臨床研究護理師執行臨床試驗角色職責之探討

高綺吟; 黃貴薰; 戴玉慈; 白雅瑛; 胡文郁

doi:10.6224/JN.62.3.30

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P30 - 40

医药卫生 > 预防保健与卫生学
医药卫生 > 社会医学

DOI： 10.6224/JN

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临床研究护理师执行临床试验角色职责之探讨

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

高绮吟(Chi-Yin Kao) ；黄贵薰(Guey-Shiun Huang) ；戴玉慈(Yu-Tzu Dai) ；白雅瑛(Ya-Ying Pai) ；胡文郁(Wen-Yu Hu)

护理杂志； 62 卷 3 期 (2015 / 06 / 01) ， P30 - 40

繁体中文 DOI： 10.6224/JN.62.3.30

临床研究护理师；临床试验；角色；职责； clinical research nurse ； clinical trial ； role ； responsibility

3 个人觉得这篇文章赞

摘要 │ 参考文献 (27) │ 国际计量

摘要〈TOP〉

并列摘要〈TOP〉

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.

参考文献 ( 27 ) 〈TOP〉

Beauchamp, T. L.,Childress, J. F.(2013).Principles of biomedical ethics.New York, NY:Oxford University Press.
Castro, K.,Bevans, M.,Miller-Davis, C.,Cusack, G.,Loscalzo, F.,Matlock, A. M.,Hastings, C.(2011).Validating the clinical research nursing domain of practice.Oncology Nursing Forum,38(2),E72-E80.
Daugherty, C. K.(1999).Impact of therapeutic research on informed consent and the etics of clinical trials: A medical oncology perspective.Journal of Clinical Oncology,17(5),1601-1617.
Emanuel, E. J.,Wendler, D.,Grady, C.(2000).What makes clinical research ethical?.JAMA: The Journal of the American Medical Association,283(20),2701-2711.
Gibbs, C. L.,Lowton, K.(2012).The role of the clinical research nurse.Nursing Standard,26(27),37-40.

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