臨床試驗與受試者保障【醫事法學教室】 試閱
Clinical Trail and Human Subject Protection
醫學的昌明發達對人類生命的存續與身心健康的維持有著極大的貢獻，惟醫學的進步有賴於努力不懈的研究，研究所需的臨床試驗往往又讓受試者的身心健康甚至生命蒙受高度風險，從而，旨在促進人類福祉的醫學，可說是以個體的犧牲奉獻作為成長的養料。為保障參與臨床試驗者的自主性與安全，除嚴守告知同意原則，試驗的過程尤須恪遵醫學正當程序，使受試者承擔的風險獲得合理的管控。此外，不完全歸屬於醫學研究與疾病治療而自成一格的試驗性治療，雖在告知同意原則的適用上，與合法的臨床試驗、醫療行為並無二致，但是否適用專為臨床試驗而定的醫學正當程序則不無疑問。為確保病人權益，唯有在具備最後手段性與緊急性的例外情況下，治療試驗始得歸於醫師的醫療裁量自由，而免於專為臨床試驗而定的醫學正當程序之約束，其他的場合則無異於臨床試驗，仍應受專為臨床試驗而定的醫學正當程序之限制。
Developed medicine has a great contribution to the survival of human life and physical and mental health maintenance. The progress of medicine depends on the unremitting study, however, the study of the clinical trials often need to let the physical and mental health and even life of subjects suffered a high degree of risk. Thus, medicine aimed at promoting human well-being could be said to be a nutrient from individual’s sacrifice. In order to ensure the autonomy and safety of subjects in clinical trials, and to strictly obey the principle of informed consent, the trial process is particularly necessary to comply with medical due process, so the risk of the subjects would be under reasonable control. Besides, whether the experimental treatment, which is not entirely belong to medical research and disease treatment, is applicable to medical due process of clinical trials, it’s still be a question. To ensure the patient’s rights and interests, only in the case of the last resort and emergency exception, the physicians have freedom to make decisions of applying and free from the clinical trial for the medical due process of the constraints. In other occasions, there are no different from clinical trials and should be limited by medical due process for clinical trials.
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