Cartoon image of a protein attached to a DNA double helix that has been spliced

Regulation of Human Genome Editing in the Dawn of the CRISPR Era

By Scott J. Schweikart

With the advent of CRISPR and the first babies born with edited genomes, gene editing technology is now cheaper and more accurate than it has been. And there is now a verifiable occurrence of heritable genome modification using CRISPR.

As such, human genome editing is naturally (and quite rightly) receiving world-wide attention. Scientists, bioethicists, lawyers, and policy makers are questioning what is the best course of action in the face of this new technology that promises great medicinal benefits, but also poses great and unknown risks.

When analyzing the consequences of genome editing, it is important to note the distinction between somatic genome editing and germline genome editing.

Somatic genome editing is that which is confined to the somatic cells, i.e. cells of the body and not the germline. Germline genome editing (also known as heritable genome editing when the process is done with intent to “generate a new human being” who can then transmit their genes) involves the editing of the germline, i.e. gametes, zygotes and embryos.

One can analyze the risks, benefits, and consequences of genome editing through classical bioethical analysis, weighing the principles of autonomy, non-maleficence, beneficence and justice. Analyzing these principles in the context of genome editing, there are some risks and benefits that come into view. For example, there are known off-target effects, where the technology makes unintended edits in the wrong spot of the genome which may potentially cause clinical injury.

However, there is notable promise of beneficial treatments that could potentially eradicate certain genetic conditions, such as sickle-cell disease. In addition to these notable safety risks and therapeutic benefits, there may be consequences that stem from whether or not the gene editing is solely therapeutic in nature or if it is designed to be an enhancement. These consequences are of gene edits done as ideally intended (i.e., as designed and without errors and without injury to the patient) but that also produce negative effects that are more societal rather than clinical, e.g. concerns about social justice in how some populations may benefit from genetic “enhancements”, furthering social classism and inequity.

Considering these risks and benefits, an approach to how best regulate this technology is necessary in order to effectuate safe and ethical outcomes in society. A national regulatory framework, guided by federal government regulatory agencies (like the FDA and the NIH), is appropriate for both somatic and germline gene editing. As with other clinical therapies and biomedical research, there is a need to establish and monitor the safety, efficacy, and ethical nature of gene editing treatments and research; federal agencies appropriately play a role in this endeavor.

However, while many of the same consequences, risks, and benefits are shared between somatic versus germline editing, there is a clear distinction between the two that shapes consequences and risk. The key difference between somatic and germline editing with regards to ethical consequences is that somatic editing is generally confined to an individual, while germline editing has potential to be heritable, thus passing genetic modifications to future generations.

Hence, a different regulatory approach must be applied to each type of gene editing, in order to best effectuate the most ethical and safe outcome. The changes to the germline are changes that can cross borders and affect the entire human population. Indeed, modifications to the genome generationally can ultimately shape human evolution and therefore have world-wide impact. Evolutionary changes, substantial in their own right, are then coupled with the enormous risk of gene editing technology. As noted above, there are risks inherently associated with genome editing and the true scope of the risks are unknown. Combining such risks of unknown magnitude with potential consequences of high magnitude and world-wide impact (e.g., human evolutionary change) requires, in the ideal sense, a global regulatory approach. This approach should be cautionary.

A possible temporary moratorium on clinical heritable genome editing has recently been voiced by experts; such a cautionary approach is prudent.

Considering the complicated nature of world politics, a true global regulatory framework is unlikely to ever be achieved. Rather, it is an idealistic goal responding to the ethical demands of germline editing.  However, recognizing such an ideal is important, as it may guide stake-holders in their individual countries to take a more cautionary approach to germline genome editing within their own national regulatory agencies.

The more jurisdictions that adopt a cautionary approach to their own regulations for genome editing (particularly heritable genome editing) the more likely negative world-wide consequences can be mitigated.


This post is part of a digital symposium hosted by Bill of Health in conjunction with the Petrie-Flom Center’s 2019 Annual Conference, “Consuming Genetics: Ethical and Legal Considerations of New Technologies.”

Read the rest of the symposium!



Scott J. Schweikart, JD, MBE is a Senior Research Associate at the American Medical Association (AMA) in Chicago, where he works for the AMA’s Council on Ethical and Judicial Affairs (CEJA), the body charged with writing and updating the AMA Code of Medical Ethics.

Mr. Schweikart provides research support for CEJA’s work, by contributing detailed research analysis, written policy reports, and analytical memoranda. Mr. Schweikart is also the Legal Editor of the AMA Journal of Ethics, where he writes articles related to law and bioethics and where he edits legally oriented journal submissions. Mr. Schweikart has research interests in health law, health policy, and legal aspects of bioethics. He earned his Master of Bioethics (MBE) from the University of Pennsylvania, his JD from Case Western Reserve University, and his BA from Washington University in St. Louis.


The Petrie-Flom Center Staff

The Petrie-Flom Center staff often posts updates, announcements, and guests posts on behalf of others.

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