Chinese scientists used CRISPR to edit human embryos, controversy erupted
over the implications of such research.38 Worries were expressed about how
to involve the public.
39 How do we monitor and gauge risks? What current
regulatory regimes can tackle the technology review process? Some critics
were concerned that relying on research self-regulation might not be ideal,
since scientists do not necessarily represent society’s interests, and their own
ambition and links to commercialization of the technology may make them
suspect decision makers.
40 Researchers have a conflict of interest with regard
to proper levels of risk assessment. Can CRISPR research in human embryos
be a slippery slope tempting researchers to engage in unsafe, unethical or
non-medical uses of the technique? 41 Such research offers huge rewards in
research prestige and commercial profitability, fueling possible unsafe
II. CRISPR RISKS
CRISPR presents at least three broad areas of regulatory concern about
risks: off-target effects; gene drives and biosecurity; and human germline
research and “humanness.”
A. Off-Target Effects.
The CRISPR-Cas9 gene editing technique works like scissors.
Cas9 inserts a protein taken from DNA into the target cell to make cuts near
the gene defect that the scientist wants to alter. A properly functioning gene
segment is then inserted at that point44 The cutting however may be
imprecise and therefore unpredictable, cutting other genes.
45 The risk is then
that the function of a gene might be changed, making the cell cancerous, for
38. David Cyranoski & Sara Reardon, Embryo Editing Sparks Debate, 520 NATURE 593,
39. See Heidari et al., supra note 9, at 7 (stating that accurate public knowledge, which is
difficult to disseminate, is required before democratic legislation can result); see also generally
CRISPR Democracy, supra note 29.
40. Heidari et al., supra note 9, at 7 (stating that because scientists are not elected, they
do not necessarily represent society’s values); see also generally CRISPR Democracy, supra
41. See Ledford, supra note 1, at 21 (stating that because of CRISPR’s accessibility and
low cost, researchers must be careful in deciding how to use its power).
42. Hank Greely, Of Science, CRISPR-Cas9, and Asilomar, STAN. L. SCH.: L. & BIOSCI.
BLOG (Apr. 4, 2015), https://law.stanford.edu/2015/04/04/of-science-crispr-cas9-and-
43. Patrick Skerrett, Experts Debate: Are We Playing With Fire When We Edit Human
Genes?, STAT (Nov. 17, 2015), https://www.statnews.com/2015/11/17/gene-editing-embryo-