The Next Generation’s Genes

“Heritable genome editing” refers to changing human reproductive cells so that the resulting fetus has genetic changes that its future offspring may inherit. 

Proponents of heritable gene-editing champion the possibility of “editing out” incurable heritable diseases, but others caution that gene editing may have unintended effects. For example, an edit to prevent a child from inheriting a disease might also reduce that child’s immunity to other diseases, a concern that is amplified by the fact that any changes to immunity would be heritable.

The debate is no longer theoretical. Shortly after reports of the first live births of gene-edited babies surfaced in 2018, a number of prominent scientists called for a ban on any further experimentation that would result in live births, at least until regulatory schemes were put in place.

This week’s Saturday Seminar explores scholarly works on current and proposed regulatory approaches to heritable gene-editing, as well as the unique challenges to effective regulation given factors like the medical tourism industry.

• Looking ahead to a world where scientific advancements may change the makeup of humanity’s gene pool, a group of scientists argues for a worldwide moratorium on heritable gene-editing. In their recent Nature comment, Eric Lander and his coauthors envision a temporary ban that would enable nations to think more carefully about how to regulate heritable gene-editing—or whether to make it permanent. The authors suggest that each participating nation should permit human gene-editing only after providing public notice, consulting the international community, evaluating proposed programs transparently, and establishing “broad societal consensus” for any such program.
• In an article for The New England Journal of Medicine, R. Alta Charo of the University of Wisconsin Law School argues that a moratorium on heritable gene-editing will not stop rogue actors. Instead, Charo advocates for a comprehensive regulatory approach. An “ecosystem” of public and private entities—such as government agencies, patent holders, funders, and ethics oversight boards—would control dangerous and unethical germline editing more effectively than a formal ban, Charo argues. 
• In a recent paper in The CRISPR Journal, Kerry L. Macintosh of the Santa Clara University School of Law reviews potential challenges for enforcing a moratorium on heritable gene-editing. Macintosh asserts that, just as people travel abroad to access assisted reproductive technologies that are unavailable to them at home, so too will people in countries with moratoriums on heritable genome editing travel abroad to access these technologies—regardless of whether they are safe. Because Macintosh thinks that heritable gene-editing is desirable from a health care perspective, Macintosh asserts that nations should carefully regulate it for safety and efficacy rather than banning it entirely.
• Writing for JAMA: The Journal of American Medical Association, researchers Richard O. Hynes, Barry S. Coller, and Matthew Porteus explore recommendations from the U.S. National Academies of Sciences and Medicine (Academies) on the application and oversight of heritable gene-editing. Hynes argues that rapid scientific advancement in heritable gene-editing creates a need to balance the potential benefits to human health with a range of ethical considerations, and that the Academies’s guidelines strike this balance for basic research, clinical disease, and germline cells.
• In an article for the Cambridge Quarterly of Healthcare Ethics, Giulia Cavaliere and her coauthors advocate for an “enlightened democracy approach” to regulating heritable gene-editing technologies. Under Cavaliere’s approach, both democractic process and expertise would meaningfully contribute to policy making. Cavaliere argues that it is especially important to involve the public in regulating heritable gene-editing because of “deep and persistent disagreement about substantive ethical questions” underlying the practice.
• In an essay for The Regulatory Review, authors from Stanford University and the University of Pennsylvania propose a regulatory framework for CRISPR germline editing therapies in light of Chinese researcher He Jiankui’s clinical trial that resulted in the birth of gene-edited twins. According to the authors, He’s research violated four principles set out in the framework, including adequate oversight and informed consent. Without such safeguards, the authors argue that researchers may damage “the public’s trust in researchers and clinicians to act in the best interest of their trial subjects and patients.”