COI Management Plan for Human Subject Research
for SFIs triggering the PI-Exclusion rule

IRB# / TITLE
Individual w/SFI
Primary Dept. Affiliation
Principal Investigator
PI’s Primary Dept. Affiliation

In view of my Significant Financial Interest (SFI) in [specify name of company and/or describe technology being evaluated], I agree to the following plan to manage my conflict of interest with respect to the above-named protocol.

  1. I will not serve as Principal Investigator (PI) on this protocol, although I may serve as a co-investigator. The PI selected must be approved by the IRB. As a co-investigator, I will be responsible for: [describe role on study].
  2. I will not be involved in the recruitment of subjects, nor will I obtain subjects' informed consent at any time.
  3. I will not engage in the recording of research data.
  4. I will not be involved in clinical assessments of study eligibility criteria and intervention outcomes.
  5. I will not directly participate in data and safety monitoring activities; however, I may participate in the open portion of DSMB meetings. I will disclose my financial interest at the beginning of each meeting and it will be noted on both the meeting agenda and minutes.
  6. I will not be the sole individual interpretingstudy results, though I may be part of a committee that evaluates study results. Final decisions about the appropriate interpretation and presentation of research results shall be the responsibility of the PI.
  7. MySFI will be disclosed in the informed consent form using the following language:

One or more of the investigators conducting this research has a financial interestin [specify name of company and/or describe technology being evaluated]. This means that it is possible that the results of this study could lead to personal profit for the individual investigator(s) and/or the University of Pittsburgh. Any questions you might have about this will be answered fully by the Principal Investigator, Dr. [enter the name and telephone number of the PI of the research study], who has no financial conflict of interest with this research, or by the Human Subject Protection Advocate of the University of Pittsburgh (866-212-2668).

  1. I will provide other individuals involved in research under this protocol with the Notification of Investigator's research-related SFI form. Students will be engaged in the protocol only with the approval of their department chair or dean.
  1. I will disclose my Significant Financial Interest in all related abstracts, publications, presentations, and press releases; and in related applications or proposals for research funding only if disclosure is required by the funding source. In cases where disclosure is not required and I wish to disclose my SFI, I will contact the funding source for permission and instructions for doing so.
  2. I will notify the Conflict of Interest Office of the titles and numbers of any present or future federal research grants supporting this protocol.

PERSON WITH SFI / DATE

I will ensure compliance with the above COI management plan.

PRINCIPAL INVESTIGATOR (if different) / DATE

Upload this document into section 7.3 of OSIRIS. Your department chair or dean (as applicable) will be provided with a copy of this management plan.

Rev. 04-2017

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