IRB Member Conflict of Interest

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IRB Member Conflict of Interest

• Presentation for IRB Members

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Regulations...

• DHHS and FDA regulations 45CFR 46.107(e) 21CFR
  56.107(e) prohibit members from participating in
  IRB reviews if they have a conflict of interest.
• No IRB may have a member participate in the IRB's
  initial or continuing review of any project in
  which the member has a conflicting interest,
  except to provide information requested by the
  IRB.

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UCI HRPP Policy for Conflict of Interest
Disclosure

• It is the expectation of the University that IRB
  members will voluntarily recuse themselves from
  review and discussion of research protocols if
  they have a conflict of interest.
• Members of the IRB must disclose to the IRB Chair
  or Administrator any conflict of interest that
  may arise in the review of research or compliance
  matters for the IRB.

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Risk of Non-Recusal

• Compromised Objectivity
• Biased opinion of the merit of the study
• Biased opinion of whether IRB criteria for
  approval have been met
• Undue influence on other IRB members
• Appearance of impropriety loss of public trust

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Conflicts of Interest that Require Member Recusal

• Members who are an investigator or faculty
  sponsor on the project under review, or whose
  spouse or child is an investigator or faculty
  sponsor
• Members who have any financial interests (i) that
  would reasonably appear to be affected by the
  research or (ii) in entities whose financial
  interests would reasonably appear to be affected
  by the research
• Members who believe existing circumstances may
  directly affect their objectivity should recuse
  themselves from the review

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Financial Interests that Require Recusal from IRB
Review

• Ownership interest, stock, stock options, or
  other financial interest related to the
  research--unless it meets 4 tests
• Compensation related to the research, including
  salary, consultant payments, honoraria, royalty
  payments, dividends, loans, other
  payments/considerations of value--unless it meets
  2 tests
• see members standards document

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Other Circumstances for Recusal from IRB Review

• A member is involved in a potentially competing
  research program
• A member has access to funding or intellectual
  information that may create an unfair competitive
  advantage
• A members personal biases may interfere with his
  or her impartial judgment

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What to Do if You Have a Conflict of Interest

• Inform the IRB Chair or Administrator as soon as
  possible
• Details of the conflict of interest should not be
  divulged
• IRB staff will capture those protocols in which
  IRB members are a part of the study team
• Recusals are recorded in the IRB meeting minutes