Ethics and Governance Analysis of Final Revisions to the Common Rule

The Obama Administration’s recent revision of the Federal Policy for the Protection of Human Subjects, known as the Common Rule, raises the questions of how we, as a society, should best translate ethical principles into law and whether law is the ideal vehicle for pursuing ethical outcomes in the case of human subjects research.   

GW Milken Institute School of Public Health Health Policy and Management Teaching Associate Professor Melissa Goldstein published an article exploring these questions, in addition to issues concerning respect for human dignity in the use of biospecimens for research and the current meaning of identifiability, in the Fall 2017 edition of the Journal of Law, Medicine and EthicsNotably, the revised Rule does not address the dignity issues inherent in the use of nonidentified biospecimens in research without participant notice or consent (such as in the case of Henrietta Lacks, whose tissues were harvested from a tumor biopsy without her consent in 1951 and later used to establish the widely used “HeLa” cell line). 

The article, “Revising the Common Rule: Ethics, Scientific Advancement, and Public Policy in Conflict,” can be found here.