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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,each IRB-02, and IRB-04board will be randomly selected for audit quarterly. IRB minutes for IRB-03quarterly (Rapidas Response IRB) will be monitored no less often than annually if the IRB has met during the year.available). The IRB will utilize HRPP policy 2.2 (Full IRB Review) and OHRP Draft Guidance “Minutes of Institutional Review Board (IRB) Meetings: Guidance for Institutions and IRBs” (dated November, 2015).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, and senior administration and through various IRB educational activities.administration.
      • 3.1.6.1. TheAs appropriate, the IRB Executive Chair and IRB Administrators willmay schedule focus group discussions with Investigators from UNMC,components UNO,of andthe CHMCOrganization 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 AssessmentFeedback oflink on the IRB form,website availableto oncommunicate their concerns, questions or suggestions to the IRB’sIRB website. This form may be submitted anonymously and/or with contact information.ORA.
      • 3.1.6.3. PIs and other study personnel may utilize the “Report a Research Problem or Complaint”Complaint tab on the UNMC IRB websitewebsite, thatwhich provides access to the University of Nebraska EthicsPoint, which allows anonymous commentsand to the IRB.UNMC Human Subjects Research Comment Portal.
    • 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 on-line questionnaires and surveys, and via focus group discussion held annually (during or following a scheduled IRB-01, IRB-02, and IRB-04 meeting). This focus group may be mediatedfacilitated by the IOResearch Subject Advocate or onedesignee) orheld more IRB Administrators, without the Executive Chair present.annually.
    • 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 utilizingconsidering, but not limited to, the following criteria:
      • 3.3.1.1. Meeting leadership
      • 3.3.1.2. General regulatory knowledge
      • 3.3.1.3. Active participation in IRB Executive Committee and involvement in activities of the ORA.
      • 3.3.1.4. Attendance at meetings
      • 3.3.1.2.5. ChairingTimeliness and completeness of IRB meetings
      • 3.3.1.3. Completeness of reviews
      • 3.3.1.4.6. Participation in IRB discussions
      • 3.3.1.7. Service on IRB subcommittees
      • 3.3.1.5.8. Feedback submitted from the IRB Members and IRB administrators via on-line questionnaires and surveys, and via focus group discussion held annually (during or following a scheduled IRB-01, IRB-02, and IRB-04 meeting). This focus group may be mediatedfacilitated by the IO,Research theSubject Executive Chair,Advocate or onedesignee) orheld more IRB Administrators, without the Chairs or Vice-Chairs present.
      • 3.3.1.6. Creative recommendations which help improve the HRPP.annually.
    • 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 usingconsidering, but not limited to, 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. CompletionGeneral ofregulatory required Continuing Education.knowledge
      • 3.4.1.2. Individual Feedback to IRB Members
        • 3.4.1.2.1. IRB members will be provided feedbackfeedback, by letter or in person, regarding their service.performance.
          • 3.4.2.1. If an IRB member’s service is judged to be satisfactory or exceptional, the IRB Executive Chair will so inform the member.
          • 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.
      • 3.4.2.3. 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.
      • 3.4.3.4. 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 feedbackFeedback submitted from the IRB Members via on-line questionnaires and surveys, and via focus group discussion held annually (during or following a scheduled IRB-01, IRB-02, and IRB-04 meeting). This focus group may be mediatedfacilitated by the IO,Research Subject Advocate or thedesignee) Executiveheld Chair, without the IRB Administrators present.annually.
        • 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. TheA designated 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

      • 3.6.1. componentThe evaluation of the HRPP will conductbe a self-assessmentconducted utilizing the Annual HRPP Assessment Form.Survey. Each component of the HRPP, IRB members, Office of Regulatory Affairs (ORA), investigators, and other research personnel will be invited to participate and provide feedback. The survey will assess the interactions between the IRBs, the ORA, investigators and other components of the HRPP, as well as the overall effectiveness of the HRPP. The IO in conjunction with the Assistant Vice-Chancellor for Regulatory Affairs and any other personnel deemed appropriate will review each component’sthe Annual HRPP Assessment Form with the objective to:

        • 3.6.1.1. Determine which items on the Annual HRPP Assessment Form are judged to be:
          • 3.6.1.1.be Excellent (E) or, Satisfactory (S) or Unsatisfactory (US).
          • 3.6.1.2. UnsatisfactoryAll (US).items Thejudged itemto requiresbe unsatisfactory will require a corrective action plan with set goal(s) in a time frame based upon the seriousness of the deficiency.
        • 3.6.2.1.3. DetermineAt whichleast itemsone item rated Excellent or Satisfactory are towill be targeted for further improvement before the next evaluation, and to set specific goals dependent upon available staff and resources.
        • 3.6.3.1.4. 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.

    DOCUMENT HISTORY:

     Written: 4/14/2016 - original author not recorded

     Revised: 2/2/2018 - revision not documented

     Revised: 8/30/2022 - Changed title of policy; clarified frequency of assessments of minutes for various boards; revised and clarified methods of feedback to the ORA/IRB by stakeholders; clarified process and basis for evaluation of Chairs and Vice-Chairs, and IRB members; clarified process of evaluation of IRB administrators and staff; clarified process and goals of Annual HRPP Assessment. {Approved Chris Kratochvil (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

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