教學醫院人體試驗委員會之管理策略分析

目的：本研究之目的為：（1）調查教學醫院人體試驗委員會（Institutional Review Board, IRB）管理現況。（2）分析教學醫院IRB管理策略之執行成效。（3）以平衡計分卡（Balanced Scorecard, BSC）的四個構面，探討教學醫院IRB較佳之管理策略。方法：本研究以平衡計分卡之四個構面為概念式架構，發展問卷後由三位曾擔任或現任教學醫院IRB之主任委員或執行秘書的學者專家，進行問卷的修正以提高建構效度，再以立意取樣對教學醫院51位IRB的工作人員發放問卷，總共回收42份有效問卷，分析IRB管理策略成功的關鍵與窒礙難行的因素。結果：本研究顯示台灣的教學醫院人體試驗委員會管理策略之重要影響因素依序為：（1）學習與成長構面方面：教育訓練、好的軟體、好的硬體設備；（2）內部程序構面方面：健全的資訊系統（資料庫）、審查過程遵守法規及合理的簡化流程；（3）顧客構面方面：IRB重視衛生福利部／醫策會的查核、受試者／計畫主持人／贊助廠商／委託研究機構重視審查的時效性及受試者／計畫主持人／贊助廠商／委託研究機構希望IRB提供適當的資訊系統或設備，方便查詢與使用；（4）財務構面方面：IRB的財務健全、增加人力可以提升服務效能及IRB制度化的預算編列。結論：本研究透過平衡計分卡為管理工具，來探討在IRB管理的成功關鍵與窒礙難行因素，並提出因應策略。具體而言，IRB要經常舉辦相關的教育訓練；要提供工作人員一個優質的工作環境外，還需有升遷、學習的管道；簡化送審流程及讓工作人員處理的業務量能夠合理化；審查流程要公開、透明及便捷，讓送審的研究人員在送審計畫時都能有所依據；透過內部的評估，觀察與評估審查委員的審查意見與審查時效；有獨立的財務能力，能夠自給自足。

關鍵字

人體試驗委員會；策略；平衡計分卡

並列摘要

Objective: The objective of this research is threefold: (1) to investigate the status quo of the Institutional Review Board (IRB) in teaching hospitals, (2) to analyze the managerial performance of IRB in teaching hospitals, and (3) to propose adequate managerial strategies for IRB with the aid of balanced scorecard (BSC). Methods: This study intended to use the four dimensions of the BSC as the conceptual framework in developing questionnaires. The main subjects of this study were staff in the Secretariat of the IRB who practically involved in the administrative operations. To enhance the validity of the questionnaires, in-depth interview were utilized. Totally 51 samples were identified and issued the questionnaire through purpose sampling and 42 valid responses returned. Data were then analyzed to obtain the inductive causes influencing the managerial strategies of IRB. Results: Four dimensions of the balanced scorecard were investigated, and the relatively important factors in sequence are: (1) Learning and growth perspective: training, software, and hardware; (2) Internal (Intrinsic) process perspective: well-equipped information system (data bank), review process comply with the rules/regulations, and more streamline processes; (3) Customer perspective: inspection of the IRB by the Department of Health, subject/investigator/sponsor/commission agency attention to the review timeline, and the expectation of subject/investigator/sponsor/commission agency for the IRB to provide more appropriate/convenient information systems or equipment; (4) Financial perspective: the finance of IRB, increase manpower to improve the service efficacy, and abundant budget of IRB. Conclusions: This study intends to explore the encountered difficulties of IRB, and consequently propose proper managerial strategies. Specifically, The IRB should regularly hold the relevant education and training programs; provide the staff a good work environment as well as appropriate promotion and learning pipeline; and simplify the submission process so the staff can undertake reasonable work loading. The review process must be open, transparent and convenient, so the investigators can amend the submission documents timely. The IRB should evaluate the review comments and effectiveness of the review committee members through internal assessment. It should possess independent fi nance so can be self-sufficient, as well.