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
(CSLAA), the Federal Aviation Administration (FAA) 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
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.