U.S. Public Health Service Financial Conflict of Interest Requirements

Table of Contents

  1. Background
  2. Researcher Responsibilities
  3. Review of Disclosures of Significant Financial Interest and Management of Financial Conflict of Interest
  4. Record Keeping and Reporting
  5. Appendix A: Sponsors of Research that Require Compliance with U.S. Public Health Service (“PHS”) Regulations
  6. Appendix B: Significant Financial Interest Disclosure Form

1. Background

In order to be eligible to apply for or receive funding from a U.S. Public Health Service Agency (“PHS Awarding Agency”) (see Appendix A), the University of Guelph and its researchers must comply with the U.S. Public Health Service (“PHS”) financial conflict of interest regulations, 42 CFR 50, Subpart F – Promoting Objectivity in Research (“PHS FCOI Regulations”).

2. Researcher Responsibilities

University of Guelph researchers responsible for the design, conduct, or reporting of research funded by a PHS Awarding Agency, or applying for funding from a PHS Awarding Agency (“Investigators”) must:

a. Disclosure.

Complete and submit to Research Services, Room 437, University Centre a Significant Financial Interest Disclosure Form (see Appendix B) as follows:

  1. No later than at the time of application for PHS-funded research;
  2. Annually, during the period of a PHS-funded award ; and,
  3. Within 30 days of discovering or acquiring (e.g. through purchase, marriage or inheritance) a new financial interest.

 

b. Training.

Complete the PHS financial conflict of interest (“FCOI”) online training tutorial, retain the Certificate of Completion and submit a copy to Research Services, Room 437, University Centre. This training must be completed prior to engaging in PHS-funded research, every four (4) years thereafter, and immediately in the following circumstances:

  1. The University of Guelph revises its financial conflict of interest policy for employees (see Section 8 of the UGFA Collective Agreement for employees who are members of the University of Guelph Faculty Association and the Human Resources 317 Conflict of Interest Policy for other employees) or related procedures in any manner that affects the requirements of Investigators applying for or receiving PHS research funding;
  2. An Investigator applying for or receiving PHS research funding is new to the University of Guelph; and,
  3. The University of Guelph finds that an Investigator applying for or receiving PHS research funding is not in compliance with the Investigator responsibilities under its financial conflict of interest policy, the PHS FCOI Regulations, or any FCOI management plan established by the University of Guelph’s designated officials (“Designated Officials”).

3. Review of Disclosures of Significant Financial Interest and Management of Financial Conflict of Interest

  1. Each Significant Financial Interest Disclosure Form that discloses a significant financial interest shall be referred to the Designated Officials who will:
    1. Determine whether the disclosure of significant financial interest relates to PHS-funded research;
    2. If the disclosure of significant financial interest is related to PHS-funded research, determine whether a financial conflict of interest exists; and,
    3. If a financial conflict of interest exists, develop and implement a management plan that specifies the actions taken or to be taken to manage such financial conflict of interest.
  2. During a PHS-funded research project, where an Investigator who is new to participating in the research project discloses a significant financial interest or an existing Investigator discloses a new significant financial interest, the Designated Officials shall, within 60 days:
    1. Determine whether the disclosure of the significant financial interest is related to PHS-funded research;
    2. If the disclosure of significant financial interest is related to PHS-funded research, determine whether a financial conflict of interest exists; and,
    3. If a financial conflict of interest exists, implement, on at least an interim basis, a management plan that shall specify the actions that have been, and will be, taken to manage such financial conflict of interest. Depending on the nature of the significant financial interest, the Designated Officials may determine that additional interim measures are necessary with regard to the Investigator’s participation in the PHS-funded research project between the date of disclosure and the completion of the Designated Officials’ review.
  3. Whenever it is discovered that a significant financial interest has not been disclosed in a timely manner by an Investigator or, for whatever reason, was not previously reviewed by the Designated Officials during an ongoing PHS-funded research project (e.g. was not reviewed in a timely manner or reported by a subrecipient), the Designated Officials shall, within 60 days:
    1. Determine whether the significant financial interest is related to PHS-funded research;
    2. If the disclosure of significant financial interest is related to PHS-funded research, determine whether a financial conflict of interest exists; and,
    3. If a financial conflict of interest exists:
      1. implement, on at least an interim basis, a management plan that shall specify the actions that have been, and will be, taken to manage such financial conflict of interest going forward;
      2. in addition, whenever a financial conflict of interest is not identified or managed in a timely manner or where an Investigator fails to comply with a financial conflict of interest management plan, the Designated Officials shall, within 120 days of the determination of non-compliance, complete a retrospective review of the Investigator’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. In the event the Designated Officials determine that there was bias in the design, conduct, or reporting of such research, the Designated Officials shall prepare a mitigation report that must 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 the Designated Officials’ 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).
  4. In cases where a management plan is implemented, the University of Guelph must monitor Investigator compliance with the management plan on an ongoing basis until completion of the relevant PHS-funded project.

4. Record Keeping and Reporting

  1. The University of Guelph must maintain records relating to all disclosures of significant financial interest and the Designated Officials’ review of, and response to, such disclosures (whether or not a disclosure resulted in a determination of a financial conflict of interest and all actions under this document) including any retrospective review, if applicable, for at least 3 years from the date the final expenditures report is submitted to the U.S. Public Health Service.
  2. In the case of a retrospective review, the University of Guelph must document the retrospective review which documentation shall include, but not be limited to the: project number and title; name of the Project Director/Principal Investigator (or contact Project Director/Principal Investigator if a multiple Project Director/Principal Investigator model is used); name of the Investigator with the financial conflict of interest; name of the entity with which the Investigator has a financial conflict of interest; reason(s) for the retrospective review; detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documents reviewed); and, findings and conclusions of the review.
  3. The University of Guelph must ensure public accessibility, via written response to any requestor, within 5 business days of a request, of information concerning any significant financial interest disclosed that meets the following three criteria:
    1. the significant financial interest was disclosed and is still held by the senior/key personnel (i.e. the Project Director/Principal Investigator and any other person identified as senior/key personnel by the University of Guelph in the grant application, progress report, or any other report submitted to the PHS by the University of Guelph under the PHS CFOI Regulations);
    2. the Designated Officials determine that the significant financial interest is related to the PHS-funded research; and,
    3. the Designated Officials determine that the significant financial interest is a financial conflict of interest. The information made available to the requestor shall include, at a minimum, the following: the Investigator’s name, title and role with respect to the research project; the name of the entity in which the significant financial interest is held and the nature of the significant financial interest; and, the approximate dollar value of the significant financial interest or a statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value.
  4. Prior to the expenditure of any funds under a PHS-funded research project, the University of Guelph must provide to the PHS Awarding Agency a financial conflict of interest report regarding any Investigator’s significant financial interest found by the Designated Officials to be conflicting and ensure that a management plan has been implemented in accordance with the PHS FCOI Regulations. In cases where the Designated Officials identify a financial conflict of interest and eliminate it prior to the expenditure of PHS-awarded funds, a financial conflict of interest report shall not be submitted to the PHS Awarding Agency.
  5. For any financial conflict of interest previously reported with regard to an ongoing PHS-funded research project, the University of Guelph must provide to the relevant PHS Awarding Agency an annual financial conflict of interest report that addresses the status of the financial conflict of interest and any changes to the management plan for the duration of the PHS-funded research project. The annual financial conflict of interest report shall specify whether the financial conflict is still being managed or explain why the financial conflict of interest no longer exists. Provide annual financial conflict of interest reports to the relevant PHS Awarding Agency for the duration of the project period (including extensions with or without funds) in the time and manner specified by the relevant PHS Awarding Agency.
  6. For any significant financial interest that the Designated Officials identify as conflicting subsequent to the initial financial conflict of interest report during an ongoing PHS-funded research project (e.g., upon the participation of a Investigator who is new to the research project as referred to in Section 3.b, the University of Guelph must provide to the relevant PHS Awarding Agency, within 60 days, a financial conflict of interest report regarding the financial conflict of interest and ensure that the Designated Officials have implemented a management plan in accordance with the PHS FCOI Regulations.
  7. Based on the results of the retrospective review referred to in Section 3.c.iii.B, if appropriate, update the previously submitted financial conflict of interest report, specifying the actions that will be taken to manage the financial conflict of interest going forward. If bias is found, notify the relevant PHS Awarding Agency promptly and submit the Designated Officials’ mitigation report referred to in Section 3.c.iii to the relevant PHS Awarding Agency. Thereafter, submit financial conflict of interest reports annually, as specified elsewhere in the PHS FCOI Regulations.
  8. Any financial conflict of interest report to a PHS Awarding Agency required under the PHS FCOI Regulations shall include sufficient information to enable the relevant PHS Awarding Agency to understand the nature and extent of the financial conflict, and to assess the appropriateness of the management plan. Elements of the financial conflict of interest report shall include, but are not limited to the following: project number; name of Project Director/Principal Investigator (or contact Project Director/Principal Investigator if a multiple Project Director/Principal Investigator model is used); name of the Investigator with the financial conflict of interest; name of the entity with which the Investigator has a financial conflict of interest; nature of the financial interest (e.g., equity, consulting fee, travel reimbursement, honorarium); value of the financial interest or a statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value; a description of how the financial interest relates to the PHS-funded research and the basis for the Designated Officials’ determination that the financial conflict of interest conflicts with such research; and, a description of the key elements of the Designated Officials’ management plan (including the role and principal duties of the conflicted Investigator in the research project, conditions of the management plan, how the management plan is designed to safeguard objectivity in the research project, confirmation of the Investigator’s agreement to the management plan, how the management plan will be monitored to ensure Investigator compliance, and other information as needed).
  9. Where an Investigator’s failure to comply with the Investigator responsibilities under the PHS FCOI, or Designated Officials’ financial conflict of interest management plan, appears to have biased the design, conduct, or reporting of the PHS-funded research, the University of Guelph must promptly notify the relevant PHS Awarding Agency of the corrective action taken or to be taken.
  10. The University of Guelph must respond to relevant PHS Awarding Agency and/or U.S. Department of Health & Human Services inquiries before, during, or after an award into any Investigator disclosure of financial interests and the Designated Officials’ review (including any retrospective review) of, and response to, such disclosure, regardless of whether the disclosure resulted in the Designated Officials’ determination of a financial conflict of interest. This may involve the submission or permit of on-site review of all records pertinent to compliance with the PHS FCOI Regulations.

5. Appendix A: SPONSORS OF RESEARCH THAT REQUIRE COMPLIANCE WITH U.S. PUBLIC HEALTH SERVICE (“PHS”) REGULATIONS

This list is not exhaustive, and the PHS FCOI regulations may apply to other agencies. Please carefully review the guidelines for competitions that you are applying to and if the PHS regulations apply, please submit the Significant Financial Interest Disclosure Form at the time of your application and complete the training prior to engaging in PHS-funded research, as noted above.

U.S. PHS Agencies

  • Administration on Aging (AoA)
  • Administration for Children and Families (ACF)
  • Agency for Healthcare Research and Quality (AHRQ)
  • Agency for Toxic Substances and Disease Registry (ATSDR)
  • Centers for Disease Control (CDC)
  • Food and Drug Administration (FDA)
  • Health Resources and Services Administration (HRSA)
  • Indian Health Services (IHS)
  • National Institutes of Health (NIH)
  • Office of the Assistant Secretary for Health (ASH)
    • Office of the Assistant Secretary for Preparedness and Response (ASPR)
    • Biomedical Advanced Research and Development Authority (BARDA)
    • Office of Minority Health Resources Center (OMH)
    • Office of Population Affairs (OPA)
    • Office of Research Integrity (ORI)
    • Office of Research on Women's Health (OWH)
    • Office of the Assistant Secretary for Preparedness and Response (ASPR)
  • Office of Global Affairs (OGA)
  • Substance Abuse and Mental Health Services Administration (SAMHSA)

Non-PHS organizations which have adopted the PHS regulations:

  • Alliance for Lupus Research
  • American Cancer Society
  • American Heart Association
  • American Lung Association
  • Arthritis Foundation
  • California Breast Cancer Research Program (CBCRP)
  • California HIV/AIDS Research Program (CHRP)
  • CurePSP Foundation for PSP | CBD and Related Brain Diseases
  • Henry M. Jackson Foundation for the Advancement of Military Medicine
  • Juvenile Diabetes Research Foundation
  • Lupus Foundation of America
  • Susan G. Komen for the Cure

Appendix B: Significant Financial Interest Disclosure Form

Significant Financial Interest Disclosure Form (Word Document)