美國2017年聯邦人體研究受試者保護政策（Common Rule）改革修正重點與規範啟示

The 2017 Revised Common Rule: Key Amendments and Normative Implications

人體研究及其相關規範隨生物醫學研究蓬勃發展逐漸受到重視。美國衛生及公共服務部雖早於1991年制定「聯邦人體研究受試者保護政策」（以下簡稱「共通規則」）。惟人體研究發展迅速，涉及議題複雜多元，透過法規改革以強化對受研究影響個體之權利保障的重要性與日俱增。因此，2017年所公告之修正版共通規則即調整舊法的相關豁免規定，並提高告知同意規範密度、容許符合法律要件之概括同意、及調整IRB程序運作規定等。本文旨在介紹2017年共通規則之改革修正重點，並基此探討其潛在之規範啟示。

Human studies and related norms have received increasing attention as biomedical research flourishes. Although the US Department of Health and Human Services formulated the “Federal Policy for the Protection of Human Subjects” (also known as “Common Rule”) as early as 1991, human research has developed rapidly, involving complex and diverse issues, highlighting the importance of strengthening the protection of the rights of individuals affected by research through regulatory reforms. Slightly modifying the categories and requirements in relation to exemptions under the old version, 2017 Revised Common Rule strengthens the rules concerning informed consent, allows broad consent under certain legal conditions, and modernizes the IRB forms and processes. This Article therefore endeavors to shed light on the key amendments of the 2017 Revised Common Rule and assess their normative implications.