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Presentation at a training program ‘Applying
the Principles of Ethics to Clinical Practice:’ held at Aramco Dhahran
April 6, 2015 by Professor Omar Hasan Kasule Sr. MB ChB (MUK). MPH (Harvard),
DrPH (Harvard) Chairman of the Ethics Committee King Fahad Medical City.
What is conflict of Interest (COI)?
·
A financial interest or other opportunity for
tangible personal benefit of an individual or his/her immediate family
·
The interest may exert a substantial and
improper influence on the individual's professional judgment in exercising any
institutional duty or responsibility, including the review of research.
·
The interest may be financial or non-financial
·
Conflicts of interest must not compromise the
rights and welfare of research participants or the integrity of the research
review process.
What is a
financial conflict of interest?
·
An interest of an individual (or his/her
immediate family) of monetary value that would reasonably appear to be affected
by the research
·
An individual’s interest in any entity whose
financial interests would reasonably appear to be affected by the research.
·
Financial interests include (but are not limited
to) salary or other payments for services (e.g., honoraria), equity interests
(e.g., stocks), and intellectual property rights (e.g., patents and
copyrights).
What is a
non-financial conflict of Interest?
·
An interest other than monetary of an individual
(or his/her immediate family) in the design, conduct, or reporting of the
research
·
Any other interest that competes with an IRB
member’s (or consultant’s) obligation to protect research participants and
potentially compromises the objectivity and credibility of the research review
process.
Examples
of COI
·
IRB members with a financial interest pertinent
to a specific study or its sponsor, as determined by the IRB, will not
participate in the review of or determination concerning that study. This
requirement applies to reviews conducted by the convened IRB and those
performed by expedited and exempt procedures.
·
Payments to physicians for referring patients to
research protocols in which the referring physician does not participate as an
investigator are prohibited.
·
Due to institutional conflict of interest, no
individual from a developmental or business office may be appointed as an IRB
member.
How does
an IRB member deal with his/her COI?
·
IRB Member/Consultant ensures any potential or
perceived conflict of interest (COI) concerning protocols reviewed by the IRB
is self-identified and made known.
·
The IRB member must leave the room during the
discussion of and voting on a project where there is COI, except if the IRB
member is providing information at the IRB’s request.
·
If questions arise during the discussion, the
IRB Chair invites the IRB member with the conflicting interest back into the
room to provide information, but will excuse him/her again before final
deliberation and voting.
How does an investigator
deal with his/her COI?
·
The investigator must disclose COI when applying
for IRB approval. Disclosure to the KFMC IRB does not relieve the individual of
this responsibility.
·
The investigator consults their Department
Chairs to determine if the department has a financial interest related to the
research and should disclosure any such information.
·
The investigator includes an appropriate
description of any relationship (including the research team) that might be
perceived as a potential conflict of interest in the research consent form
provided to subjects.
How does an investigator
deal with his/her COI?
·
The investigator discloses recruitment bonuses
paid per participant or for reaching an accrual goal within a specific time
frame, as well as being offered a finder's fee for referral of potential
participants
·
The investigator discloses information
pertaining to new or changed financial interests during the course of the
research.
·
The investigator discloses financial interests
as required by the funding or reviewing agency or other governmental agencies.
·
The PI informs the IRB regarding the source(s)
of funding and funding arrangements for each protocol.
Some questions used to assess potential
COI
·
Relationships between the PI and a commercial
sponsor?
·
Does the PI have any proprietary interests in
the product?
·
Does the PI receive significant payments of
other sorts? (e.g. grants)
·
What are the details for payment?
·
Who receives the compensation?
The
IRB of a major hospital sat to consider a proposal sponsored by a
multi-national pharmaceutical firm and all 5 members declared their interests.
The Chairman has been engaged as a temporary consultant for the firm over the
past 5 years mainly to give lectures on drug development processes to potential
researchers. The son in law of the deputy chairman had shares worth SAR1000 in
the firm acquired during course training course on stock investment. One member
was the brother in law of the principal investigator. The principal
investigator a member for 6 years had not attended the meeting. Only one member
had no interests to declare. The committee proceeded to consider the proposal
because everybody’s interests were now known.
Case
Scenario 2:
The
hospital received a big grant from a pharmaceutical company to do a post
marketing survey on a new analgesic. After trial initiation it was discovered
that the physicians in the hospital rarely prescribed the drug. The principal
investigator called a meeting of all physicians in the outpatient clinic and
asked them to start prescribing the drug so that the hospital would not lose
the grant. He explained that the drug had already been found to be effective
and was safe.