유전자 검사 및 연구에서의 동의 획득의 문제

Abstract

Various genetic tests are available. Genetic research is expected to contribute to the development of medicine. Genetic test and research, however, have raised some important ethical issues including genetic privacy, confidentiality, and discrimination. Due to the sensitive characters of genetic information, protecting privacy and keeping confidentiality are the basic requirements. Obtaining informed consent is also mandatory to respect a donor’s or a patient’s autonomy and protect their personal information. Bioethics and Safety Act in Korea regulates genetic test and research. The same rule to regulate genetic test applies to genetic research. Especially the Act enacted a single legal form for both genetic test and research. But genetic research fundamentally differs from genetic test in that the former is research. Thus, the legal form reveals some problems when it is used for genetic research. First, the right to know the outcomes of genetic test might be often waived in genetic research while it should be respected in genetic test. Second, the period for keeping genetic samples should be consented after researchers basically set it up. It is not a good idea that “5 years” is provided as an option in the current legal form. Third, the right to withdrawal of consent should be respected at any time in the course of research regardless of its reasons. Samples should be destroyed without generating further data although data already made until the withdrawal may be used with the permanent deletion of personal identifiers. Therefore, a new consent form for genetic research should be made.