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National Chung Hsing University Institutional Repository - NCHUIR > 法政學院 > 法律學系 > 依資料類型分類 > 碩博士論文 >  以未取得同意及未去連結的外科手術所切取之人體組織作為醫學研究材料相關法律問題探討

Please use this identifier to cite or link to this item: http://nchuir.lib.nchu.edu.tw/handle/309270000/153040

標題: 以未取得同意及未去連結的外科手術所切取之人體組織作為醫學研究材料相關法律問題探討
The Study of Applicable Regulations Toward Research Information Linked Material Derived From Medical Surgery without Prior Informed Consent
作者: 許月禎
Hsu, Yueh-Chen
Contributors: 許舜喨
Shun-Liang Hsu
法律學系科技法律碩士班
關鍵字: 醫療剩餘檢體;人體生物資料庫管理條例;人體研究法;檢體管理
Medical residual sample;Human Biobank Act;Act on Human Subjects Research;Specimen management
日期: 2013
Issue Date: 2013-11-18 11:51:48 (UTC+8)
Publisher: 法律學系科技法律碩士班
摘要: 2010年人體生物資料庫管理條例與2011年人體研究法相繼頒佈後,對於研究用人體檢體開始有了法律階層的規範,但醫療機構中之人體研究材料,大多來自病患之醫療剩餘檢體,而病理檢體係屬病歷之一部分,依醫療法規定需保存至少七年,但尚未屆至保存期限之病理檢體用於研究,係同時涉及醫療行為及研究行為,在醫療法規與研究法規之適用上競合及適用順序的問題,應有檢討的必要。人體研究相關法規所預設取得研究參與者檢體的情境,係在研究參與者知情同意後,再取得檢體供研究使用,與醫療機構研究單位使用病患醫療剩餘檢體來研究的情境有異。故本研究先以實際訪談的方式先瞭解醫療機構對於檢體的管理流程,並瞭解現檢體管理流程在適用人體研究法規上的應變方式,在人體研究相關法規之檢討與比較後,重新檢討醫療機構在檢體管理的流程上是否適法。本文研究結果認為,利用外科手術之剩餘檢體進行醫學研究,其人體檢體必須等病理診斷程序完成後,檢體才符合「醫療剩餘檢體」的定義,始可用於研究。而病理檢體尚未完成法定至少七年保存期限,若切取部分用於研究,雖難認違反醫療法保存之義務,但恐違反人體研究相關法規知情同意之規定。由於醫療行為與研究行為係由不同法領域所管轄,不因兩種行為在時間上重疊性而生競合問題,而係由各領域之規定各自檢視應受規範的拘束。本研究比較人體研究相關法規之條文發現,人體研究相關法規關於去連結之檢體可例外保存的條文,已逾越憲法保障人性尊嚴之自主權,而允許法定代理人,代理健康之胎兒及未成年人參與研究的同意,則缺乏合理的必要性。因此本研究提出對於人體研究相關法規以及主管機關應依法修正之建議,以期對未來相關法規之修法及醫療機構對醫療剩餘檢體之管理,提供更明確更適法的參考依據。
Following the promulgation of Human Biobank Act in 2010 and Act on Human Subjects Research in 2011, legal norms for research involving human subjects have become available. However, the human research materials in medical institutions mostly come from medical residual samples of patients, while specimens for pathology are part of medical history. According to the Medical Act, specimens should be retained for a period of at last seven years. However specimens for pathology within the shelf life used for research involve medical acts and research behaviors. In terms of the appropriateness of medical acts and research acts, the issue of competition and order of applicability are yet to be reviewed. As for the preset condition for the acquisition of research participants’ specimens in accordance with the Act on Human Subjects, the specimens are available for research use after obtaining informed consent from research participants. This condition is not practiced in medical institutions and research units where researches are conducted with the use of patients’ medical residual samples. Hence, through the interview approach, an insight was gained into the specimen management processes of medical institutions and the response approaches of the specimen management processes that are applicable in accordance with the Act on Human Subjects. After reviewing and comparing the Act on Human Subjects related laws and regulations, the applicability of the specimen management processes adopted in medical institutions was reviewed again. The research results show that the definition of human specimens will fit the profile of the definition of “medical residual samples” only after the pathological and diagnostic procedures are completed. Human specimens can then be allowed for research. For specimens for pathology that have not completed the the 7-year shelf life legal requirements, although partial sections for research purpose are not in violation of the preservation obligations in accordance with Medical Act, they are in violation of informed consent requirements in accordance with the relevant provisions of Act on Human Subjects. As medical behaviors and research acts are under the jurisdiction of different legal areas, competing issues as a result of the time overlapping of the two behaviors do not arise. However, they are bound by the necessary norms of the respective areas. It was found after comparing the Act on Human Subjects related laws and regulations that provisions for exceptional preservations of delinked specimens stipulated in Act on Human Subjects related laws and regulations have gone beyond the autonomy of human dignity protected by the Constitution. Meanwhile, allowing legal representatives to consent to healthy fetuses and minors’ participation in research simply lacks any reasonable necessity. Thus, Act on Human Research laws and regulations, as well as recommendations for amendments to be made by the competent authorities in accordance with the law were put forth in this study, with the hope of providing a clearer and more appropriate reference for related future law amendments and medical residual sample management.
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