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1.22 Assessment of the Effectiveness and Efficiency of the HRPP

1.0 Purpose

The purpose of this policy and procedure is to describe the Organization’s requirements for assessment of the quality, effectiveness, efficiency and support of the Organization’s HRPP in carrying out its mission to ensure protection of human subjects and compliance with all applicable federal, state and organizational requirements.

2.0 Policy

It is the policy of the Organization that there will be an ongoing assessment of the HRPP, as well as a comprehensive annual HRPP assessment. These assessments are designed to ensure: 1) that the HRPP is fully capable of protecting the rights and welfare of research subjects; and 2) the HRPP will continue to evolve and improve in its effectiveness and efficiency.

3.0 Procedures

  • 3.1. On-going Assessment of the HRPP

    • 3.1.1. HRPP policies and procedures will be assessed on an ongoing basis by the IO, IRB Executive Chair and IRB staff.
    • 3.1.2. Organizational officials may bring problems, or suggestions for improvement, to the attention of the IO and IRB Executive Chair for appropriate action.
    • 3.1.3. The IO, IRB Executive Chair, and IRB staff will continually monitor the efficiency of the IRB review process, identify problems and seek timely resolutions.
    • 3.1.4. Metric data on HRPP efficiency will be discussed in the ORA as well as at IRB staff meetings. These data will be provided to the IO, IRB Executive Committee and other Organizational officials as requested.
    • 3.1.5. One set of IRB minutes for IRB-01, IRB-02, and IRB-04 will be randomly selected for audit quarterly. IRB minutes for IRB-03 (Rapid Response IRB) will be monitored no less often than annually if the IRB has met during the year. The IRB will utilize HRPP policy 2.2 (Full IRB Review) and OHRP Draft Guidance “Minutes of Institutional Review Board (IRB) Meetings: Guidance for Institutions and IRBs” (dated November, 2015)
    • 3.1.6. PIs and other study personnel are provided an on-going opportunity to assess the effectiveness of the HRPP, including policies, quality of IRB review, efficiency of IRB review, IRB staff support and other components of the HRPP through communication with the IRB Executive Chair, IO, IRB staff, senior administration and through various IRB educational activities.
      • 3.1.6.1. The IRB Executive Chair and IRB Administrators will schedule focus group discussions with Investigators from UNMC, UNO, and CHMC to discuss the effectiveness of the HRPP, including policies, quality of IRB review, and efficiency of the IRB and other components of the HRPP.
      • 3.1.6.2. PIs and other study personnel may utilize the Investigator Assessment of the IRB form, available on the IRB’s website at http://www.unmc.edu/irb. This form may be submitted anonymously or with contact information.
      • 3.1.6.3. PIs and other study personnel may utilize the “Report a Problem or Complaint” tab on the UNMC IRB website that provides access University of Nebraska EthicsPoint, which allows anonymous comments to the IRB.
    • 3.1.7. All information gathered during the HRPP assessment will be utilized to identify areas of concern as well as identify areas for growth and development.

  • 3.2. Evaluation of the IRB Executive Chair

    • 3.2.1. The IO will evaluate the performance of the IRB Executive Chair on an annual basis utilizing a discussion format. The focus of the discussion will be on IRB leadership, accomplishments during the past year and goals for the future.
    • 3.2.2. The IO will obtain feedback submitted from the IRB Members and IRB administrators via focus group discussion held annually (during or following a scheduled IRB-01, IRB-02, and IRB-04 meeting). This focus group may be mediated by the IO or one or more IRB Administrators, without the Executive Chair present.
    • 3.2.3. If the IRB Executive Chair’s performance is judged to be deficient, the IO will discuss his/her concerns with the Executive Chair and seek a satisfactory resolution. If the IRB Executive Chair’s performance continues to be deficient, the IO may remove the individual as the Executive Chair, in consultation with the Vice Chancellor for Research.

  • 3.3. Evaluation of the Chairs and Vice-Chairs

    • 3.3.1. The IRB Executive Chair will review the performance of the IRB Chairs and Vice-Chairs on an annual basis utilizing the following criteria:
      • 3.3.1.1. Attendance at meetings
      • 3.3.1.2. Chairing IRB meetings
      • 3.3.1.3. Completeness of reviews
      • 3.3.1.4. Service on IRB subcommittees
      • 3.3.1.5. Feedback submitted from the IRB Members and IRB administrators via focus group discussion held annually (during or following a scheduled IRB-01, IRB-02, and IRB-04 meeting). This focus group may be mediated by the IO, the Executive Chair, or one or more IRB Administrators, without the Chairs or Vice-Chairs present.
      • 3.3.1.6. Creative recommendations which help improve the HRPP.
    • 3.3.2. If an IRB Chair or Vice-Chair’s performance is judged to be deficient, the IRB Executive Chair will discuss his/her concerns with the Chair or Vice-Chair and seek a satisfactory resolution. Upon recommendation of the IRB Executive Chair, the IO at his/her discretion may remove the individual as an IRB Chair or Vice-Chair.

  • 3.4. Evaluation of IRB Members

    • 3.4.1. The IRB Executive Chair will convene a meeting with the IRB Administrators and staff to evaluate the IRB Members using the following:
      • 3.4.1.1. Metric data for individual IRB members based on the following criteria:
        • 3.4.1.1.1. Attendance at meetings for which they have been assigned review items
        • 3.4.1.1.2. Timeliness and completeness of IRB reviews
        • 3.4.1.1.3. Participation in IRB discussions
        • 3.4.1.1.4. Service on IRB subcommittees
        • 3.4.1.1.5. Completion of required Continuing Education.
      • 3.4.1.2. Individual Feedback to IRB Members
        • 3.4.1.2.1. IRB members will be provided feedback regarding their service.
        • 3.4.1.2.2. If an IRB member’s service is judged to be significantly deficient, the IRB Executive Chair will discuss the concerns with the member in a private setting and seek a satisfactory resolution.
        • 3.4.1.2.3. If an IRB member’s service is judged to be satisfactory or exceptional, the IRB Executive Chair will so inform the member.
    • 3.4.2. Any IRB member whose contribution to the IRB is judged to be continually deficient despite feedback, may have their appointment terminated by the IO upon recommendation of the IRB Executive Chair.
    • 3.4.3. Upon request of individual IRB members, the IRB Executive Chair and/or the IO will write letters of recommendation which attest to the quality and value of the member’s service on the IRB.

  • 3.5. Evaluation of IRB Administrators and Staff

    • 3.5.1. The Assistant Vice-Chancellor for Regulatory Affairs will evaluate the performance of the IRB Administrators utilizing the UNMC Employee Evaluation Form and feedback submitted from the IRB Members via focus group discussion held annually (during or following a scheduled IRB-01, IRB-02, and IRB-04 meeting). This focus group may be mediated by the IO, or the Executive Chair, without the IRB Administrators present.
      • 3.5.1.1. The Assistant Vice-Chancellor for Regulatory Affairs will provide feedback verbally to each IRB Administrator during the annual review process, as well as written comments on the UNMC Performance Evaluation Form.
      • 3.5.1.2. The Assistant Vice-Chancellor for Regulatory Affairs will also provide ongoing feedback about the performance of the IRB Administrators throughout the year.
    • 3.5.2. The supervising IRB Administrator will evaluate the performance of the IRB staff utilizing the UNMC Employee Evaluation.
      • 3.5.2.1. The supervising IRB Administrator will provide feedback verbally to each IRB staff during the annual review process, as well as written comments on the UNMC Employee Evaluation Form.
      • 3.5.2.2. The supervising IRB Administrator will also provide on-going feedback about the performance of the IRB staff throughout the year.

  • 3.6. Annual Evaluation of the HRPP

    Each component of the HRPP will conduct a self-assessment utilizing the Annual HRPP Assessment Form. The IO in conjunction with the Assistant Vice-Chancellor for Regulatory Affairs and any other personnel deemed appropriate will review each component’s Annual HRPP Assessment Form with the objective to:

    • 3.6.1. Determine which items on the Annual HRPP Assessment Form are judged to be:
      • 3.6.1.1. Excellent (E) or Satisfactory (S).
      • 3.6.1.2. Unsatisfactory (US). The item requires a corrective action plan with set goal(s) in a time frame based upon the seriousness of the deficiency.
    • 3.6.2. Determine which items rated Excellent or Satisfactory are to be targeted for further improvement before the next evaluation, and to set specific goals dependent upon available staff and resources.
    • 3.6.3. Accomplishment of the goals arising out of the HRPP Evaluation will be evaluated by the IO in conjunction with the appropriate personnel in accordance with the corrective action and specified time frame.

ADMINISTRATIVE APPROVAL: BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL

POLICY AMENDED:

 REVISED FEBRUARY 2, 2018

 INITIAL APRIL 14, 2016

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