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「생명윤리 및 안전에 관한 법률」 전부개정안의 내용과 의의 : 임상연구와의 관계를 중심으로
A study on the proposed amendment bill of Bioethics and Safety Law (2010): focusing on the meaning of significant contents related to the clinical research

첫 페이지 보기
  • 발행기관
    대한의료법학회 바로가기
  • 간행물
    의료법학 바로가기
  • 통권
    제12권 제1호 (2011.06)바로가기
  • 페이지
    pp.99-131
  • 저자
    김은애
  • 언어
    한국어(KOR)
  • URL
    https://www.earticle.net/Article/A145722

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원문정보

초록

영어
To strengthen the protection of human research subjects and human materials, the Korean Ministry of Health and welfare proposed the amendment bill of Bioethics and Safety Law(2010) to the Congress. It includes so many meaningful clauses. According to the bill, the scope that this act shall apply will be expended to the research involving human subjects and human materials. In the bill, there are the principles of this act; the protection of the life, health, and dignity of the human subjects, the obtaining of the adequate informed consent, the protection of the human subject’s information confidentiality and the human subject’s privacy, the assessment and minimizing of the risks involved and the guarantee of the safety for the human subjects, the preparation of the special protection program for the vulnerable human subjects, and so on. According to the bill, Institutional Bioethics Review Board(the same as Institutional Review Board) will be responsible for the auditing and monitoring on the research that was approved by IBRB, conducting the education program for the researchers, IBRB members and administrative staffs, preparing of the special protection program for the vulnerable human subjects, and forming the guidelines for the researchers as well as the review of the research protocols. And the State and local governments shall take necessary measures to support the expending of the social infrastructure. In addition to, IBRB will have to be assessed and to be gained the accreditation by the Korean Ministry of Health and welfare. So, if Bioethics and Safety Law is amended, it will contribute enormously to enhance the level of the human research subjects protection. Also, if this Law is amended, IBRB will play a major role for the conduct of the ethically, scientifically, and legally proper research. But now, as a matter of fact, the capability of IBRB members and IBRB office members is not enough to charge of this role because some people and some organizations does not know the importance of IBRB exactly. In spite of, IBRB shall be able to this role to protect the human subjects and to develop the level of the research On the international level. Therefore, the State, local governments and the Organization shall back up the administrative and financial terms of the IRB and IRB Office.

목차

I. 들어가며
 II. 생명윤리법 전부개정안의 주요 내용 및 의의
  1. 동법 적용 대상 범주의 확대를 통한 연구 신뢰도 수준 향상 및 국제화도모
  2. 기본원칙의 천명을 통하여 연구 분야에서 생명윤리 이념의 실천 강조
  3. 기본법적 위상 정립을 통하여 연구 분야에서 기본적 기준의 통일적 일관적 제공
  4. 국가와 지방자치단체의 책무 강화 등을 통한 사회적 인프라 구축 추진
  5. 기관생명윤리위원회의 역량 강화를 통한 자율적 규제의 활성화 도모
  6. 동의와 심의 관련 기준의 구체화 및 인체유래물은행 등록에 관한 규정마련
 III. 마치며: 생명윤리법 개정안에 따른 향후 과제
 참고문헌
 ABSTRACT

저자

  • 김은애 [ Eun-Ae Kim | 서울아산병원 임상연구심의위원회 사무국 전임간사, 법학박사 ]

참고문헌

자료제공 : 네이버학술정보

간행물 정보

발행기관

  • 발행기관명
    대한의료법학회 [The Korea Society of Law and Medicine]
  • 설립연도
    2000
  • 분야
    사회과학>법학
  • 소개
    대한의료법학회는 “법학계, 법조계, 의료계가 공동하여 의료법학의 학제적 연구와 판례 평석 등을 통하여 전문분야에 있어서의 법률문화 향상에 기여함을 그 목적”으로 하여 1994년 2월에 태동한 이후 1999년 4월 24일에 공식 출범한 이래 2006년 3월 30일 법무부 산하의 사단법인으로 등록된 세계적 수준의 순수 학술단체이다.

간행물

  • 간행물명
    의료법학 [THE KOREAN SOCIETY OF LAW AND MEDICINE]
  • 간기
    반년간
  • ISSN
    1229-8069
  • 수록기간
    2000~2018
  • 등재여부
    KCI 등재
  • 십진분류
    KDC 360 DDC 343.099

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