{"id":510876,"date":"2025-01-08T09:00:00","date_gmt":"2025-01-08T14:00:00","guid":{"rendered":"https:\/\/spacenews.com\/?p=510876"},"modified":"2024-12-31T15:18:09","modified_gmt":"2024-12-31T20:18:09","slug":"how-to-conduct-safe-and-robust-medical-research-in-thenew-space-age","status":"publish","type":"post","link":"https:\/\/spacenews.com\/how-to-conduct-safe-and-robust-medical-research-in-thenew-space-age\/","title":{"rendered":"How to conduct safe and robust medical research in the new space age"},"content":{"rendered":"\n

It usually starts with a headache. Headaches are one of the earliest symptoms of Space Adaptation System, a type of space motion sickness that affects 60% to 80% of astronauts during their first few days in microgravity, with subsequent symptoms ranging from fatigue and nausea to facial stiffness and back pain as the body adjusts to the absence of gravity. Most recently described by the crew aboard Polaris Dawn<\/a>, the onslaught of symptoms can significantly affect an explorer\u2019s capabilities to perform even simple tasks.<\/p>\n\n\n\n\n\n\n\n

For over two decades, meticulously selected, trained astronauts have maintained a continuous human presence in low Earth orbit (LEO) on the International Space Station (ISS). In the short term, NASA plans to replace the ISS with Commercial LEO Destinations built, owned and operated by private companies that would charge governmental space programs and private customers alike for any scientific, exploratory, or even recreational activity in space.<\/p>\n\n\n\n

In the long term, LEO missions enable us to prepare for deep-space journeys. As we contemplate leaving Earth\u2019s protective atmosphere to return to the moon and eventually journey to Mars, astronauts may face more than debilitating headaches.<\/p>\n\n\n\n

As Executive Director of the Translational Research Institute for Space Health (TRISH), an organization tasked by NASA with finding new ways to keep astronauts healthy, this new era of commercial spaceflight offers unprecedented opportunities to study the effects of space travel on the human body. To successfully care for humans in space, from career astronauts to civilians, it is mission-critical in these early days to build the right foundation for research and data collection.<\/p>\n\n\n\n

The right stuff<\/h3>\n\n\n\n

Impactful science is reproducible, appropriately controlled, well-documented\u00a0and annotated with experimental conditions. Most importantly, we must exercise restraint in drawing overreaching conclusions, particularly with spaceflight data gathered from a small number of subjects in conditions that are often difficult to reproduce.<\/p>\n\n\n\n

Fewer than 700 people have ventured into space. Most of them were professional astronauts, but civilian travelers are increasingly venturing off-world as well. The appetite of individuals and nations without human space programs to pay for a seat to space appears to be increasingly robust, and both private citizens and government-trained astronauts are now potential contributors to our knowledge about human adaptation to spaceflight. We find ourselves in a critical inflection point for a burgeoning industry to demonstrate efficiency and responsibility in conducting health studies.<\/p>\n\n\n\n

In 2023, we co-authored a Science Policy Forum article<\/a> calling for the establishment of guidelines for ethical research by private entities and people accessing space. This was the product of an Astro-Ethics workshop convened by TRISH that brought together a wide group of experts including international medical ethics experts, astronauts, commercial space leaders, scientists and government officials from NASA and other agencies. We developed four principles to guide ethical human research in space: social responsibility, scientific excellence, proportionality\u00a0and global stewardship. Commercial missions to space must prioritize social good, and those conducting human health research in space or on individuals accessing space must do so thoughtfully. TRISH is putting its money where its mouth is by supporting formal accredited ethical consultations<\/a> for any U.S. based research team needing support navigating an ethical, legal, or social challenge in their proposed space research.<\/p>\n\n\n\n

There is a need for a rigorous, standardized approach for preflight, inflight and postflight data collection from private spaceflight participants that still ensures data privacy. Protocols need to be harmonized to the essential measures that NASA\u2019s Human Research Program monitors on governmental astronauts so that the new datasets can be meaningfully combined to increase our understanding.<\/p>\n\n\n\n

TRISH launched a program called Enhancing eXploration Platforms and Analog Definition (EXPAND) to answer some of the challenges of standardizing medical data from space travelers, but collective input is necessary for solving collective challenges. As more private astronauts sign into the program and our database grows, we seek diverse expertise to help us uphold appropriately high data standards.<\/p>\n\n\n\n

Data standardization<\/h3>\n\n\n\n

It\u2019s not just data that\u2019s important, but also the data collection processes, as variations make it harder to reach insightful results. EXPAND\u2019s data and biosample collection process is standardized across all missions, empowering researchers to compare data accurately across missions of different durations and with different crews. We also require data-sharing agreements to minimize friction among collaborating scientists and enable the program to respond to data requests by the scientific community.<\/p>\n\n\n\n

Crew members conducting research aboard commercial spaceflights have diverse educational and occupational backgrounds and are not necessarily trained scientists. They are also performing research in a complex, unfamiliar environment. To maintain data integrity, we must design research protocols that are feasible, understandable, robust and easily replicable across spaceflights, all while ensuring that the studies prioritize participant safety, mirroring guidelines set on Earth.<\/p>\n\n\n\n

Inspiration4<\/a> crew members on a recent flight tested a miniaturized, handheld ultrasound device to capture images of the eye, with minimal training. BioButtons and smartwatches tracked real-time health responses to inflight changes in the most recent Polaris Dawn<\/a> flight. With user-friendly tools and standardized processes and reporting, we can accurately track physiological changes in response to various stressors across spaceflights.<\/p>\n\n\n\n

Privacy safeguards<\/h3>\n\n\n\n

The health data collected through biomedical research is highly sensitive and requires stringent privacy precautions, especially due to the celebrity status of crewmembers. Safeguarding privacy is necessary to encourage future crew members\u2019 participation and contribution to the growing body of space health knowledge, particularly because we are collecting genetic samples. Our solution at TRISH has been to establish an external expert data privacy and release board to safeguard personal information, and, because crew members hail from numerous countries, consult other nations\u2019 privacy laws to ensure compliance for all private astronauts.<\/p>\n\n\n\n

Conclusions derived from small data sets or from single missions may be inaccurate, misleading, or misinterpreted, making data privacy all the more important. As we collect more data from the broadening pool of commercial spaceflight participants, we can better anonymize findings and conduct meaningful analyses to inform future measures and interventions. The eventual goal is to provide both governmental and private human spaceflight programs with insights about the health of their astronauts to make informed decisions about their operations. With sufficient data collected and synthesized, the EXPAND database will hopefully serve as a sandbox for researchers to query and inform new scientific hypotheses.<\/p>\n\n\n\n

Spaceflight invokes many physiological, anatomical and molecular adaptations. While it might be too soon to make specific health predictions for each explorer, it is of paramount importance that we as researchers don\u2019t get in our own way. Collecting reliable information can accelerate the timeline for new insights into how we stay healthy, whether in space or on Earth. This is painstaking work, but it\u2019s a necessary investment for our future in space, ensuring a robust new economy and a sustainable research platform for new discoveries.<\/p>\n\n\n\n

<\/em>Dorit Donoviel is the executive director of the <\/em>Translational Research Institute for Space Health (TRISH), a NASA-funded consortium based at Baylor College of Medicine (BCM), with partners Caltech and MIT. Dr. Donoviel is also an associate professor of space medicine and Associate Director of the Center for Space Medicine at BCM.<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"

It usually starts with a headache. 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