Conflict of Interest (COI) Requiring Management
A COI requiring management generally exists when an Investigator in University Research has a significant financial interest that is related to their University research and could directly and significantly affect the design, conduct, or reporting of their University research.
Identification
The COI Division identifies potential individual conflicts of interest (COIs) by reviewing:
- Outside activities, interests, and relationships disclosed in MyDisclosures
- Proposals, awards, contracts, or agreements referred by the Office of Sponsored Programs
- Human subjects research studies when the PI or a study team member indicates a financial interest in the IRB protocol
- Animal research studies when the PI or a study team member indicates a financial interest in the IACUC protocol
When a potential individual COI is identified, the COI Division will contact the investigator to determine if their outside activity, interest, or relationship is related to their University research.
Review and Management
When an investigator has an outside activity, interest, or relationship that relates to their University research, the COID conducts a COI review, which may involve COI Committee review.
If the COI requires management, a CMP is implemented by the COI Division. The CMP that applies is based on the type and level of the investigator’s significant financial interests and nature of the related research. Most conflicts will be subject to either a “Standard” CMP or a “PI-Exclusion” CMP as indicated in this chart. Following are links to examples of Standard or PI-Exclusion CMPs:
- Standard CMP for Non-Human, Non-Animal or Animal Research
- Standard CMP for Exempt Human Subject Research
- PI-Exclusion CMP for Human Subject Research
COI Chair or Vice Chair or COI Committee Review
The COI Committee Chair or Vice Chair or the COI Committee may modify the Standard or PI-Exclusion CMPs as appropriate to adequately manage a COI. For example, the CMP may be modified to include oversight of the related research by a data steward or data steward committee. When such oversight is required, Data Steward Guidelines and a template Data Steward Report are provided to the data steward and the investigator.
Execution of the CMP
The investigator will be required to sign their CMP via DocuSign. The COI Division will provide a copy of the signed CMP to their Department Chair or equivalent supervisor and any other relevant individuals, such as the Principal Investigator of the related research.
Animal or Human Related Research
When the CMP applies to animal or human research, the COI Division will upload a copy of the signed CMP to the relevant IACUC or IRB protocol. The COI Division will also communicate to the IACUC or IRB if the study team must submit a protocol modification to indicate a study team member’s financial interest in the research or, for human research when relevant, to include financial interest disclosure language in consent forms or scripts.
Appeals
If an investigator does not agree with their CMP, they may submit an appeal via email to the COI Division within 30 days of receipt of the CMP. The appeal will be reviewed by the COI Committee or the Senior Vice Chancellor for Research.
Public Health Service (PHS)
In accordance with PHS regulations on Promoting Objectivity in Research (42 C.F.R. Part 50, Subpart F), the University of Pittsburgh ensures public accessibility of certain information regarding identified and managed financial conflicts of interest (FCOIs) in PHS-funded research. To submit a request for this information, complete the Public Request for Information form and submit it by email to coi@pitt.edu with “PHS Public Request for Information” entered as the subject line.
All required fields of the form must be completed. One request may be submitted per form.
The University of Pittsburgh will not respond to multiple requests submitted in a single form or to incomplete requests.
Within five business days of receipt of a complete request, the University of Pittsburgh will send a written response to the email address provided by the requestor. If an FCOI exists, the response will include the following information:
- Name of the investigator.
- Title and role of the investigator with respect to the research project.
- Name of the entity in which the investigator has a significant financial interest.
- Nature of the investigator’s significant financial interest.
- Approximate dollar value (in ranges) of the investigator’s 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.