인체생물학적 물질의 이차적 이용과 「Informed Consent」 법리

Secondary Uses of Human Biological Materials and Informed Consent

&nbsp;&nbsp;Informed consent has been at the heart of medical ethics in the modern era.<BR>&nbsp;&nbsp;In fact, one could argue that the emergence of informed consent is the hallmark of the modern era in medical ethics. The informed consent concept emanates from the principle of autonomy and envisions a shared, interactive decision-making process.<BR>&nbsp;&nbsp;Autonomy is understood as a cluster of notions including self-determination, freedom, independence, liberty of choice and action.<BR>&nbsp;&nbsp;Legally valid informed consent is mandated in the clinical sphere for diagnostic and therapeutic, as well as research-related, interventions.<BR>&nbsp;&nbsp;However, in addition to exercising the right to make choices about which diagnostic or screening tests therapeutic procedures or medications, and research protocols to undergo or participate in, individuals increasingly enjoy (or are confronted with, depending on one&quot;s perspective) other, non-clinical decisions that may well affect their health care deeply.<BR>&nbsp;&nbsp;While the socio-ethical and legal issues surrounding secondary uses human biological materials have long been the subject of international interest, the thorny questions of genetic research and biobanking are more recent. Add to this the fact that national guidelines and laws usually precede international policymaking, and the delay in international approaches is understandable.<BR>&nbsp;&nbsp;This article examines informed consent requirements for use of stored human biological materials and explores specific approaches for reconciling the informed consent requirements for banked-specimen research under regulations.