150608P - CONFLICT OF INTEREST IN RESEARCH (FROM KFMC CPP ON COI)

Presentation at an “IRB Training Program” at the Ministry of Health Riyadh on 8 June 2015 By Professor Omar Hasan Kasule Sr. MB ChB (MUK). MPH (Harvard), DrPH (Harvard) Chairman of the Institutional Review Board at 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? - 1

·        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? - 2

·        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?

Case Scenario 1:

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.