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Public acceptance of gene therapy for serious diseases now exceeds 90 per cent, yet advances in CRISPR-Cas9 and other genetic engineering tools have intensified debates about human enhancement, equitable access and long-term societal impact. This article provides an authoritative overview of ethical issues in genetic engineering and therapy, mapping foundational bioethical principles, distinctions between germline and somatic interventions, the designer-baby debate, public engagement dynamics, equity challenges, global governance and applications beyond humans. Readers will gain clear definitions, mechanisms, risks and benefits, supported by comparative tables and structured lists, to inform policy, research and public discourse on this rapidly evolving field.
Genetic engineering and gene therapy raise core bioethical duties by defining how interventions promote welfare, avoid harm and respect individual rights. Beneficence ensures that editing techniques enhance health outcomes, non-maleficence guards against unintended genetic damage, autonomy secures informed decision-making by patients or research participants and justice demands fair distribution of emerging technologies. These four principles guide clinicians, regulators and researchers in evaluating the moral permissibility of interventions and in shaping consent protocols that support responsible innovation.
Below are the foundational bioethical principles as applied to gene editing:
By clarifying these duties, stakeholders can assess new therapies—and this framework leads naturally into the specific ethical distinctions between germline and somatic editing.
Germline editing targets reproductive cells—sperm, eggs or embryos—producing heritable changes, whereas somatic therapy modifies only non-reproductive cells in the treated individual. Germline interventions carry profound consequences for future generations and trigger debates over irreversible alterations to the human gene pool. Somatic therapy, by contrast, focuses on diagnosed patients and avoids transgenerational risks, which makes it ethically more acceptable for treating monogenic disorders.
Below is a comparison of germline versus somatic gene editing:
ApplicationScope of ChangeEthical ImplicationGermline Gene EditingReproductive cellsRaises concerns about consent from future generationsSomatic Gene TherapyNon-reproductive cellsFocuses on individual benefit, limiting heritable change
This distinction underscores why many regulators permit somatic treatments while prohibiting clinical use of germline editing, and it also frames the debate on designer-baby technologies.
The pursuit of "designer babies" through genetic engineering raises significant ethical questions about human enhancement and the potential for societal stratification.
Designer Babies: Ethical and Social Implications of Genetic Engineering
This article highlights the ethical considerations involved in the use of CRISPR-Cas9, preimplantation genetic diagnosis (PGD), and in vitro fertilisation (IVF) in the pursuit of designer babies, and the potential for this to become a commonplace practice.
Designer Babies: Revealing the ethical and social implications of genetic engineering in human embryos, S Sanjay, 2023
Designer-baby interventions would allow parents to select or enhance non-medical traits—height, intelligence or appearance—raising fears of commodifying human life and creating genetic underclasses. Such enhancements echo eugenic practices by favouring particular genotypes, potentially exacerbating social inequality and reducing genetic diversity. Moreover, genetic privacy concerns intensify when personal genomic data become part of enhancement protocols, exposing individuals to discrimination or data misuse.
Key moral questions include:
Addressing these issues requires balancing innovation with social responsibility and anticipating the impact on human identity and community cohesion.
Public perception shapes policy and research priorities by reflecting collective values and risk tolerance. Media framing of CRISPR breakthroughs can either heighten hope for cures or fuel fear of “playing God.” Effective engagement—through citizen assemblies, community workshops and transparent consultation—fosters informed consensus and mitigates polarisation. Educational initiatives that explain mechanisms, potential benefits and hazards help citizens evaluate trade-offs and support evidence-based regulation.
Common engagement methods include:
When communities are empowered with clear information, regulators can design policies that reflect societal values rather than expert-only decisions.
Gene therapies often cost millions per patient, making them accessible only to wealthy individuals or well-funded health systems. High research and manufacturing expenses create barriers for insurers and national health services, threatening to widen health disparities between countries and socioeconomic groups. In low- and middle-income regions, limited infrastructure and regulatory capacity further impede clinical trials and approved treatments.
Primary access challenges comprise:
Overcoming these obstacles demands innovative financing models, tiered pricing and international collaboration to ensure justice in distribution.
States and transnational bodies have developed diverse frameworks to govern gene editing. Some countries maintain outright bans on germline editing, while others permit it only under strict research licences. International organisations—such as the World Health Organization, UNESCO and the National Academies of Sciences, Engineering, and Medicine—issue guidelines that aim to harmonise standards and advise on oversight mechanisms.
Key regulatory bodies and their roles:
OrganisationFocus AreaInfluenceWorld Health Organization (WHO)Global health ethicsDevelops frameworks for safe researchUNESCO International Bioethics CommitteeEthical standardsAdvises UN member states on normative rulesNational Academies of Sciences, Engineering, MedicineScience policy and guidancePublishes consensus reports on gene editing
These instruments guide national legislation and foster shared norms, yet divergent legal regimes highlight the challenge of achieving global policy coherence.
The revolutionary nature of CRISPR/Cas9 technology has brought forth a new wave of ethical considerations, particularly concerning its application to the human germline.
CRISPR/Cas9 Genome Editing: Ethical Issues and Societal Impact
The practice of CRISPR/Cas9 germline editing and its ethical implications, considering current social, ethical, and legal considerations surrounding the potential to alter the human germline.
CRISPR/Cas9 genome editing–new and old ethical issues arising from a revolutionary technology, 2016
Gene drives use CRISPR-based constructs to spread genetic changes rapidly through wild populations, promising control of invasive species or disease vectors. However, they risk unintended ecosystem disruption and irreversible species alterations. Robust risk assessment and reversible drive designs are essential to uphold ecological integrity.
Crops engineered for pest resistance or yield improvement can benefit food security but may threaten biodiversity and local farming practices. Containment failures, cross-pollination and corporate seed monopolies pose justice and environmental sustainability concerns.
Exploring these environmental dimensions underscores that ethical scrutiny must extend beyond human health to the planet’s ecological systems.
The application of genomic editing techniques like CRISPR-Cas9 presents a complex landscape of ethical challenges, encompassing safety, the scope of intervention, therapeutic goals, and equitable access.
Ethics and Genomic Editing with CRISPR-Cas9: Challenges and Conflicts
The principal issues can be categorised into four areas: efficacy and safety; the types of cells that can be targeted by the technique (somatic, embryonic, and gametes); the objective of the therapy; and accessibility and equity.
Ethics and genomic editing using the crispr-cas9 technique: challenges and conflicts, M Esquerda, 2022
The main concerns include unintended off-target mutations, exacerbating social inequities through unequal access, the moral boundary between therapy and enhancement, and the permanence of germline alterations without consent from future generations.
Germline changes are heritable, potentially affecting the human gene pool forever and raising consent issues for descendants, whereas somatic editing confines effects to treated individuals.
Designer-baby scenarios generate fears of eugenics, reinforce socioeconomic divides, compromise human diversity and challenge notions of parental responsibility and child autonomy.
Innovative approaches—such as outcome-based pricing, public-private partnerships and tiered licensing—are under discussion to reduce costs and expand global availability of life-saving treatments.
Gene editing and therapy stand at a crossroads of human health, social justice and environmental stewardship. As CRISPR-based advances accelerate, responsible frameworks grounded in beneficence, non-maleficence, autonomy and justice will shape whether these technologies deliver inclusive benefits or deepen divisions. Continuous public engagement, equitable financing and harmonised governance remain essential to navigate the ethical frontiers of genetic innovation and secure a future where scientific promise aligns with shared human values.
