Finding a Regulatory Balance for Genetic Biohacking

“Biohacking” has emerged as a cultural and scientific phenomenon. Although there is no consensus on the precise definition of “biohacking,” the term generally describes biological investigations and interventions that are conducted outside of typical scientific settings by individuals who may not have traditional scientific training. Easier access to biological information and resources has enabled biohacking to flourish. Its participants often describe their activities as motivated by a belief in a right to “do science,” a high value placed on bodily autonomy, and a view that traditional scientific institutions and regulations have systematically failed to benefit society. At the same time, the November 2018 announcement that a scientist in China used CRISPR to genetically modify viable human embryos — allegedly resulting in the birth of the first “CRISPR babies” — has reinvigorated concerns about the distribution of genetic technologies. For genetic biohacking, these concerns may be heightened by a belief that mechanisms to regulate the activity are absent or inadequate to address its risks. But, as this chapter details, genetic biohacking is likely subject to numerous oversight mechanisms, both public and private. Before calling for additional regulations, these extant mechanisms should be evaluated.Ope

23andMe, the Food and Drug Administration, and the Future of Genetic Testing

On November 22, 2013, the US Food and Drug Administration (FDA) effectively halted health-related direct-to-consumer genetic testing in the United States by sending a warning letter to 23andMe, the leading company in the field, directing it to stop providing such testing. The FDA acted as the era of widespread, clinical use of DNA sequencing rapidly approaches. The agency’s action will contribute to changes in which genetic tests are offered to patients and how testing is provided.Ope

The Rise of the Ethical License

The Broad Institute's recent licensing of its gene editing patent portfolio demonstrates how licenses can be used to restrict controversial applications of emerging technologies while society deliberates their implications.Ope

The Changing Life Science Patent Landscape

What have we learned from 20 tumultuous years of patent law in the life sciences? Is patenting likely to be as important for the industry in the future?Ope

Ethical, legal, and social issues in the Earth BioGenome Project

The Earth BioGenome Project (EBP) is an audacious endeavor to obtain whole-genome sequences of representatives from all eukaryotic species on Earth. In addition to the project’s technical and organizational challenges, it also faces complicated ethical, legal, and social issues. This paper, from members of the EBP’s Ethical, Legal, and Social Issues (ELSI) Committee, catalogs these ELSI concerns arising from EBP. These include legal issues, such as sample collection and permitting; the applicability of international treaties, such as the Convention on Biological Diversity and the Nagoya Protocol; intellectual property; sample accessioning; and biosecurity and ethical issues, such as sampling from the territories of Indigenous peoples and local communities, the protection of endangered species, and cross-border collections, among several others. We also comment on the intersection of digital sequence information and data rights. More broadly, this list of ethical, legal, and social issues for large-scale genomic sequencing projects may be useful in the consideration of ethical frameworks for future projects. While we do not—and cannot—provide simple, overarching solutions for all the issues raised here, we conclude our perspective by beginning to chart a path forward for EBP’s work

Voices of biotech leaders

Nature Biotechnology asks a selection of leaders from across biotech to look at the future of the sector and make some predictions for the coming years

Voices of biotech leaders

Nature Biotechnology asks a selection of leaders from across biotech to look at the future of the sector and make some predictions for the coming years.</p

Publisher Correction:Voices of biotech leaders (Nature Biotechnology, (2021), 39, 6, (654-660), 10.1038/s41587-021-00941-4)

In the version of this article initially published, an author name was given as Abasi Ene Abong. The correct name is Abasi Ene-Obong. Also, the affiliation for Sebastian Giwa was given as Elevian, Pagliuca Harvard Life Lab, Allston, MA, USA. The correct affiliations are Biostasis Research Institute, Berkeley, CA, USA; Sylvatica Biotech, North Charleston, SC, USA; and Humanity Bio, Kensington, CA, USA. An affiliation for Jeantine Lunshof was given as Department of Genetics, Harvard Medical School, Boston, MA, USA. The correct affiliation is Wyss Institute for Biological Engineering, Harvard University, Boston, MA, USA. The errors have been corrected in the PDF and HTML versions of the article

The Earth BioGenome Project 2020: Starting the clock

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