유전자 검사 및 연구에서의 동의 획득의 문제

• 영문명: Issues in Obtaining Informed Consent to Genetic Test and Research
• 발행기관: 이화여자대학교 생명의료법연구소
• 저자명: 배그린(Bae Green) 최경석(Kyungsuk Choi)
• 간행물 정보: 『생명윤리정책연구(제 9권 제 3호 이전)』제3권 제1호, 21~38쪽, 전체 18쪽
• 주제분류: 법학 > 법학
• 파일형태: PDF
• 발행일자: 2009.04.30

영문 초록

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.

목차

Ⅰ. 머리말

Ⅱ. 유전자 검사 또는 연구에서 동의 획득의 중요성

Ⅲ. 유전자 검사동의서의 문제점 및 해결방안

Ⅳ. 동의 철회의 문제와 대책

Ⅳ. 해외 유전자 연구기관의 문제와 규제방안

Ⅳ. 맺음말

키워드

유전자 검사(genetic test) 유전자 연구(genetic research) 열람청구권(right to know) 동의철회(withdrawl of consent) 법정서식 유전자검사동의서(legal form of consent to genetic test)