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  • 學位論文

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

指導教授 : 陳仲嶙

摘要


生醫研究與臨床醫療密切相關,有論者認為晚近臨床活動中,研究與醫療之區分漸趨模糊甚至無法區分。惟研究與醫療在基本概念、倫理及法律規範上均有不同之處,即使有重合之可能,本文仍認為該兩者能被區分且有區分實益。為瞭解本文所提出研究與醫療之界分與重合之架構下,可能產生之挑戰,本文以個別研究結果提供為重心探討之。在生醫研究過程中,可能發現與個別參與者相關之研究結果,目前國際上傾向認為在符合特定條件下,應將該結果提供予參與者。而反對提供者之一項疑慮是,提供個別研究結果可能使參與者產生治療誤解之情形,由此議題可延伸出另一議題—提供個別研究結果之性質為何,是否可能影響原本活動之性質,此議題可由本文對於活動性質之界分標準探討之。另外,本文亦以個別研究結果提供為例,探討在性質重合之活動中如何適用倫理與法律規範,以及不同性質活動中利益衝突之議題。 本文認為界定活動性質之標準為「活動之主要追求目的」,並藉由該標準將所有活動分為單一性質之活動、單一性質活動中具有其他性質之行為、性質重合之活動三種類型。提供個別研究結果可能屬於上述三種類型之其中一種,視具體實踐方式而定。關於性質重合之活動應適用研究或醫療之原則或規範議題,本文認為應同時適用兩者之規範,即應遵守較高義務,故性質重合活動中,提供個別研究結果之義務與較高程度之醫療上義務相同。最後,不同性質之活動中可能發生不同利益衝突情境,其中,個別研究結果提供在三種類型活動中,均可能因利益衝突情境,受到其他因素之不當影響,造成對於提供標準之告知不明確,因而產生治療誤解,或對於提供義務之履行不確實之情況。透過揭露、迴避及審查等因應措施,或許能避免或降低利益衝突所造成之不當影響,進而避免影響活動性質之情況。

並列摘要


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.

參考文獻


一、中文文獻
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