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Common Sense: Rethinking the New Common Rule’s Weak Protections for Human Subjects

Posted by on Friday, October 19, 2018 in Notes, Volume 71, Volume 71, Number 5.


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.

Ahsin Azim