Consent Without Data: The Regulatory Gap for Female Commercial Spaceflight Participants Under the FAA’s Informed Consent Regime

Abstract

The expansion of commercial human spaceflight has exposed a regulatory tension that has received less attention than vehicle safety, liability, or the definition of the astronaut. During the statutory learning period established by the Commercial Space Launch Amendments Act of 2004 , the Federal Aviation Administration is substantially constrained from imposing prospective regulations directed specifically at the safety of human occupants during launch and re-entry. The principal federal protection for commercial spaceflight participants is therefore the informed-consent regime in 14 C.F.R. § 460.45. That regime requires disclosure of known hazards, an acknowledgement that unknown hazards exist, disclosure of the vehicle’s safety record, an opportunity to ask questions, and written consent. This article argues that the regime contains a population-specific evidentiary blind spot. The scientific literature concerning female physiology in spaceflight remains limited, and the literature that does exist is concentrated in career-astronaut populations that differ materially from the heterogeneous population of commercial participants. A 2024 systematic review, for example, identified only sixteen qualifying studies of human reproductive health in spaceflight or relevant analogues, of which five included female participants (Gimunová et al., 2024). The problem is not that female participants cannot assess risk or that they should be excluded from flight. It is that a consent regime cannot fully perform its informational function if it permits the absence of population- specific evidence to remain invisible behind a generic disclosure that some hazards are unknown. The article therefore distinguishes four categories that should not be collapsed in regulatory practice: known risk, unknown risk, known uncertainty about risk, and known inadequacy of evidence for a particular population. It then examines the doctrinal relevance and limits of medical informed-consent jurisprudence and human-subject research ethics; compares the United States with the United Kingdom and New Mexico; places the issue within the international responsibility and continuing-supervision framework of Article VI of the Outer Space Treaty; and proposes a two-part regulatory response. First, the FAA should develop a standardised, periodically updated, sex- and age-disaggregated evidence summary for incorporation into commercial consent materials. Second, operators should be required to disclose material evidentiary gaps in specific health categories rather than relying solely on a JLGP JLGP E-ISSN 2579-051X generic unknown-hazards statement. The article concludes that guidance may support implementation only to the extent it interprets existing requirements; where the FAA seeks to create a binding new substantive obligation, notice-and-comment rulemaking and a clear statutory basis would be required. The proposal is therefore framed as the maximum disclosure improvement reasonably supportable within the existing statutory framework, not as an attempt to circumvent the learning-period restrictions.

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