SOP #36 Conflict of Interest and COI Disclosure for IRB Members

Owner: Vice President of Academic Affairs
Author: CSS IRB
Contact: irb@css.edu
Policy Number: 36
Effective Date: 10/8/2021

Policy

Federal regulations do not permit an IRB member to participate in the review of research in which he/she has a conflicting interest, except to provide information requested by the IRB. This requirement helps to ensure that financial or other interests do not compromise the rights and welfare of human research subjects. (45 CFR § 46.107 (d).)  It is the responsibility of each IRB member to disclose any COI related to a study submitted for review and recuse him/herself from the deliberations and vote by leaving the room.  All CSS IRB members and alternate members of the IRB complete a conflict disclosure when first appointed and annually thereafter or sooner if their circumstances change.

Purpose

The IRB is charged with protecting research subjects from risks in experimental studies. Principles codified in the Nuremberg Code, the Declaration of Helsinki, Belmont Report, and existing federal regulations are employed to provide a framework for ethical considerations and assessment of risk and benefit in individual studies. The decisions made by the IRB are guided by these principles, but the IRB can only be successful if members are free of conflict of interest (COI).

IRB Members

The CSS IRB  includes, as part of the IRB Member and Staff education program, information on conflict of interest and disclosure requirements for IRB Members and for research investigators.  This education is part of the CSS CITI requirements (See, CSS IRB SOP# 37 IRB Human Subjects Research Required Education).

Prior to discussion of protocols at a convened meeting, the IRB Chair will ask if any member, including the IRB Chair, has a COI with any protocol being discussed at that meeting. A conflict of interest may include financial interests of the IRB member or immediate family members (spouse, domestic partner, and dependents), as well as non financial issues. A financial interest exists when the member has a financial relationship with the sponsor, product or service being tested.

Should an IRB member declare involvement in any way in a research protocol under review by the IRB, or state a COI with the research protocol the following is required:

  • IRB member is excluded from discussion and voting except to provide information requested by the IRB.
  • IRB member leaves the meeting room during discussion and voting.
  • IRB member is not counted towards quorum.

IRB members with a conflict are documented in the minutes as being absent with an indication that a conflict of interest was the reason for the absence.

Designated Reviewers for Expedited Review

IRB members who have been designated by the IRB Chair as reviewers for initial or continuing review of research protocols, reports of noncompliance, protocol deviations, unanticipated problems, and amendment requests that qualify for expedited review will self-identify any COI that they may have with the research or PI. In such cases, the review responsibility will be reassigned to another experienced IRB member.

Examples of IRB Member COI

IRB members are considered to have a conflict of interest if they:

  1. Are involved in the design, conduct, or reporting of the research study.
  2. Have direct administrative powers over the investigators or the study.
  3. Have a financial and/or ownership interest of any amount in or related to the research and the value can be readily determined.
  4. Have a financial and/or ownership interest in or related to the research but the value cannot be readily determined.
  5. Received or will receive compensation and/or have ownership interest of any amount with value that may be affected by the outcome of the study.
  6. Have received in the past year, currently are receiving, or will receive from the sponsor of the study, honoraria, payments, or compensation of any amount.
  7. Have a proprietary interest in the research, including but not limited to a patent, trademark, copyright, or licensing agreement.
  8. Serve as directors, board members, scientific advisors or hold other decision-making positions in the entity sponsoring the research.
  9. Are not an investigator, co-investigator, or consultant on a study, but are closely associated with the investigators on the study being reviewed, or other studies.
  10. Have personal, familial, or intimate relationships with the principal investigator.
  11. For any reason, believe they cannot be objective concerning a study.

Disclosure of Researcher COI

For IRB purposes, researcher conflict review occurs at the time of new study submission, continuing review, with the addition of a new researcher, and whenever a researcher updates their COI disclosure indicating a new or changed interest. IRB staff notify the CSS IRB whenever a submission requiring conflict review is received. The IRB Chair reviews the researchers’ disclosures and either notifies the IRB staff that no researcher COI was identified or that one or more researchers has an interest that requires evaluation by the IRB Committee. In the event a conflict that requires disclosure or management is identified, the IRB Chair will provide a written summary describing the conflict and a plan for managing the conflict.

Evaluation of COI

The IRB will review COIs and the plan to manage the conflict to determine:

  • Whether the COI affects the rights or welfare of research subjects;
  • Whether the COI might adversely affect the integrity or credibility of the research or the research program; and
  • Whether the plan to manage the conflict effectively protects research subjects and the integrity and credibility of the research and the research program.

In evaluating COIs and management plans among other factors the IRB may consider:

  • How the research is supported or financed;
  • The nature and extent of the conflict;
  • The role and responsibilities of the conflicted individual in the design, conduct, and reporting of the research; and
  • The ability of the conflicted individual to influence the outcome of the research.

Management of COI

The IRB has final authority to determine whether the research, the COI, and the management plan, if any, allow the research to be approved. With regard to the management plan, the IRB shall either affirm or request changes to strengthen it. The IRB can require additional measures to manage a COI so that the research may be approved.

For example, in addition to the conflict management plan, the IRB may require:

  • Disclosure of the COI to subjects through the consent process;
  • Modification of the research plan or safety monitoring plan;
  • Monitoring of research by a third party;
  • Disqualification of the conflicted party from participation in all or a portion of the research;
  • Appointment of a non-conflicted PI;
  • Divestiture of significant financial interests;
  • Severance of relationships that create actual or potential conflicts.

In the event the conflict cannot be effectively managed, the IRB may disapprove the research.

Gray Areas

Some COI’s are easily identified, others may fall into a gray area.  For example, if a Chair of a department is on the IRB, is it a conflict if they review and vote on a protocol from a member of their department? The CSS IRB may have recruited that IRB Member because they have the expertise to review those types of protocols from their department. Can an IRB Member who is a faculty member review a protocol from another faculty member in their department?  Again, they may have the best expertise to conduct that review.  It is wise to remember that a conflict does not only apply to the principal investigator, but to any member of the research team.  Do not automatically disqualify or allow a reviewer without  careful discussion and, of course, documentation.  Education, awareness, disclosure, discussion, and decision making about conflicts are essential to maintain the integrity of the CSS IRB and ultimately to protect human subjects in research.

Resources

IRB EasyEd. Financial and Non-financial Conflicts of Interests of IRB Members. Volume 2 Number 2.

© 2017 Apex Ethical

Allina Health HRPP/IRB SOPs -

https://www.allinahealth.org/-/media/allina-health/files/for-medical-professionals/research/allina-r esearch-administration-home/hrpp-irb-sop-manual.pdf?la=en&hash=50A1A5F7B07CC65A86FB9F9B 34718003

University of Texas at Austin – Office of Research and Compliance https://research.utexas.edu/ors/human-subjects/irb-policies-and-guidance/policies-and-procedures/ University of Kentucky. Conflict of Interest Statement for IRB Members, https://www.research.uky.edu/uploads/ori-f170000-irb-member-conflict-interest-statement-pdf

This is a new policy per the 2018 Common Rule Requirements.

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