인체자원 관리과정에서 윤리적 문제 확보방안_KBP사업
이 보고서는 한국인체자원은행사업 2기 계획수립 과제 내 위탁과제
“인체자원 관리 과정에서 윤리적 문제 확보방안”의 연구용역 결과보고서입니다. (한국보건산업진흥원)
* 국가생명윤리정책연구원 사업결과보고서는 도서관내에서 열람가능하며 대출불가 자료입니다. (PDF 파일 배포 불가)
위탁연구용역보고서 - 인체자원 관리과정에서 윤리적 문제 확보 방안
주관연구기관 : (재)국가생명윤리정책연구원
연구책임자 : 김성덕
공동연구원 : 백수진
연구원: 박인경 차승현 이준원 최슬비
연구보조원: 김도연
도서관 소장확인 :https://www.bprlib.kr/web/odi/odiTotalSearchDetail.do?controlNo=4983&marcGubun=mt
| 청구기호 | 18.1 국12ㅇ |
|---|---|
| 단체저자 | 국가생명윤리정책연구원 한국보건산업진흥원 보건복지부 |
| 서명저자사항 | 인체자원 관리과정에서 윤리적 문제 /주관연구기관 :국가생명윤리정책연구원 ; 보건복지부 |
| 발행사항 | 서울 : 국가생명윤리정책연구원 , 2012 |
| 형태사항 | 108p. : 도표 ; 26 cm + |
| 총서사항 | 2012년 KBP사업 위탁과제 |
| 일반주기 | 한국인체자원은행사업 2기 계획수립 과제 내 위탁과제로 한국보건산업진흥원에 제출한 결과보고서임. |
| 가격 | \ |
| 비통제주제명 | 한국보건산업진흥원 결과보고서 위탁과제 인체자원은행 인체유래물 연구용역 하위법령 자원은행 바이오뱅크 표준 운영지침 보관 |
목 차
1. 개요 ·························································1
가. 추진배경 ·······················································2
나. 목적 ···························································3
2. 하위법령 마련을 위한 법·제도 WG 활동 ························5
가. 구성 ···························································5
나. 주요 논의 사항 ··················································5
1) 개정법의 주요 내용 ············································5
2) 하위법령 주요 논의 사항 ·······································6
3) 논의 내용 ····················································20
4) 시행령(안) ···················································24
5) 시행규칙(안) ·················································25
3. 인체자원은행의 윤리적 관리 방안 ·····························30
가. 인체유래물에 대한 개념 및 특징 ·································30
나. 인체유래물의 윤리적 관리에 대한 해외 규정 ······················31
1) 헬싱키 선언 ··················································31
2) COIOMS 가이드라인 ··········································32
3) 미국 OHRP 코드화된 개인정보와 인체유래물 연구를 위한 지침 ···34
4) 영국, 인체조직법 ·············································34
다. 바이오뱅크 관련 표준운영지침에 대한 국제적 기준 ················35
1) OECD 기준 ··················································35
2) ISBER 기준 ·················································41
라. 인체유래물은행에서의 인체자원의 윤리적 관리 기준 ···············49
1) 인력 및 시설 측면 ············································50
2) 인체유래물 수집 관리 ·········································50
3) 문서 관리 ····················································53
4) 보관 및 안전관리 ·············································54
5) 품질 및 정도 관리 ············································55
6) 익명화 및 보안 관리 ··········································55
7) 표준작업지침서 ···············································56
8) 분양 관리 ····················································56
9) 기관위원회 구성 및 운영 ······································57
4. 인체유래물은행 표준운영지침(안) ·····························58
가. 목적 ··························································58
나. 적용범위 ······················································58
다. 기본원칙 ······················································58
라. 인체유래물은행의 설립 ··········································60
1) 법적 근거 ····················································60
2) 법률적 허가 요건 ·············································60
3) 기관위원회 구성 및 등록 ······································63
4) 제출서류 및 절차 ·············································63
5) 기타 업무 ····················································66
마. 인체유래물은행의 준수사항 ······································71
1) 법률적 준수사항 ··············································71
2) 개인정보보호 ·················································71
3) 무상 제공 ····················································72
4) 보안책임자의 의무 ············································72
바. 인체유래물의 수집(기증 및 기탁) ································74
1) 획득 및 처리 절차 ············································74
2) 동의서 관리 ··················································80
사. 익명화 및 보안 ················································81
1) 익명화란 ·····················································81
2) 개인정보보호 및 보안책임자 지정 ······························82
3) 익명화 방식 및 절차 ··········································83
4) 정보관리 ·····················································88
5) 보안 조치 ····················································91
6) 문서관리 ·····················································92
아. 인체유래물의 보관 및 관리 ······································94
1) 보관 ························································94
2) 관리 ························································97
자. 인체유래불의 제공(분양) ······································101
1) 분양관리 ···················································101
2) 분양절차 ···················································104
3) 분양 ·······················································107
4) 연구결과 관리 및 조사·감독 ··································108