研究與醫療之界分與重合—以個別研究結果提供之倫理與法律議題為中心

劉冠佳

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研究與醫療之界分與重合—以個別研究結果提供之倫理與法律議題為中心

The distinctions and convergences between biomedical research and clinical practices: focusing on the ethical and legal issues of returning individual research results

劉冠佳 , Masters　　Advisor：陳仲嶙　　

繁體中文

研究與醫療之界分；研究與醫療之重合；研究倫理；醫學倫理；行政管制；契約義務；個別研究結果提供；治療誤解；利益衝突； The distinctions between biomedical research and clinical practices ； The convergences between biomedical research and clinical practices ； Research Ethics ； Medicine Ethics ； Administration Control ； Contractual Obligation ； Return of Individual Research Results ； Therapeutic Misconception ； Conflict of Interest

Abstract │ Reference (107) │ Altmetrics

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Biomedical research is inextricably correlated with clinical practices. Some argue that the distinctions between biomedical research and clinical practices have become blurred or even nonexistent. However, some stark contrasts between studies and practices are readily perceivable in terms of concepts, ethics and regulations. Even though research and clinical practices may overlap in some cases, this article still believes that they can be distinguished. In order to understand the challenges to the definitive frameworks of studies and practices, this article focuses on exemplifying “the return of individual research results.” In the process of biomedical research, researchers may discover some research results concerning individual participants. Recently, most people consider that researchers should provide the results to the participants under some specific conditions. Commentators who are opposed to returning individual research results worry that the participants may have therapeutic misconception if the results are provided. This leads to another issue: what are the implications of returning individual research results? Would it influence the core nature of the original activities? This article will investigate these questions based on the standards that distinguish the nature of these activities. Besides, this article also discusses how to apply ethics and regulations in some dual-natured activities, and issues concerning conflict of interest in different activities.
This article considers that the key standard which categorizes different activities is the purpose of such activity. According to the standard, activities can be categorized into three types: mono-natured activities, mono-natured activities containing elements of other nature, and dual-natured activities. Depending on the researchers’ practices, returning individual research results may be one of the three types. Research studies and clinical practices are also guided by different sets of principles and regulations. In the case of a dual-natured activity, this article considers that it should observe and follow the guidelines of both. Therefore, in dual-natured activities, the obligation to return individual research results is the same as in the clinical practices. Finally, the circumstances of potential conflict of interest may vary in accordance with the type of activities. On cases of returning individual research results, all three types are susceptible to the inappropriate influence of conflict of interest. The inappropriate influence may bring about an inadequately informed consent, a therapeutic misconception or an incomplete return. Through some measures such as a disclosure, avoidance or review, the inappropriate influence may be avoided or reduced. As a result, the measures may prevent undue influence on the nature of the activities.

Reference ( 107 ) 〈TOP〉

一、中文文獻
1.專書
Bruce Dennis Sales, Susan Folkman主編，李是慰譯（2009），研究倫理：以人為受試對象，臺北：五南。[Sales, Bruce D. & Susan Folkman, eds. 2000. Ethics in research with human participants. Washington, D.C.: American Psychological Association.]
Peter A. Singer著，蔡甫昌譯（2004），臨床生命倫理學，臺北：財團法人醫院評鑑暨醫療品質策進會。[Singer, Peter A. 1999. Bioethics at the Bedside: A Clinician's Guide. Ottawa, Ontario, Canada: Canadian Medical Association.]
王玫、王薏雯、江虹瑾、吳建華、李元鳳、汪徽五、林志六、林勇良、林建興、林首愈、林婉婷、邵愛玫、徐麗娟、陳易宏、陳恆德、陳淑儀、陶楷韻、黃千真、葉嘉新、廖宗志、歐士田、盧青佑、蕭嘉玲、蘇莉莉（2008），新藥開發與臨床試驗，臺北：秀威。

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