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題名 | 論英國生物銀行之「告知後同意」=Comments on Informed Consent for UK Biobank |
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作者 | 顏上詠; 陳冠旭; 唐淑美; | 書刊名 | 清華科技法律與政策論叢 |
卷期 | 2:2 民94.06 |
頁次 | 頁189-224 |
分類號 | 368 |
關鍵詞 | 生物銀行; 告知後同意; 推定同意; 告知後選擇; 集體告知後同意; Biobank; Informed consent; Presumed consent; Informed choice; Group informed consent; |
語文 | 中文(Chinese) |
中文摘要 | 從醫病關係下之同意法理的發展來看,昔日父權模式(Paternalistic Model)下單純的「同意」模式已漸式微,另以尊重病患自主權的「告知後同意(Informed Consent)」取而代之。有鑒於「推定同意」在冰島「衛生部門資料庫法(Act on a Health Sector Database)」所引發全球各地之科學、社會、倫理學家以及隱私權運動者之嚴厲抨擊,英國生物銀行在參與同意上採取不同的蹊徑,要求經充分的說明程序後方取得潛在參與者的同意,來落實對參與者基因資訊自決權的保障。針對英國生物銀行之建置,本文提出四項觀點,(一)英國生物銀行以個人之「告知後同意」為手段,採集個別人體血液、組織等樣本,在未經由集體之告知後同意(Group Informed Consent)下,卻可能因個人基因資訊之蒐集而獲得特定族群之基因資訊。(二)釐清英國生物銀行與參與者間之關係。(三)參與者一旦應允加入生物銀行,對其捐贈之檢體所獲得之基因資訊應被視為貢獻給社會大眾(Dedicate to the Public),而此種貢獻有助於醫學之發展與進步,英國生物銀行應該將其研究之資訊分享給社會大眾。(四)生物銀行之參與同意不應僅僅規範於告知後同意這個階段,而宜嘗試更進一步引入「告知後選擇(Informed Choice)」,將之強調並適用於生物銀行之參與同意中。 |
英文摘要 | In view of the development of jurisprudence on informed consent surrounding patient-doctor relationship, Paternalistic Model has become outdated and replaced by autonomy-based Informed Consent. However, the Act on a Health Sector Database enacted in Iceland still has evoked global criticisms from scientists, sociologists, philosophers and privacy-activists. UK Biobank has adopted a different approach. UK Biobank seeks to introduce a formal procedure, which provides a sufficient elaboration and subsequently acquires consent from potential participants so that participants' autonomy for their genetic information can be protected. As global attention has turned to the ethical, legal and social implications (ELSI) of biobank, informed consent has played a key role in these controversial issues. It is propounded in this paper: (1) sampling of individuals' biological samples, such as blood, tissue and urine based on individual informed consents in UK Biobank, group genetic information of particular races might be gathered without group informed consent, (2) the relationship among participans in UK Biobank should be clarified, (3) once participants agree to join UK Biobank, their biological samples and genetic information should be regarded as contributions to the public and be placed in public domain as shared information, and (4) adopting the concept of informed choice, providing additional choices to the participants. |
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