臨床研究護理師執行臨床試驗角色職責之探討

An Investigation of the Role Responsibilities of Clinical Research Nurses in Conducting Clinical Trials

背景：臨床研究護理師（clinical research nurses, CRNs）在臨床試驗中扮演重要角色以維持試驗品質。而CRNs在臺灣正開始發展，故瞭解目前CRNs的角色職責有助於建立其專業發展。目　的　瞭解臺灣執行臨床試驗的CRNs對其角色職責之認同、重要性與執行困難度，進而提出對其護理專業發展的建議。方　法　採問卷調查法，於臺北市某醫學中心針對已於院內登錄執行臨床試驗的CRNs進行收案，共完成80份問卷填寫。結　果　CRNs的角色職責中，「受試者保護」的認同度最高，其次依序為「研究協調與管理」、「受試者臨床照護」與「進階護理職能」。認同度越高的角色職責，其重要性也越高，執行困難度則越低。相較於未接受試驗相關訓練的受訪者，已接受試驗相關訓練者覺得「受試者臨床照護」與「研究協調與管理」的執行困難度較高（p＜.05）。進一步分析已接受試驗相關訓練的受訪者，接受長期訓練課程者較接受短期在職教育者對CRNs角色職責四個向度的重要度評分均較高（p＜.05），且對執行「受試者保護」與「研究協調與管理」之困難度評分均顯著較低。「整體角色職責認同度」與「接受臨床試驗相關訓練」為顯著預測CRNs整體角色職責執行困難度之重要因子，可解釋變異量共21.9%。結　論／實務應用　為協助CRNs的專業發展，建議應訂出CRNs的核心能力，並將該專業納入正式護理進階教育的範疇，透過長期且有規劃的教育培訓，讓CRNs了解其角色職責的重要性，進而對其專業產生認同，並落實於臨床實務，以提升試驗品質。

Background: Clinical research nurses (CRNs) play an important role in improving the quality of clinical trials. In Taiwan, the increasing number of clinical trials has increased the number of practicing CRNs. Understanding the role responsibilities of CRNs is necessary to promote professionalism in this nursing category. Purpose: This study investigates the role responsibilities of CRNs in conducting clinical trials / research. Method: A questionnaire survey was conducted in a medical center in Taipei City, Taiwan. Eighty CRNs that were registered to facilitate and conduct clinical trials at this research site completed the survey. Results: ＂Subject protection＂ was the CRN role responsibility most recognized by participants, followed by ＂research coordination and management＂, ＂subject clinical care＂, and ＂advanced professional nursing＂. Higher recognition scores were associated with higher importance scores and lower difficulty scores. Participants with trial training had significantly higher difficulty scores for ＂subject clinical care＂ and ＂research coordination and management＂ than their peers without this training (p ＜ .05). Participants who had participated in a long-term trial-training course earned higher importance scores for ＂CRN four-subthemes role responsibilities＂ (p ＜ .05) and lower difficulty scores for ＂subject protection＂, ＂research coordination and management＂ (p ＜ .005) than their short-term course peers. ＂Recognition of overall responsibilities＂ and ＂receiving trial training＂ were the significant predictors of difficulty in performing CRN role responsibilities, explaining 21.9% of the total variance. Conclusions: To further promote CRN as a professional career in Taiwan, the findings of this study recommend identifying the core competences of CRNs and adding CRN-related study materials into the advanced nursing curriculum. Long-term and systematic educational training may help CRNs understand the importance of their role responsibilities, better recognize their professional role, and reflect these responsibilities in clinical practice.