생명윤리 및 안전에 관한 법률 하위법령 수립 지원
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생명윤리 및 안전에 관한 법률 하위법령 수립 지원
| 청구기호 | 2.1 국12ㅎ |
|---|---|
| 단체저자 | 국가생명윤리정책연구원 |
| 서명저자사항 | 『생명윤리 및 안전에 관한 법률』하위법령 수립 지원 / 국가생명윤리정책연구원 |
| 발행사항 | 서울 : 국가생명윤리정책연구원, 2012 |
| 형태사항 | 314p. : 도표 ; 30cm |
| 일반주기 | 보건복지부 위탁연구용역보고서임. |
| 가격 | 비매품 |
| 비통제주제명 | 생명윤리 안전 법률 하위법령 공청회 설명회 생명윤리법 기관생명윤리위원회 인간대상연구 인체유래물연구 유전자검사 |
주관연구기관 : (재)국가생명윤리정책연구원
연구책임자 : 김성덕
공동연구원 : 김명희 백수진
연구원: 박인경 차승현
연구보조원 : 김도연
- 목차 -
목 차
1. 연구개요 ···································································1
가. 연구 배경 및 목적 ·······················································1
나. 연구 방법 ·······························································2
1) 추진 일정 ······························································2
2) 수행 방법 ·····························································2
가) 비교법적 문헌 연구 ··················································3
나) 각 분야 전문가 활용 ················································3
다) 실무자간 관련사항 협의 ··············································5
라) 공청회를 통해 일반의견 수렴 ·········································5
3) 연구 수행 체계 및 단계별 연구 수행 사항 ································7
가) 연구 수행 체계 ·····················································7
나) 단계별 연구 수행 사항 ···············································7
2. 주요개정내용 ·······························································9
가. 시행령 주요개정내용 ·····················································9
나. 시행규칙 주요개정내용 ··················································11
3. 개정 주요쟁점별 연구 ······················································14
가. 인간대상연구 관련 사항 ·················································14
1) 개요 ··································································14
2) 인간대상연구의 적용범위 ···············································14
가) 관련 쟁점 ··························································14
나) 연구 진행 및 내용 ··················································15
다) 공청회안 ···························································20
라) 공청회안에 대한 의견 ··············································21
마) 검토의견 ··························································22
3) 인간대상연구의 심의면제 ···············································23
가) 관련 쟁점 ··························································23
나) 연구 진행 및 내용 ··················································23
다) 공청회안 ··························································32
라) 공청회안에 대한 의견 ···············································33
마) 검토의견 ···························································34
- ii -
4) 대리동의 및 동의면제 ··················································34
가) 관련 쟁점 ··························································34
나) 연구 진행 및 내용 ··················································35
다) 공청회안 ···························································37
라) 공청회안에 대한 의견 ··············································38
마) 검토의견 ···························································38
5) 기록 보관 및 관리 ·····················································39
가) 관련 쟁점 ··························································39
나) 연구 진행 및 내용 ··················································39
다) 공청회안 ···························································40
라) 공청회안에 대한 의견 ··············································41
마) 검토의견 ···························································41
나. 기관위원회 관련 사항 ···················································43
1) 개요 ··································································43
2) 기관위원회 설치대상 ···················································43
가) 관련쟁점 ···························································43
나) 연구 진행 및 내용 ··················································43
다) 공청회안 ···························································44
라) 공청회안에 대한 의견 ···············································45
마) 검토의견 ···························································45
3) 기관위원회 업무 위탁 협약 ·············································46
가) 관련쟁점 ···························································46
나) 연구 진행 및 내용 ··················································46
다) 공청회안 ··························································47
라) 공청회안에 대한 의견 ···············································47
마) 검토의견 ···························································47
4) 기관위원회 등록 ······················································48
가) 관련쟁점 ···························································48
나) 연구 진행 및 내용 ··················································48
다) 공청회안 ···························································48
라) 공청회안에 대한 의견 ··············································53
마) 검토의견 ···························································53
5) 기관위원회 인증기준 등 ················································53
- iii -
가) 관련쟁점 ···························································53
나) 연구 진행 및 내용 ··················································53
다) 공청회안 ···························································59
라) 공청회안에 대한 의견 ··············································60
마) 검토의견 ···························································60
6) 공용위원회 지정 및 업무 ···············································61
가) 관련쟁점 ···························································61
나) 연구 진행 및 내용 ··················································61
다) 공청회안 ···························································65
라) 공청회안에 대한 의견 ···············································66
마) 검토의견 ···························································67
7) 기관위원회의 공동운영 ·················································67
가) 관련쟁점 ···························································67
나) 연구 진행 및 내용 ·················································67
다) 공청회안 ···························································68
다. 인체유래물연구 관련 사항 ···············································70
1) 개요 ·································································70
2) 인체유래물연구의 심의면제 ·············································71
가) 관련쟁점 ···························································71
나) 연구 진행 및 내용 ··················································71
다) 공청회안 ···························································72
라) 공청회안에 대한 의견 ···············································73
마) 검토의견 ···························································73
3) 인체유래물연구 동의 및 동의면제 ······································74
가) 관련쟁점 ···························································74
나) 연구 진행 및 내용 ··················································74
다) 공청회안 ···························································75
라) 공청회안에 대한 의견 ··············································77
마) 검토의견 ···························································77
4) 연구자의 인체유래물등의 제공 ··········································79
가) 관련쟁점 ···························································79
나) 연구 진행 및 내용 ··················································79
다) 공청회안 ···························································80
- iv -
라) 공청회안에 대한 의견 ···············································81
마) 검토의견 ···························································82
5) 인체유래물 채취 시 동의 ···············································85
가) 관련쟁점 ···························································85
나) 연구 진행 및 내용 ··················································85
다) 공청회안 ···························································86
라) 공청회안에 대한 의견 ·············································86
마) 검토의견 ···························································87
6) 인체유래물은행에서의 인체유래물등의 제공 ······························88
가) 관련쟁점 ···························································88
나) 연구 진행 및 내용 ·················································89
다) 공청회안 ···························································91
라) 공청회안에 대한 의견 ···············································93
마) 검토의견 ···························································94
7) 인체유래물은행 허가・신고 및 변경신고 ·································97
가) 관련쟁점 ···························································97
나) 연구 진행 및 내용 ··················································97
다) 공청회안 ···························································98
라) 공청회안에 대한 의견 ·············································100
마) 검토의견 ··························································100
라. 기타 위임 조항 ······················································102
1) 개요 ································································102
2) 배아 등의 생성과 연구 ···············································102
가) 배아의 생성 등에 관한 동의 ········································102
나) 배아의 보존 및 폐기 ··············································104
다) 잔여배아 및 잔여난자의 제공 등 ····································106
라) 난자기증자의 보호 등 ··············································108
마) 배아생성의료기관의 준수사항 ·······································109
바) 체세포복제배아등의 연구 ··········································110
3) 유전자치료 및 검사 등에 대한 사항 ···································112
가) 유전자치료기관의 신고 및 변경신고 ·································112
나) 유전자치료에 대한 서면동의 ········································114
다) 유전자검사기관의 신고 및 변경신고 ·································117