Quantum Trials: An FDA for Quantum Technology
By Editor
Stanford, CA, March 12, 2024—In a Stanford Law School working paper titled Quantum Trials: An FDA for Quantum Technology, Alexandra Waldherr, I. Glenn Cohen, and Mauritz Kop propose a phased regulatory framework that borrows its architecture from one of the most successful institutions in modern science policy: the clinical-trials regime overseen by the U.S. Food and Drug Administration. The proposal builds directly on the Ten Principles for Responsible Quantum Innovation that Kop and colleagues developed at Stanford, and it was first presented—in an earlier form—at the Stanford Responsible Quantum Technology Conference in 2024. The paper has been posted as a preprint and circulated as a working paper while the authors invite critique from the physics and legislative communities.
Quantum Trials — an FDA-style phased regime for dual-use quantum technology (illustrative editorial image).
Why borrow the FDA's playbook for quantum?
The authors begin from a now-familiar diagnosis: quantum technology promises high innovational rewards but is "not yet sufficiently guarded by legal and ethical guidelines." Educational barriers remain high, and the risk/benefit curve is still poorly understood. Their move is to look for a regulatory structure that is already globally legible, that maps onto how researchers and industry actually work, and that has a track record of guiding a young, high-stakes field from the laboratory bench to public use. Pharmaceutical regulation, they argue, is exactly such a structure. Since James Lind ran what is often called the first controlled clinical trial aboard ship in the eighteenth century, drug approval has matured into a strictly supervised, phased endeavor coordinated worldwide through the International Council for Harmonisation. The FDA's pipeline—a preclinical stage, three clinical phases (I–III), and a post-approval pharmacovigilance phase (IV)—keeps two values in permanent focus: safety and efficacy.
The paper's central thesis is that this four-phase scaffolding can be translated into an analogous structure for assessing quantum developments, with "efficacy" reread as technical innovation and "safety" reread as the absence of unresolved ethical and legal concerns. The translation is deliberate rather than literal: the authors stress that the pharmaceutical phases are an analogy, an "originator" workflow on which to draw, not a template to be copied verbatim.
The authors frame quantum governance around three core pillars—researchers, who decide which ideas are pursued; regulators, who weave developments into national society; and global consortia, which determine what is ethically permissible for the benefit of humanity. The United States, they observe, leads strongly in the first pillar, with both universities and large private companies dominating quantum information science, but lags—along with much of the world—in the second and third. The existing legal scaffolding is thin: the National Quantum Initiative Act of 2018, a pair of 2022 directives on post-quantum cryptographic risk, and a 2023 executive order on outbound investment screening. The Quantum Trials proposal is offered as a way to thicken that scaffolding without freezing the science in place.
The authors Alexandra Waldherr, I. Glenn Cohen, and Mauritz Kop posing at Stanford RQT 2.0.
First-generation versus second-generation quantum technology
A useful precision in the paper is its insistence on distinguishing first-generation (1G) from second-generation (2G) quantum technology, because the two carry very different risk profiles. A 1G quantum technology is built from hardware that naturally exhibits quantum phenomena—atomic clocks, lasers, MRI scanners—harnessing energy levels preset by nature. A 2G quantum technology, by contrast, actively constructs, manipulates, and tunes quantum states using the tools of quantum information science; the quantum computer, where a quantum algorithm induces change on tailored qubit hardware, is the paradigm case. As development moves from exploiting natural states toward engineering them, both the educational barrier and the risk potential rise. It is precisely 2G quantum technology, the authors argue, that needs a structure adaptive enough to grow with the field yet capable of applying brakes early enough to safeguard societal values. The regime they propose is therefore aimed squarely at 2G developments and the federal agency that might one day market-authorize them.
The four phases of a Quantum Trial
The heart of the framework is a four-phase pipeline, each phase concluding with standardized documentation and feeding a binding, structured registry. In Phase I, a "first-in-quantum" moment—a theoretical idea or a small proof-of-concept experiment under ideal laboratory conditions—is documented in a concise technical one-pager, ideally machine-readable, so that colleagues can replicate or build on it. In Phase II, the technology undergoes a proof-of-principle validation against the true problem class, accompanied by an ethical checklist that carries the project's original intentions forward and flags scenarios to avoid. In Phase III, a strong confirmatory stage, the benefit on real-world devices and problem sets is challenged harshly and the findings are summarized in a Summary of Quantum Characteristics (SmQC)—the quantum analogue of the pharmaceutical Summary of Product Characteristics (the EU's SmPC; the U.S. counterpart is the Prescribing Information)—submitted for regulatory assessment. After a regulatory check grants market access, Phase IV follows the technology's lifecycle: the SmQC is released for public comment, educators feed it into curricula, and regular failure reports plus regulatory audits ensure real-world integration. The four documents—technical one-pager, ethical checklist, SmQC, and failure reports—are the connective tissue that lets a single registry serve regulators, engineers, educators, and the public at once.
SEA TURTLE: a fast checklist for responsible quantum technology
Layered over the phases is a quick-assessment tool the authors call the SEA TURTLE checklist, which can be applied to any Quantum Trial in progress. It distills the Ten Principles and the broader Responsible Quantum Technology paradigm into a memorable, six-point barometer of whether a given technology is both technically innovative and responsibly developed. The "SEA" element names what the authors describe as a "steadfast commitment to Safeguarding, Engaging and Advancing quantum technology, society and humankind," triaging actions by whether they genuinely increase awareness, establish trust, and steer quantum technology toward beneficial societal outcomes from a pro-innovation stance. The tool is designed for triage rather than adjudication: if only the early, technical questions are answered affirmatively, regulatory intervention is not yet pressing; once the later, societal questions remain unanswered as a technology nears real-world use, ethical, educational, and legal discussion becomes urgent.
One piece of low-hanging fruit: register the trials
The authors are candid that standing up an "FDA for Quantum"—they sketch four steps, beginning with making registration binding by law and culminating in a coordinating agency that audits and monitors the database—will require time and significant political capital. But they identify one regulatory first step that could be taken immediately and separately from the rest: mandatory registration of quantum developments. Just as Section 113 of the Food and Drug Administration Modernization Act of 1997 seeded the public database that became clinicaltrials.gov, a legislative act—whether a presidential executive order or a congressional bill—could require quantum developments to be registered in a standardized format, perhaps at a notional quantumtrials.gov. Registration, they argue, gives regulators the data they need to balance underregulation against overregulation, to target funding, and to lower educational barriers for every stakeholder. The longer-term ambition is an agreed ontology of quantum subdisciplines and a set of standard benchmark measurements, developed in concert with the international quantum community rather than imposed on it.
An invitation, not a verdict
What distinguishes Quantum Trials is the modesty of its register. The paper closes by calling on the quantum-physics community to debate the framework's applicability and feasibility, and by inviting legislators to test, adopt, evaluate, and provide feedback. That posture is consistent with the standards-and-evidence logic that runs through the authors' broader work, including the standards-first approach to quantum governance they have argued for in Science, and with the interdisciplinary method the framework first received at Stanford's law-and-biosciences forums. The deeper claim is structural: a young, dual-use, exponentially developing technology is better served by a phased, documentation-driven, evidence-generating pipeline than by either premature prohibition or laissez-faire. Whether the analogy to drug approval ultimately holds is, by the authors' own design, a question they want the field to answer.
This article summarizes a working paper for general information; it is not legal advice. For the framework's authoritative statement, consult the paper itself.
Last updated: June 7, 2026.