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  • 學位論文

「告知後同意」原則適用於人體試驗之研究-以受試者自主權為核心

Informed Consent in Human Subject Research: An Analysis of Human Subject's Autonomy

指導教授 : 雷文玫
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摘要


論 文 摘 要 醫學的進步造福了社會大眾,其背後除了科學家的智慧與努力以外,還有受試者冒著風險接受人體試驗。受試者是人體試驗中最脆弱而欠切自我防護能力之環節,且我國目前保障受試者的制度上不健全,因此,有必要檢討目前制度,做出更精密設計,以保護受試者之必要。 由於人體試驗通常需要受試者犧牲個人的身體健康,以換取醫學新知,因此,只有受試者的同意才足以讓人體試驗具備正當性。「告知後同意」制度被運用在醫療相關領域,作為取得同意的程序性制度,若完善踐行該程序,即取得相對人合法有效的同意。這項制度在國外的常規醫療領域已行之有年,在人體試驗領域則仍許多議題有待討論。在我國人體試驗領域,「告知後同意」程序主要規定於醫療法第七十九條規定,以及一些行政規則之中,例如:「藥品臨床試驗一般基準」等等。 「告知後同意」原則的構成要件包括:研究者必須向受試者「說明」人體試驗的相關資訊,受試者「理解」後,出於「自願」的「同意」參與試驗,且該受試者必須具備「同意能力」。那麼,研究者的說明義務範圍如何?哪些受試者具備同意能力?欠缺同意能力的受試者是否完全不能參與試驗?如何確保受試者參與試驗的確出於「自願」,而非受到脅迫或不當引誘?例如:同意參與安慰劑對照試驗的病患,是否真正出於自願?或者只是迫於無奈而同意參與?這樣的試驗該如何規範?如何確保原住民族群不會受到研究者的欺騙或不當引誘?此外,法律可否基於國家特殊政策的考量而強制某類族群參與或不參與試驗?例如:可否為了保護胎兒而禁止孕婦參與試驗,或基於特別權利關係而強制受刑人參與試驗?以上問題即為本文的核心議題。 在論述方式上,本文參考並檢討國內外之相關規範與文獻之討論,以及國內現況之統計資料,期能為我國日後的相關法制提供一些思考面向。本文所參考的國外人體試驗規範,主要包括紐倫堡倫理守則、世界醫學會的赫爾辛基宣言、國際醫藥法規協和會的優良臨床試驗準則、歐洲理事會的「關於生物醫學實施之人權及人性尊嚴保護公約」、美國的貝蒙特報告書與聯邦法令等等,然後針對個別議題引述相關規定統整與檢討,並配合我國現行法制與社會實際概況提出建議。

並列摘要


Abstract The progress in medical science has benefited the public. Aside from scientists contribute their wisdom and make efforts to make the progress, in addition, we cannot neglect the contribution made by those who risk their lives to undergo human subject experiments. These people, or so-called human subjects, are so fragile that they lack the ability to protect themselves in the link of human experiment. Currently, the ROC’ regulation system of protecting these human subjects is not sound. It is hoped that the authorities can improve the system to thoughtfully take care of these subjects. Because the experiments, more often than not, are made at the cost of subjects’ health, they cannot be legalized without the consent of the subjects. So “Informed Consent” doctrine is applied and functions as a procedure of securing the subjects’ autonomy and dignity. This system can make experiments legal. It should be noted that this system has been existed in foreign countries in the medical field for years. However, there are still many issues on experiments that left to be discussed. In Taiwan, “Informed Consent” is largely based on the Article 79 of the Medical Law and some administrative regulations such as GCP Guidelines. In applying the principle of “Informed Consent,” the researchers are supposed to disclose and explain to the subject the related information about the experiment. After getting a good understanding of the experiment, the subject can show his/her willingness to participate the experiment. In this case, the subject must have the autonomous ability of giving such consent, that is, the subject must be “competent”. How to define the researcher’s obligation of explanation? How to decide whether the subject is competent? Is it possible for the incompetent person to take part in the experiment? How to make sure that the subject participate in the experiment voluntarily (that is, they are not forced or unduly induced to do so)? For example, are those who consent to take part in placebo-controlled researches volunteers? Do they feel that they have no choice but to do this because of their illness? How to impose proper regulations on this kind of experiments? How to make sure that the aborigines won’t be cheated or unduly induced by the researchers? In addition, can the authorities force certain groups to participate in or not to participate in the experiments because of special “public good” considerations? For instance, can we forbid pregnant women to participate in the experiments in order to protect their fetus? Can we force the prisoners to take part in the experiments because they are get stripped of certain rights? These are the core issues in this paper. In this paper, I use some documents at home and abroad as references. I also examine certain statistical data about the current social reality of Taiwan. It is hoped that this paper can be used as a reference for Taiwan’s medical law making in the near future. The regulations of experiments abroad I referred mainly include the Nuremberg Code, WMA’s Declaration of Helsinki, ICH GCP, Convention on Human Rights and Biomedicine, USA’s Belmont Report and Code of Federal Regulations, and what not. Besides, concerning individual issue, I make comments on related regulations, current local laws, and social reality. In this way, I sincerely advance my suggestions.

參考文獻


楊秀茹,從病患自主權看病患家屬參與醫療決定之權限,中原大學財經法律研究所碩士論文(2004/7)。
李素華,SARS疫苗研發與應用之告知後同意--以歐洲生技專利法制發展為例,科技法律透析,第15卷第6期(2003/6)。
鄧曉芳,從告知後同意程序評析「研究用人體檢體採集與使用注意事項」,科技法律透析(2002/5)。
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被引用紀錄


洪敏瑜(2009)。醫學研究中告知後同意之法律意涵〔碩士論文,國立清華大學〕。華藝線上圖書館。https://doi.org/10.6843/NTHU.2009.00481
胡哲瑊(2013)。從告知後同意論高齡者之醫療困境與保障〔碩士論文,中原大學〕。華藝線上圖書館。https://doi.org/10.6840/cycu201300780
楊慶泉(2005)。人群生物資料庫之醫研成果分享 -以樣本提供者為中心-〔碩士論文,中原大學〕。華藝線上圖書館。https://doi.org/10.6840/cycu200500640
溫珮君(2011)。仿單標示外使用(Off-label Use)與用藥安全〔碩士論文,臺北醫學大學〕。華藝線上圖書館。https://doi.org/10.6831/TMU.2011.00112
李俊良(2015)。論人體檢體生物醫學研究之管制體系─以委員會控核機制及研究倫理法律義務為核心〔碩士論文,國立臺灣大學〕。華藝線上圖書館。https://doi.org/10.6342/NTU.2015.00665

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