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.


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:

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”):

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:


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 70.013.
  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.

Disclosure, Review, Management and Reporting