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.
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.
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

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
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
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
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