CHAPTER 4

4.1 IRB Members at Full Board Meeting

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

Prior to discussion of protocols at a full board meeting, the IRB Chair will ask if any member has a COI with any protocol being discussed at that meeting. A conflict of interest may include significant financial interests of the IRB member or immediate family members (spouse, domestic partner, and dependents), as well as nonfinancial issues, such as involvement in design, conduct, or reporting of the research. 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:

• Conflicted IRB members may provide information as requested by the IRB.
• Conflicted IRB members will leave the meeting room and are excluded from discussion and voting.
• Conflicted IRB members are not counted towards quorum.
• The meeting minutes will indicate that the conflict of interest is the reason for the member’s absence.

4.1.1 Reviewers Designated 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 non-compliance, 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.

4.1.2 Examples of IRB member COI

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

• Are involved in the design, conduct, or reporting of the research study.
• Have direct administrative powers over the investigators or the study.
• Have a financial and/or ownership interest of any amount in or related to the research and the value can be readily determined.
• 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.
• 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.
• Have a proprietary interest in the research, including but not limited to a patent, trademark, copyright, or licensing agreement.
• Serve as directors, board members, scientific advisors or hold other decision-making positions in the entity sponsoring the research.
• 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.
• Have personal, familial, or intimate relationships with the principal investigator.
• If they believe they cannot be objective concerning a study for any reason.

4.2 Principal Investigator or Research Team

PIs and their research staff are required to disclose financial interests according to the University HOOP. The COI Official will review disclosures to determine whether a real or perceived financial interest in research exists (interest in the sponsor, produce or service being tested). Records of disclosures and management plans are maintained according to university retention requirements and for a minimum of 3 years from the completion of a related research project.

The IRB will adhere to the following policies regarding conflict-of-interest requirements for research staff engaged in human subject research.

Exempt research: PIs who have a potential financial conflict of interest relating to the submitted study are required to submit Research Certifications confirming financial disclosures are current.

When reviewing initial exempt submissions or changes to PI on exempt submissions, IRB staff will review the PI’s response to the financial conflict of interest prompt in the exempt submission form or provided via feedback and if a potential financial conflict of interest is identified, the IRB staff will initiate the COI certification process. IRB staff will verify COI review is complete prior to issuing an exempt determination letter.

Non-exempt research (e.g., expedited and full board research): PIs and research staff identified by the PI as Covered Individuals are required to submit Research Certifications confirming financial disclosures are current.

When reviewing initial submissions and modifications to non-exempt research adding personnel identified as Covered Individuals, IRB staff will identify the PI and research personnel designated as Covered Individuals and initiate the COI Certification process. IRB staff will verify that PIs and Covered Individuals have completed their Research Certification and that the COI review is complete prior to final IRB approval.

Covered Individuals are defined in The UTEP Handbook of Operating Procedures.

An assessment of potential conflicts of interest for each Covered Individual on a study will be completed by the COI Coordinator, as applicable. Disclosed financial interests that might affect the protection of subjects, or the objectivity of the research must have a management plan in place. Management plans may include partial or complete divestment, limiting involvement of the conflicted individual, additional oversight, or disclosure. The COI Coordinator determines if formal COI management strategies are required.

The COI Coordinator will work with the researcher to develop and finalize a COI Management Plan. When finalized, the COI Management Plan will be submitted to the IRB for review and final approval.

4.3 Institutional Financial Interests

Institutional COIs are identified by the Research Protections COI program through evaluation of annual personnel disclosures, as well as internal communication and verification processes between university departments related to licensing agreements, institutional investments, and research gifts.