유전체 맞춤의학 연구와 위험의 개념 이해 = The Concept of Risk in the era of Personalized Genetic Medicine

다국어 초록 (Multilingual Abstract)

Personalized genetic medicine(PGM) is an attempt to understand the relationship between human genetic information and diseases, and to find a potential treatment and diagnostic method. Large research projects are under way with social concerns. ELSI research is aimed at understanding the implication of an innovative research from humanistic perspectives, and communicating the understanding with society and with scientists, thereby providing practical and concrete recommendations and guides. Of the ELSI studies, ethics of PGM research searches the value problems embedded in various perspectives on PGM and tries to answer the question whether it is permissible to implement certain types of research. A framework for ethical analysis is proposed and explained. The concept of risk in general was explored and its implication for ethical review of PGM in relation with the natures of PGM was given. The risks can be categorized: risks associated with the inherent characteristics of research/practice, risks associated with human eras and risks related social construction and (in)justice. Understanding the nature of risk will help the IRB’'s reviewing the PGM researches.

목차 (Table of Contents)

• I. 서론: 유전자의 시대
• II. 유전체 맞춤의학에 대한 윤리적 귤율
• III. ELSI연구에서 윤리적 분석의 프레임워크
• IV. 윤리적 평가 근거로서 위험과 이익
• 1. 개요
• 2. 위험의 개념
• 3. 유전체 맞춤의학의 이해
• 4. 유전체 맞춤의학에 관한 주요한 윤리적 논의
• 5. 유전체 맞춤의학 연구와 실천 과정의 위험과 편익
• V. 마치는 말
• Abstract

참고문헌 (Reference)

1 이일학, "의학 연구에서 위험성 평가: 기관생명윤리심의위원회의 평가를 위해 고려할 사항들" 2 (2): 215-230, 2008

2 "미국 국립보건원 유전체 관련성 연구(Genom-wide Association Studies, GWAS)"

3 "http://www.genome.gov/sequencingcosts/"

4 "http://en.wikipedia.org/wiki/Omics"

5 M.Dunn, "Toward Methodological innovation in Empirical Ethics Reserach, Camb" 21 (21): 466-480, 2012

6 OHRP, "The Nuremberg Code"

7 "The Gemonics and Personalized Medicine Act"

8 D. Resnik, "The Ethics of Science: An Introduction" Routledge 147-171, 1998

9 Donald M. Bruce, "Social Contract for Biotechnology: Shared Visions for Risk Technology?" 15 (15): 279-, 2002

10 Jonathan Wolff, "Risk, Fear, Blame and Shame: The Regulation of Public Safety" 22 : 409-, 2006

11 I. Lee, "Framework for Ethical Analysis of ELSI Issues in Genomics and Personalized Medicine" Asian Institute for Bioethics and Health Law 2012

12 H. Zwart, "ELSA Research in Europe: Lessons from CSG" Asian Institute for Bioethics and Health Law 2012