irb member conflict of interest presentation for irb members

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IRB Member Conflict of Interest Presentation for IRB Members

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Page 1: IRB Member Conflict of Interest Presentation for IRB Members

IRB Member Conflict of Interest

Presentation for IRB Members

Page 2: IRB Member Conflict of Interest Presentation for IRB Members

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.

Page 3: IRB Member Conflict of Interest Presentation for IRB Members

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.

Page 4: IRB Member Conflict of Interest Presentation for IRB Members

Risk of “Non-Recusal”

Compromised ObjectivityBiased opinion of the merit of the

studyBiased opinion of whether IRB criteria

for approval have been metUndue influence on other IRB

membersAppearance of impropriety; loss of

public trust

Page 5: IRB Member Conflict of Interest Presentation for IRB Members

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

Page 6: IRB Member Conflict of Interest Presentation for IRB Members

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

Page 7: IRB Member Conflict of Interest Presentation for IRB Members

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 member’s personal biases may interfere with his or her impartial judgment

Page 8: IRB Member Conflict of Interest Presentation for IRB Members

What to Do if You Have a Conflict of Interest Inform the IRB Chair or Administrator

as soon as possibleDetails of the conflict of interest

should not be divulgedIRB staff will capture those protocols

in which IRB members are a part of the study team

Recusals are recorded in the IRB meeting minutes