the retrospective review will also be provided to the vice chancellor for research, who will determine whether additional corrective actions or other sanctions are appropriate, in consultation with the dean of the appropriate school. Examples of potential sanctions/corrective actions are outlined in Section 3.

f. Based on the results of the retrospective review, if appropriate, WUSTL shall update the previously submitted FCOI report, specifying the actions that will be taken to manage the financial conflict of interest going forward. 

g. If bias is found, WUSTL will notify the PHS Awarding Component promptly and submit a mitigation report to the PHS Awarding Component. The mitigation report will include, at a minimum, the key elements documented in the retrospective review above and a description of the impact of the bias on the research project and WUSTL's plan of action or actions taken to eliminate or mitigate the effect of the bias (e.g., impact on the research project; extent of harm done, including any qualitative and quantitative data to support any actual or future harm; analysis of whether the research project is salvageable). Thereafter, WUSTL will submit FCOI reports annually, as required by the regulations.

3. imageSanctions for Non-Compliance or other Corrective Actions
Based on the WUSTL Research COI Policy, corrective actions or other sanctions as deemed appropriate for non-compliance will be determined by the vice chancellor for research in consultation with the dean of the appropriate school.  Sanctions/corrective actions will be communicated in writing to the covered individual, and others as appropriate, and will also include the details of the compliance failure. The covered individual will be required to agree to the sanctions/corrective actions.

Examples of potential sanction/corrective actions: 

  • Education
  • Require the CIRC’s review of the covered individual’s personal financial relationships more frequently (e.g. every six months)
  • Restriction of access to all project funds until compliance is obtained
  • Removal of allocated salaries for the non-compliant individual from the research funds for the period of non-compliance
  • Suspension of protocol approvals
  • Removal of the individual from having further involvement in the applicable research
  • Require the individual to relinquish the personal financial interests
  • Require the individual to write the editor of the journal indicating the non-compliance
  • Require the individual to convey in writing to each study team member the extent of the non-compliance
  • Ongoing monitoring of the affected research and/or the individual’s other research activities
  • Independent oversight of the research 
  • Independent monitoring of manuscript submissions
  • Specifically for human studies, WUSTL’s IRB will assess the failure and determine the corrective actions related to the protocol and research participants. Typically, the PI will be required to notify the research participants of the compliance failure and may be required to re-consent the participants. 
  • Specifically for human studies, referral to the Human Subjects Quality Assurance/Quality Improvement Committee to assess compliance with the protocol. Compliance failures identified by the HR QA/QI committee will be addressed in accordance with its processes.
  • If the objectivity of the research was impacted, and if it is warranted, the situation may be referred to the Committee on Research Integrity.
  • Other potential employment sanctions as determined by the applicable dean

12. How to Disclose

WUSTL Annual Financial Disclosure Statement is required: 

 

For all covered individuals who have any type of WUSTL appointment, the disclosure statement can be accessed at http://researchgateway.wustl.edu. System instructions are available on the Financial Disclosure System page.

If the individual is transferring to WUSTL, an appointment can be entered into the Human Resources Management System by the applicable payroll department, which will allow access to the system within 24 hours

COI Certification or Non-WUSTL form is required:

For covered individuals who do not have an appointment at WUSTL. Fulfillment of the disclosure requirement may occur in one of the following ways, unless a disclosure is required as part of the subrecipient agreement:

1.  Non-WUSTL Financial Disclosure Statement

    • The individual will complete a Non-WUSTL Financial Disclosure Statement and submit it to coi@wustl.edu or via fax to 314.362.8712. If a financial conflict is identified, the PI/PD of the project and the individual will work with the CIRC to develop an acceptable management plan; and,
    • The individual will be required to complete the University’s Financial Conflict of Interest education module, if the project is funded. 
      • At the time the Non-WUSTL Financial Disclosure Statement is processed, the Research Ethics and Compliance Office will provide, via email, the individual with his/her user name and password along with the URL to access the education module. 
      • It is the responsibility of the individual to complete the education module if the project receives funding.

- or -

2.  Letter of Compliance

    • The individual may obtain a letter from his or her home institution, certifying compliance with federal requirements regarding financial conflicts of interest. A letter tem​plate​ is provided for your reference. 

 

Travel Disclosure

For those individuals required to disclose travel, they will be emailed each month and prompted to disclose any material travel using a spreadsheet that will be included in the email. Then the individuals will emai​l the spreadsheet back to the CIRC for review. ​​​​​​