Abstract
Gene therapy represents a transformative biomedical advancement that intervenes at the genetic level, treating or even curing disease at its root. It holds remarkable potential for patients with rare and degenerative chronic conditions such as spinal muscular atrophy. However, despite its technical promise, gene therapy development faces persistent challenges in safety, trust, accessibility, and public legitimacy.
This project investigates the question: How do sociotechnical networks shape the development and legitimacy of gene therapy? Drawing on Actor-Network Theory (ANT), the project examines how gene therapy is more than a scientific innovation; it is a product of negotiations among technologies, institutions, cultural narratives, and ethical values. To address a specific technical gap revealed by this framework, we propose the design and development of a digital risk assessment dashboard that systematically integrates stakeholder and actor concerns into the gene therapy pipeline.
Case Background and Research Context
Although gene therapy continues to advance in terms of scientific capability, particularly with the development of CRISPR-based editing and novel vector systems, it faces recurring obstacles in achieving stable social legitimacy. For instance, the 1999 death of Jesse Gelsinger in a gene therapy trial revealed profound gaps in informed consent and regulatory oversight. More recently, companies such as Bluebird Bio have suspended trials or withdrawn products due to safety concerns and lack of public confidence, despite achieving early-stage clinical milestones (Mast, 2024; Reuters, 2024).
These examples indicate that gene therapy's trajectory cannot be fully understood through technical metrics alone. The technology is shaped by interacting systems of regulation, ethics, history, religion, psychology, and media representation. This research seeks to reframe our understanding of gene therapy by analyzing how these diverse actors come together to shape the ethical boundaries and public legitimacy of the technology.
Research Focus and Theoretical Framework
The guiding question of this project is: How do sociotechnical networks shape the perceived legitimacy of gene therapy? Actor-Network Theory (ANT) provides a useful analytical framework for investigating this question. ANT, developed by scholars such as Bruno Latour (1996), establishes that technological systems are composed of a variety of actors, including humans, institutions, texts, artifacts, and norms, whose relations determine the functioning and meaning of the system.
A central concept in ANT is translation, the process through which actors negotiate roles, stabilize meanings, and align their interests. In the context of gene therapy, translation occurs when regulatory bodies, researchers, patients, ethical guidelines, and cultural narratives converge, or fail to converge, on how the therapy should be defined, controlled, and valued. This project will explore how moments of controversy, failure, or suspension (e.g., Gelsinger’s case or Bluebird’s market withdrawal) reveal disruptions in these translation processes and expose the fragility of the actor-network.
Methods and Sources
This project will use qualitative textual analysis to investigate how gene therapy is shaped by its surrounding sociotechnical networks. The research draws on a variety of sources to build a multi-layered account of how legitimacy and ethics are built. Scientific and medical publications will provide the technical backdrop, helping to contextualize the claims made about gene therapy’s innovation and efficacy. These sources will be examined not simply for their clinical content, but for how they present gene therapy as a breakthrough or as a risky frontier.
In parallel, the project will engage with historical texts that trace legacies of eugenics and social engineering, which continue to influence how the public and regulatory bodies interpret genetic intervention. Regulatory documents such as the Belmont Report and the Declaration of Helsinki will be analyzed as non-human actors within the actor-network, shaping what counts as ethical practice in biomedical development.
Media narratives from outlets like Stat News and The New York Times will offer insight into the cultural storytelling that surrounds moments of controversy or crisis, such as the Jesse Gelsinger trial or Bluebird Bio’s market withdrawal. These narratives will be utilized not only for content but also for tone, framing, and the inclusion or exclusion of actors.
Theoretical guidance will come from foundational ANT texts, which will inform how actors are identified and how translation, stabilization, and breakdown are interpreted. Finally, personal experience with FSHD will serve as a situated lens, grounding the analysis in the patient’s perspective and illustrating how technologies are experienced differently depending on one’s position within the network.
Conclusion
This project reconsiders gene therapy not as a neutral medical advance, but as a sociotechnical construct whose legitimacy emerges through networks of negotiation. By applying Actor-Network Theory, the project offers a deeper understanding of how gene therapy becomes ethical within society. Rather than prescribing specific actions or reforms, the research contributes a theoretical account of how legitimacy, identity, and power are distributed among the many actors involved in high-stakes biomedical innovation. It aims to inform future STS works by clarifying the processes through which biomedical technologies are socially constructed, stabilized, and sometimes unraveled.
