Financial Conflict of Interest Policy

Purpose

  1. Advancing the research mission of St. Jude Children’s Research Hospital and Children’s GMP, LLC (“St. Jude”) requires facilitating the translation of new discoveries into therapies that contribute to larger society. Increasingly, collaboration with the private, for-profit sector plays an important role in this process. St. Jude encourages collaborative relationships with the private sector; however, the financial and other incentives that accompany such involvement may lead to Conflicts of Interest or Commitment (“Conflicts”) that may need to be reduced, managed or eliminated.
  2. The purpose of this policy is to maintain best practices for ensuring objectivity in research and preserve the credibility of St. Jude and its employees, faculty and professional staff through a transparent procedure for conflict disclosure and resolution. This policy is guided by federal regulatory requirements for the disclosure, review, management, and reporting of Conflicts.

Scope

This policy applies to all St. Jude employees, Faculty and Professional Staff who are Investigators involved in the design, conduct or reporting of research. Designated provisions of this policy apply only to Investigators applying for or conducting research funded by the Public Health Service. Investigators who conduct studies regulated by the Food and Drug Administration or who conduct research funded by the other federal agencies, including the National Science Foundation, are subject to agency‐specific regulations relating to reporting Financial Interests and/or Financial Conflicts of Interest (non-PHS) in research.

Policy

  1. Any form of remuneration received from or any Financial Interest an employee has in any Vendor shall be in strict accordance with this policy and policy 70.03.003.
  2. Investigators shall avoid activities that may create bias in research design, conduct or reporting.
  3. Any activities that interfere with or dilute a primary commitment to St. Jude (a “Conflict of Commitment”) should be avoided.
  4. Investigators must disclose their Significant Financial Interests (“SFIs”) and Extramural Activities that are reasonably related to their Institutional Responsibilities for the previous 12 months. To comply with National Science Foundation (“NSF”) requirements, estimated values for any Significant Financial Interest or Extramural Activity expected over the next 12 months must also be disclosed. Note: NSF disclosure requirements may soon be revised to be consistent with PHS requirements.
  5. All Investigators must complete Financial Conflict of Interest (“FCOI”) training.
  6. St. Jude shall report all FCOIs as required by the applicable funding agency.

Procedure

Note: The procedures and conditions of this policy are more fully described in the Corporate Compliance Conflict of Interest and Commitment standard operating procedure found on the Compliance Office (“Compliance”) intranet site.

  1. Disclosure, Review, Management and Reporting 
     
        A. Disclosure

1) Upon hire or commencement of other relationship (e.g. signing a contract) with St. Jude, and annually thereafter, Investigators must disclose all SFIs and Extramural Activities that are reasonably related to their Institutional Responsibilities. Investigators must also disclose the SFIs of their Immediate Family and Household Members, when such interests relate to an Investigator’s Institutional Responsibilities.

2) Investigators must update their Disclosure Forms within 30 days of receiving equity or remuneration for a new Extramural Activity or when they or their Immediate Family or Household Members acquire a new SFI related to an Investigator’s Institutional Responsibilities.

3) Investigators planning to engage in research or consulting, should update their Disclosure Forms when:

a. externally-funded research applications (e.g. PHS or industry sponsored applications) are submitted to Grants and Contracts Management Office (“GCMO”); or

b. research protocols are submitted to the Institutional Review Board (“IRB”); or

c. consulting agreements are signed.

4) Investigators must disclose if they supervise any relative (individual related by blood, adoption or marriage) or Household Member.

B. Disclosure Review, Conflict Determination and Management Plans

1) Disclosure Forms will be routed to the Investigator’s department chair or supervisor and Compliance Investigators, department chairs and supervisors will assist Compliance in determining whether any disclosed SFI relates to research and thus requires a FCOI evaluation.

2) As appropriate, Compliance or the COIC shall determine if a COI or FCOI exists, and recommend a Management Plan.

3) If a FCOI exists a Management Plan is required and will be approved by the COIC. As appropriate, the COIC shall develop Management Plans, or amend, approve or veto any proposed Management Plan and communicate its decision in writing to Compliance.

4) Compliance shall notify the Investigator and his/her department chair or supervisor of the Conflict determination and the recommended Management Plan.

5) If the department chair or supervisor and/or the Investigator disagree with the COI or FCOI decision or the recommended Management Plan, the issue will be referred to the COIC for review and final determination.

6) Compliance will be responsible for monitoring compliance with all Management Plans.

7) for review.

C. Reconsideration Process

1) An Investigator may submit a written request for reconsideration within 10 calendar days of being notified of a Conflict determination and Management Plan.

2) After reconsideration, the COIC’s subsequent decision regarding the Conflict and any related Management Plan shall be final.

D. Reporting to External Funding Agencies

1) Initial FCOI (PHS) Report

a. New PHS-funded Research Projects – If a FCOI (PHS) exists, an initial FCOI report will be sent to PHS prior to the expenditure of funds. However, if a FCOI (PHS) is eliminated prior to the expenditure of funds, a report shall not be required.

b. Ongoing PHS-funded Research Projects - Within 60 days of making a FCOI determination, a report will be sent to PHS for any FCOI (PHS) identified subsequent to the initial FCOI report.

2) PHS Retrospective Review and Mitigation Reports

a. If a SFI was not disclosed or reviewed in a timely manner in an ongoing PHS-funded research project, Compliance or the COIC shall (within 60 days of discovery) determine if the SFI relates to research and if a FCOI (PHS) exists.

b. If a FCOI (PHS) exists, Compliance and/or the COIC shall implement an interim Management Plan, report to PHS and (within 120 days of discovery of noncompliance) conduct and document a retrospective review of the Investigator’s activities and the research to determine if there is any bias in research design, conduct or reporting.

c. If appropriate, an update to the previously submitted FCOI report shall be sent to PHS.

d. If bias is found, a mitigation report will be developed and PHS shall be notified promptly.

2) Annual FCOI Report

a. For any previously reported FCOI (PHS), an annual FCOI report will be submitted to PHS for the duration of the PHS-funded research project.

b. For any previously reported FCOI (non-PHS), FCOI or other reports will be submitted to the extent required by the applicable funding agency.

E. Confidentiality

1) All Disclosure Forms and their contents shall be treated as confidential and such information shall only be revealed as necessary to implement and enforce this policy or as required by applicable law.

F. Non-Compliance and Disciplinary Actions

1) Individuals subject to this policy are expected to comply fully and promptly with it.

2) Individuals who deliberately or repeatedly fail to fully and truthfully disclose Extramural Activities or Significant Financial Interests, or fail to comply with any Management Plan shall be subject to institutional disciplinary actions up to termination.

G. Sponsored Research and Consulting

1) An Investigator is prohibited from serving as both a paid consultant to a company and as a recipient of sponsored research funds from the same company without approval of the Director/CEO.

2) Annual cash compensation to employees from consulting relationships with all organizations shall not exceed twenty-five percent (25%) of the individual’s annual salary or $75,000/year, whichever is less. Consulting activities with any entity must not interfere with a primary commitment to St. Jude and must be disclosed as Extramural Activities.

3) Employees are permitted to consult up to the equivalent of 24 working days per calendar year with for-profit entities.

4) There is no strict limit on consulting time employees may devote to non-profit or government entities.

5) The use of St. Jude property, name or facilities for personal benefit or non-hospital activities (e.g. consulting) is prohibited.

H. Sponsored Travel Disclosure Requirements

1) All Sponsored Travel must be disclosed via the St. Jude Travel Authorization Form prior to travel.

2) Professional Society Sponsored Travel, while requiring internal disclosure via the travel authorization form, does not affect the design, conduct or reporting of research and therefore does not require further institutional review to determine if the travel constitutes a FCOI.

3) All Sponsored Travel shall be in strict accordance with institutional policies 70.013 and 10.201, “Reimbursement of Travel Expenses.” Specifically Vendor-sponsored travel is not permissible unless an exception is granted.

I. Intellectual Property Disclosure Requirements

1) Investigators must disclose income from intellectual property rights (e.g. royalties from patents and copyrights) upon receipt of income from an entity other than St. Jude.

J. Public Accessibility

1) This policy shall be made available via www.stjude.org.

2) Compliance shall respond within 5 business days of receipt of written requests for information on FCOIs (PHS) disclosed and still held by Senior/Key Personnel.

3) Compliance shall notify the Senior/Key Personnel and his/her department head/chair and supervisor on the same day that it receives a written request for information regarding a FCOI (PHS).

K. FCOI Training

1) All Investigators must train on this policy:

a) Upon hire or commencement of other relationship with St. Jude; and

b) Annually thereafter; and

c) Prior to engagement in research; and

d) Immediately if noncompliance is discovered or if policy revisions affect the requirements of those individuals subject to this policy.

L. Subrecipients (PHS-funded)

1) For any PHS-funded research in which St. Jude is the awardee institution, a written agreement is required to establish which institution’s FCOI policy will apply to a subrecipient institution and its Investigators.

2) If the subrecipient’s policy applies, the agreement shall certify that the policy complies with 42 C.F.R. Part 50 and 45 C.F.R. Part 94. Otherwise the agreement shall state that the subrecipient Investigators are subject to this policy 70.03.001, Conflicts of Interest and Commitment in Research.

3) The agreement shall specify timeframes for disclosing any SFI or FCOI to St. Jude.

4) Disclosed FCOIs shall be reported to PHS prior to the expenditure of any funds and within 60 days of any subsequently identified FCOI.

M. Record Retention

1) Compliance shall maintain all records relating to Conflict of Interest and Commitment disclosures for at least 3 years from the date of submission of the final expenditures report to PHS or for the time period required by the applicable external funding agency. If there is no external funding, records shall be kept for 3 years from the date that the Conflict or research activities cease to exist.

Definitions

Academic Teaching Hospital: A hospital associated with a medical college or university that provides clinical education and training to healthcare professionals in addition to delivering care to patients.

Agent: A person or firm who is authorized to act on behalf of St. Jude through employment, by contract or apparent authority.

Conflict of Commitment: Exists when an Extramural Activity requires a commitment that could interfere with an employee, Faculty or Professional Staff member’s obligation to St. Jude.

Conflict of Interest: Occurs when professional obligations or interests could be undermined or jeopardized by personal interests, such as a financial or fiduciary interest in an entity besides St. Jude or a personal relationship or interest that may benefit from research or project results.

Conflict of Interest Committee: The Conflict of Interest Committee (“COIC”) is appointed by the St. Jude Director and Chief Executive Officer (“Director/CEO”) and comprises the Scientific Director/EVP, the Clinical Director/EVP, the Cancer Center Director/EVP, Senior Vice President of Support Operations and Human Resources, Director of the Office of Technology Licensing, a representative from the Compliance Office, a representative from the Office of Legal Services and at least two Faculty members (representing basic and clinical research) appointed by the Director/CEO. The Director/CEO also appoints the COIC Chair. The COIC meets at least quarterly.

Consulting: Consulting is a professional activity related to an individual’s field or discipline that includes a fee-for-service or equivalent relationship. St. Jude employees are required to submit to the Office of Technology Licensing for review any consulting agreement that includes an offer of equity or remuneration.

Disclosure: An individual’s disclosure of Significant Financial Interests and Extramural Activities to St. Jude.

Disclosure Form: A paper or electronic form used to make disclosures of Significant Financial Interests and Extramural Activities.

Extramural Activities:

  • Any professional activity resulting in equity or remuneration from an entity other than St. Jude.
  • St. Jude assesses the risk of Extramural Activities and assigns a risk category. A description of the categories, a range of examples and a general guide for each category can be found on the Compliance Office (“Compliance”) intranet site.

Faculty: Individuals who hold the rank of Member, Associate Member, Assistant Member or Research Associate, as defined in the Faculty Handbook, Section 100.7.

Financial Conflict of Interest (PHS): A Significant Financial Interest related to Public Health Service ("PHS”)-funded research that could directly and significantly affect the design, conduct or reporting of research, as determined by Compliance or the St. Jude Conflict of Interest Committee.

Financial Conflict of Interest (Non-PHS): A Significant Financial Interest not related to PHS-funded research in an entity other than St. Jude that could jeopardize or influence an individual’s professional obligations, judgment or interests, or could directly and significantly affect research design, conduct or reporting, as determined by Compliance or the St. Jude Conflict of Interest Committee.

Financial Interest: Anything of monetary value including but not limited to salary or other payments (e.g., consulting fees, paid authorship or honoraria); equity interests (e.g., stocks, stock options or other ownership interests); intellectual property rights (e.g., patents, copyrights, trademarks, trade secrets) and royalties from such rights; an interest with a value that cannot be readily determined (e.g., a future royalty interest or stock option); and any other similar financial interest that an employee, Faculty or Professional Staff member may have in an entity outside of St. Jude (e.g. travel sponsored by external entities).

Household Member: Any individual who resides in the same household as an individual subject to this policy, e.g. domestic partner (an unmarried cohabiting couple), elderly parent.

Immediate Family Member: An employee, Faculty or Professional Staff member’s spouse or dependent children (all children, regardless of age, who receive significant financial support from the employee, Faculty or Professional Staff member).

Independent Contractor: A person or business that provides agreed upon goods or services to St. Jude, but is not subject to an employee/employer relationship.

Institution of Higher Education: An institution in any US state that provides education at the college or university level.

Institutional Responsibilities: Professional responsibilities on behalf of St. Jude, including but not limited to research, research consultation or administration, teaching, professional services (such as clinical care, purchasing, financial, legal or compliance), service on institutional committees or review boards and duties related to influencing or committing St. Jude resources.

Investigator: Any person, regardless of title or position, who is responsible for research design, conduct or reporting (e.g. principal investigator, project director, clinical research associates, collaborators or consultants).

Medical Center: A health care facility or a hospital.

Management Plan: Formal plan for managing, reducing or eliminating a Conflict as agreed by Compliance or the St. Jude Conflict of Interest Committee.

Professional Staff: St. Jude Agents or Independent Contractors who are Investigators with responsibility for the design, conduct or reporting of St. Jude research.

Reporting: St. Jude’s provision of a FCOI or other related report to PHS or other funding agency.

Research Institute: An establishment where basic or applied research is performed.

Senior/Key Personnel: Any person, including subrecipients or subcontractors, identified as senior or key personnel of a research project in the grant application, a progress report or any other report submitted to PHS (e.g., the project director, principal investigator, biostatisticians, etc).

Significant Financial Interest (“SFI”):

  • A Financial Interest held by the Investigator (or his/her Immediate Family or Household Member) consisting of one or more of the following that reasonably appears to be related to the Investigator’s Institutional Responsibilities:
    • Publicly traded entity - The value of any equity interest (as of date of disclosure) in any entity that when added to any other Financial Interest in the same entity (during the 12 months preceding the disclosure) exceeds $5,000; or
    • Non-publicly traded entity - Any equity interest (regardless of the value) in any entity (as of the date of disclosure) or any other Financial Interests in the same entity (during the 12 months preceding the disclosure) that when totaled exceed $5,000; or
    • Intellectual Property Rights and Interests - Any rights and interests (e.g., royalties from patents or copyrights) upon receipt of income related to such rights and interests from an entity other than St. Jude; or
    • Sponsored Travel - Travel expenses reimbursed or paid by an entity other than St. Jude.
  • Exceptions to the definition above include:
    • reimbursed or paid travel, income from seminars, lectures and teaching engagements or service on advisory committees or review panels if they are sponsored by or are for:
      • a federal, state or local government agency; or
      • a U.S. institution of higher education (or a research institute affiliated with an institution of higher education); or
      • an academic teaching hospital; or
      • a medical center
    • income from the ownership of shares in an investment vehicle, such as a mutual fund or retirement account, in which the individual or his or her Immediate Family Member or Household Member does not directly control the investment decisions; or
    • salary, royalties or other remuneration received from St. Jude in an employer/employee capacity.

Sponsored Research: Research, training or an instructional project that involves funds, materials or other compensation from an outside source under an agreement with St. Jude.

Vendor:

  • Any third party that is a current or potential business partner, or a collaborator that is for‐profit or affiliated with a for‐profit enterprise, including but not limited to all pharmaceutical companies, medical device companies, medical equipment manufacturers and medical supply companies, as defined in institutional policy 70.03.003, “Relationships With Vendors.”
  • Exceptions to the definition above include:
    • Professional societies; or
    • Not-for-profit organizations; or
    • Federal, state or local government agencies; or
    • U.S. institutions of higher education.

References

  • Faculty Handbook
  • Compliance Office Intranet Site
  • 42 CFR Part 50 and 45 CFR Part 94 - Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought and Responsible Prospective Contractors
  • Travel Authorization Form – Available on Financial Services web site

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