Standard Operating Procedures - Chapter 18

MANAGING CONFLICTS OF INTEREST

Conflict of interest (COI), defined as a set of conditions in which judgment concerning a primary interest may be biased by a secondary interest, is inherent to the conduct of research. In any given situation, conflict of interest must be managed through a system of identification, disclosure, containment, reduction, and elimination. While the focus has traditionally been on financial conflicts, which are quantifiable, non-financial interests exist as well. Non-financial interests may clash with the protection of research participants and should also be disclosed and managed when present.

18.1	Research Personnel
18.2	IRB Members
18.3	Institutional Officials

18.1 Research Personnel

The IRB and the HRPO staff help investigators to understand how COI can influence the protection of human participants.

The IRB requires that investigators provide written information in the application regarding any potential COI relevant to research studies submitted for IRB review. To ensure that COI does not compromise the rights and welfare of human participants of research, the IRB will determine: (1) if methods used for management of financial interests of parties involved in the research adequately protect the rights and welfare of human participants; (2) if other actions are necessary to minimize risks to participants; and (3) the kind, amount, level of detailed information to be provided to research participants regarding a conflict of interest and any management techniques applied.

18.2 IRB Members

No IRB member may participate in the initial review, continuing reviews or modification requests of any research study in which the member has a conflict of interest (COI), except to provide information requested by the IRB. A member with a COI will be required to refrain from participation by absenting him/herself from the room or by automatic exclusion during the final deliberation and voting for any research in which the member has a potential conflict of interest due to an investigator role, relationship to the investigator, or a financial interest with regard to the research. Such members are excluded from the quorum count for the study being considered. The minutes will reflect by name all individuals not participating due to a COI and their absence from the room and re-entry. In cases where a designated reviewer has a conflict of interest, the individual is required to inform the HRPO prior to the meeting and the study is reassigned to another reviewer.

IRB members are permitted to vote on studies submitted by members of their own department or division, because often they are the most knowledgeable about the topic being investigated, but only if the IRB member has no other potential conflicting interest, such as responsibility for the design and oversight of the study. Members who believe they have been involved in attempts by investigators or others to influence the review of a particular study will bring the matter to the attention of the IRB Chair. The member may be advised to exclude him/herself or abstain from the final deliberation and vote if a perceived conflict of interest exists.

Possible conflicts of interest for IRBs may originate at the individual or institutional level and may include:

Individual Level

Member is investigator on research study under review
Member or staff hold significant financial interest in research sponsor
Loyalty to colleagues submitting for review
Members too closely tied to area of research under review
Possible impact of decisions on member’s own work (e.g., policy changes)
Personal agenda
Non-IRB roles

Institutional Level

Pressure or desire to protect the institution
Concern for institution’s reputation or prestige
Promotion of research vs. protection of human participants
Under evaluation of IRB service
Potential liability
Institutional or community values
Pressure for rapid reviews
Institutional equity or ownership

Management of IRB conflicts of interest will include: (1) excusal of members from the final deliberation and voting on studies in which they have declared a potential conflict of interest; (2) placement of the IRB within the institution in a position of independence to avoid undue influence and bias in reporting structures and policies; and (3) proactive education to increase awareness of existing policies and the potential for conflicts of interest.

18.3 Institutional Officials

As academic institutions have increasingly entered into financial and collaborative research arrangements with private industry, institutional conflicts of interest have become a topic of growing concern and increasing public scrutiny. To avoid potential COI, institutional officials shall not serve as an IRB board member unless a compelling situation exists.