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Public Health Service Financial Conflict of Interest

Principal investigators (PIs) applying to or receiving funding from Public Health Service (PHS) sponsors must adhere to requirements on the disclosure and management of financial conflicts of interest (FCOI).

A growing number of federal and private sponsors use the PHS FCOI regulations, and the Federal Demonstration Partnership maintains a list of known participating sponsors. If you are aware of additional sponsors, believe your sponsor adheres to the regulations, or have questions about UT’s PHS FCOI policy or procedures, please contact Dairin Malkemus, UT’s Research Conflict of Interest Officer, at dmalkemu@utk.edu.

Basic Information

In 2011, the US Department of Health and Human Services (DHHS) updated the Public Health Service regulations governing applicants’ responsibilities for promoting objectivity in research. In order to better address when a significant financial interest could affect or bias the design, conduct, or reporting of research, PHS applicants must follow additional disclosure and training requirements for financial conflicts of interest.

The University of Tennessee is committed to ensuring that research is conducted responsibly and consistent with the highest ethical standards. UT recognizes its responsibility to uphold all applicable federal rules and regulations as a condition of accepting public funding for sponsored projects, and has updated Fiscal Policy FI0125 (Part II) to comply with the new PHS FCOI policy.

All full-time UT employees are also required to complete an annual conflict of interest disclosure to comply with Fiscal Policy FI0125 (Part I). Follow the link at the end of the policy for the “Part 1 – Outside Interest Disclosure Form – Faculty and Staff (PerfectForms)”.

Definition of Investigator

According to UT Fiscal Policy FI0125, the definition of investigator used for PHS “means the project director (PD) or principal investigator (PI) and any other person (including but not limited to a student, resident, fellow, post-doctoral appointee, and affiliate, volunteer, and adjunct faculty appointee), regardless of title or position and regardless of whether compensated or not, who is responsible for the design, conduct, or reporting of PHS-funded research, or proposed for such funding, which may include, for example, collaborators or consultants.” The investigator role can also refer to individuals who are not employed by the University of Tennessee, including independent external consultants and employees of subaward/subcontract institutions or companies.

The PI is responsible for determining which personnel meet the definition of investigator on any PHS project.

Proposal Stage Instructions

Before the Office of Sponsored Programs can submit a proposal to a sponsor following the PHS FCOI regulations, the following internal procedure must be completed.

  1. OSP identifies participants who are listed on both on the budget document and listed as key personnel in the proposal.
  2. OSP will confirm which individuals have already completed the PHS FCOI form, and which individuals need to complete the PHS FCOI form or an annual renewal.
  3. OSP will send an email to the PI and copy the RCOI Officer (and Business Manager if desired) with the names of the “investigators” that do not have a current PHS FCOI disclosure form on file.
  4. The PI must ensure that each person identified completes a PHS FCOI form.
    • If a subaward/subcontract institution or a consulting company has a PHS-compliant FCOI policy of its own, and if its Office of Sponsored Programs (or equivalent) confirms this in the required Subrecipient Commitment Form Appendix A or Consultant Commitment Form, that institution’s or company’s employees do not need to complete UT’s PHS FCOI form. If the subaward/subcontract institution or consulting company cannot certify that its FCOI policy complies with the PHS regulations, or if it does not have an FCOI policy, then all participating employees of that institution or company must follow UT’s PHS FCOI procedure.

UT offers paper and web-based PHS FCOI forms that may be used by university investigators (UT faculty, staff, and students) and non-university investigators alike, according to preference.

    • Paper form: Paper forms must be signed by the PI’s supervisor (department head, director, or associate dean for research) as well as the individual completing the form. Please return completed forms to Dairin Malkemus in PDF via email (dmalkemu@utk.edu).
    • Web-based form: Web-based forms must be certified by the PI’s supervisor (department head, director, or associate dean for research). PIs should provide non-university investigators with the correct supervisor name and email address required to certify the form.
  1. After the PHS FCOI forms for each identified person have been completed, signed/certified by the PI’s supervisor, and returned to the RCOI Compliance Officer, the proposal can be submitted to the sponsor after OSP internal review.

Award Stage Instructions

Before the Office of Sponsored Programs can accept an award from a sponsor following the PHS FCOI regulations, the following internal procedure must be completed. We encourage PIs to begin this process before an award is issued (for example, when a just-in-time notification is received from the sponsor) in order to ensure timely award processing.

  1. When the Office of Sponsored Programs receives official award notification from the sponsor, they will contact UT’s Research Conflict of Interest Officer. The PI must send an email to UT’s Research Conflict of Interest Officer, listing the names and contact information of all individuals “responsible for the design, conduct, or reporting of research” on the project. The PI should refer to the definition of investigator listed above when making this determination.  to confirm the individuals who need to complete the PHS FCOI form or an annual renewal. At this time, the PI should also identify individuals listed as TBD at the proposal stage.
    • The PI must ensure that each person identified completes a PHS FCOI form. If a subaward/subcontract institution or a consulting company has a PHS-compliant FCOI policy of its own, and if its Office of Sponsored Programs (or equivalent) confirms this in the required Subrecipient Commitment Form Appendix A or Consultant Commitment Form, that institution’s or company’s employees do not need to complete UT’s PHS FCOI form. If the subaward/subcontract institution or consulting company cannot certify that its FCOI policy complies with the PHS regulations, or if it does not have an FCOI policy, then all participating employees of that institution or company must follow UT’s PHS FCOI procedure.

UT offers paper and web-based PHS FCOI forms that may be used by university investigators (UT faculty, staff, and students) and non-university investigators alike, according to preference.

    • Paper form: Paper forms must be signed by the PI’s supervisor (department head, director, or associate dean for research) as well as the individual completing the form. Please return completed forms to Dairin Malkemus in PDF via email (dmalkemu@utk.edu).
    • Web-based form: Web-based forms must be certified by the PI’s supervisor (department head, director, or associate dean for research). PIs should provide non-university investigators with the correct supervisor name and email address required to certify the form.

At this stage, any potential financial conflicts of interest must be addressed before the award can be accepted. Potential conflicts are reviewed by a committee, and if a conflict is confirmed, a management plan will be created by the Research Conflicts of Interest Committee to address the conflict.

  1. The PI must ensure that each person identified as an “investigator” completes the CITI Conflict of Interest compliance training module. Please read the access instructions for the training module before proceeding. Completion of the training guarantees compliance for four years.
  2. After the items above are complete, the Research Conflict of Interest Officer will send confirmation to the Office of Sponsored Programs to indicate that the PHS FCOI requirements have been met and the award can be accepted after their internal review.

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