2012 기관위원회 세부운영방안 마련연구
* 국가생명윤리정책연구원 사업결과보고서는 도서관내에서 열람가능하며 대출불가 자료입니다. (PDF 파일 배포 불가)
도서관 소장 확인 : https://www.bprlib.kr/web/odi/odiTotalSearchDetail.do?controlNo=4984&marcGubun=mt
기관위원회 세부운영방안 마련 연구
2012. 10
보건복지부
(재)국가생명윤리정책연구원
보건복지부 위탁연구용역보고서
기관위원회 세부운영방안 마련 연구
주관연구기관 : (재)국가생명윤리정책연구원
연구책임자 : 김성덕
공동연구원 : 김명희 백수진
연구원 : 박인경 차승현 이준원 최슬비
연구보조원 : 김도연
목 차
제1장 목적 및 필요성································································································· 1
1. 연구 배경 및 필요성········································································································· 1
2. 연구 내용··························································································································· 2
제2장 국외 유사 연구윤리위원회 제도 ···································································· 4
1. 영국··································································································································· 4
가. NRES (National Research Ethics Service) ··························································· 4
나. 영국 보건부의 연구 거버넌스 프레임워크
(Research Governance Framework for Health & Social Care) ······················· 13
다. 영국 경제사회연구재단(ESRC)의
연구윤리 프레임워크 Framework for Research Ethics ········································· 17
라. 대학 연구윤리위원회·································································································· 22
2. 미국································································································································· 25
가. 미시건대학의 인간대상연구 보호프로그램
(Human Research Protection Program, 이하 HRPP) ········································· 25
나. 버클리(berkeley) 대학의 HRPP ··············································································· 47
다. 코넬(Cornell) 대학의 HRPP ····················································································· 60
제3장 기관생명윤리위원회 전문성 향상 방안························································· 63
1. 기관생명윤리위원회의 관련 교육···················································································· 63
2. 표준 지침서 마련············································································································ 84
가. 개요···························································································································· 84
나. 기관위원회 설치 전 검토 사항·················································································· 88
다. 기관위원회의 설치······································································································ 96
라. 기관위원회 구성······································································································· 100
마. 기관위원회 등록······································································································· 105
바. 기관위원회 운영······································································································· 109
사. 심의(회의) ················································································································· 123
아. 심의 사항 및 기준···································································································· 128
자. 심의 결과의 통보 ···································································································· 144
차. 기록 보관 등············································································································ 144
3. 기관생명윤리위원회 관리 방안 마련············································································· 146
가. 기관위원회 지원 방안 수립······················································································ 146
나. 기관위원회 평가 및 인증 활용················································································ 146
제4장 공용기관생명윤리위원회 구성 및 운영방안················································ 148
1. 해외 운영 사례 조사····································································································· 148
가. 미국·························································································································· 148
나. 영국 NRES (National Research Ethics Service) ·············································· 150
다. 호주의 HREC(Human Research Ethics Committee) ········································· 153
2. 국내 공용기관생명윤리위원회 수요 분석······································································ 155
가. 조사 개요·················································································································· 155
나. 국내 연구 현황········································································································· 156
다. 인간대상연구 및 인체유래물연구 관련 기관현황····················································· 173
라. 정책연구 현황··········································································································· 190
마. 소 결························································································································· 192
3. 운영 모델 제안·············································································································· 194
가. 구성·························································································································· 194
나. 운영·························································································································· 196
4. 심의································································································································ 200
가. 절차·························································································································· 200
나. 방법·························································································································· 200
다. 심의·························································································································· 208
5. 수행 중인 과제에 대한 조사·감독················································································· 209
가. 지속심의··················································································································· 209
나. 현장점검 등 모니터링······························································································ 210
6. 기타 활동······················································································································· 211
가. 예산·························································································································· 211
나. 교육·························································································································· 211
다. 지침 개발 및 공유···································································································· 211
7. 표준운영지침서(안) ········································································································ 212
제5장 기관생명윤리위원회 평가·인증제도 정착 방안·········································· 240
1. 현황 : 대한기관윤리심의기구협의회(KAIRB) IRB 평가제도 현황····························· 240
가. 설립 목적 및 목표 ·································································································· 240
나. 연혁 ························································································································· 240
다. 평가대상 (평가주기 매 3년) ···················································································· 241
라. 연도별 실적 ············································································································ 241
마. 2010~2012 심의 분포도 ························································································· 246
2. 해외 평가 및 인증제도·································································································· 248
가. 미국의 인간피험자보호프로그램을 위한 인증협회(AAHRPP) ······························ 248
3. 국내 유사 평가 및 인증제도························································································· 252
가. 어린이집 평가인증제································································································ 252
나. 사회복지시설 평가제도 ··························································································· 254
다. 의료기관 인증제도 ·································································································· 260
4. 평가 기준 및 절차········································································································· 265
가. 필요성······················································································································· 265
나. 목표·························································································································· 268
다. 기준(안) ···················································································································· 269
라. 수행체계··················································································································· 271
마. 절차(안) ···················································································································· 271
제6장 결론··············································································································· 279
1. 기관위원회 표준운영지침의 마련·················································································· 279
2. 기관위원회 전문성 향상 및 질 관리············································································· 280
3. 공용위원회의 활성화 도모····························································································· 280
4. 기관위원회 관련 정보 공유··························································································· 281
5. 기관위원회 평가 및 인증제도의 정착··········································································· 282
제7장 참고 문헌······································································································ 284
< 표 차례 >
표 1 각 연구별 지침 (2008년 기준) ························································································· 4
표 2 REC 관리 체제················································································································ 7
표 3 국내 임상시험 전문 교육 현황······················································································· 69
표 4 국내 IRB 대상 교육 현황······························································································ 70
표 5 국내 연구윤리 관련 교육 현황······················································································· 73
표 6 OHRP 온라인 교육········································································································ 75
표 7 연구개발 주체별 기관, 조직, 연구원 수······································································· 156
표 8 연구분야별, 연구개발주체별 연구개발 투자비······························································ 157
표 9 연구분야별, 연구개발주체별 연구원 수········································································ 157
표 10 공공기관 유형별 연구개발수행기관 수, 연구원 수, 연구개발비································· 158
표 11대학 법인별 연구개발수행기관 수, 연구원 수, 연구개발비········································· 161
표 12 대학 유형별 연구개발수행기관 수, 연구개발비·························································· 162
표 13 기업체 유형별 연구수행기관 수, 연구원 수, 연구개발비··········································· 164
표 14 기업체의 산업분야별 연구개발수행기관수, 연구원 수, 연구개발비··························· 165
표 15 기업체의 산업, 연구원 수 규모별 연구개발수행기관 수, 연구원 수, 연구개발비····· 166
표 16 지역별, 연구개발주체별 연구개발수행기관 수, 연구개발수행조직 수························ 169
표 17 지역별, 연구개발주체별 연구개발수행기관 수, 연구개발수행조직 수························ 170
표 18 지역별, 연구개발주체별 연구원 수············································································· 171
표 19 지역별, 연구개발주체별 연구개발비··········································································· 172
표 20 생명윤리관련 학과 분류······························································································ 173
표 21 대학 및 전문대학의 생명윤리관련 대계열 수, 학과 수············································· 174
표 22 전문대학의 지역별 생명윤리관련 대계열 수, 학과 수··············································· 175
표 23 대학의 지역별 생명윤리관련 대계열 수, 학과 수······················································ 176
표 24 지역별, 병상규모별 병원 수······················································································· 178
표 25 설립구분별, 병상규모별 병원 수················································································· 180
표 26 학술기관별, 주제별 기관 수······················································································· 183
표 27 학술기관별, 지역별 기관수 ······················································································· 184
표 28 학술기관별, 주제별 등재(후보)지 수·········································································· 185
표 29 학술기관별, 발행간기별 등배(후보)지 수··································································· 185
표 30 학술기관별, 발행지수별 기관 수················································································· 186
표 31 IRB설치대상별 기관 수······························································································ 187
표 32 배아관련 기관별 지역별 기관 수················································································ 188
표 33 유전자 관련 기관별, 지역별 기관 수········································································· 189
표 34 2011년 정부부처별 정책연구 및 인간대상연구 수····················································· 190
표 35 현장관찰자 자격·········································································································· 253
표 36 현장평가위원 자격요건······························································································· 257
표 37 사회복지시설 평가절차······························································································· 259
표 38 주요 평가 기준 및 내용····························································································· 277
<그림 차례>
그림 1 REC 관리 체제············································································································· 7
그림 2 REC의 종류·················································································································· 9
그림 3 코넬 대학 인간대상연구 확인 Decision Tree ··························································· 62
그림 4 ···································································································································· 95
그림 5 기관위원회 등록 방법 흐름도(안) ············································································· 105
그림 6 기관위원회 업무 흐름도···························································································· 115
그림 7 심의 면제 대상 인간대상연구 자가점검표································································ 122
그림 8 WIRB 업무 흐름도··································································································· 150
그림 9 영국 NRES 신청 절차····························································································· 152
그림 10 호주의 HREC 체계 ······························································································· 153
그림 11 지역 및 설립구분별 병원 현황················································································ 179
그림 12 설립구분 및 병상규모별 전국병원 현황·································································· 181
그림 13 공용위원회 심의 절차(안) ······················································································· 200
그림 14 유형별 분포도·········································································································· 246
그림 15 등록기관별 분포도··································································································· 246
그림 16 IRB 운영방식별 분포도·························································································· 247
그림 17 기관별 평가결과의 분포도······················································································· 247
그림 18 인증제 수행 절차····································································································· 261
그림 19 인증조사 일정 및 위원···························································································· 261
그림 20 기관위원회 평가·인증제의 목표·············································································· 268
그림 21 기관위원회 평가·인증사업 추진 체계······································································ 271
그림 22 평가 절차(안) ·········································································································· 272
그림 23 평가의 예상 흐름도(안) ··························································································· 272
그림 24 인증 절차················································································································· 278