Winter, 2005
Outer space is inimical to human life, and constructing sub-environments that preserve life in a cold vacuum far from earth is no easy task. Along with other harsh environments - Antarctica, the Himalayas, the deep
sea - the need to sustain and repair the body in hostile territory has led to the development of a specialty known as "Medicine in Extreme Environments" 1 and journals such as Human Performance in Extreme Environment. 2 As long as human beings insist on colonizing these inhospitable places, they will be faced with an ongoing set of medical and bioethical dilemmas.
Walter Robinson's thoughtful article, "Ethics for astronauts," (Lahey Clinic Medical Ethics, Fall 2004, http://www.lahey.org/
ethics/) correctly identifies three of the thorniest current bioethical issues facing the space program: 1) astronauts' rights as research subjects versus our need for data on the physiological and psychological impacts of space flight; 2) astronauts' right to privacy versus the need to disseminate such data to the scientific community, and 3) the difficult decisions facing clinical care for astronauts on long duration space flights. all three evoke much debate and handwringing at the National Aeronautics and
Space Administration (NASA), which is one of the reasons that NASA asked the institute of Medicine (IOM) to create the Committee on Creating a Vision for
Space Medicine During Travel Beyond Earth Orbit, on which Dr. Robinson served. the Committee produced a report, Safe Passage: Astronaut Care for Exploration
Missions, 3 which was a thoughtful and probing study of the medical needs of
long-duration flight, and NASA is incorporating many of its insights into its planning for such missions. In such a new and difficult area, there will be differences and debates, and so I welcome an opportunity not only to respond to dr. Robinson's article, but also to the broader set of recommendations made in the Safe Passage report.
Dr. Robinson is correct that the participation of astronauts in clinical research and the related issue of astronaut privacy are problematic. However, Dr. Robinson claims, "The fact that astronauts always consent to participate in all the offered protocols strongly suggests a problem: An Institutional Review Board (IRB) should question the effectiveness of a voluntary consent process in which no one ever declines consent." But it is simply not so that astronauts never decline protocols. In the Life Sciences Spacelab Missions, for example, there was about 20 percent non-participation in planned protocols.4 (In a post-flight exercise test asked of astronauts in five separate missions, only 30 percent participated.) Of course, that very fact presents the exact opposite dilemma - if the data collected is crucial to understanding the health and treatment of astronauts in future flights, and the number of subjects in any space-based protocol is of necessity severely limited, how can we permit astronauts to refuse to participate in protocols at all?
Similarly, Dr. Robinson and Safe Passage both make the claim that astronaut privacy concerns have impeded the collection of important data; dr. Robinsons suggests that issues of astronaut privacy were "repeatedly cited by NASA" as a barrier to collecting data, and Safe Passage similarly states, "The possibility that an astronaut could be identified is seen as an inescapable barrier to the collection and interpretation of astronaut health data." However, the incidence of refusing to release medical information is actually quite low; in Skylab, for example, all nine astronauts concurred, and six out of seven in Spacelab Life Sciences Mission 1. 5
In other words, two problems are postulated by Dr. Robinson and IOM: the first has to do with astronaut consent (either Dr. Robinson's contention that it is coerced and so is never declined, or the opposite problem that astronauts refuse to participate and so important data is not gathered), and the second is data lost to astronaut insistence on the privacy of their medical information. Establishing the validity of these claims is important because they are the hook on which both Dr. Robinson and the IOM committee hang their policy recommendations. Yet in neither Dr. Robinson's article nor in the close to 300 pages of Safe Passage is any data brought forth to support either claim. They are simply asserted as true.
The truth of the claims would not be of much concern, except they are being used to justify a modification of the Common Rule, 6 our single most important regulatory standard of subject protection.
For example, Safe Passage states it explicitly:
NASA should pursue ...a longterm, focused health care research strategy to capture all necessary data on health risks and their amelioration... [which would require] a modification of the interpretation of the Common Rule (45 C.F.R., Part 46, Subpart A) for human research participants.
The reality is that the astronaut is, in most cases, the only individual from whom clinical information relevant to space travel can be collected. Therefore, reliance on the voluntary participation of astronauts in clinical research to the same extent as reliance on volunteer participants on the ground may not be appropriate. This is
especially true when the information gained is potentially critical to the lives and well-beings of both the individual astronaut and the astronaut corps.
It is true that astronauts are in a unique position to gather certain kinds of information on human functioning in space, and that the data is important for the future of space flight. And here Dr. Robinson's suggestion, if not the reasons he gives, seems right to me: We should consider some kinds of data collection in an occupational health model (and, in fact, already do; but the kinds of data included should be expanded). I also agree with Dr. Robinson that other kinds of research, not related to the safety of flight but with terrestrial commercial or industrial uses, clearly falls within the Common Rule and should never be forced upon astronauts.
However, space research does not fall so neatly into those two categories. Spacebased medical research can be invasive or uncomfortable and yet still be directly related to future medical or life science needs. drugs metabolize differently in microgravity, and we must understand that process to accurately prescribe in space, and so drug trials are necessary.
Space research can involve blood draws, muscle biopsies, the wearing of harnesses (which can actually be hazardous during some space-based activities), sleep studies that require waking up periodically (sleeping in space is very difficult as it is, many astronauts are severely sleep deprived, and such studies can exacerbate the problem) and so on. In which of Dr. Robinson's categories do invasive or hazardous studies that are precisely for the health and well-being of future astronauts fall? Calling those "occupational health data gathering" is incorrect, and if the astronauts decide to assert their right to refuse consent for these studies, I suspect the Office of Human research Protections will agree with their right to do so.
It seems to me that NASA should pursue a different strategy, one it has begun but must fully implement. Much astronaut refusal to consent in the past was due to lack of astronaut buy-in, coupled with poor central planning. For example, astronauts might be asked to participate in multiple drug studies, which confounded each other, or they would be involved in a number of studies, each requiring a blood sample, and instead of a single stick and shared blood, there would be multiple, separate blood draws. More recently, these problems have been addressed. Astronauts are now involved in the science of NASA from the top down (Shannon Lucid, who has spent more hours in orbit than any other American, has served as Chief Scientist of NASA; the Associate administrator and head of the space program at NASA is William Readdy, also an experienced astronaut). Astronauts work in the medical corps at NASA, act as principle investigators on studies and sit on the IRB. The solution is not to replace coercion with new or modified regulation (simply another form of coercion), but to include astronauts in every aspect of scientific research at NASA, to reinforce participation in the life sciences as an integral part of astronaut responsibility.
The issue of clinical care is of a different nature, and here I fully agree with Dr. Robinson. The ethical issues of clinical care in long duration spaceflight beyond earth orbit are tricky. In the shuttle and space station platforms, the assumption has been that we can get an injured or ill astronaut back to earth fairly quickly, and so the goal was maintenance until the person could get full care terrestrially. The strategy breaks down on a trip to Mars where the ship is a year away from any possible rendezvous with earth. Before the mission leaves, careful thought must be given to what kinds of medical training to give the crew and what kinds of equipment should and should not be included on the ship. On such long duration flights, every ounce of weight must be carefully considered; higher likelihood injuries and illnesses must be served before rare or unlikely ones. Even so, the inevitable may occur; an astronaut may have an injury or illness that the available resources are ill-suited to treat. All involved - astronauts, their families, the NASA medical personnel - must be ready for such an eventuality.
Which brings us, finally, to clinical bioethics in space. What is the right thing to do if an astronaut suffers from a traumatic head injury and gets violent in a small craft millions of miles from earth, or becomes clinically depressed? What do we tell or not tell an astronaut, isolated in a way no human has ever been before, if his or her spouse develops cancer, or their child dies tragically? As Dr. Robinson suggests, these issues cannot be left to chance. NASA is already gathering together committees to discuss the medical needs of long duration flight, to establish protocols and procedures, and to try and grapple with some of these seemingly intractable problems. Do we now need the Journal of Extreme Bioethics?
Paul Root Wolpe, PhD
Center for Bioethics Department of Psychiatry, Medical
Ethics, and Sociology University of Pennsylvania Chief of Bioethics, National aeronautics and Space Administration
Editor's note: This column, is written in Paul Root Wolpe's capacity as a faculty member at the University of Pennsylvania and should not be construed as reflecting NASA opinion or policy.
Footnotes
1 Palinkas LA, Gunderson EK, Holland AW, Miller C, Johnson
JC. Predictors of behavior and performance in extreme environments: the antarctic space analogue program. Aviation Space & Environmental Medicine. 2000;71(6): 619-625.
2 http://www.hpee.org/aboutjournal.html
3 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
4 Personal Communication: Charles Sawin, Director of research Johnson Space Center and Chair, Committee for the Protection of Human Subjects (JSC's IRB), November, 2001.
5 Personal Communication: Charles Sawin, November, 2001.
6 The Common Rule is Title 45, the Code of Federal regulations that provides protection of human research subjects. It can be accessed at http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
Let me be clear: The problem with medical protocols in spaceflight is that they are mistakenly classified as conventional research and so are monitored using the Common Rule. Instead, many of these protocols should be viewed using an occupational model that recognizes the unique aspects of spaceflight and astronauts.
I continue to believe that astronauts consent to research protocols based on the possibility, as stated clearly in the NASA IRB handbook, that they may not be selected for a mission if they decline to participate. I was told by IRB members, astronauts and NASA researchers that consent is very rarely withheld. The problem here is not that there may be "coercion" but that using conventional consent and protocol review procedures mistakenly views a highly unusual activity - gathering information about the physical and psychological effects of space flight - through the lens of conventional medical research.
I was also told by astronauts, flight surgeons, researchers and those responsible for medical operations that the possibility of identifying the data from an individual astronaut was a major restriction to gathering data on the physiologic consequences of space flight. If this is a misperception, it is a common one, raised again and again by all concerned.
Dr. Volpe argues that protocols that involve risk cannot be considered "occupational data gathering" and should not be required of astronauts. Some of the monitoring may indeed be risky, but risk alone does not classify it as research. Almost all activities during spaceflight entail a high degree of both uncertainty and risk. In flight activities that are now required, e.g., mitigation protocols that are not considered "research," would be legitimately considered research if they were to take place with different subjects in a different context. The point is that there is very little about being an astronaut that resembles being a conventional research subject.
Spaceflight is a unique activity undertaken by a unique population under unique social, cultural, economic, political and psychological constraints; application of a set of regulations and procedures developed for an altogether different set of circumstances is mistaken. The current system does not work. Thirty years of experience in human spaceflight has yet to yield sufficient clinical information to make long duration flights medically possible. Without serious and sustained efforts to rethink the study of humans during spaceflight, we unnecessarily risk the health and safety of astronauts on future longterm missions.
Walter M. Robinson, MD, MPH
Assistant Professor of Pediatrics and Medical Ethics
harvard Medical School, Boston, MA
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.
