Chapter 20 - Conflict of Interest

Disclosure

The IRB leadership, staff and affiliated IRB members are required to disclose significant financial interests (SFI) in accordance with University of Pittsburgh Conflict of Interest policies (http://www.coi.pitt.edu/index.htm), including Policy 11-01-03 Conflict of Interest Policy for Faculty, Scholars, Researchers, Research Staff/Coordinators.

IRB Members

IRB members who are considered unaffiliated with the institution will not be required to complete the standard conflict of interest form.  These members will be required to sign a statement at the time of their orientation indicating that the conflict of interest policy has been provided to them.

To ensure understanding of Conflict of Interest (COI) issues, all members will be provided with the University definitions of COI at the time of their orientation.  In addition, the IRB COI Policy will be reviewed on an annual basis with all committee members to ensure they are aware of acceptable COI thresholds.

Potential conflicts of interest (COI) include but are not limited to:

  • being a listed investigator (or having an immediate family member including the spouse, dependents, and all members of the employee’s household including domestic partners listed as an investigator);
  • having a significant financial interest (or having an immediate family member with such an interest) in the sponsor of the research or the technology being evaluated; or
  • having any other conflict that might be perceived to inhibit a fair and unbiased review of the research.

Reviewer Assignment

The IRB Exempt/Expedited Vice Chairs will not review or approve a research study in which s/he has a conflict of interest.

No IRB reviewer will be assigned to review a research study in which s/he has a conflict of interest. 

Consultants

Consultants to the IRB will be asked, at the time they are contacted to review a research study, if they (or a member of their immediate family) have a conflict with the study on which they are being asked to consult. No consultants will be assigned to review a research study in which s/he has a conflict of interest. 

Investigators

  • Research investigators are not permitted to participate in decisions relating to the selection of IRB members responsible for performing the review of their research studies.
  • Investigators must disclose if they have any of the significant financial interests listed in the COI section of the protocol application that are related to the research covered by the IRB protocol.
  • As outlined in Chapter 8, for research studies submitted for initial and continuing IRB review, the Conflict of Interest Office is notified if the investigator indicates that there is a conflict of interest.
  • Investigators who have a financial conflict of interest (FCOI) with research covered under an IRB protocol must agree to a Conflict of Interest Management Plan (CMP) developed by the COI Office or Committee, consistent with the requirements outlined in University Policy 11-01-03. Exceptions to this policy may be requested through the COI Office. Certain exceptions must be approved by the authorized institutional official for human subject research, the Vice Provost for Research Conduct and Compliance.

The IRB and/or the investigator with the SFI should direct any requests for exceptions to the COI policy (e.g., to add/remove elements to/from the CMP) to the director of the COI Office. The request will then be forwarded to a subcommittee of the Conflict of Interest Committee, and, as required, to the Vice Provost for Research Conduct and Compliance for deliberation. The results of these deliberations will be reported to the IRB and the investigator with the SFI within two weeks of receiving the request.

In the unlikely event that the IRB is not in agreement with the proposed COI management plan and an agreement cannot be reached following the above procedures, the decision to grant IRB approval of the protocol remains with the IRB. This includes an assessment (for the purpose of protecting the rights and welfare of the human subjects) of the COI provisions under which the research would be conducted.

Placement of Study on Agenda

No IRB reviewer or consultant will be assigned to review a research study in which s/he has a conflict of interest.  

Research submissions will not be placed on the agenda of an IRB committee meeting if the IRB Vice Chair who will preside over the meeting is a listed investigator on the submission or holds a significant financial interest in the sponsor of the research or the technology being evaluated. Under extenuating circumstances, exceptions to this policy can be made by the IRB Chair or his designee. In the event an exception is deemed necessary, the conflicted IRB Vice Chair will be asked to step out of the room during the review, discussion and vote of the research submission. Another IRB Committee member will act as vice chair for that portion of  the meeting and will review and approve the minutes related to the study where the conflict exists.

Evaluations of Potential Conflicts at Meetings

IRB members and consultants are polled upon initiation of each IRB meeting to determine if they (or a member of their immediate family) are a listed investigator on any research study being reviewed at the meeting, or if they (or a member of their immediate family) hold a significant financial interest in the sponsor of any research study or any technology being evaluated in a research study being reviewed at the meeting or if any other potential conflicts exists.

Abstentions from Deliberations

IRB members and consultants will abstain from participation in any IRB deliberations or approval decisions relating to a research study in which they (or a member of their immediate family) have a potential financial conflict-of-interest.

IRB members and consultants will absent themselves from the IRB meeting room during IRB deliberations and decisions relating to a research study in which the individual (or a member of his/her immediate family) is listed as an investigator or has a potential non-financial conflict (e.g., consultant on the project).  An exception is to provide information specifically requested by the committee. 

Documentation in Minutes

The absence of members or consultants due to a conflict (i.e., a listed investigator, financial or other conflict) during the discussion of the research protocol and the vote will be documented in the minutes of the full board IRB meeting to include the reason for their absence.

 

version 12.10.2015