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Sunset on the RAC: When Is It Time to End Special Oversight of an Emerging Biotechnology?
Jeffrey P. Kahn & Anna C. Mastroianni

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...

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Target Article

Facial Feminization Surgery: The Ethics of Gatekeeping in Transgender Health
Alex Dubov & Liana Fraenkel

The lack of access to gender-affirming surgery represents a significant unmet health care need within the transgender community, frequently resulting in depression and self-destructive behavior. While some transgender people may have access to gender reassignment surgery (GRS), an overwhelming majority cannot afford facial feminization surgery (FFS). The former may be covered as a “medical neces...

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

In 2012, a new and promising gene manipulation technique, CRISPR-Cas9, was announced that seems likely to be a foundational technique in health care and agriculture. However, patents have been granted. As with other technological developments, there are concerns of social justice regarding inequalities in access. Given the technologies’ “foundational” nature and societal impact, it is vital ...

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