This Symposium confronts the reality that genetic technologies – not just genetic tests, but tools for altering plant, animal, and human genomes – are rapidly becoming and indeed already are consumer technologies. People can experiment with and apply these technologies in disintermediated formats, potentially without the involvement of national research funding agencies, professional scientists, physicians, genetic counselors, regulators, and traditional medical product manufacturers. The framework of 20th -century medical product and practice regulations assigned each of these parties a role in promoting ethical, safe, and effective biomedical research and health care. Do-it-yourself biotechnology (DIYbio), which includes direct-to-consumer (DTC) and do-it-yourself (DIY) genomic technologies, threatens to disrupt these roles. This raises concerns about how to protect consumer safety, the safety of research participants, and environmental and public safety to the extent these technologies are deployed in uncontained, open-release applications. Some of these concerns relate to the mechanics of regulation – for example, how to stretch existing regulatory principles and authorities to cover novel products and delivery pathways. Yet these technologies also raise questions about the very goals of regulation, forcing us to reexamine first principles such as, “What is the regulatory enterprise trying to accomplish?” This Article touches on both these themes before concluding that some of the gaps in the current regulatory framework for DIYbio are appropriate and ought to be preserved.
Barbara J. Evans, Minding the Gaps in Regulation of Do-it-Yourself Biotechnology, 21 DePaul J. Health Care L. (2020)