생명윤리법 관련 기관 운영지침(2013)

-기관생명윤리위원회, 유전자검사기관, 인체유래물은행 -

발 간 등 록 번 호 : 11-1352000-001152-01

- 목차 -

제1장 기관생명윤리위원회(IRB) 관리안내 _ 1

Ⅰ. 기관위원회의 설치 ······································································ 3
1. 기관위원회의 업무 ········································································ 3
2. 기관위원회의 설치 ········································································ 6 

Ⅱ. 기관위원회의 구성･운영 ··························································· 12
1. 기관위원회의 구성 ······································································ 12
2. 기관위원회의 운영 ······································································ 13
3. 기관위원회의 통합 운영 ······························································ 17
4. 기관위원회의 공동 운영 ······························································ 19 

Ⅲ. 기관위원회의 등록 ···································································· 20
1. 등록 신청 방법 ··········································································· 21
2. 등록 신청 기간 ··········································································· 22
3. 등록 대상 ··················································································· 22
4. 등록증 교부 ················································································ 23 

Ⅳ. 기관위원회의 심의 ···································································· 26
1. 심의대상 연구의 범위 ································································· 26
2. 인간대상연구 ··············································································· 28
3. 인체유래물연구 ··········································································· 36 

Ⅴ. 기록의 보관･관리 ····································································· 50
1. 기록의 보관･관리 ········································································ 50
2. 자기정보공개청구 ········································································ 51

제2장 유전자검사기관 관리안내 _ 57 

1. 유전자검사기관 신고 등 ····························································· 59
가. 유전자검사기관의 신고 ································································ 59
나. 유전자검사기관의 변경 신고 ······················································· 78
다. 유전자검사기관의 휴·폐업 신고 ················································· 80 

2. 유전자검사의 동의 등 ································································ 83
가. 유전자검사의 동의 ······································································ 83
나. 검사대상물의 제공에 따른 동의 ·················································· 84
다. 동의가 필요 없는 경우 및 서면동의 면제 ··································· 85
라. 유전자검사 의뢰시 동의서 익명화 조치 ······································ 86
마. 유전자검사와 유전자연구 관련 동의 ············································ 86 

3. 검사대상물의 제공, 폐기 등 ······················································· 92
가. 검사대상물의 제공 ······································································ 92
나. 검사대상물의 폐기 ······································································ 94 

4. 기록보관 및 정보공개 등 ··························································· 95
가. 기록의 보관 ················································································ 95
나. 정보의 공개 ················································································ 95 

5. 유전자검사의 제한 등 ······························································ 101
가. 일반적 유전자검사 ···································································· 101
나. 배아･태아 대상 유전자검사 ······················································· 101
다. 질병의 예방, 진단 및 치료와 관련한 유전자검사 ······················ 102
라. 거짓표시 또는 과대광고 제한 ··················································· 103 

6. 유전자검사의 정확도 평가 등 ·················································· 114


제3장 인체유래물은행 관리안내 _ 117 

Ⅰ. 인체유래물은행의 허가 및 변경신고 등 ·································· 119
1. 인체유래물은행의 허가 ····························································· 119
2. 인체유래물은행의 변경신고 ······················································· 124
3. 인체유래물은행의 휴･폐업신고 ·················································· 126 

Ⅱ. 인체유래물등의 채취 및 제공 ················································· 129
1. 인체유래물 채취 동의 ······························································· 129
2. 인체유래물의 제공 ···································································· 134 

Ⅲ. 인체유래물은행 준수사항 ························································ 136 

참 고 벌칙 및 행정처분 _ 139