Balancing Progress and Precautions with Emerging Biotechnologies: Evaluating the Process of Gene Therapy Research Becoming "Normal".

In recent years, we have seen an immense expansion in recombinant DNA, especially in its use in gene therapy applications. Throughout its history, the United States set up several mechanisms of national safety and ethical oversight for rDNA to ensure that we proceeded with its use appropriately. As our knowledge and experience with it grew, there has been increasing pressure to decrease the oversight and monitoring requirements for its use. In 2019, the National Institutes of Health amended the NIH Guidelines for Research Involving Recombinant DNA Molecules eliminated three national mechanisms for guidance, monitoring, and review of this biotechnology. Four years later, we revisit these changes and their implications for a current emerging biotechnology: xenotransplantation. By better understanding the motivations for these mechanisms and analyzing the test case, we argue that these changes have worrisome implications for our ethical oversight of emerging biotechnologies both in the realm of gene transfer technologies and beyond.