Fall, 2004
By Walter M. Robinson,
MD, MPH Assistant Professor of Pediatrics and Medical Ethics
Harvard Medical School Boston, MA
The exploration of space is an uncertain enterprise. Fictional accounts of space exploration are at great odds with the dangerous reality of space flight; the recent tragic deaths of shuttle astronauts are an important corrective to the common view of space flight as a routine undertaking. From a medical standpoint, our fantasies often encourage us to believe that we know more about space flight than we actually do. Despite more than three decades of experience in space, there is a paucity of information about the normal consequences of prolonged low gravity or radiation exposure. Since the majority of U.S. space flights have been of short duration, our accrued knowledge has had little impact. In planning for longer duration flights, our lack of knowledge could be ruinous.
My interest in this topic arises from my work as a member of the Institute of Medicine's Committee on Creating a Vision for Space Medicine During Travel Beyond Earth Orbit. 1 I had the pleasure of reviewing the existing plans for medical care and research for a long duration space mission, such as a trip to Mars, and the greater pleasure of meeting with current and former astronauts and flight surgeons. What was clear is the remarkable dedication and skill of the astronaut corps and the ground staff in charge of their medical care; my remarks should not be construed as criticism of their expertise. However, I believe that NASA's attempt to apply existing clinical and research tenets to what is essentially a unique experience has failed to meet the needs of the space exploration program.
In planning for long duration flights, ethical issues arise in three related areas: the privacy of astronaut medical data, the participation of astronauts in clinical research, and the in-flight clinical care for astronauts. Given the small number of astronauts and the small number of flights, there is a reasonable concern that the medical data from any individual astronaut may be identifiable. The legal mandates to protect an astronaut's medical privacy were repeatedly cited by NASA as a barrier to collecting data on the human response to spaceflight. The concern is not only a matter of principle, as astronauts evidently fear that identifiable information gathered about their experience before, during or after a mission might have a very undesirable consequence: it might be used to bar them from future missions.
To understand this concern for privacy it is important to understand the relationship between astronauts and flight surgeons. The astronaut corps, like pilots before them, may come to view the flight surgeon as less an advocate than an adversary who has the power to prevent them from flying. The flight surgeon's ability to certify individuals as flight ready may motivate an astronaut to conceal or minimize symptoms. The wariness inherent in this flight surgeon-astronaut relationship is intensified by both the lifelong preparation of the astronauts corps and the intense competition for a small number of missions. The result is that clinical events in spaceflight may not be disclosed to the flight surgeon, and if information is disclosed, the flight surgeon may be prevented by privacy concerns from passing such data on to those responsible for making spaceflight safe.
Let us take as an example the relatively common occurrence of an ileus-like syndrome, a paralysis of the intestine, during the first few days in microgravity. This can be discomforting and may cause astronauts to restrict their food intake or to use inappropriate medications such as laxatives. Astronauts might not report these symptoms to their flight surgeons or they might not permit the flight surgeon to report such symptoms, for fear that they indicate an idiosyncratic response to microgravity which might limit their ability to return to space. In this way a "normal" physiological response to microgravity might go unreported and thus inappropriately treated.
How might this systematic pressure to underreport symptoms related to space travel be addressed? In part, the answer lies in reconfiguring the medical privacy laws as they apply to astronauts, perhaps in the form of an administrative structure that better balances the need for confidentiality with the need to create a safe environment for space flight. It may be necessary, given the small number of flights and crew, for the astronauts to cede some medical privacy rights in return for the chance to participate in missions; any changes in the privacy rules should take place after careful consultation with the astronaut corps and the flight surgeons. An additional part of the answer lies in adjustments to the flight surgeon astronaut relationship, which may not be easy. Shifting the flight readiness aspect of medical care away from the flight surgeon simply passes the buck.
A second and related ethical issue is the participation of astronauts in clinical research. In the current practice, all clinical protocols in which astronauts might participate are reviewed by an institutional review board (IRB) at Johnson Space Center and the Common Rule principles of voluntary informed consent are followed. In my view, application of the Common Rule, the federal regulations that set out the ethical precepts for federally funded research in the United States, fails to recognize astronauts, and space exploration, as unique.
It is reasonable to propose that astronauts have an obligation to participate in clinical data gathering that facilitates the design and maintenance of a safe space flight environment. To apply the standard informed consent procedures to this sort of data gathering implies that astronauts could opt out of activities designed to make space flight safe by declining consent. NASA recognizes this as a problem, and includes a provision in the IRB handbook allowing for astronauts to be taken off missions if they decline participation in protocols deemed important to the mission. The fact that astronauts always consent to participate in all the offered protocols strongly suggests a problem: An IRB should question the effectiveness of a voluntary consent process in which no one ever declines consent. In applying the earthly standards, one of two problems has occurred: either there has been inappropriate pressure, in the form of mission selection, brought to bear on potential research participants, or there has been a category error in calling this sort of data gathering activity research in the usual regulatory sense of the word.
An earthbound example may help suggest a solution. Imagine that the first nuclear power plants are being built and operated. Workers in the plant may have to provide clinical data and clinical samples such as urine and blood in order to monitor their radiation exposure, in order to see if the expected safety precautions are effective, and in order to detect unexpected consequences of their exposure. As more plants are built, and more knowledge is gained about their safety, less monitoring will be needed.
Astronauts are like those workers in the very early plants. Little is known about the risks of the work, and understanding their physiologic responses to the work environment is necessary to protect them from both expected and unexpected risks. Is every activity that leads to such understanding, research in the usual regulatory meaning of the word, such that it should trigger the use of informed consent? I think it is not, in that astronauts ought not decline to participate and still go on the flights, just as the plant workers ought not refuse to participate and still work in the early plants. Instead, I think that an occupational model of health best describes this activity, and that occupation models of data gathering should be used instead of invoking the Common Rule. If the Common Rule procedures continue to be used, and mission selection pressure is applied, then the voluntary nature of the informed consent is in serious doubt.
On the other hand, there will be research protocols designed for astronauts that closely approximate clinical research done in an earthbound setting. Such protocols will involve research on medications or devices that would not be used to make subsequent spaceflights safer or even possible. The purpose of this research would be to examine physiologic variables or to test pharmacologic therapies that would have terrestrial commercial or industrial uses. In this type of research, it is completely appropriate to use the standard informed consent procedures and IRB review, but inappropriate to apply mission selection pressure in order to encourage participation.
The last set of ethical issues raised by long-term space flight is clinical. On long duration flights such as that to Mars, communication with the ground will be limited and delayed, and there is likely to be no possibility of returning mid-flight due to illness. The result is an uncoupling of the sent from the sender; the crew will be on its own in resolving some difficult ethical issues. How should they decide when to use, and when to withhold, advanced medical treatment?
While there is understandable pressure to include the capacity for technologically advanced medical support on any long-term flight, normative guidelines for the use of such equipment should be developed prior to leaving the ground. For example, should mechanical ventilators be included on long duration flights? What would be the criteria for initiating or discontinuing ventilation? How might the crew balance mission needs against medical needs? Traditional wartime triage rules, which distribute medical care based on the ability to return the patient to active duty, might form the basis of a policy, but to adopt such rules requires a prior agreement of the sender and the sent, of the space flight agencies and the astronauts. Might it be better to limit which types of equipment are sent, so that the options are clearer? Given these issues and the likelihood of an international crew with a variety of ethical perspectives on triage, careful attention should be paid to these issues in setting up clinical protocols.
In summary, space exploration and space explorers have unique characteristics that do not easily fit into the existing ethical templates for medical privacy, medical research, and clinical decision making. This is not to say that a new ethics must be devised, but that in this new situation, care must be taken to devise a set of ethical standards that are appropriate to a new environment.
Footnotes
1 Ball JR, Evans CH Jr. (eds). Committee on Creating a Vision for Space Medicine During Travel Beyond Earth Orbit. Safe Passage: Astronaut Care for Exploration Missions. Washington, DC: National Academy press, 2001.
An extended discussion of the ethical issues in long duration space flight can be found in the Institute of Medicine Committee's report noted above. However, the author's opinions here are his own and may not reflect the views of the IOM Committee.
in collaboration with
Dartmouth-Hitchcock Medical Center
The opinions expressed in the journal, Lahey Clinic Medical Ethics,
belong to the individual contributors and do not represent the institutional position
of Lahey Clinic on any subject matters discussed.
