인간대상연구에 있어서 기관생명윤리위원회의 역할에 관한 한국과 미국의 규제법 비교

Abstract

Bioethics and Safety Act and Common Rule have some provisions that are both similar and different aspects on the scope of human subjects research, waiver of IRB review, informed consent form, oral consent, waiver of consent, waiver of written consent, required elements for informed consent, authority of IRB, types of IRB review, membership, operation and function, evaluation and certification system, relatioship between institute and IRB, etc. Also, both law and regulation have big difference in that Bioethics and Safety Act applies to all the human subjects research regardless of who pay the research money and Common Rule only applies to the federal government funded research. Nevertheless, both law and regulation have the same goal in that they try to protect the rights·safety·welfare of human research subjects through IRB. In order to protect both human research subjects and investigators at the same time based on this same goal and by the adequate and proper review of the varying protoctols in the future, I suggest some solutions to establish and manage IRB successfully such as the need to understand the goal of IRB, the recognition of independence of IRB from the head of the institute, the need to retain qualified members and to educate them, the administrative and financial support for assisting IRB affairs, to provide sufficient incentives and protections to the members, to establish the proper standards for selecting chair person and members etc.