2013 기관위원회 평가인증사업 결과보고서
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국가생명윤리정책연구원
2013 사업결과보고서
기관생명윤리위원회 평가·인증사업
2013. 12.
보건복지부
(재)국가생명윤리정책연구원
주관연구기관 : (재)국가생명윤리정책연구원
목 차
1. 사업개요 ··················································································································· 1
가. 목적 및 필요성 ·············································································································· 1
나. 사업 목표 및 내용 ·········································································································· 3
다. 조직 및 역할 ··················································································································· 6
2. 2013년 주요 사업 내용 ························································································ 7
가. 위원회 운영 및 사업방향 정립 ···················································································· 7
1) 운영 방안 수립 ············································································································· 7
2) 추진위원회 구성 및 운영 ····························································································· 7
3) 기준수립위원회 구성 및 운영 ···················································································· 12
나. 질적 인프라 확충 ········································································································ 15
1) 국외 연구윤리위원회 동향 파악 ················································································ 15
2) 시범평가 기준 마련 ··································································································· 26
3) 평가위원 모집 및 구성 ······························································································ 37
4) E-based 평가·인증 시스템 구축 ··········································································· 44
다. 기관위원회 교육 및 지원 ······························································································ 49
1) 시범평가 위원 대상 워크숍 ······················································································· 49
2) 시범평가 사업 설명회 ································································································ 56
라. 시범평가 기획 및 운영 준비 ························································································· 62
1) 시범평가 시행 계획 수립 ··························································································· 62
2) 시범평가 운영 준비 ··································································································· 64
3. 향후 제언 및 계획 ································································································· 68
가. 기관위원회 평가·인증 사업 운영 방향 정립 ································································· 68
나. 시범평가 및 모니터링 체제 마련 ·················································································· 69
다. 교육 및 컨설팅 서비스 지원 ························································································· 69
※ 별첨 1. 기관위원회 시범평가 기준
※ 별첨 2. 기관위원회 시범평가기준 평가위원용 해설서
※ 별첨 3. 기관위원회 시범평가 사업 설명회 자료집
표 목 차
표 1 2013년 기관위원회 평가인증사업 추진위원회 위원명단 ················································ 8
표 2 2013년 추진위원회 회의개최 현황 ················································································· 8
표 3 기준수립위원회 위원명단 ······························································································· 12
표 4 기준수립위원회 회의 개최 현황 ···················································································· 13
표 5 평가영역 정립 방안 ······································································································· 28
표 6 시범평가 시 서류평가전문위원(Analyst) 현황 ···························································· 39
표 7 교육 수료한 평가위원 명단 ··························································································· 39
표 8 시범평가 및 모니터링을 통한 기대 역할 ······································································ 69
표 9 기관위원회 등록현황(2013년 12월 18일 현재) ························································· 70
그 림 목 차
그림 1 단계별 사업 추진 목표 ································································································· 3
그림 2 2013년 사업 조직도 ···································································································· 6
그림 3 2013-15 추진 방향 ································································································· 11
그림 4 평가영역별 항목 ········································································································· 29
그림 5 시범평가기준안 ··········································································································· 29
그림 6 현재 교육 수료된 평가위원 구성 현황 ······································································ 42
그림 7 관리자 화면 ················································································································ 45
그림 8 검색화면 ····················································································································· 46
그림 9 평가위원 화면 ············································································································· 46
그림 10 대상기관 화면 ·········································································································· 47
그림 11 시범평가 절차 ·········································································································· 63
그림 12 운영위원회의 기대 역할 ··························································································· 68