Since 1991, the Federal Policy for the Protection of Human Subjects, known as the "Common Rule," has protected the identifiable private information of human subjects who participate in federally funded research initiatives. Although the research landscape has drastically changed since 1991, the Common Rule has remained mostly unchanged since its promulgation. In an effort to modernize the Common Rule, the Federal Policy for the Protection of Human Subjects Final Rule ("Final Rule') was published on January 19, 2017. The Final Rule, however, decreases human-subject protections by increasing access to identifiable data with limited administrative oversight. Accordingly, the Final Rule demands reconsideration. This Note conducts a comparative analysis of the Final Rule and the Health Insurance Portability and Accountability Act Standards for Privacy of Individually Identifiable Health Information ("Privacy Rule'). Ultimately, this Note argues that a revised Final Rule should incorporate a modified version of the Privacy Rule that in turn provides human subjects with legally enforceable rights, remedies, and control over how information about them is used.
Common Sense: Rethinking the New Common Rule's Week Protections for Human Subjects,
71 Vanderbilt Law Review
Available at: https://scholarship.law.vanderbilt.edu/vlr/vol71/iss5/7