A 대학병원 Institutional Review Board 위원 기반 내부 점검 사례 및 Quality Assurance 담당자 내부 점검과의 비교: 내부 점검 결과에 영향을 미치는 요인

Comparison of Internal Audits by A University Hospital Institutional Review Board Members and Quality Assurance Officers: Factors Influencing Internal Audit Results

Purpose: The purpose of this study is to introduce the Institutional Review Board (IRB) member-based internal audit method performed at A University Hospital, a secondary medical institution, and to identify the differences in audit results according to the characteristics of each auditor and the factors affecting the internal audit results. Furthermore, we will find out what needs to be improved in the internal audits to achieve Quality assurance (QA) objectives for human subject research conducted in medical institutions. Methods: The auditors were divided into group A (IRB member belonging to institution A) and group B (clinical trial QA administrator belonging to other institutions) and independently inspected the 2 studies using the same internal audit checklist (consisting of 11 domains, 130 items), and the differences in the internal inspection checklists written by each auditor were compared and analyzed. Results: In the case of audit for the study 1, the number of missing checklists is 1 for group A and 0 for group B, and the number of the matters to be pointed out is 1 for group A and 12 for group B. In the case of audit for the study 2, the number of missing checklists is 2 for both A and B, and the number of points is 5 for A and 4 for B. The differences in the internal audit results written by each auditor that the authors verified are summarized as follows. First, there were more comments from group B auditor than from group A auditor. Second, the results may vary because each auditor has different criteria for evaluating the appropriateness of an item. Third, there are cases where the questions on the checklist are vague or the definition is not clear, so they have the same opinion but check it with different answers. Fourth, if the auditors make a mistake when filling out the checklist, it causes to led to different the results. Conclusion: We propose the following items that should be improved in order to conduct consistent and efficient internal audits. First, it is necessary to test the tool in order to carry out reliable and consistent internal audits. Second, it is necessary to complete specialized training related to internal audit before conducting internal audit. Third, before notifying the audit results, it is necessary to have a procedure or a final review system to check whether the audit contents are appropriate. Fourth, Institutional support is needed to recruit specialized personnel for internal audits.