Implementation of the Revised Common Rule in the United States and its implications for Human Research in Korea

미국 Common Rule의 주요 개정 내용과 시사점

The U.S. Department of Health and Human Services and fifteen other Federal Departments and Agencies have issued final revisions to the Federal Policy for the Protection of Human Subjects (the Common Rule, 45 CFR 46, Subpart A). The Common Rule was initially promulgated in 1991 and amended in 2005. The Final Rule to update the current regulations was published in the Federal Register on 19 January 2017. The final compliance date of the revised Common Rule including the cooperative research requirement is effective on 20 January 2020 after twice to delay. The revised Common Rule aims to make more effective conduct of minimal risk research reflecting modern research activities and recognize evolving technologies, including mobile technologies, internet, and the growth in computing power. The revisions to the Common Rule were based on a variety of sources of public, stakeholder, and expert comments. The author summarized the key changes and the implications to Korean human research regulations.