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Name: Financial Conflicts of Interest Policy and Guidelines - Interim
Responsible Office: Research

Applies to: (examples; Faculty,Staff, Students, etc)

Faculty , Staff , Students , Contractors_Vendors

Policy Overview:

Issued: 05-01-2017
Next Review Date: 05-01-2018
Frequency of Reviews: Annually

The goal of this policy is to assure that the objectivity and integrity of the researcher, the College, 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.

Applies to all College faculty, students, and any other individual who is independently responsible for the design, conduct, or reporting of research at STLCOP, 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 initial determination of any other individuals who meet this definition.


Definitions:

Term

Definition

Research Integrity and Safety Committee (RISC)

The committee responsible for assessment of personal financial interests reported by Covered Individuals

Covered Individual

See Applies To section above

Entity

Includes public or non-publicly traded companies/non-profit organizations

Equity or Debt Instrument

includes, but is not limited to, preferred and common stock, stock options, warrants, bonds, and notes

Family 

a covered individual’s spouse and/or dependent children

Financial Conflict of Interest (FCOI)

a financial conflict of interest exists when it is reasonably determined that a personal or “family” (see above) financial interest could directly and significantly affect the design, conduct, or reporting of research

Financial Interest 

anything of monetary value, whether or not the value is readily ascertainable

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 the St. Louis College of Pharmacy Institutional Review Board

 

Institutional responsibilities

an individual's professional duties and responsibilities on behalf of the College.  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

 

Manage

taking action(s) to address a FCOI, to ensure, that the design, conduct, and reporting of research will be free from bias

 

Research

a systematic investigation, including research development, testing, and evaluation, 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)

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

Details:

All Covered Individuals are required to complete or update and submit to the Research Integrity and Safety Committee (RISC) Chair or designee 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 (See Form, Financial Conflicts of Interest Disclosure Statement) .  However, only certain personal financial interests will be deemed material in determining whether a financial conflict of interest (FCOI) exists. Individuals involved in Public Health Service funded research must disclose payment of travel related expenses paid for by outside parties other than government agencies, higher education institutions (including affiliated academic or research institutes).  A Covered Individual should resolve any doubt about whether research or a personal financial interest should be disclosed, in favor of disclosure. The RISC will work with Covered Individuals to effectively manage and monitor material FCOIs.

Procedures

  1. RISC and CRA Roles
    The RISC is a standing committee designated with the authority to implement and oversee compliance with this policy.  The Deans, in consultation with the Faculty Senate and Chief Research Administrator (CRA), shall appoint no less than five (5) faculty members to serve on the committee for a two year term.  The committee members shall elect a chair who shall also serve as a voting member of the RISC.  The CRA is designated with managing the administration of the College’s research conflicts of interest program and provides support to the RISC.
  2. Responsibilities
    1. The RISC’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 FCOIs and management plans;
      3. Establishing procedures to determine when a personal financial interest is material;
      4. Determining FCOIs and appropriate management plans;
      5. Overseeing the development of education for Covered Individuals; and
      6. Coordinating any reporting to government agencies or sponsors that may be required.
    2. Members of the RISC 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.
    3. The CRA will work with the RISC Chair or designee to ensure that the RISC has adequate support including, but not limited to:
      1. Completing preliminary assessments of the financial disclosures to determine whether further review is required, in accordance with RISC processes;
      2. Documenting the review and outcome of the financial disclosure reviews;
      3. keeping and maintain records necessary for compliance with applicable policies and federal regulations;
      4. Developing procedures and forms to obtain and review financial disclosure information;
      5. Monitoring compliance with management plans and applicable policies and processes;
      6. Evaluating potential non-compliance, initiating investigations, and overseeing implementation of corrective actions;
      7. Submitting appropriate reports to federal, state, sponsor, or regulatory agencies;  and
      8. Assuring the delivery of education for Covered Individuals.
  3. TIMING OF DISCLOSURES
    The RISC Chair will work with the CRA and Deans to obtain annual FCOI disclosures. Covered Individuals must also disclose any personal FCOI when submitting a research proposal, establishing a research fund, or prior to engaging in research, and at such other times as may be required by law or federal regulations. Covered Individuals must provide new or updated disclosures whenever the covered individual’s personal financial interest, as previously disclosed, has changed.
  4. DETERMINATION OF A CONFLICT OF INTEREST
    1. Material Financial Interests
      A Covered Individual must disclose personal and family financial interests, defined as anything of monetary value, regardless of whether the value is readily ascertainable. 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 RISC in accordance with applicable federal, state, sponsor, or regulatory agencies, as appropriate. The minimum requirements for disclosing FCOIs are set forth in Appendix A.
    2. Assessment of Risks
      In assessing a FCOI, the RISC will 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.
  5. MANAGEMENT OF MATERIAL CONFLICTS OF INTEREST
    1. If the RISC determines a covered individual has a FCOI related to his/her research, it shall develop a management plan governing the FCOI. A management plan will impose conditions and prescribe actions necessary to manage a FCOI.
    2. 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.
    3. The management tool chosen will depend on the RISC's assessment of the relatedness and risk of the FCOI.
    4. The RISC 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.
    This policy provides additional guidance and examples of FCOI management plans in Appendix A.
  6. MONITORING FOR COMPLIANCE
    The CRA will ensure that regular monitoring of financial disclosure statements and management plans occurs to determine compliance with this policy, and applicable federal regulations or sponsoring agency requirements. If a compliance failure involves PHS research funding (e.g. National Institutes of Health funding), STLCOP will complete a retrospective review as prescribed in 42 C.F.R. Part 50 and 45 C.F.R. Part 94.
  7. DISPUTE RESOLUTION/APPEALS PROCEDURE
    The RISC will refer any unresolved disagreements concerning the application of this policy for final resolution by the appropriate Dean.
  8. FCOI EDUCATION REQUIREMENTS
    STLCOP will take appropriate steps to ensure that Covered Individuals complete training regarding this policy and applicable federal regulations.
  9. CONFIDENTIALITY
    All 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 College, federal regulations or sponsoring agencies. The RISC will only allow access or disclose information relating to financial disclosures to persons who have a need to know in connection with their job duties or responsibilities.
  10. EXTERNAL REPORTING REQUIREMENTS
    To the extent required, the CRA or his/her designee shall report applicable information to appropriate governmental or sponsoring agencies or others as required.
  11. PUBLIC HEALTH SERVICE TRAVEL
    Cover​ed Individuals involved in the design, conduct, or reporting of PHS (e.g. National Institutes of Health)-funded research 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 STLCOP, 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.

    Travel must be disclosed within 30 days after the travel activity. Covered Individuals will disclose travel using the STLCOP Public Health Service Travel Disclosure Form attached to this policy. Review of travel disclosure forms will be handled in accordance with the procedures for determining and managing financial conflicts 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.
  12. SANCTIONS
    Violations of this policy may subject the covered individual to corrective actions or other sanctions by the appropriate dean or department or division head.

Responsibilities:

Position/Office/Department

Responsibility

Chief Research Administrator

Oversee and coordinate implementation of this policy

RISC designee

Provide administrative support to the RISC and assist CRA

 

 

Resources:

Appendix A, Financial Conflict of Interest Guidelines

Form A, Financial Conflicts of Interest Disclosure Statement

Form B, Public Health Service Travel Disclosure

Policy Contacts:

Name

Contact Information

Karen Seibert, Chief Research Administrator

Karen.Seibert@stlcop.edu, 446-8422