인체 유래물 등과 역학정보의 폐기

초록

Principle of respect for autonomy in medical practice and biomedical research is realized by means of informed consent from patients and subjects, which is further applied to consent withdrawal in addition to obtaining informed consent. In the investigator’s perspective, consent withdrawal may lead to undesirable situations such as study discontinuation or amendment, destabilizing the study status. Investigators’ freedom of research may come into conflict with respect for autonomous decision by patients or subjects. Specifically, genetic research in human participants that requires retention and maintenance of large scale human biological materials and epidemiological data in a biobank raises a problem associated with the scope in which individual can make a decision, as it is more likely to process characteristics of population instead of individuals. Rationale of request for disposal of human biological materials and epidemiological data is rooted in the principle of respect of autonomy and privacy protection. Every human being naturally has a right to make a decision on his/her own life and body, which is called the right of self-determination as a legal right Human biological materials and epidemiological data are subject to the right of self-determination and thus people can request disposal of their biological materials and epidemiological data in the sense that the law requires subjects’ voluntary informed consent to obtain those. In addition, confidentiality of personal data must be protected unless otherwise specified in a very special circumstance. The two notions are supported by the Bioethics and Safety Act and Personal Data Protection Act. The Nuremberg Code also states subjects’ right that they can freely withdraw their study participation, which is now considered important in the research ethics. When a subject discontinue a study, it is very difficult to determine what kinds of human biological materials and epidemiological data collected from the subject until the time of withdrawal need to be disposed and what criteria should be applied, and establishing a legal regulation on the matter is more so. To determine the extent and methodology of appropriate legal controls, a great understanding on actual practices and the nature of biomedicine is a prerequisite and the fact that biomedical research is a fast growing area that no one can estimate the future direction adds a significant burden of framework. Framework must consider all factors of respect for autonomous decision and protection for privacy as well as interests of conduct of a study. In some cases, the right to request disposal of human biological materials and epidemiological data may be inevitably limited. The constantly changing field of biomedical research should be also fully accounted to establish legal framework.

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