Boston University
Charles River Campus IRB
Policies and Procedures
Title: IRB Member and Consultant Conflict of Interest
Date: November 7, 2014

Purpose

The purpose of this policy is to outline the process for identifying and managing conflicts of interest for Institutional Review Board (IRB) members. This policy applies to any type of review (e.g. initial, continuing review, amendments, events, non-compliance, unanticipated problems, expedited, exempt determination, etc.)

Defined Terms

Conflict of Interest (COIConflict of Interest Learn about BU's Financial Conflict ...): Any situation in which an IRB member has an interest (financial or non-financial) in the research being reviewed.

Immediate Family: Spouse and dependent children of IRB member

Policy

IRB members are prohibited from participating in review of research in which they have a conflict of interest, except to provide information requested by the IRB. IRB members are expected to notify the IRB Chair and/or IRB Director of any conflict of interest that they might have with the research being reviewed.

Procedures

Convened Meeting

  1. IRB members should review the protocols listed on the agenda for the upcoming meeting prior to the meeting and notify the IRB Chair or IRB Director if there are any conflicts.
  2. An IRB member will not be assigned as a reviewer on a protocol if he/she has a conflict
  3. At the beginning of the IRB meeting, the IRB Chair will ask if any member has a conflict
  4. If an IRB member has a conflict, the following will occur:
    • The IRB member will be excluded from the discussion and voting except to provide information requested by the IRB
    • The IRB member will leave the meeting room for discussion and voting
    • The IRB member is not counted towards quorum
    • The IRB members with a conflict are documented in the minutes as being absent with an indication that a conflict of interest was the reason for the absence

Expedited Review/Exempt Determination

  1. IRB members who conduct expedited reviews will self-identify any conflicts of interest that they may have with the research.
  2. An IRB member will not be allowed to review the research if he/she discloses a conflict
  3. If a conflict exists, another IRB member will be assigned as the reviewer
      IRB members are considered to have a conflict of interest if they or a member of their immediate family:
  • Is a member of the research team
  • Has a financial interest in the research with value that cannot be readily determined
  • Has a financial interest in the research of any amount
  • Has received or will receive compensation of any amount
  • Have received, in the past year, are currently receiving, or will receive from the sponsor of the study, honoraria, payments, or compensation of any amount
  • Has a proprietary interest in the research, such as a patent, trademark, copyright, or licensing agreement
  • Has received payments form the Sponsor in any amount
  • Is an executive director, board member, scientific advisor, or holds other decision-making positions of the agency or company sponsoring the research
  • Any other reason for which the IRB believes that he/she has a conflict of interest with the research

Consultant Conflict of Interest

Consultants will follow the same policy for identifying, disclosing, and managing conflict of interest as IRB members. If a consultant has a conflict of interest, they will not be assigned to the project. However, if the consultant with the conflicting interest is the only appropriate resource for the IRB (e.g. is the only person with sufficient understanding/expertise of the project) that person will be allowed to serve as a consultant on that project provided that the conflict is disclosed to the IRB. Consultants with a conflicting interest will be excluded from the discussion except to provide information and must not be present for the discussion and voting.

Title: IRB Member and Consultant Conflict of Interest

Author: Cynthia Monahan

Effective Date: November 7, 2014

Last Review/Update Date:

Revision #:

Approved: Cynthia Monahan, IRB Director Kathryn Mellouk, Associate Vice President-Research Compliance

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