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M

assive public and private investment in scientific research has 

enabled the commercial spaceflight industry to expand opportunities in space beyond primarily 

government-sponsored missions 

(1). Commercial companies endeavor to fly 

thousands of commercial spaceflight participants (cSFPs) and workers to space in 

the decades ahead (2). Although the future 

of safe commercial spaceflight depends on 

rigorous and inclusive research, the ethical 

conduct of such research is complicated by 

scientific uncertainty, high attendant risks 

(3), and poorly defined rules for research 

ethics oversight within the commercial 

spaceflight industry. Now is the opportune 

time to develop clear rules for ethical cSFP 

SPACEFLIGHT

Ethically cleared to launch?

Rules are needed for human research in commercial spaceflight 

INSIGHTS

POLICY FORUM

By Vasiliki Rahimzadeh1, Jennifer Fogarty2, Timothy Caulfield3, Serena Auñón-Chancellor4, Pascal Borry5, Jessica Candia6, I. Glenn Cohen7, 

Marisa Covington8, Holly Fernandez Lynch9, Henry T. Greely10, Michelle Hanlon11, James Hatt12, Lucie Low13, Jerry Menikoff14, Eric M. Meslin15, 

Steven Platts16, Vardit Ravitsky17,18, Tara Ruttley19, Rachael D. Seidler20,21, Jeremy Sugarman22, Emmanuel Urquieta2 , Michael A. Williams23,24, 

Paul Root Wolpe25, Dorit Donoviel2, Amy L. McGuire1

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research while space activities are ramping 

up and the regulatory environment for commercial spaceflight is actively being shaped. 

We propose an ethical framework based on 

terrestrial human research that is anchored 

in four guiding principles—social responsibility, scientific excellence, proportionality, 

and global stewardship—and is applicable 

to the responsible conduct of research in 

commercial spaceflight.

Well-established norms, policies, and 

national regulations guide the ethical conduct of most traditional research involving 

humans on Earth. There is also consensus 

on ethical principles guiding research with 

government astronauts (4). However, there 

are no clear frameworks that govern privately funded research with civilians on 

commercial space vehicles. Existing research ethics safeguards may not apply because of gaps in how research regulations 

govern private industry, and international 

space research must contend with interjurisdictional issues. Many of the regulatory and ethics challenges we identify for 

commercial spaceflight research are amplified by the rare opportunity cSFPs have 

to travel to space and the outsized social 

value that only they can provide through 

research participation (see the box). 

The emerging commercial spaceflight 

sector will have global impact, but the 

United States currently leads the world in 

overall spending on space programs, including investment in developing the commercial arm of spaceflight. We therefore 

highlight ethical tensions posed by the regulatory vacuum for responsible research 

conduct, primarily in the United States. 

For example, the US Federal Aviation 

Administration (FAA) moratorium on occupant safety regulations aboard commercial space vehicles is set to sunset in 

October 2023 (5). The FAA is working to 

encourage the development of industry 

consensus standards and revise the US 

government’s human spaceflight safety 

practices (6), and has established an aerospace rule-making committee to garner industry input on a new safety framework. 

Meanwhile, the Biden administration confirmed that the United States will decommission the International Space Station 

as soon as 2030, which effectively ends 

decades of collaboration on the only microgravity research platform shared with 

other spacefaring nations. International 

agreements, including the Outer Space 

Treaty (OST)—signed and ratified by 112 

countries—are silent on whether principles 

for peaceful human space exploration apply to human research sponsored by commercial firms (7), and diverse research 

partners and complex funding and sponsorship relationships can lead to redundancies in the science and provide insufficient oversight. 

Gaps in policy intended to protect cSFP 

health and safety in commercial spaceflight research threaten the industry, hamstring scientific collaboration between 

public and private partners, and limit the 

translation of research benefits to society. 

To foster research safety and utility, our 

primary objectives are twofold: (i) create 

an expectation that commercial spaceflight 

companies provide the infrastructure and 

resources necessary to engage in highquality human research, and (ii) inform 

approaches to safe and effective commercial spaceflight research by advocating for 

robust ethical principles and standards that 

reflect consensus among diverse stakeholders and account for the distinct research 

environments to which future cSFPs will 

be exposed. 

GUIDING PRINCIPLES

Social responsibility 

Most commercial flights currently depend 

on cofunding from the government and 

private sources. Additionally, commercial 

spaceflight services are only possible now 

because of substantial public investment in 

past research. Therefore, the public has an 

important role in helping to shape the commercial interests of companies, and data 

that builds on initial public investments 

in spaceflight research should be treated 

as community resources. What we learn in 

the early years of commercial spaceflight 

will be critical for ensuring the safety of future missions, and research with cSFPs has 

the potential to improve human health not 

only in space but also on Earth (8). Thus, 

early cSFPs arguably have a heightened social responsibility to help advance research 

to build the evidence base. 

Appealing to principles of social responsibility differs from preexisting ethical 

frameworks that give primacy to autonomy 

because it explicitly calls on those privileged to have the opportunity to travel into 

space to contribute to research activities 

that benefit society at large. 

Scientifi c excellence

Poorly designed, duplicative, and low-priority studies beget poor-quality data. They 

cloud the evidence base, endanger participants, and waste resources. Bad science 

is also bad for business. It can misguide 

strategy, permit inefficiency, and expose 

organizations to liability. By adhering to 

standards of excellence, those who sponsor and conduct research in commercial 

spaceflight show by example how rigorous 

science drives successful business practice. 

Proportionality

Spaceflight research, like all research that 

involves humans, is only permissible if it 

maximizes social value and minimizes the 

likelihood and severity of harms to participants, crew members, and other personnel. Spaceflight is a high-risk activity, and 

research procedures that pose minimal 

risks on Earth could pose substantially 

increased risk when performed in space. 

The add-on risks of research participation 

should therefore be evaluated against the 

baseline risks of spaceflight, minimized to 

the extent possible, and proportionately 

balanced in relation to the anticipated benefits to the individual cSFP and to society.

Global stewardship

The benefits of human space exploration 

and its resources should be enjoyed by all 

(7). Spaceflight research should therefore 

engage, and be conducted by, individuals 

and communities representative of humankind’s diversity. We draw on stewardship principles and concepts advanced in 

space governance (9), the environmental 

sciences, and natural resource fields to 

inform how we might fairly distribute the 

knowledge benefits of commercial spaceflight research. We emphasize responsible 

use of time, data, and natural resources in 

ways that take full and balanced account of 

the interests of society, future generations, 

and other species, as well as of private interests to advance the science of safe human space exploration (10).

NEW APPLICATIONS OF 

EXISTING POLICIES AND PRACTICES

Free and informed consent

If we take seriously the principle of social 

responsibility, we might condition commercial spaceflight on informed research 

participation focused on improving human 

health or safety, at least in the early years. 

Although all astronauts are thoroughly 

briefed on research protocols and voluntarily consent to participate, many view 

their participation as an occupational responsibility to support longitudinal health 

surveillance that benefits future crew. Privately funded cSFPs may not be motivated 

by the same occupational responsibility 

but rather could be moved to participate in 

minimally invasive or minimal risk studies 

under the principle of social responsibility. 

To compel cSFP participation in research as a condition of spaceflight in 

the commercial context could undermine 

The SpaceX Falcon 9 rocket with the Crew Dragon 

spacecraft lifts off from the Kennedy Space Center 

in Cape Canaveral, Florida, on 21 May 2023.

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the business interests of privately funded 

companies, including their ability to attract future customers. It could also violate cSFP autonomy by providing an excessive benefit that challenges voluntariness. 

Travel to space can present an opportunity 

so compelling that cSFPs could opt in to 

risky research not customarily tolerated 

on Earth without appropriate safeguards. 

Furthermore, some cSFPs are employees of 

commercial space companies, and conditioning employment on research participation is generally impermissible. 

All prospective cSFPs should be fully 

informed about the social value of any 

proposed research protocols and be encouraged to participate. Incentivizing participation may be justified, so long as the 

incentive is calibrated with the risks and 

does not create undue inducement (11). 

Commercial companies may give preference to those cSFPs willing to participate 

in research, but further ethical attention 

is needed to determine whether cSFPs 

should remain flight eligible even if they 

decline research participation.

Maximizing benefi ts to society

The social value of research increases 

proportionately to the usefulness of new 

knowledge gained. Well-annotated datasets—including information about the 

flight protocol, operational endpoints, and 

adverse events—should be of sufficient scientific quality to substantiate social value. 

Those who conduct research in space 

should share these data to ensure findability, accessibility, interoperability, and 

reusability for the scientific community 

and society well into the future. Indeed, 

private companies must commit to openly 

sharing scientific data if they are operating 

on behalf of a signatory to the 2020 Artemis Accords (10), which includes Australia, Canada, Italy, Japan, Luxembourg, the 

United Arab Emirates, the United Kingdom, and the United States.

Minimizing risks

Known physiological effects of spaceflight 

stem from research principally performed 

with government astronauts and other 

highly trained personnel who cleared 

stringent medical tests before flight. Prospective cSFPs may not undergo the same 

tests, and commercial companies indeed 

plan to fly cSFPs with preexisting health 

conditions (such as cancer) and physical 

disabilities (for example, the European 

Space Agency parastronaut program). The 

attendant risks of cSFP research participation are expected to compound as a result. 

This is particularly true for cSFPs with less 

experience managing adverse events that 

affect fellow crew or responding to operational emergencies during spaceflight. 

Missions that enable quick and safe return 

to Earth could thus be prioritized for crews 

composed mostly of cSFPs without prior 

spaceflight experience. Competent adults 

ought nevertheless to be able to assume 

risks for the advancement of knowledge 

and betterment of society. 

cSFPs may participate in multiple studies, each with their own set of risks and 

safeguards against adverse events. Future 

planned studies are likely to reflect different types of research (ranging from noninvasive, to minimally invasive, to invasive), 

with a broad spectrum of risk potential. 

Companies, principal investigators, and 

ethics committees therefore need to consider the portfolio of risks for cSFPs individually, as well as in the aggregate (3). 

Different risk thresholds may be justifiable 

for different crew members. Companies 

may, for example, limit a crew medical officer or commander from participating in 

research that could lead to impairment or 

incapacitation because their role is essential to the safety and welfare of the entire 

crew. 

To further substantiate spaceflight 

safety and enhance informed consent for 

prospective cSFPs, a formal system for 

reporting adverse events should be developed like what is required of pharmaceutical drug companies. Such a system should 

be focused on adverse events related to 

research involving cSFPs, separate from 

adverse events from operational failures or 

crew error.

Data protections and governance

Some instances of research data sharing 

can be in tension with the proprietary interests of commercial companies or their 

customers. The commercial spaceflight 

industry would benefit from direct engagement with regulators to develop and 

Ongoing cSFP research related to spaceflight-associated 

neuro-ocular syndrome (SANS). 

SANS is associated with long-duration spaceflight and is thought to be the result of 

increased intracranial pressure (ICP). Symptoms include optic disc edema, changes 

in near vision, and possible reductions in cognitive functions that could compromise 

mission-critical tasks (15). Nearly 70% of NASA astronauts develop some degree of SANS, 

underscoring the need to identify its pathophysiologic mechanisms and find effective 

countermeasures. Commercial companies have a vested interest in management and prevention of SANS and support cSFP participation in studies of the issue. The most accurate 

method for measuring ICP—inserting a probe directly into the brain or cerebral ventricles—

is too risky for spaceflight. Investigators developed a less risky method: a catheter surgically implanted in the lumbar cerebral spinal fluid space and attached to a subcutaneous 

telemetric ICP sensor that would enable ICP readings before, during, and after flight. After 

NASA concluded that the risks of the modified implant on long-duration missions were 

also too high, this approach was pursued by the Translational Research Institute for Space 

Health and a competitively selected experienced research team in coordination with a 

commercial spaceflight company to include a healthy cSFP in this study (https://taskbook.

nasaprs.com/tbp/index.cfm?action=public_query_taskbook_content&TASKID=15266).

1Center for Medical Ethics and Health Policy, Baylor College of Medicine, Houston, TX, USA. 2Translational Research Institute for Space Health, Baylor College of Medicine, Houston, TX, 

USA. 3Faculty of Law and School of Public Health, University of Alberta, Edmonton, AB, Canada. 4Louisiana State University Health Science Center Baton Rouge Campus, Baton Rouge, 

LA, USA. 5Centre for Biomedical Ethics and Law, Department of Public Health and Primary Care, KU Leuven, Leuven, Belgium. 6Component Office of Human Research Protections, Air 

Force Medical Readiness Agency, Department of the Air Force, Falls Church, VA, USA. 7The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, 

Cambridge, MA, USA. 8Office of Research Assurance, Office of the Chief Health and Medical Officer, National Aeronautics and Space Administration, Houston, TX, USA. 9Department of 

Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA. 10The Center for Law and the Biosciences, Stanford University, Stanford, 

CA, USA. 11Center for Air and Space Law, University of Mississippi, Oxford, MS, USA. 12Space Policy Division, Office of Commercial Space Transportation, Federal Aviation Administration, 

Washington, DC, USA. 13Axiom Space, Houston, TX, USA. 14Centre for Biomedical Ethics, National University of Singapore, Republic of Singapore. 15Council of Canadian Academies, 

Ottawa, ON, Canada. 16Human Research Program, NASA Johnson Space Center, Houston, TX, USA. 17School of Public Health, University of Montreal, Montreal, Canada. 18Harvard Medical 

School, Boston, MA, USA. 19Orbital Reef, Blue Origin, Washington, DC, USA. 20Department of Applied Physiology and Kinesiology, University of Florida, Gainesville, FL, USA. 21Department 

of Neurology, University of Florida, Gainesville, FL, USA. 22Berman Institute of Bioethics and Department of Medicine, Johns Hopkins University, Baltimore, MD, USA. 23Department of 

Neurology, University of Washington School of Medicine, Seattle, WA, USA. 24Department of Neurological Surgery, University of Washington School of Medicine, Seattle, WA, USA. 25Center 

for Ethics, Emory University, Atlanta, GA, USA. Email: amcguire@bcm.edu

INSIGHTS | POLICY FORUM

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implement methods to share data for research purposes without compromising 

intellectual property. An industry-wide 

database should be created to securely 

store and manage controlled access to relevant study data for research purposes [for 

example, (12)]. Robust data governance 

mechanisms—including penalties or sanctions to hold users accountable for data 

misuse—should be developed simultaneously with data infrastructures and should 

reflect the interests of contributors as well 

as downstream users of the data.

Similar data types may be collected to 

monitor cSFPs’ health and welfare while 

in space and later repurposed for space 

health research (13), with appropriate consent. Privacy and confidentiality of these 

data rely heavily on the ability to deidentify them. However, the small sample size 

per mission and extensive data linkages 

needed to support robust data analyses 

means that cSFP privacy could be compromised even for minimal risk studies (14). 

Limits to data privacy should be disclosed 

to cSFPs at the time of consent, and prospective cSFPs should demonstrate that 

they fully comprehend the realistic risks 

that research data could be attributed to 

individual cSFPs and other privacy-related 

consequences of participation.

EXTENSION OF EXISTING POLICIES 

AND PRACTICES

Setting research priorities 

Research investigating the effects of spaceflight on cSFPs can be expensive, risky, and 

difficult to reproduce because opportunities are rare, and only a select few cSFPs 

can be accommodated on space vehicles. 

Such extreme resource constraints have 

both practical and ethical consequences 

for setting research priorities, which places 

a premium on prioritizing scientifically 

rigorous studies that add the most social 

value, address questions about which there 

is genuine uncertainty, and can only be 

carried out in space as opposed to an Earth 

analog. 

There may also be competing priorities 

for commercial spaceflight companies and 

sponsors of research in terms of what scientific questions to ask and where to invest research dollars. Those who conduct 

commercial spaceflight research should 

develop a transparent research agenda 

that meaningfully incorporates input from 

diverse stakeholders, including the public, 

scientists, regulators, funding agencies, 

and other industry partners. To avoid redundancy and increase scientific impact, 

research sponsors should consolidate 

studies that ask similar scientific questions or call for participation from cSFPs 

with similar health and demographic profiles whenever possible. This will require 

collaboration within a competitive space 

and sharing data for the public good as 

gestures of responsible stewardship, while 

protecting trade secrets to stimulate commercial investment.

Scientifi c and ethics review

Independent ethics review of research involving humans in space is expected, as it 

is on Earth. Although federally funded research is legally required to obtain ethics 

review, research funded entirely by private 

organizations is not. Legal authorities can 

also be unclear for research that involves 

cSFPs funded through multinational space 

agency collaborations, in which each 

agency maintains their own requirements. 

Research that involves cSFPs should nevertheless undergo independent ethics review 

that is free of any real or perceived investigator conflict of interest even if not strictly 

required by law because it is a longstanding ethical obligation that predates many 

legal requirements. 

Given the specialized research focus, 

many research ethics committees will not 

have the necessary expertise to conduct 

quality, comprehensive reviews of spaceflight research. A specialty body could 

be named, external experts could be consulted, or membership on ethics committees could be expanded to include human 

spaceflight experts. 

Promoting diversity of cSFPs and 

researchers

cSFPs have not so far been representative of 

society in terms of gender, age, genetic ancestry, health, and socioeconomic status. Where 

such individual attributes are known or suspected to have physiological ramifications 

for spaceflight, findings from research with 

less diverse cSFPs may not be generalizable. 

This raises at least two justice concerns: inequity in knowledge gained for those living 

on Earth, and inequity in evidence collected 

to support safe spaceflight for more diverse 

cSFPs in the future. 

Investigators should be encouraged to 

consider diversity when designing research 

protocols, but ultimately, sample diversity 

will be driven by the specific research questions. With proper oversight, commercial 

spaceflight research presents a historic opportunity to address prior underrepresentation and redefine who can safely experience 

the wonders of spaceflight. Companies that 

fly their own staff as well as prospective customers on research missions should therefore also invest in the training, recruitment, 

and retention of researchers and cSFPs from 

diverse backgrounds to sustain a thriving 

commercial spaceflight workforce (2) and 

participant pool. 

CONCLUSION

To demonstrate trustworthiness and reduce their own risk and liability, companies should issue policies and develop 

best practices to ensure that sponsored 

research is performed in a socially responsible and ethical manner. To demonstrate 

their commitment to global cooperation 

and responsible stewardship of space resources, regulatory agencies will need to 

strategize how to effectively implement 

and ensure accountability for ethical research standards across public and private 

sectors. We believe that there is ample opportunity for collaboration on both fronts 

that is consistent with our proposed ethical framework. Future work should focus 

on identifying specific responsible actors 

and determining what level of policy is appropriate for ensuring implementation of 

the framework. j

REFERENCES AND NOTES

 1. R. Skibba, “Spaceflight companies promised to do science—So how’s it going?” Wired, 28 December 2022; 

https://www.wired.com/story/spaceflight-companiespromised-to-do-science-so-hows-it-going.

 2. M. Marge et al., J. Space Saf. Eng.10, 22 (2023). 

 3. E. L. Antonsen et al., npj Micrograv. 8, 1 (2022).

 4. Institute of Medicine, Health Standards for Long 

Duration and Exploration Spaceflight: Ethics Principles, 

Responsibilities, and Decision Framework (National 

Academies Press, 2014).

 5. E. Mahoney, Ed., “NASA provides updated International 

Space Station transition plan” (NASA, 2022); http://

www.nasa.gov/feature/nasa-provides-updated-international-space-station-transition-plan.

 6. FAA, “Recommended practices for human space flight 

occupant safety” (FAA, 2014).

 7. United Nations Office of Outer Space Affairs, “Treaty on 

principles governing the activities of states in the exploration and use of outer space, including the Moon and 

other celestial bodies” (United Nations, 1967).

 8. M. Shelhamer et al., npj Micrograv. 6, 5 (2020).

 9. T. Aganaba, Albany Law Rev. 85, 409 (2022).

 10. The Artemis program, “The Artemis Accords: Principles 

for cooperation in the civil exploration and use of the 

moon, Mars, coments and asteroids for peaceful purposes” (NASA, 2020).

 11. I. Seane-Viaño, J. J. Ong, A. W. Basit, A. Goyanes, Int. J. 

Pharm. X 4, 100121 (2022). 

 12. E. Urquieta, J. Wu, J. Hury, D. Donoviel, Nat. Med. 28, 611 

(2022). 

 13. R. T. Scott et al., Nat. Mach. Intell. 5, 196 (2023). 

 14. E. L. Antonsen, R. D. Reed, Houston J. Health Law Pol.19, 

1 (2020).

 15. J. Ong et al., Br. J. Ophthalmol.107, 895 (2023). 

ACKNOWLEDGMENTS

The views expressed in this article are the authors’ own and 

do not necessarily reflect those of their affiliate institutions. 

This work is supported by the Translational Research Institute 

for Space Health through NASA Cooperative Agreement 

NNX16AO69A. The ethical principles and their applications that comprise this framework were produced after a 

workshop held at the Banbury Center, Cold Spring Harbor 

Laboratory. The authors wish to sincerely thank R. Leshan and 

the Banbury Center, Cold Spring Harbor Laboratory for their 

combined financial and coordination support.

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to original U.S. Government Works

Ethically cleared to launch?

Vasiliki Rahimzadeh, Jennifer Fogarty, Timothy Caulfield, Serena Auñón-Chancellor, Pascal Borry, Jessica Candia, I.

Glenn Cohen, Marisa Covington, Holly Fernandez Lynch, Henry T. Greely, Michelle Hanlon, James Hatt, Lucie Low, Jerry

Menikoff, Eric M. Meslin, Steven Platts, Vardit Ravitsky, Tara Ruttley, Rachael D. Seidler, Jeremy Sugarman, Emmanuel

Urquieta, Michael A. Williams, Paul Root Wolpe, Dorit Donoviel, and Amy L. McGuire

Science 381 (6665), . DOI: 10.1126/science.adh9028

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