Who decides acceptable risks in human gene editing?

Deciding which risks in human gene editing are acceptable is not a single technical judgment but a layered social process that combines scientific evidence, regulatory frameworks, ethical review, and public values. Risk assessment begins in laboratories and clinics where researchers characterize safety and efficacy, but judgments about acceptability require institutions that translate evidence into rules and social commitments.

Expert and regulatory roles
Scientific bodies evaluate technical risks. The National Academies of Sciences, Engineering, and Medicine recommends rigorous preclinical research, transparent reporting, and independent oversight before any clinical applications proceed, and it urges broad societal deliberation before heritable germline interventions move toward practice. The World Health Organization has convened expert advisory groups and proposed a global registry and governance mechanisms to coordinate oversight across borders and to discourage premature clinical use of germline editing until safety, effectiveness, and ethical concerns are addressed. Individual scientists also shape norms: Jennifer Doudna, University of California, Berkeley, has publicly urged international governance and restraint, arguing that technical possibility does not by itself justify clinical deployment.

Ethics committees and professional societies translate scientific risk into policy. Institutional review boards, national regulators and professional licensing bodies weigh potential clinical benefits against harms, equity, and consent. Legal frameworks vary by country, producing different thresholds for acceptable risk. The widely condemned case of researcher He Jiankui, who announced edited embryos leading to live births, demonstrated how unilateral action outside accepted regulatory processes can provoke legal sanctions and reinforce calls for stronger oversight.

Public values and cultural contexts
Acceptable risk is also a cultural and political judgment. Bioethicists such as Françoise Baylis, Dalhousie University, emphasize that communities must consider broader social consequences including justice, reproductive autonomy, and the risk of exacerbating inequalities. Public engagement exercises organized by researchers and institutions reveal divergent priorities: some communities prioritize therapeutic benefits for serious inherited disease, while others highlight concerns about eugenic uses, stigma, or altering future generations without their consent. Indigenous and marginalized populations may view gene editing through histories of medical exploitation and territorial sovereignty, insisting that consent processes and benefit-sharing account for cultural values and collective rights.

Consequences and territorial implications
How societies resolve acceptable risk has practical consequences. Permissive regimes can spur medical innovation but also create cross-border “research tourism” and regulatory arbitrage that shift harms onto vulnerable populations. Strict bans can limit access to potentially life-saving therapies and drive research underground. Environmental and intergenerational concerns complicate assessments: heritable edits carry potential impacts that extend beyond individuals to families, communities, and future citizens. International coordination can reduce destructive competition and promote shared standards, but such coordination must respect national sovereignty and cultural diversity.

Ultimately, acceptable risk in human gene editing is determined through interaction among scientists, regulators, ethicists, and the public, mediated by institutions with the authority to enforce rules. Trustworthy governance requires transparent evidence generation, inclusive deliberation, and mechanisms that make decisions accountable to those most affected.