54:4 Common Courtesy: How the New Common Rule Strengthens Human Subject Protections

Abstract

Medical science and research depend on human subject testing. In the United States, the Federal Policy for the Protection of Human Subjects, colloquially known as the “Common Rule,” is the regulation ensuring the protection and dignity of all human subjects. Whether the participants are answering questionnaires or testing prescriptions, the Common Rule describes the ethical requirements of testing on human subjects. Initially promulgated in 1991, the Common Rule has remained mostly unchanged, despite the vast changes in human subject research. As technology changes, the current regulations are failing to provide adequate protection to research participants. In response, the Department of Health and Human Services published an Advanced Notice of Public Rule Making in the Federal Register in 2011. Four years later, on September 8, 2015, HHS published a Notice of Proposed Rule Making in the Federal Register. On January 19, 2017, the final rule for the Federal Policy for the Protection of Human Subjects was announced.
This Comment analyzes the relationship between the NPRM and the Final Rule regarding three specific protections of the Common Rule regulations proposed in the NPRM: (1) the additions to the informed consent documents; (2) the evolving role of the Internal Review Board’s obligations and procedures; and (3) the treatment of secondary biospecimens. Further, this Comment addresses the history of human testing, the current Common Rule, the proposed changes, and the implications of the Final Rule. In doing so, this Comment analyzes submitted public comments to the Notice of Proposed Rule Making and how the Final Rule incorporates, or fails to incorporate, these provisions. The Final Rule shows that despite the failure to incorporate every aspect of the proposed rule, the changes to the Common Rule will promote human subject dignity and autonomy without jeopardizing crucial, and much-needed, research.