정책-보건의료-2011-73

 

국가생명윤리정책 발전방안 연구
2011․12
한국보건산업진흥원
KOREA HEALTH INDUSTRYDEVELOPMENTINSTITUTE

 

 

N1396_120106_국가생명윤리정책발전방안연구(최종보고서수정).pdf

 

 

￭주관연구기관 :한국보건산업진흥원
￭연 구 책 임 :이 윤 태 (한국보건산업진흥원,전문위원)
￭참여 연구원 :곽 미 숙 (한국보건산업진흥원,연구원)
박 수 범 (한국보건산업진흥원,연구원)
조 경 미 (한국보건산업진흥원,연구원)

 

차 례

제1장 서론 / 1

1.연구의 목적 및 필요성 ··················································································1

2.연구내용 및 방법 ··························································································2

3.연구 추진체계 ·······························································································4

제2장 국가생명윤리심의위원회 활성화 방안 / 5

1.국가생명윤리심의위원회 설립의 필요성과 배경 ··············································5

2.우리나라 국가생명윤리심의위원회의 현황 ······················································8

3.외국의 윤리위원회 설립 및 운영현황 ···························································16

4.국가생명윤리심의위원회 활성화 방안 ···························································31

5.소결 ············································································································36

제3장 국가생명윤리정책 지원체계 구축 방안 / 38

1.우리나라 생명윤리 정책지원체계 현황 ·························································38

2.외국의 생명윤리정책연구센터 사례 ······························································43

3.국내 생명윤리 정책지원 전담기구 구축방안 ·················································51

4.소결 ············································································································55

제4장 생명윤리 관련 의제제기 다양화 방안 / 57

1.우리나라의 생명윤리 관련 의제제기 현황 ····················································57

2.생명윤리 관련 의제제기 다양화 방안 ···························································58

3.소결 ············································································································59

제5장 기관생명윤리위원회(IRB) 활성화 방안 / 61

1.개요 ············································································································61

2.현황 ············································································································70

3.문제점 ·········································································································77

4.발전방안 ······································································································81

ii

제6장 인체자원의 수급 관리체계 개선방안 / 85

1.개요 ··············································································································85

2.우리나라 인체자원 관리 현황 및 문제점 ························································90

3.외국의 인체자원 관리체계 현황 및 시사점 ···················································146

4.인체자원 수급 관리체계 개선방안 ································································173

5.소결 ············································································································182

•참고문헌 / 185

•부록 / 190

1.국가생명윤리심의위원회 정책감담회(2011.8.30)참고자료 ·························191

2.국가생명윤리심의위원회

 

 

 

[ 개요]

○ 국가생명윤리심의위원회(대통령 소속) 활성화 방안 모색
- (회의 정례화) 그동안 사안이 발생할 때마다 비정기(평균 연2회)로 개최되는 위원회 회의를 분기별 1회로 정례화 추진 검토
- (논의 범위 확대) 현재 생명과학기술(인간 배아.세포.유전자 등)로 한정되어 있는 논의범위를 우선 인간대상연구 전체로, 점진적으로 존엄사 등 의료윤리 전반까지 확대 방안 연구
-(적극적 의제발굴 지원) 위원회 자체적인 ㅣ의제발굴 및 공론화가 가능하도록, 정책지원체계 구축
- 전문위원회 내실화 방안 및 향후 발전방안 등 연구

○ 생명윤리 정책 지원 체계 구축
- 정부내 생명.의료윤리 관련 정책을 체계적으로 지원할 수 있는 Think Tank(정책연구소) 신설 방안 검토
- 현재 산재되어 있는 지정 및 민간위탁 기능을 하나의 기관을 설립, 점진적으로 통합하고, 법 개정을 통해 전담 기구에 대한 근거 마련

○ 새로운 이슈에 대한 공론의 장 마련
- 각 분야 대표성 있는 단체가 정기적으로 의제를 제기할 수 있도록 하고, 합리적 의제는 국생위 논의를 의무화하는 방안 검토
- 홈페이지 등을 통해 국민들의 다양한 의견을 수렴할 수 있는 소통의 장을 마련할 수 있는 방안 마련

○ 인체자원의 수급 관리체계 개선
- 인체자원 기증에 대해 기증자 가족과 기증받는 자 뿐만 아니라 국민들이 함께 기념하고 숭고한 뜻을 기릴 수 있는 방안 추진
- 각 기관별 인체자원 보유현황, 분양방법 등을 네트워크로 구축하고 일반 국민, 연구자, 기업 등에게 맞춤형 서비스를 제공하는 정책지원체계 구축 방안 연구

○ 기관 자율적 윤리심사(IRB) 강화
- (심의대상 확대) 현재 기관 중심에서 연구 중심으로 IRB 심의 체계를 개선하고, 특히 인체와 관련된 연구는 IRB심의 의무화 검토
- (IRB평가 강화) IRB 평가를 의무화하고, IRB가 부실하거나 심의가 형식적일 경우 등에는 공공연구참여 제한 등 불이익 검토
- (공용 IRB 활성화) 일정 규모 이하 또는 비정기적 임상실험 등으로 상설 IRB가 비효율적인 기관에 대해서는 공용 IRB 지원방안 모색

○ 국가생명윤리심의위원회 정책토론회 지원
- 제 3기 국가생명윤리심의위원회의 운영 및 국가생명윤리정책의 발전방아을 모색하기 위한 정책토론회 개최지원"