Gene Editing: Ethics and Governance Vardit Ravitsky, PhD

Gene Editing: Ethics and Governance Vardit Ravitsky, PhD

Gene Editing: Ethics and Governance Vardit Ravitsky, PhD Bioethics Program University of Montreal Institute for Science, Society and Policy Ottawa September 28, 2016 Hype

Polarized debate: benefits may be overstated risks are presented as immense TED talk by Jennifer Doudna: We can now edit our DNA but lets do it wisely Some basic distinctions Gene editing in plants / animals v. humans focus on humans

Somatic v. germline cells implications for individual v. future generations consent of research participant / patient v. inability to get consent from those we create Treatment v. enhancement enhancement raises a host ethical /social concerns

of Some basic distinctions Pre-clinical v. clinical research how to decide when ready to start clinical trials? Research in embryos that will not be implanted non-viable embryos: conducted in China already healthy embryos: first trial approved Feb 2016 in the UK

Research on reproductive use global consensus that we are not ready need more data on effectiveness and safety need more ethical reflection Chronology of international events March 2015: Society for Stem Cell Research moratorium on clinical application in human germline April 2015: Chinese researchers report editing nonviable

human embryos; results reveal serious obstacles for clinical applications April 2015: NIH statement will not fund any use of geneediting in human embryos June 2015: US Congress holds a hearing to review the science & ethical implications; to explore how to build a responsible framework Chronology of international events Sep 2015: The Hinxton Group (a global network of researchers, bioethicists, and policy experts)

issues consensus Statement: research with human embryos is essential to gain basic understanding of biology and germ cells and should be permitted but the technology is not sufficiently developed to consider human genome editing for clinical reproductive purposes at this time Chronology of international events

December 2015: International Summit on Human Gene Editing in DC exploring the scientific, ethical, and policy issues associated with human gene editing research February 2016: first approval of study in viable human embryos in the UK April 2016: second Chinese team publishes results of using CRISPR to introduce HIV-resistance mutation into embryos safety issues remain

DC Summit: key points Clinical use in somatic cells: Many of the most promising applications concern somatic cells editing out mutations that cause sickle-cell anemia in blood cells gene editing to improve the ability of immune cells to target cancer Existing and evolving regulatory frameworks can

appropriately evaluate this use DC Summit: key points Clinical use in the germline raises issues: inaccurate or incomplete editing difficulty predicting harmful effects obligation to consider implications for individual & future generations once changes are introduced into the population, they would be difficult to remove

genetic enhancements to subsets of the population could exacerbate inequities or be used coercively ethical considerations in purposefully altering human evolution DC Summit: key points Bottom line: It would be irresponsible to proceed with any clinical use of germline editing unless and until safety and efficacy issues have been resolved

Need broad societal consensus Need appropriate regulatory oversight DC Summit: key points Going forward: create ongoing international forum that engages a wide range of perspectives establish international norms concerning acceptable uses of human germline editing in order to discourage unacceptable activities while

advancing human health and welfare Whats at stake for Canada? Assisted Human Reproduction Act (2004): criminal prohibition on germline modification 5 (1) No person shall knowingly () (f) alter the genome of a cell of a human being or in vitro embryo such that the alteration is capable of being transmitted to descendants;

Whats at stake for Canada? Should Canada fund research on gene editing in non-viable embryos? Should the federal Act be modified to allow research on viable embryos and potentially - some day - clinical use? to ensure Canadians access to cutting edge treatments to promote Canadas competitiveness on the international scene

Whats at stake for Canada? Should Canadian regulators address bio-hacking and DIY gene-editing occurring outside of research institutes? Thank you!

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