Exploring the urgent need for public engagement in human heritable genome editing policies and governance frameworks
In November 2018, the scientific world was rocked by an announcement that sounded like science fiction. Chinese scientist He Jiankui revealed that he had used CRISPR technology to edit the genes of human embryos, resulting in the birth of twin girls—the first "gene-edited" babies in history. The global response was immediate and intense. CRISPR pioneer Jennifer Doudna described being "horrified," while NIH director Francis Collins called the experiments "profoundly disturbing." Nobel laureate David Baltimore labeled it "a failure of self-regulation by the scientific community" 1 .
This dramatic event thrust an obscure scientific debate into the international spotlight, raising urgent questions that extend far beyond laboratory walls: Who should decide how powerful genetic technologies are used? What role should the public play in shaping policies that could alter the human species? As we stand at the precipice of unprecedented control over our genetic destiny, the conversation about heritable human genome editing (HHGE) has become too important to leave to scientists and politicians alone.
The scientific community universally condemned the unauthorized experiment, highlighting the lack of proper oversight and ethical considerations.
The case prompted fundamental questions about governance, public participation, and the future direction of genetic research.
To understand the high stakes of this debate, we must first grasp the revolutionary technology at its center. Genome editing—often called "gene editing"—is a group of technologies that give scientists the ability to change an organism's DNA. Among these tools, CRISPR-Cas9 has generated particular excitement because it's faster, cheaper, more accurate, and more efficient than previous methods 6 .
The CRISPR system was originally adapted from a naturally occurring defense mechanism in bacteria. When infected by viruses, bacteria capture small pieces of viral DNA and insert them into their own DNA in a pattern called CRISPR arrays. These arrays allow bacteria to "remember" the viruses. If the same viruses attack again, the bacteria produce RNA segments that recognize and attach to the viral DNA, then use the Cas9 enzyme to cut the DNA apart, disabling the virus 6 .
Researchers create a guide RNA that matches the target DNA sequence.
The guide RNA binds to the Cas9 enzyme, forming a complex.
The complex locates and binds to the target DNA sequence.
Cas9 cuts both strands of the DNA at the target location.
The cell's repair machinery fixes the break, allowing for gene modification.
Not all genome editing applications raise the same ethical questions. This distinction is crucial:
Targets non-reproductive cells, meaning changes affect only the individual and are not passed to future generations. This approach is already being used in clinical trials for conditions like sickle cell disease, HIV, and certain cancers 6 . In 2025, we're seeing approved CRISPR-based medicines like Casgevy for sickle cell disease and ongoing trials for heart disease and liver conditions 2 .
The debate around heritable genome editing extends far beyond technical questions of what we can do into ethical territories of what we should do. Many concerns "are rooted in deeply held moral, religious, or ideological beliefs that science alone cannot address" 1 . These include:
When scientific developments have such broad societal implications, inclusive governance becomes essential. As the World Health Organization emphasizes, aligning "the research and policy agenda" with "public values, experiences, interests and priorities" is crucial for responsible stewardship of these powerful technologies 5 .
There's an important distinction between merely educating the public and truly engaging with diverse perspectives:
Involves one-way communication, such as lectures or educational materials. While valuable for sharing information, it doesn't constitute genuine engagement 1 .
Requires multi-way communication or dialogue among scientists, stakeholders, and the public. It involves "listening and synthesizing outside information, perspectives, and thoughts in the process of developing recommendations or policy" 1 .
| Rationale | Explanation | Key Supporting Organizations |
|---|---|---|
| Democratic Governance | Policies affecting society should reflect public values, not just expert opinions | WHO, Nuffield Council on Bioethics |
| Social License | Public trust is essential for scientific progress and acceptance of new technologies | National Academies of Science |
| Identifying Concerns | Public input reveals ethical concerns experts might overlook | Various public engagement studies |
| Policy Implementation | Policies addressing public concerns are more likely to be successfully implemented | National Academies of Science |
Meaningful engagement requires recognizing different groups with distinct perspectives:
"Interested or affected parties" who often have organized perspectives. In HHGE, this includes scientists, patients and their advocates, disability rights groups, research funders, and those with strong ethical or religious views about genetic modification 1 .
A comprehensive analysis of public engagement efforts from 2012-2023 reveals substantial gaps between the ideal of inclusive engagement and current practices. Researchers identified 3,464 articles on public engagement with human germline gene editing, ultimately analyzing 31 distinct engagement studies 5 .
The findings reveal three critical limitations in current approaches:
| Shortcoming | Findings | Consequences |
|---|---|---|
| Limited Inclusion | 74% of studies engaged only general public; specific underrepresented groups were rarely included | Perspectives of indigenous peoples, minority ethnic groups, and specific patient groups are missing |
| Superficial Data Collection | Focus on measuring acceptance levels rather than understanding underlying values | Inability to align research with deeply held public values |
| Limited Impact Pathways | Few studies specified how public input would influence actual policy decisions | Disconnection between engagement activities and governance outcomes |
The review found that most studies gathered opinions through surveys or focus groups rather than creating opportunities for meaningful dialogue and reflection. This approach tends to capture superficial attitudes rather than the deeply held values that should guide long-term policy 5 .
Additionally, specific strategies to include traditionally underrepresented groups—such as indigenous peoples, minority ethnic groups, or specific faith communities—were rarely implemented. As the WHO notes, without these deliberate efforts, the development of "societally aligned governance of HGGE will be threatened" 5 .
Just as the scientific community grapples with the ethics of editing single genes for hereditary diseases, a new frontier is rapidly approaching: heritable polygenic editing (HPE). This involves editing multiple genes simultaneously to influence complex conditions like heart disease, diabetes, Alzheimer's, and mental health disorders 9 .
Recent analysis suggests that editing a relatively small number of genomic variants could dramatically reduce susceptibility to common diseases. For example, editing just ten variants associated with Alzheimer's disease could theoretically reduce lifetime risk from 5% to under 0.6%. Similar dramatic reductions appear possible for schizophrenia, coronary artery disease, and type 2 diabetes 9 .
Polygenic editing raises even more complex ethical questions than single-gene editing:
Theoretically positive individual benefits could dramatically deepen health inequalities if only available to the wealthy 9 .
Many gene variants affect multiple traits—a variant that reduces depression risk might also decrease creativity or empathy 9 .
Widespread editing could reduce human genetic diversity with unpredictable consequences 9 .
Unlike current embryo selection techniques, which are limited by the genetic diversity of the embryos parents naturally produce, HPE could theoretically create combinations of traits not present in the parental genes 9 .
These emerging capabilities make public engagement increasingly urgent. As the technology evolves from abstract possibility to concrete capability, the window for meaningful public influence on governance frameworks is narrowing.
| Reagent Type | Function | Examples & Applications |
|---|---|---|
| CRISPR Guide RNAs | Molecular "address labels" that direct Cas9 to specific DNA sequences | Synthetic or expressed formats; predesigned for guaranteed editing 7 |
| Cas9 Nuclease | The "molecular scissors" that cuts DNA at targeted locations | Available as protein or mRNA for DNA-free editing workflows 7 |
| Delivery Vehicles | Methods to transport editing components into cells | Lipid nanoparticles (LNPs), viral vectors, electroporation 2 3 |
| Edit-R Controls | Reference materials to validate editing efficiency | Proper controls to ensure system optimization 7 |
| HDR Templates | DNA templates for precise genetic modifications | Synthetic single-strand DNA oligonucleotides for specific gene corrections 7 |
Guide RNAs enable precise targeting of specific DNA sequences with high accuracy.
Cas9 enzyme acts as molecular scissors to cut DNA at precise locations.
Advanced delivery systems transport editing components into cells effectively.
Based on a critical review of engagement literature, researchers have identified five ideals that should guide public and stakeholder engagement efforts for emerging technologies like HHGE 1 :
Deliberate inclusion of diverse perspectives, especially traditionally underrepresented groups
Creating spaces for reflection and informed discussion, not just opinion sampling
Clear communication about how public input will influence decisions
Specific plans for incorporating public perspectives into governance
Treating engagement as an ongoing process, not a one-time event
Some recent initiatives point toward more meaningful approaches:
The WHO's global, multi-disciplinary Expert Advisory Committee has consulted widely to develop governance frameworks for human genome editing, recognizing the need for both national and transnational oversight 4 .
Innovative methods like citizens' assemblies that bring diverse community members together for extended learning and deliberation show promise for capturing the depth of public values rather than superficial opinions.
Deliberative polling that combines expert information with extended discussion can help reveal informed public preferences rather than initial reactions.
As one analysis concludes, "co-created efforts are needed to engage underrepresented groups as well as to yield values rather than acceptance levels, and to concretise how engagement might result in societal impact" 5 .
The debate over heritable human genome editing represents more than a technical policy discussion—it's a conversation about what kind of future we want to create together. The decisions we make today about how to govern these powerful technologies will ripple across generations.
The challenge before us is not merely to invent smarter regulations but to create more inclusive conversations. It requires moving beyond tokenistic consultations to genuine partnerships between scientists, policymakers, and diverse public voices. As the past decade of research shows, we have often fallen short of this ideal, but the path forward is becoming clearer.
In the end, the most important question may not be whether we can edit the human germline, but whether we can develop the democratic wisdom to guide these technologies toward broadly beneficial ends. Our genetic future is too important to be left to any single group—it must be shaped by all of us together.
The development of governance structures for emerging technologies requires balancing scientific innovation, ethical considerations, and public values—a challenge that demands ongoing dialogue across all sectors of society.