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Administrative assessment reviews are conducted at the discretion of the QIP Coordinator, the ORI Director and/or the VPR. The QIP Coordinator shares the results of administrative assessments with the ORI Director. The results may impact current practices and may require additional educational activities for ORI staff and IRB members.

Administrative assessments may include but are not limited to:

  • A thorough examination of the IRB records for improvement of management or to evaluate the procedures applied and/or issues addressed by the ORI staff and the IRB for protection of human subjects in research;

  • At least annually, dissemination of an IRB Performance Evaluation Questionnaire to select individuals to assess representation of appropriate knowledge, skills, and abilities respective to IRB member, IRB Chair, and IRB Vice Chair roles;

  • Periodic outreach evaluation concentrating on the quantity and nature of information available to research subjects through the ORI web site (i.e., enabled by analysis of compiled monthly web page “visitor” reports);

  • Program Assessment for Accreditation, a significant component in support of maintaining AAHRPP accreditation, focuses on maintenance of applicable documentation representing current policy and procedures; utilization of the AAHRPP Self-Evaluation Instrument; and evaluation of current HRPP practices to ensure appropriate fulfillment of accreditation standards.

The ORI Research Education Specialist develops educational programs/announcements for investigators, their research staff, ORI staff, and IRB members based on the results of the QIP reviews. If/when findings from QIP reviews are reported to the IRB, the IRB determines whether to report the findings to the FDA, OHRP, the study sponsor, the VPR, or other internal departmental faculty/staff.

A1.2400 Institutional Program Review and Assessment

The IRB, ORI, OSPA, and the OSPA Conflict of Interest administrator all have roles in conducting annual and ongoing program review and assessment. Information provided in the Annual Report of unit activity for the fiscal year links closely to the budget process and provides the basis for VPR assessments of HRPP needs to ensure that sufficient resources are available to support effective functioning of the HRPP. The ORI conducts program assessment and review of HRPP administration and also communicates new regulatory policy to the University community through formalized programs of education and development of pertinent education materials. Standard operating procedures maintained by the ORI on behalf of the HRPP delineate specific responsibilities for development, review, and revision of policies and procedures related to research review and the HRPP.

A1.2450 Suggestions, Comments, Questions, Complaints, and Concerns with the Human Research Protection Program

The ORI, in accordance with the VPR’s commitment to continuous improvement in institutional HRPP policies, practices and procedures, has established a formal process to register suggestions, questions, comments, problems, concerns, obtain information, or offer input regarding the HRPP, the ORI and/or the IRB administrative procedures. Any individual may file suggestions, questions, complaints, or concerns regarding the HRPP, ORI, and IRB

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