Illustrative image for Moratorium on Human Genome Editing Time to Get It Right

Bioethics Forum Essay

Moratorium on Human Genome Editing: Time to Get It Right

On March 13, Nature published a call for a global moratorium on heritable human genome editing signed by several prominent CRISPR researchers and bioethicists, including Eric Lander, Françoise Baylis, and Emmanuelle Charpentier. They proposed a temporary moratorium on germline genome editing to create gene-edited children. This moratorium is not designed to stop in vitro research in the laboratory or research on somatic (nonreproductive) cells, but it would cover the implantation of gene-edited embryos or the creation of children using gene-edited sperm or eggs. The authors specifically cite safety, scientific, technical, medical, and ethical/moral/societal reasons for calling the moratorium. Importantly, it is supported by the National Institutes of Health in the United States and the European Society for Human Reproduction and Embryology (ESHRE).

Although some criticism, notably from CRISPR pioneer Jennifer Doudna (who did not sign the moratorium statement), has focused on the possibility of a moratorium “of indefinite length,” this argument is somewhat of a straw man as the proposed moratorium is temporary. Doudna has also criticized a moratorium as being something that will suppress open discussion and transparency. In our view (and likely that of the Nature authors), this is not the case. A moratorium will allow time for open discussion, broad societal consensus-building (which may not happen if germline genome editing is pushed quickly into clinical trials), and the creation of international and national governing bodies to help ensure transparency and proper regulation.

We find it curious that the WHO expert advisory committee on developing global standards for governance and oversight of human genome editing has also avoided using the word moratorium. When asked about it at a press conference, the codirector of the committee responded, “I don’t think a vague moratorium is the answer to what needs to be done.” Vague is not a word that characterizes the proposed moratorium (in fact, it’s quite specific in its requests) and it seems to perpetuate the misunderstanding that the moratorium would not have a defined length.

A particularly interesting unanswered question is why some people are resistant to using the word moratorium, even when they would admit that there is an “effective moratorium” imposed by self-regulation in science. However, pushing against moratoria is a regular occurrence regarding genome editing. For example, in 2015 Harvard psychology professor Steven Pinker, a proponent of “more gas” and “less brake” in relation to CRISPR gene editing, was quoted in an interview with Paul Knoepfler as saying that a “moratorium would only reinforce the pernicious aura of dread that surrounds genomic modifications.” He went on to discuss the death of Jesse Gelsinger and the subsequent moratorium in 2003 on gene therapy trials by the Food and Drug Administration. Pinker also said that he was “skeptical that we’ll ever see genetic enhancement of babies—the outcome that the prohibitionists and moratoristas dread and that many bioethicists blithely assume is inevitable.”

Some have considered the Chinese scientist He Jiankui’s gene editing of babies, Lulu and Nana, to be enhancement because of unknown effects of the edited gene in the brain and because the question of whether HIV resistance is an enhancement occupies a grey zone. In this regard, it only took three years to prove Pinker wrong and perhaps a bit naïve. It now seems clear that in the face of the current culture surrounding frontier science, the fast-paced progress in CRISPR gene editing may continue to outpace even the most alarmist of bioethicists.

The proposed moratorium on heritable human genome editing would be a big step in the right direction by allowing for Slow CRISPR Science. This would allow for further safety and efficacy studies to take place in the laboratory before pushing forward into clinical trials. The moratorium call is careful not to prohibit these activities, which will be vital to address concerns, especially those of safety such as off-target effects of gene-editing techniques and the long-term consequences of modifying human genes.

The ethical and societal concerns raised by this technology – such as reaching broad societal consensus – are another matter. The creation of an appropriate forum for having these discussions is a necessary step to ensure a broad conversation. The primary considerations when building a public forum for these discussions will be ensuring an accessible – for lay audiences – focus on the scientific and technical issues, as well as the societal and ethical issues while meaningfully including the public.

An article in the journal Science by the people behind Editing Nature disapprovingly notes that “most frameworks for regulatory decision-making continue to largely preference science-based knowledge and technical risk assessments.” This kind of organizing, like the Asilomar conference on recombinant DNA Technologies held in 1975, has been considered misguided by some because it leaves out policy-makers, ethicists, philosophers, and the public while focusing heavily on scientific voices.

In practice, participatory processes can be effective and helpful for ensuring that a community feels involved in decisions that directly affect them. Public participation seeks to engage the people who will be affected by a decision and involve them in the decision-making process with the goal that their input will impact the final action taken. At its heart are three key aspects: the pragmatic, the political, and the epistemic. It is pragmatic because is purported to lead to more valuable outcomes and “increase the usefulness of the knowledge that is created.” It is political because it builds public trust, accountability, and transparency for the decision-making process. Finally, it is epistemic because it ultimately produces more complete knowledge; public participation “aims to enhance the validity of the produced knowledge.” This kind of process could allow for broad public input on the issue of human germline genome editing.

Consider the work being done by by Kevin Esvelt on Nantucket and Martha’s Vineyard. Esvelt is working on a CRISPR implementation of gene drive that would modify white-footed mice to be resistant to the bacterium that causes Lyme disease. In this way, ticks would not pick up the bacterium from the mice and pass it on to humans. Importantly, Esvelt immediately contacted and started working with the local governments and communities to determine if they were interested in attempting this, and he has respected their decisions thus far. He has even helped develop a local governance framework, in the form of a steering committee, to help organize these conversations and give deciding power to the communities.

Esvelt’s process allows for enhancing public trust, as well as accountability and transparency, regarding the decision to move forward with his field testing of gene-editing technology. Esvelt’s work will lay some foundational building blocks for how we might explore achieving broad societal consensus on whether to continue with human germline genome editing and if so, how we ought to do it.

Public participation is likely the only way we can ensure that the decisions made are those that are in the public interest and for the common good, and that they represent the will of the people of any given society. Although opinions on whether to continue with germline genome editing will vary, as will the reasons for these opinions, we believe there is a moral imperative to ensure that the public, the owners of the human genome, are included in this conversation. Ultimately, a moratorium on editing in the human germline allows us time to get this right.

Landon J. Getz is a PhD candidate in microbiology and immunology at Dalhousie University in Canada, @LandonGetz. Graham Dellaire is director of research and a professor of pathology at Dalhousie University, @DocDellaire


45% of The Hastings Center’s work is supported by individual donors like you. Support our work.
Read More Like This
  1. If one looks at the various conditions laid out in the call for a moratorium, they are almost the same — indeed, not quite as complete or rigorous — as those laid out in the 2017 NAS/NAM report or those laid out in the statement from the organizers of the Hong Kong genome editing summit. So the question becomes — what is gained by calling something a moratorium, when in fact it is merely a restatement of a set of conditions already laid out by others?

    1. My question would be: What is gained by NOT calling it a moratorium? Indeed, A temporary pause/stop on germ-line genome editing clinical trials (which most people will agree is what needs to happen at this time, if only for safety/technical reasons) is the same whether or not we call it a moratorium. However, I think being on certain terms (that it is absolutely irresponsible to continue with germ-line genome editing in humans at this time) is vitally important to preventing further “rogue” action, and I think using the word moratorium is required to achieve this level of certainty.
      I would contest the idea that the moratorium call, and the 2017 NAS/NAM report and the Hong Kong summit actually are calling for the same thing. The moratorium call is quite clear that the authors have not decided whether or not we should continue with germ-line genome editing in humans at all (which is a decision left up to individual nations). However the 2018 Summit calls for a “translational pathway” and the 2017 NAS/NAM report lays out rules for how we might “direct the use of genome editing” for both somatic and germ-line interventions. This difference – in whether or not we should continue with these interventions – is a significant one.

    2. In my view Landon is correct that neither the 2017 NAS/NAM report nor the most recent HK genome meeting statement were at all the same as the type of temporary moratoriums some of us have called for in the last few months (e.g. see my call in early December 2018 here:
      I also do not see substantive risk associated with an explicitly temporary moratorium only on implantation of gene-edited/genetically modified embryos. For instance, it should have no effect on in vitro CRISPR work on human embryos or on somatic therapy development.
      On the positive side, a temporary moratorium, while not perfect, is a much stronger deterrent and sends a much clearer “don’t do this” message to the wider community.
      A moratorium can also be coupled to ongoing efforts toward societal consensus, which even if not fully achievable can have beneficial outcomes.

      1. One kind of moratorium currently being discussed recognizes that broadly inclusive public deliberations are needed to address the question of WHETHER we should set out to engineer the genes and traits of future generations. Another variety, which apparently dares not speak its name, assumes that the only open question is HOW germline modification should be carried out, and allows for public comment about the details and around the edges.

        Many people – along with a good number of civil society organizations, biotech companies, and nations – have concluded that heritable genome editing would be unsafe, meet no compelling medical need, and pose unacceptably dangerous societal risks. (See, for example, “Civil society statement to the organizers of the Second International Summit on Human Genome Editing,” which the Center for Genetics and Society co-organized: .)

        At the same time, we are committed to a democratic resolution of this high-stakes question. The time afforded by a real moratorium will help ensure that the deliberative process we need is based on a shared accurate understanding of what’s in question and what’s at stake, and that it gives meaningful say to a full range of perspectives and voices.

  2. Given that a “moratorium” is defined as a “temporary prohibition” and given that there is essentially unanimous agreement that clinical germline genome editing should not be used at present, what’s the problem with calling the current state of affairs by its correct name: a moratorium? We should not be squeamish about using the “M-word.”
    The question is not whether we should have a moratorium: we have one, whether or not we use the noun. The important place to focus is on the processes—especially the appropriate international governance framework—by which we might weigh possible applications.

Leave a Reply

Your email address will not be published. Required fields are marked *