Written and prepared by Professor Omar Hasan Kasule 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
· Sn 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.
·
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?
