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American Journal of Bioethics.

Sunset on the RAC: When Is It Time to End Special Oversight of an Emerging Biotechnology?

National Institutes of Health (NIH) Director Francis S. Collins and Food and Drug Administration (FDA) Commissioner Scott Gottlieb recently coauthored a New England Journal of Medicine commentary suggesting that special oversight of gene transfer research in humans was no longer necessary. Their views followed on the 2014 recommendations of an Institute of Medicine (IOM) consensus committee, and are reflected in proposed policy changes recently made available for public comment. If implemented, those changes would mark a significant departure from the more than 40 years of special national safety and ethics oversight of so-called gene therapy research through the Recombinant DNA Advisory Committee (RAC).

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Volume 18, Issue 12
December 2018

Target Articles.

Patenting Foundational Technologies: Lessons From CRISPR and Other Core Biotechnologies Oliver Feeney, Julian Cockbain, Michael Morrison, Lisa Diependaele, Kristof Van Assche & Sigrid Sterckx