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delegate through the ORI the responsibility for serving as primary reviewer or expedited reviewer for continuation reviews to qualified IRB members.

A1.1000 Institutional Review Board Membership

IRB membership requirements comply with federal regulations to ensure appropriate and diverse representation from multiple professions, various ethnic backgrounds, both genders, and both scientific and non-scientific backgrounds. One member must have no affiliation with UK or the VAMC. IRB members serve on the committee for designated terms of service. Selected UK administrative units and the ORI nominate individuals for chair, vice chair, and member roles on the IRB after review of scholarly, scientific, and other credentials. The VPR makes all appointments to these roles, as authorized by the UK President. The VA Research and Development Committee nominates members from the VAMC. The VA Director and the VPR, as authorized by the President of UK, make VA member appointments. Consideration of the nature and volume of research under review by a specific IRB shall be a factor in the appointment process. The ORI maintains appropriate documentation of professional credentials of each IRB member, and membership rosters contain information on members to ensure appropriate representation at IRB meetings for each protocol under review.

Non-voting ex officio members provide the IRB the expertise of specific units with significant institutional roles for human research protection and ensure coordination among UK administrative units in carrying out all provisions of the HRPP. The Medical IRB membership includes but is not limited to ex officio members representing the following units: University Legal Counsel, the ORI Director, the Investigational Drug Service (IDS), the Radiation Safety Officer (RSO) and Biological Safety Officer (BSO) of UK Environmental Health and Safety. For VAMC reviews, a representative of the VAMC Research and Development Committee serves as an ex officio member as well. The Director of the ORI and University Legal Counsel also serve as ex officio members on the Nonmedical IRB. Provisions for non-voting ad hoc consultants ensure the availability of special expertise as needed by the IRB prior to and/or during a convened meeting. Alternate IRB members serve in the absence of standing members.

A1.1050 Institutional Review Board Expertise and Qualifications

The IRB chairs, vice chairs, members, and staff must be familiar with the ethical principles guiding human research; the requirements of federal regulations, applicable state law, and the institution’s Assurance; and institutional policies and procedures established for the protection of human subjects. The IRB as a whole must also have effective knowledge of subject populations and other factors which can potentially contribute to a determination of risks and benefits to subjects and which can impact subjects’ informed consent. Institutional HRPP policies and procedures delineate specific education requirements for IRB members and appropriate tools and educational programs for meeting these requirements.

A1.1100 Conflict of Interest and IRB Members, ORI Staff, and Consultants

IRB chairs, members (standing and alternate), staff, and consultants may not participate in research review in which a conflict of interest exists. Specific policies and procedures govern the conduct of individuals in these positions and the process for recusal from the review process.

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