人體組織物採集之民事法律關係初探──從人體生物資料庫之建置談起

A Preliminary Approach to the Legal Relationship in Civil Law Regarding to the Bio-bank: The Dual Structure of Informed Consent Doctrine and Law of Property Rights

生物資料庫之建置必須採集人體組織或蒐集與人體組織相關之資訊，各國相關法規之訂定多偏重「告知後同意」原則之踐行，甚少著墨於相關基礎民事法律關係。「告知後同意」固然可作為阻卻人體組織採集行為違法性之「意思通知」，但非必然等同於處分離體組織之「意思表示」；因此，除「告知後同意」之踐行外，實尚須有處分人體組織物之法律行為，方能產生財產權上之法律效果。因人體生物資料庫管理條例之立法目的不在於處理人體組織物之財產權問題，尚難據以妥適處理當事人間民事法上之爭議。本文從人體組織財產權性格之視角切入，主張人體組織物之取得，除須踐行「告知後同意」原則外，必須同時適用民事財產法之規定，以提供完整穩定之法律基礎。

Establishment of a biobank requires the collection of human tissues and related information. Related regulations in most countries worldwide typically adopt the doctrine of informed consent and rarely address the basic relationship of civil law. Although informed consent can be regarded as a notice of intention that serves as the legal justification of the unlawfulness of human tissue collection, it is not necessarily equivalent to the mutual assent regarding the disposition of the isolated tissues. Thus, apart from the practice of informed consent, the legal act of disposing human tissues must be performed to yield the legal effect on property right. Thus, the legislative purpose of the Human Biobank Management Act is not to deal with the property right of the human tissues and therefore cannot properly manage the civil law deputes between the involved parties. From the perspective of the nature of property rights in human tissues, this study argues that the civil property law must be applied to the acquisition of human tissues, in addition to the implementation of the doctrine of informed consent, to provide a complete and stable legal basis.