2013 공용기관생명윤리위원회 운영사업 결과보고서
본 보고서는 열람 및 배포가 불가능한 자료입니다.
국가생명윤리정책연구원
2013 사업결과보고서
2013 공용기관생명윤리위원회
운영 사업
2013. 12
보건복지부
(재)국가생명윤리정책연구원
주관연구기관 : (재)국가생명윤리정책연구원
목 차
1. 사업개요 ········································································································· 1
1.1 사업 목적 및 필요성 ······················································································· 1
1.2 사업 목표 및 주요 과제 ················································································· 4
1.3 사업 내용 ··········································································································· 4
1.4 운영체계 ············································································································· 5
2. 공용위원회 운영 ··························································································· 6
2.1 공용위원회 지정 ······························································································· 6
2.1.1 목적 및 필요성 ·························································································· 6
2.2 구성 및 운영 ····································································································· 8
2.2.1 운영위원회 ·································································································· 8
2.2.1.1 구성 ······································································································ 8
2.2.1.2 위원회 활동 ························································································ 9
2.2.2 심의위원회 ······························································································· 14
2.2.2.1 구성 ···································································································· 14
2.2.2.2 위원회 활동 ······················································································ 18
2.2.3 공용위원회 사무국 ················································································· 38
2.2.3.1 구성 ···································································································· 38
2.2.3.2 활동 ···································································································· 38
3. 연구자교육 ·································································································· 45
3.1 교육내용 개발 ································································································· 45
3.1.1 목적 및 필요성 ······················································································· 45
3.1.2 추진내용 ··································································································· 45
3.1.2.1 기관위원회 정보포털 사이트 관리 ·············································· 45
3.1.2.2 공용위원회 이용 안내 책자 제작 및 배포 ································ 46
3.1.2.3 질병관리본부 온라인 교육자료 개발 참여 ································ 47
3.1.3 추진일정 ··································································································· 47
3.1.4 결과 및 기대효과 ··················································································· 47
3.2 집합교육 실시 ································································································· 48
3.2.1 협약기관 소속 연구자 대상 워크숍 ··················································· 48
3.2.2 방문 교육 ································································································· 58
4. 표준운영 절차의 보완 및 확립 ······························································ 60
4.1 해외 유관 기관 방문 ····················································································· 60
4.1.1 목적 및 필요성 ······················································································· 60
4.1.2 방문기관 및 출장일정 ··········································································· 60
4.1.3 기관 방문 내용 ······················································································· 62
4.1.4 평가 및 시사점 ····················································································· 78
4.2 표준운영지침 ··································································································· 80
4.2.1 표준운영지침 마련 및 보완 ································································· 80
4.2.2 표준운영지침 공유 ················································································· 85
4.3 이용자 만족도 조사 ······················································································· 86
4.3.1 목적 및 필요성 ······················································································· 86
4.3.2 방법 ··········································································································· 86
4.3.3 결과 활용방안 ························································································· 88
5. 향후 운영 계획(안) ·················································································· 95
5.1 2014년 목표 ··································································································· 95
5.2 세부사업 내용 및 추진방법 ········································································· 95
5.2.1 공용위원회 운영 및 기준 수립 ··························································· 95
5.2.2 심의 및 과제 관리 ··············································································· 96
5.2.3 교육 ··········································································································· 95
5.3 추진계획 ··········································································································· 99
※ 별첨 2013 공용기관생명윤리위원회 표준운영지침서(ver. 3.0)
표 목 차
표 1 공용위원회 구성 ············································································································· 5
표 2 공용위원회 운영위원 명단 ··························································································· 8
표 3 공용위원회 운영위원회 회의개최 현황 ······································································ 9
표 4 공용위원회 심의위원 명단 ························································································· 14
표 5 제1위원회 명단 ············································································································· 16
표 6 제2위원회 명단 ············································································································· 17
표 7 공용위원회 2013년 개최 현황 ·················································································· 18
표 8 신규과제 심의 목록 ····································································································· 19
표 9 2013년 심의면제 확인 신청 목록 ············································································ 32
표 10 사무국 구성 현황 ······································································································· 38
표 11 위원 참여 현황 ··········································································································· 41
표 12 공용위원회 업무 위탁 협약기관 현황 ··································································· 43
표 13 표준운영지침서 목차 ································································································· 82
표 14 표준운영지침서 별지 및 권고 서식 목록 ····························································· 84
그 림 목 차
그림 1 공용위원회 운영체계 ································································································· 5
그림 2 공용위원회 지정서 ····································································································· 7
그림 3 심의위원 구성 현황 ································································································· 16
그림 4 월별 신규과제 심의 건수 ······················································································· 26
그림 5 신규심의의 연구 종류 ····························································································· 27
그림 6 신규심의의 연구 목적 ····························································································· 27
그림 7 신규심의의 연구 방법 ····························································································· 28
그림 8 신규심의의 심의방법 ······························································································· 28
그림 9 신규심의에서 인간대상연구의 세부 분야 ··························································· 29
그림 10 신규심의의 심의신청 기관 현황 ········································································· 29
그림 11 신규심의의 연구책임자 직위 ··············································································· 30
그림 12 신규심의의 지역별 신청 현황 ············································································· 30
그림 13 신규심의의 연구비지원기관 종류 ······································································· 31
그림 14 신규심의의 심의결과 현황 ··················································································· 31
그림 15 심의면제 연구 분야 ······························································································· 34
그림 16 심의면제 중 인간대상연구 세부분야 ································································· 35
그림 17 심의면제 연구방법 ································································································· 35
그림 18 공용위원회 위원 워크숍 ······················································································· 37
그림 19 월별 행정점검 수 현황 ························································································· 40
그림 20 기관위원회 정보포털 사이트 공용위원회 소개 ··············································· 46
그림 21 공용위원회 이용안내 리플릿 ··············································································· 46
그림 22 공용위원회 협약기관 소속 연구자 대상 집합 교육 ······································· 51
그림 23 소속기관의 유형 ····································································································· 52
그림 24 직위 현황 ················································································································· 52
그림 25 전공 분야 ················································································································· 53
그림 26 연구의 유형 ············································································································· 53
그림 27 교육내용 만족도 ····································································································· 54
그림 28 교육내용 이해도 ····································································································· 54
그림 29 교재 만족도 ············································································································· 55
그림 30 강의시간 만족도 ····································································································· 55
그림 31 사전정보 만족도 ····································································································· 56
그림 32 교육과정 진행 만족도 ··························································································· 56
그림 33 교육과정 전반에 대한 만족도 ············································································· 57
그림 34 회의 모습 ················································································································· 67
그림 35 NRES 방문 기념 사진 ·························································································· 67
그림 36 KCL REC 관련자들과의 회의 모습 ··································································· 70
그림 37 KCL의 연구유형 판단 흐름도 ············································································· 70
그림 38 NRES REC의 심의 과정 및 시간표 ·································································· 72
그림 39 NRES의 심의신청 흐름도 ···················································································· 75
그림 40 브리스톨 지역 REC 센터 관련자들과의 회의 모습 ······································· 76
그림 41 표준운영지침서 표지 ····························································································· 81
그림 42 보건복지부 지정 기관위원회 정보포털 공용위원회 자료실 화면 ··············· 85
그림 43 이용자만족도조사 설문지 ····················································································· 87