Medical Ethics in Military Biomedical Research
Chapter 18
MEDICAL ETHICS IN MILITARY
BIOMEDICAL RESEARCH
MICHAEL E. FRISINA*
INTRODUCTION
THE NATURE OF MILITARY BIOMEDICAL RESEARCH
Military Disease Hazards Research
Medical Biological Defense Research
Combat Casualty Care Research
Human Systems Technology Research
Medical Chemical Defense Research
THE ETHICAL LEGITIMACY FOR MILITARY BIOMEDICAL RESEARCH
Should Military Biomedical Research Be Prohibited?
The Nonparticipation Point of View
The Participation Point of View
National Risk vs National Security
Summary
THE ETHICAL CONDUCT OF RESEARCH
Criteria for Conducting Ethically Responsible Research
Informed Consent
Is It Ethical to Conduct Research on Soldiers?
Practicality and American Moral Ideals
The Persian Gulf War Experience
The Dilemma of Choice
Summary
ETHICS AND THE ISSUE OF ANIMAL EXPERIMENTATION
The Moral Status of Animals
Animal Suffering vs the Primacy of Human Life
Application of Ethical Theory
A Definitive Rights Position
Summary
MILITARY WOMEN S RESEARCH PROGRAM
THE PROBLEM OF EXCLUSION
CONCLUSION
*
Lieutenant Colonel (Retired), Medical Service Corps, United States Army; formerly, Director, Bioethics Program, Medical Research and
Development Command, Fort Detrick, Maryland; formerly, Assistant Professor, Philosophy Division, Department of English, United States
Military Academy, West Point, New York; currently, Administrative Director, Surgical Services, Tuomey Healthcare System, 129 North
Washington Street, Sumter, South Carolina 29150
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Military Medical Ethics, Volume 2
J.O. Chapin Research Heroic The Self-Inoculation 1944
The sixth of seven images from the series The Seven Ages of a Physician As the painting title implies, the physician-researcher,
following the ethical guidelines of research, is willing to inoculate himself in the pursuit of scientific knowledge for
the betterment of all patients.
Art: Courtesy of Novartis Pharmaceuticals.
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Medical Ethics in Military Biomedical Research
INTRODUCTION
In his preface to Principia Ethica, Moore writes, find, for example, no ethical objection to military
biomedical researchers vaccinating soldiers to pre-
it appears to me that in ethics, as in all other philo-
vent them from dying of disease.5 Is it just as ethi-
sophical studies, the difficulties and disagreements,
cal for those same researchers to investigate the ef-
of which history is full, are mainly due to a very
ficacy of chemical protective clothing, or combat
simple cause: namely to attempt to answer ques-
helmets and body armor with the same end in mind,
tions without first discovering precisely what ques-
preventing harm to the soldier? This view begs a
tion it is which you desire to answer.1(pi)
question of whether any military biomedical re-
The  precise question of this chapter has two parts: search can be constructive, even vaccine research
(1) is there an ethical justification for military bio- dating to Walter Reed himself. Consequently, there
medical research? and (2) if military biomedical re- are various groups who advocate that all military
search is an ethically legitimate enterprise, can mili- vaccine research and development be controlled by
tary biomedical researchers conduct their work in public health agencies to preserve the constructive
an ethically responsible manner? nature of this research. The purpose would be to
As Moore suggests, the question of whether mili- reduce the potential for ethical conflict among re-
tary biomedical research is ethically legitimate has searchers and to limit destructive applications of
its own history of difficulties and disagreements. the science.6 Arguments for distinguishing between
Although there is little challenge that an ethical basis offensive and defensive research will follow later
for biomedical inquiry exists in general, the line of in this text.
distinction is extremely thin between (a) legitimate If there is an ethical distinction between construc-
and ethical biomedical military research and (b) tive (defensive) and destructive (offensive) military
nonmedical research activity causing some research- biomedical research, there is a need to examine
ers extreme moral anxiety over what they call,  the whether this research can be conducted in an ethi-
militarization of the biomedical sciences. Certain cally responsible manner. Protection of research
scientists see the need to protect the benevolent subjects in military biomedical research is ethically
nature of biomedical science (reducing morbidity essential. Currently, the Department of Defense
and mortality) by maintaining complete dissocia- (DoD) policy for the conduct and review of human
tion from military-sponsored biomedical research.2 subjects research, which applies to all elements of
An argument for nonparticipation, based on vari- the DoD and to its contractors and grantees, up-
ous sources, is the focus of a main section of this holds the protection of the fundamental rights,
chapter, as is a counterargument for participation welfare, and dignity of human test subjects.5(p12)
that concentrates on the first part of the question Likewise, the DoD purports to adhere to the strict-
the moral legitimacy of military biomedical research. est guidelines regarding the use of animal models
By their very nature, military biomedical research in its research and development programs.6 Animal
programs appear to be ethically suspect.3 Even protocols are subjected to layers of review at vari-
though military medicine enjoys a rich history of ous command and service levels. While the entire
scientific advances in preventive medicine, the So- subject of animal use remains under intense ethical
ciety for Social Responsibility in Science, for ex- scrutiny, the military seeks to be sensitive to the
ample, advocates,  a tradition of personal moral obligation of humane treatment of research animals
responsibility for the consequences for humanity of and resolute in complying with all federal require-
professional activity& to ascertain the boundary ments for their care and use in biomedical research.
between constructive and destructive work. 4(pp25 Finally, a discussion of the ethical conduct of
26)
The idea is that military biomedical research that military biomedical research needs to examine the
is constructive, which I take to mean supports the efforts to expand scientific studies specific to the
goals and ideals of the healing tradition of medi- needs of military women. In the past, protocol de-
cine, is ethically legitimate. Military biomedical re- signs have excluded military women for a variety
search that is destructive, contributing to harming of reasons. Now it is ethically essential to under-
or directly supporting the killing of human life, stand the reasons for the past exclusion of women
would be unethical. The ethical tension derives from and establish guidelines to alter the practices of the
trying to determine what biomedical research is past. As the roles of military women expand, they
constructive and what is destructive. One might will confront a host of new medical challenges. Re-
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Military Medical Ethics, Volume 2
search efforts must look to address these new chal- conducting this research. The ethical tension in the
lenges to preserve and maintain the health and first part of this question is profound. If there is no
safety of military women. inherent moral legitimacy to conducting military
In summary, this chapter will consider the ethi- biomedical research, that is to say, if all military
cal nature of military biomedical research to deter- biomedical research is destructive in nature, then
mine its moral legitimacy. If found to be an ethi- no amount of ethical conduct, regulatory compli-
cally legitimate enterprise, it then must consider the ance, or open disclosure to the public can change
ethical obligations and responsibilities inherent to the inherent immorality of the research.
THE NATURE OF MILITARY BIOMEDICAL RESEARCH
The nature of military biomedical research is medical research laboratories, institutes, and non-
linked to the objective of conducting research and governmental laboratories through contracts with
development studies that address relevant and sig- universities and industry. The fundamental purpose
nificant military-related problems.7 To be militar- of this research, as stated previously, is to solve
ily significant, the research and development study military medical problems of importance to national
must have immediate or long-range usefulness, as defense. Each of these research areas pose a pro-
distinguished from the general advancement of verbial double-edged sword regarding their medi-
knowledge of medicine. The requirement for the cal orientation thereby upholding principles of heal-
research to be militarily significant stems from the ing and preventing harm as opposed to the notion
passage of the Mansfield Amendment in the 1970 of destructive applications of the research that
military appropriations bill. The amendment re- would then associate this research with nonmedi-
quired that the DoD only fund research that could cal purposes. This tension is pervasive throughout
solve military problems. The intent of this legisla- the ethical analysis of military medical research and
tion has been stretched in recent years with the DoD this discussion will return to it continually.
budget containing funding for breast cancer re-
search. Critics of the funding of military biomedi- Military Disease Hazards Research
cal research point to this program as lacking a  di-
rect and apparent relationship to a specific military The major thrust of military disease hazards re-
function or operation. 7(p78) Many scientists would search includes basic and applied studies related to
prefer to be funded from sources other than the prevention, diagnosis, and treatment of infectious
military and face personal ethical conflict about diseases that could threaten the success of military
whether to apply for grant money from the military. operations. Basic research in microbiology, immunol-
This conflict aside for the moment, the Mansfield ogy, pathogenesis, and vectors transmission of dis-
Amendment does place practical and ethical limi- ease is designed to improve the technology base for
tations on military biomedical research that opens development of disease prevention, war-fighting sus-
the door to problematic, contentious, and serious tainment, and treatment measures. Applied research
ethical issues about its nature and conduct. Conse- focuses on the development and testing of vaccines,
quently, to better understand the ethical issues at prophylactic and therapeutic drugs, and rapid iden-
stake, a brief description of the various military bio- tification and diagnostic methods and equipment.
medical research programs is appropriate. Once the The military human immunodeficiency virus
nature of these programs is understood, one can (HIV) research program is a component of the mili-
begin to determine the fundamental question of tary disease hazards research program. The goals
their moral legitimacy, clarify the constructive and of this program are aimed at reducing the incidence
destructive aspect of their applications, and develop of new HIV infection in military populations, re-
an ethical construct for the conduct of this research. ducing the rate of progression from asymptomatic
Currently, military biomedical research com- to symptomatic disease, and reducing the HIV-at-
prises five major research areas: (1) military disease tributable death rate. Research projects focus on
hazards research, (2) medical biological defense re- evaluating the courses of infection in military popu-
search, (3) combat casualty care research, (4) human lations, identifying risk factors related to transmis-
systems technology research, and (5) medical sion, testing and evaluating vaccines for prophy-
chemical defense research. The military conducts laxis, and testing and evaluating drugs and vaccines
biomedical research and development in its own for early intervention.
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Medical Ethics in Military Biomedical Research
Medical Biological Defense Research Combat Casualty Care Research
The goal of medical biological defense research The mission of combat casualty care research is
is to ensure the sustained effectiveness of US mili- to provide integrated capabilities for medical care
tary forces in a biological warfare environment by and treatment of injured soldiers at all levels of care,
providing medical countermeasures that deter, con- far forward on the battlefield, to reduce mortality
strain, and defeat a biological warfare threat. Basic and morbidity, and effect early return of soldiers to
research concentrates in three areas of protecting their military duties. Research and development are
the US military s war-fighting capability during a conducted in areas of wound healing, thermal
biological attack: (1) prevent casualties with medi- burns, hemorrhagic shock, sepsis, organ system in-
cal countermeasures (vaccines, toxoids, drugs); (2) jury, blood preservation and blood substitutes, com-
diagnose disease (forward deployable kits, confir- bat stress, and field medical materiel. Basic research
mation assays); and (3) implement treatment meth- in areas of wound healing and the pathophysiologi-
ods (antitoxins and drugs) to prevent lethality and cal response to trauma of cellular and organ me-
maximize return to duty rates. tabolism attempt to minimize mortality, lost duty
An essential element of this program is publish- time, and unnecessary evacuation due to minor
ing in scientific journals to maintain scientific cred- combat trauma. Enhanced readiness to treat com-
ibility, demonstrating an open program in support bat casualties focuses on developmental efforts in
of the Biological Weapons Convention (BWC) treaty, surgical equipment, resuscitation fluid production
and developing an element of deterrence. The ele- systems, and computer-assisted diagnosis and life-
ment of deterrence associated with a medical bio- support equipment.
logical defense research program differs from the The ethical tension created by combat casualty
concept of nuclear deterrence. In nuclear deterrence care research stems from the type of research nec-
potential adversaries basically play the old game essary to solve the problems of the modern day
of  chicken with each party to a potential conflict battlefield. Projectile weapons with high muzzle
threatening a retaliatory strike in the event the other velocities create different types of wounds than
side conducts a first strike. The possibility of either those normally seen in hospital emergency rooms.
side launching an offensive strike with the oppos- Thus, training combat surgeons on wounds created
ing side capable of retaliating deters either side from by weapons with low muzzle velocities does not
using the weapon. This concept of retaliation does prepare them for what they will see in combat.
not apply to biological weapons. Simulation with gelatin molds is inadequate in
The problems inherent with biological weapons wound healing experiments as well. Consequently,
include verification (what countries have them) and military medical researchers have sought for years
enforcing mechanisms against their development to gain approval to study ballistic phenomena us-
and use (ie, the BWC ). Unlike a nuclear attack, bio- ing animal models. However, to date, animal rights
logical agents for use as weapons are readily avail- groups have prevented the establishment of any
able. Another dissimilar factor is the capability of such facility. The prospect of military medical re-
terrorists to acquire and use biological agents. searchers shooting anesthetized, stray dogs to gain
Therefore, the element of deterrence in the biologi- knowledge for improving the level of care of
cal arena is not one of retaliation but of defense if wounded soldiers on the battlefield was believed
it is possible to be protected from biological agents, to be unethical by these groups. Further discussion
then the use of those agents by an adversary has no of the issue of the use of animals in military medi-
tactical or strategic advantage from a military per- cal research follows in a later section of this chapter.
spective. Defense against biological weapons in-
cludes the need for effective international measures Human Systems Technology Research
of verification; international agreements against
proliferation of offensive research programs; and a The purpose of human systems technology re-
defensive research program for detection, identifi- search is to enhance human capability to function
cation, and treatment measures to decrease the mili- safely and effectively in military systems and op-
tary advantage and usefulness of biological warfare erations. This research attempts to identify and
agents. Specific arguments regarding the deterrence solve health problems posed by new combat mate-
effect of a medical biological research program will riel and new concepts for combat operations. The
be developed in the following section of this chapter. results of this research help health policy makers
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Military Medical Ethics, Volume 2
and combat materiel developers keep the limits of future threats, to provide the degree of individual-
human physiological and psychological endurance level protection and prevention to preserve the
in mind when developing new doctrine and new fighting strength of combat units, and to provide
military hardware. The major areas of this research for the medical management of chemical casualties
include physiology in extreme environments, bio- to enhance survival and to maximize and expedite
mechanical stress, operational medicine and human returning soldiers to duty. Basic research includes
performance, health effects of toxic hazards, and investigation of pharmacology, pathophysiology,
non-ionizing radiation bioeffects. Program goals and toxicology of chemical warfare agents, pretreat-
seek to enhance soldiers performance under all ment and antidote drugs, and skin decontamination
operational conditions; protect soldiers from haz- compounds to determine both their mechanisms of
ards of military materiel and operations; develop action and their interaction with one another.
human performance models; and improve military The ethical dilemma associated with medical
operations concepts, policies, and doctrine. chemical defense research is the inability to conduct
The central focus of human systems technology human trials to demonstrate the efficacy of pretreat-
research, like the other research areas, is prevent- ment or antidote drugs because to do so would
ing injury to the combat soldier. Although the aim mean having to expose research subjects to actual
of this research is consistent with the goal of medi- chemical agents. Consequently all current pretreat-
cine to sustain and enhance the quality of human ment and antidote drugs remain unlicensed by the
life the potential for ethical conflict is consider- US Food and Drug Administration (FDA). In a let-
able when medical researchers conduct studies that ter dated 30 October 1990, during Operation Desert
do not focus solely on the welfare of a human be- Shield (ODS), the deployment phase of the Persian
ing but focus also on maintaining and sustaining a Gulf War, the Department of Defense applied for a
person s physical and psychological efficiency as a waiver to use investigational pretreatment drugs
soldier a human weapon system. under an investigational new drug application filed
One aspect of this potential conflict concerns the with the FDA.9(pp346 348) Such use, intended for thera-
use of soldiers as human research subjects. To de- peutic use, not research, caused an acrimonious
termine the possible deleterious effects of new mili- debate in the editorial pages of the country s lead-
tary hardware on military personnel, human trials ing newspapers. The charge against the DoD was
must eventually be conducted. Historically, military that it was experimenting with these drugs on sol-
researchers have been negligent in protecting the diers without their informed consent. References to
rights of research subjects.8 The advent of institu- the Nazi doctors experiments during World War II
tional review boards (IRBs), other systematic review were elicited in statements against the approval of
procedures, and federal regulations provide the the FDA waiver. Maintaining a distinction between
means for protecting human subjects even sol- research and accepted medical practice is a philo-
diers. Nonetheless, there is a tension, if not compe- sophical problem that has troubled medical ethics
tition, between protecting the rights of research for a long time. The conclusion of the National Com-
subjects on the one hand and conducting research mission for the Protection of Human Subjects of
that some view essential to national security inter- Biomedical and Behavioral Research holds two key
ests on the other. factors in mapping this distinction: (1) the level of
risk, and (2) the intent of the medical professional.8
Medical Chemical Defense Research The waiver issued by the FDA for the Persian Gulf
War did not solve the ethical problem of the mili-
The mission of medical chemical defense research tary in trying to balance the rights and welfare of
is to preserve combat effectiveness by timely pro- its members against the military necessity of sus-
vision of medical countermeasures in response to taining a combat ready force. Nor, for that matter,
chemical warfare defense needs. Research efforts in does the criteria of level of risk and intent settle the
this area strive to maintain the technologic capabil- issue of whether a medical professional is doing
ity to meet present requirements and to counter research or providing accepted medical therapy.
THE ETHICAL LEGITIMACY FOR MILITARY BIOMEDICAL RESEARCH
[I]t is deemed unethical for physicians to& weaken without therapeutic justification [and to] employ sci-
the physical and mental strength of a human being entific knowledge to imperil health or destroy life.10
538
Medical Ethics in Military Biomedical Research
In examining the ethical justification for military ducted. Hence any scientist who accepts military
biomedical research, one finds that the literature on sponsorship is de facto working for the military, its
this issue runs the gamut of political and sociological aims, goals, and objectives. Because military activ-
perspectives. Views tend to be polarized ranging ity is antithetical to the principles of science, ethi-
from complete prohibition of any military-sponsored cal problems exist for those scientists who partici-
biomedical research on the one hand, to secret pro- pate in military-sponsored research to include
grams that would include testing on an unwitting medical research. The question to ponder is whether
and uninformed populace on the other. Both of these those who support a military biomedical research
extreme views are unethical positions. Complete pro- program and those who oppose it can stand to-
hibition of military medical research cannot be gether on the same moral high ground.
morally acceptable because it results in moral evil, As alluded to earlier, complete dissociation from
namely failing to preserve the health and welfare military medical research, while eliminating any
of soldiers deployed in combat. Secret programs moral problems for scientists, also risks losing the
also result in moral evil and consequently are un- benevolent gains in vaccines, drug therapies, and
ethical. If there is any possibility of bringing these material preventive and protective measures rel-
diverging groups closer to some middle ground per- evant to military problems but also to direct civil-
haps it is found in the quotation cited above from ian applications of this research. For example, the
the World Health Association. development of a number of investigational vac-
Implicit in this quotation is the  do no harm cines against diseases such as Venezuelan equine
principle. The many efforts by those opposed to encephalomyelitis (VEE), tularemia, anthrax, Q fever,
biomedical research by the military stem from their and botulism were safe and efficacious in reducing
attempt to preserve this principle keep medical disease from accidental exposure to laboratory
scientific knowledge from becoming  militarized workers. The use of VEE vaccine proved useful in
and used to harm rather than to heal. Ironically, eradicating the disease in horses in the epizootic in
those who support military biomedical research also Texas in 1971. The Rift Valley Fever vaccine was
base their arguments on a  firstly, do no harm prin- used successfully in high-risk personnel during an
ciple. The aim of military biomedical research is, in outbreak of the disease in Egypt in 1977 and 1978.
fact, to go beyond this principle of nonmaleficence In 1989 military investigators identified an Ebola-
(avoiding harm) by preserving and enhancing the like virus in monkeys and in 1995 military investi-
lives of those who serve the military forces of the gators were part of the World Health Organization
United States (the principle of beneficence). team to investigate the Ebola outbreak in Africa.
The ethical tension that develops from the prin- Since the 1950s, military medical researchers have
ciple of nonmaleficence is whether the moral legiti- been investigating the Hantaan virus known to
macy of medical research, in general, applies to cause the disease called Hemorrhagic Fever with
military medical research. The moral legitimacy of Renal Syndrome (HFRS) that has already killed
medical research is based on the good that results more than 50 people in the United States.
from the research enterprise. So too, the moral le- Although these research advances have direct
gitimacy of military biomedical research must stem civilian application, the research has greatly reduced
from the good it produces mitigated against any the morbidity and mortality of military personnel.
harm that is likely to result as well. Because most Historically disease and nonbattle injuries have ac-
medical researchers desire that their science allevi- counted for over two-thirds of the combat losses suf-
ate human suffering, many are reluctant to partici- fered by the United States in past military engage-
pate in military medical research for fear that medi- ments. In Vietnam, although disease was the single
cal research is akin to weapons research in the greatest cause of morbidity, the admission rate was
physical sciences and engineering. The fear that 40% less than the Korean War due largely, in part,
military medical research aids in the development to the efforts of military biomedical research and
of biological and chemical weapons keeps many development.11 This point alone should be sufficient
scientists from participating in military medical re- to undermine the moral claim that complete disso-
search and others calling for its complete prohibition. ciation from military medical research completely
The major claim of this argument is that scientists upholds the principle of  do no harm or eliminates
who participate in military research fuel the arms any ethical problems for medical scientists. Clearly
race. Military sponsorship of scientific research de- the loss of medical advances stated previously
termines and influences the type of research con- would result in tremendous harm but the misuse
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Military Medical Ethics, Volume 2
of this medical knowledge also presents the possi- of developing nations where the United States is
bility of greater evil than the good that results from it. most likely to engage in offensive operations.
Despite the possibility of consensus building Disagreements about the funding of the scien-
upon the  do no harm principle, military biomedi- tific enterprise in the United States and how to best
cal research does present a double-edge sword. achieve the goals associated with that enterprise
Most often what is learned in the area of biomedi- extend beyond military biomedical research. Those
cal research has potential uses for both good and evil. opposed to military programs view the use of lim-
Clearly, in some cases, there is a distinction between ited national resources for military purposes as
offensive (destructive) and defensive (constructive) immoral. They contend that shifting of military
research. Consistent with previous discussion of the dollars to public health agencies, such as the Na-
just war doctrine, the distinction between offensive tional Institutes of Health, will provide the same
and defensive research (and medical research is benefits the military program currently produces.
defensive unless one views biological defense as The difficulty with this position is that some mili-
offensive in bioweapons development) becomes tary problems have no immediate direct impact on
morally important. Certainly scientists who view public health; thus research aimed specifically at
their work as consistent with this doctrine are no military problems would be neglected. The economic
more unethical than soldiers who do the fighting. burden, which has a moral component, is balancing
Likewise, scientists who choose not to participate the use of financial resources for social purposes miti-
are no more unethical than a pacifist or conscien- gated against the needs to protect national security.
tious objector who would object to any participa- Considering the history of the development of
tion in killing even a just war. What is critical re- the atomic bomb, many scientists have come to be-
gardless of the path chosen by a scientist is that if lieve that they have no control over the results of
military medical research is morally legitimate, ar- their work when conducted under the auspices of
eas of scientific inquiry remain open programs and military funding and oversight. Their argument is
the knowledge gained from this research cannot be simple: The only way to control the results of one s
subverted by weapons designers to defeat advances work is to control what one works on in the first
in reducing injury and disease. place. The ambiguity related to biological defensive
Consequently, in reviewing the arguments on this versus offensive research is such that many scien-
issue, three major areas of dispute emerge. First, tists claim the only way to control proliferation of
there is disagreement because funding is limited biological weapons, for example, is to not partici-
and continued financing of a military program com- pate in any military-sponsored biological research.
pels university and industry to accept military Some contend there is no distinction at all between
projects to get much-needed research grants. As offensive and defensive biological research and con-
time goes on, so it is suggested, these researchers, tend the military simply mislabels offensive re-
having been coerced into accepting DoD money, are search as defensive to attract researchers. This ar-
compelled to work solely on military goals that may gument is critical to the moral legitimacy claim of
detract, for example, from vaccine research in pub- military biomedical research and will be developed
lic health initiatives. Second, there is the argument further in this chapter.
that the defensive (constructive and benevolent) Finally, is it possible that if the United States can
component of segments of the military biomedical protect its military from endemic diseases in a com-
research programs is ambiguous enough to cause bat zone or use technology to advance healing of
other nations to believe that the United States is its wounded soldiers, that these medical interven-
working on offensive developments. Hence, mili- tions constitute contributing to the military aims of
tary biomedical research could lead to a prolifera- war fighting and hence lack the moral legitimacy
tion of biological and chemical weapons. Third, of the healing arts in general? The question of the
there is, at a minimum, an implicit position that the extent to which a member of the healing profession
production of vaccines and drugs against devastat- may participate in activities not strictly medical and
ing disease, although a laudable goal, cannot be still uphold the principle of  do no harm is an in-
viewed in isolation solely for the protection of US teresting and debatable one. It is, however, to ask a
military forces. The production and selective use different question (back to Moore again) than
of military biomedical advances can be viewed as a whether medical professionals directly engaged in
component of strategic offensive policy that would preventing or relieving suffering of soldiers consti-
not benefit general populations, particularly those tute direct contribution to offensive activity.
540
Medical Ethics in Military Biomedical Research
Should Military Biomedical Research Be tual one but rather one of differing values and de-
Prohibited? ciding how to proceed. There are honest disputes
about whether the medical advances produced by
The question of specifically prohibiting military military biomedical research are worth the possible
biomedical research is embedded in a larger argu- risk of medical scientists being exploited and the
ment regarding the ethics of prohibiting or limit- proper end of the healing arts being perverted for
ing research.12 15 The ethical issues at stake in this evil purposes. Hence the fundamental question
debate are part of a spectrum of issues revolving shifts from one of moral legitimacy of military medi-
around fundamental decisions of scientists to par- cal research to one of whether the potential ben-
ticipate or refuse to participate in research based efits of this research are such to pursue it, knowing
upon the perceived social consequences of their the potential for harm. In other words, can this re-
work. The dual nature of military biomedical re- search be conducted in such a manner as to pre-
search fundamentally establishes this ethical con- serve the integrity of the research? Can a system of
flict for researchers pondering participation in mili- appropriate checks and balances be established that
tary programs. The conflict stems from a genuine will allow the conduct of research when the prob-
conviction that doing what can be done to enhance ability of harm resulting from the research is un-
the lives and well-being of members of the US mili- known? A review of the basic arguments is appro-
tary is a moral obligation what ethicists call a priate at this time.
prima facie duty one ought to do good when one
is able to do it. When taken alone, this principle is The Nonparticipation Point of View
unassailable. When juxtaposed to a competing
claim, namely,  do no harm, these ethical prin- Those who hold that physicians should not par-
ciples appear in conflict. The problem then becomes ticipate in any form in military research believe that
how to decide which principle carries greater there are three  steps that occur in the corruption
weight in the ethical decision-making process. One of military medical research. These are: (1) the mili-
method is to conduct a risk/benefit analysis to de- tarization of medicine, (2) the inevitable escalation
termine which action produces the greater benefits of biologic and chemical weaponry because of the
(good) while limiting harm (evil). products of military medical research both in US
There are several versions of risk and benefit argu- forces and the forces of any adversary, and (3) with
ments used by those opposed to direct involvement this escalation a violation of law, morality, and eth-
of biomedical scientists in military biomedical re- ics. I will discuss each in turn.
search.3,16,17 The forms of the arguments tend to run
from the general to the specific. One attempts to Militarization
argue that there are good reasons to limit scientific
inquiry in general and then demonstrate limiting or Those opposed to military biomedical research
restricting specific inquiry. Such arguments are per- argue against the possible offensive uses of this re-
suasive only to the extent that the general argument search. The most contentious and likely research
itself is sound in its reasoning that the general pre- program for possible offensive applications is the
mises are true and that the conclusion to limit or pro- Medical Biological Defense Research Program. Crit-
hibit research follows from those premises.13 ics contend that defensive research to protect mili-
Usually these types of arguments are difficult to tary members from naturally occurring diseases and
answer. In developing a risk/benefit ratio, the facts biological weapons is,  highly ambiguous, provoca-
needed to evaluate a premise or calculate a risk or tive, and strongly suggestive of offensive goals& it
benefit are not known. This is not the case with is urged that physicians refuse participation in such
military biomedical research. It is known with a research. 18(pp25 26)
great degree of certainty that medical research can Nonparticipationists document that overall fund-
produce a host of preventive and therapeutic treat- ing for military programs increased by more than
ments that will benefit the lives of military person- 400% in the late 1980s. Over the same period of time,
nel with considerable applications to the general federal support for research in basic science issues
populace at large. The inherent risk, based on his- in the civilian sector sharply declined.18 From 1980
torical evidence, of the likely perversion of this re- to 1984, total federal research support in the United
search for nefarious purposes is also known.3,6,16 The States for life sciences decreased by 2% while DoD
difficulty faced in solving this problem is not a fac- funding increased by 26%. With 100 university labo-
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Military Medical Ethics, Volume 2
ratories participating in DoD programs with this medical scientists have the responsibility not only
increased funding, nonparticipationists perceive a to avoid working directly in ways that support of-
trend that could alter research priorities in devel- fensive development, but also to act in such a way
oping fields, such as genetic engineering.5 as to avoid contributing to the arms race, even if
Nonparticipationists also argue that military engaged in clearly defined defensive research.
operations can never be exclusively defensive, that
biological research is fraught with ambiguity be- Violation
tween offensive and defensive applications and,
therefore, medical professionals who conduct research Following from the assertion that biological
for the military are in  ethical peril. To strengthen medical research by the military cannot be solely
this claim, critics of the military program contend defensive in nature, medical scientists have an ob-
that public funding supporting a military program ligation to not participate in research. US govern-
does not serve the public interest, particularly in ment policy and international agreements forbid the
time of budget cutting. The nonparticipationist also development, production, and stockpiling of micro-
claims that the threat of disease either endemic or bial or other biological agents, or toxins that have
as a biological weapon is overstated by the mili- no justification for prophylactic, protective, or other
tary. Further they suggest that the responsibility for peaceful purposes. Interpretation of Article I of the
governmentally sponsored medical research for Biological Weapons Convention19 (BWC) is ambigu-
prophylactic, protective, and other peaceful pur- ous in that it does not preclude research into offen-
poses in the United States belongs to the National sive agents necessary to determine what means are
Institutes of Health (NIH) and the Centers for Dis- required to defend against them.
ease Control (CDC). Consequently, the NIH or CDC Nonparticipationists contend that because the
should have the responsibility and, more impor- line of distinction between offensive and defensive
tantly, the resources for this type of medical re- research remains blurred, medical scientists violate
search.3,16 Such a position is less likely to pervert the spirit if not direct intent of the various agree-
nature of biomedical research and, most impor- ments to avoid work that would contribute to the
tantly, less likely to place medical professionals in development of offensive capabilities with biologi-
ethical peril. cal agents. Opponents of military biomedical re-
search argue that material developments in diag-
Escalation nostic equipment and sensor devices potentially
could produce vector delivery systems and that
Universal agreement exists by those opposed to antibiotic therapy could really produce means to
military biomedical research (within the area of defeat or inhibit diagnosis, defeat current vaccine
vaccine and drug development) that such research use, or generate a novel agent.
will lead to a biological arms race analogous to the The advocates of nonparticipation concede that
development of nuclear weapons.16 Although the the study and production of some biological agents
nonparticipationist will concede that the produc- (for example, toxin proteins) may have scientific
tion of vaccines against devastating diseases is a merit, but such work raises questions regarding US
laudable goal, such conduct cannot be ethically compliance with the BWC. Consistent with the logic
judged in isolation from the purposes of the agen- of having the NIH conduct disease-oriented re-
cies who directly supervise the research effort. It is search, moving control of this type of research to
possible that a medical scientist might consent to, civilian agencies would dispel concern about the
or be misled into, work that has offensive applica- offensive intent of the work, uphold the deterrent
tions under the guise of defensive work. effect of the BWC, and protect against the perver-
When the military supports large programs to sion of the healing arts in medical research.
develop vaccines against exotic diseases that pose no
likely public health concern such as dengue fever, The Participation Point of View
anthrax, VEE, and numerous pathogens, one can make
informed speculations of the likely use of these patho- Those who hold that physicians should partici-
gens as offensive weapons knowing one s own sol- pate in military research answer the three  steps
diers are protected against them. Consequently this by (1) exploring the complexities that the militari-
research can be construed as a potential component zation argument overlooks, (2) maintaining that
of offensive strategy that would drive likely adver- existing safeguards preclude inevitable escalation,
saries into similar research programs and hence the and, thus, (3) there are no violations of law, moral-
escalation of a biological arms race. Therefore, ity, or ethics. Once again, I will discuss each in turn.
542
Medical Ethics in Military Biomedical Research
Militarization military biomedical research is perhaps the most
closely monitored, regulated, and inspected re-
Those who advocate participating in military bio- search that occurs within the United States. An ex-
medical research reject the militarization viewpoint haustive environmental impact review of the mili-
as confusing the primary aims of public health re- tary program was conducted in 1989 culminating
search versus the national defense interests and the with the publication of a final programmatic envi-
health of military personnel. If the NIH, for ex- ronmental impact statement (PEIS).21 Congressional
ample, were directed to accept the mission require- scrutiny is applied to this program in the annual
ments of a military-oriented medical research pro- budget review process. The military prepares re-
gram, this realignment of mission would hinder source requirements and program description and
NIH research in diseases of national interest. If NIH justification in the Congressional Descriptive Sum-
sought to contract this research, it would be no dif- mary that becomes part of the President s budget.
ferent from the current program with the exception The House and Senate Armed Services Committees
of civilian control. Some scientists advocate civil- evaluate this program and authorize its funding.
ian control because of a prevailing attitude of dis- These committees perform their own evaluations
trust of military-sponsored research. Some contend and review of the military program prior to any fi-
that it is ethical to participate with the military in nal authorization and appropriation of funds. The
times of national crisis but doubt that permanent General Accounting Office conducts periodic re-
association has any moral imperative. Advocates of views and hearings on the appropriateness of the
a military program counter this claim with evidence research and the use of resources consistent with
of the proliferation of biological warfare capabili- the aims and intents of the program. Special inter-
ties even by some countries who signed the BWC. est groups, using the Freedom of Information Act,
As long as activities of Third World countries re- gain access to both research data and laboratories
main unpredictable regarding their intentions in on a routine basis. The public and scientific com-
offensive biological capabilities, a credible biologi- munity can and do act on their own initiative to
cal defense research program is needed. review military research. Finally the military pro-
This point is particularly relevant given that the vides reports annually to the United Nations and
United Nations revealed in August of 1995 that Iraq to the Biological Weapons Convention. Conse-
had an active offensive biological and chemical quently, rather than view this research as some se-
weapons program.20 For over 4 years, Iraq had hid- cret, clandestine program that could mask offensive
den all information of a program to produce and research or increase the paranoia of a potential ad-
deploy almost 200 biological warheads in bombs, versary, participationists contend the opposite
artillery shells, and missiles, all capable of reach- that a completely open program, to include pub-
ing Saudi Arabia and Israel during the Persian Gulf lishing in peer-reviewed journals, serves a function
War. The bacterium anthrax was loaded in at least of deterrence (the use of an agent would have little
50 bombs, and botulin the toxin causing botu- or no strategic or tactical military advantage) and
lism had been loaded into approximately 100 hence stability.
bombs. Additionally, Iraqi scientists grew a poison-
ous fungus found on peanuts and corn to produce Violation
aflatoxin, to be used as a warfare agent.20
Consequently, advocates of biomedical military Advocates of military biomedical research dem-
research contend that given examples such as Iraq, onstrate the legal aspect of their work based upon
participation by university and industry is consis- the research conforming to regulations and stan-
tent with an ethical imperative of developing the dards of the following agencies: the US Department
means by which the United States can protect and of Agriculture, Department of Health and Human
defend the lives of military personnel against a con- Services, Food and Drug Administration, National
sistent threat of a potential adversary that threat- Institutes of Health, Public Health Service, Centers
ens its national security. for Disease Control, Department of Labor, Depart-
ment of Transportation, Environmental Protection
Escalation Agency, Department of Energy, Department of
Commerce, and the Nuclear Regulatory Commis-
The participationists espouse the view that what- sion. Proponents of military medical research con-
ever potential may exist for creating offensive ap- tend that this research is consistent with the intent
plications from defensive research (the escalation of the BWC, particularly Article X that gives States
factor), the possibility is extremely minute because that are Parties to the Convention the right to par-
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Military Medical Ethics, Volume 2
ticipate in the fullest possible exchange of informa- tary biomedical research, as beneficial as it might
tion, equipment, and materials for peaceful purposes. be to military personnel with subsequent civilian
Finally, regarding the alleged ambiguity of offen- applications, by its nature creates significant risks
sive and defensive research, supporters of military for local civilian populations and hence ought to be
biomedical research hold that there is an empirical prohibited. The solution to this vexing problem again
distinction that separates offensive from defensive hinges upon some kind of risk and benefit analysis.
research.17 Citing the regulatory controls over this Dispute currently exists about what risks are
research, participationists contend that the likeli- worth taking when pursuing research. These risks
hood of a rogue scientist developing an offensive include potential harm to research subjects, non-
capability under the guise of defensive research is research subjects, and the researchers themselves.
highly suspect. Additionally, advocates of this re- Identifying risks to research subjects (participants)
search point to the historical record to substantiate requires formulating risk and benefit equations as
the benevolent aspect of their work the marked discussed previously. These risks are different from
decrease in morbidity and mortality of soldiers de- the kind that populations at large face from poten-
ployed to combat zones. Participationists contend tial accidents or sabotage. Furthermore, the public
that those who doubt the defensive intent of their has demonstrated resolve to protect itself from such
work can only talk of the potential to create offen- risks.22 25 Based on the principle of justice, current
sive uses of biomedical advances or the possibility ethical practices in research require a fair and equi-
that military could develop offensive capabilities table distribution of burdens and benefits. When the
or future hypotheticals for offensive development. issues of human subject research in the military are
Meanwhile, countries like Iraq continue to demon- in question, if the risks are disproportionate to the
strate a resolve to blatantly ignore international benefits then there would be grounds to ethically sus-
agreement to limit the development and use of bio- pect the conduct of the research.
logical warfare agents, and worse, in doing so see Risks to nonresearch participants include the is-
themselves gaining a military equalizer to imbal- sue of public safety. Several aspects of military
ances of their conventional military capability. Cur- medical research, particularly in the area of infec-
rently, there is little evidence to support the fears tious disease, pose at a minimum a potential pub-
of the nonparticipationists regarding the legal as- lic health threat in the event of a laboratory acci-
pects of military biomedical research. The ethical dent. The issue of public safety revolves around the
concerns remain in doubt, however, regarding the idea of real versus perceived threat that the research
consistent application of law and ethics to military poses to public health. Nonetheless, there have been
biomedical research in the future. several challenges to military medical research
projects being conducted at university labs as well
National Risk vs National Security as government facilities. How much risk is ethically
acceptable must be mitigated against the potential
Whether the merits of the contrasting views of harm to an unsuspecting or, worse, uninformed lo-
militarization, escalation, and violation are persua- cal population. Finally, there is also the question of
sive depends upon one s first principle the ethical how much risk is acceptable for the researchers
standard one holds as dominant over other principles. themselves. For example, should a lab worker work-
To date, there is little in the professional literature ing with virulent anthracic cells drop the flask con-
of ethics demonstrating how traditional ethical taining the cells on the floor, the infected lab worker
principles apply to the dual nature of military medi- could be treated with penicillin. The spill would be
cal professionals. Although the literature does dis- treated with chlorine bleach that would kill the cells.
cuss the social responsibility of medical profession- Hence, the issue of public risk versus military ben-
als to include medical scientists, there is, in fact, efit is mitigated by the ability to conduct risk and
very little to clarify the competing duties of the benefit analysis.
uniformed medical professionals to the military, to Having said all this, the general principle of pro-
society, and to their patients. Thus far this discus- hibiting research that poses unacceptable risk (and
sion has focused on the competing nature of the the operative word is unacceptable) has merit. There
duty of military medical professionals between their is a trade-off regarding the perceived risks and the
patients and society but only from the standpoint reasonable precautions or likelihood of there being
of preserving the ethical integrity of the healing a real threat to a community, particularly from mili-
professions. Another aspect to consider is that mili- tary biomedical research. Currently, all biomedical
544
Medical Ethics in Military Biomedical Research
research protocols conducted by the military un- cal personnel to verify the lethal or nonlethal aspects
dergo intense scrutiny at all levels of institutional of the weapon. This is the case with recent studies
review for scientific merit, protection of research in the development of nonlethal microwave weapon
subjects, and safety. The application of the risk prin- technology that has a lethal capability. Such an ex-
ciple applies to the entire research community, not ample poses a more vexing issue for the biomedi-
just the military.26 Consequently, the question be- cal researcher who may be participating in research
comes one not about the moral legitimacy of mili- that has no benevolent goal, even if one argues that
tary biomedical research but one of inherent risks, a nonlethal incapacitating weapon is benevolent
in magnitude far greater than civilian research so versus a lethal weapon. Using medical knowledge for
as to limit or prohibit its conduct. the purpose of causing harm, for instance to vali-
date that a particular weapon has capacity to kill
Summary or maim in order to increase the capacity of that
weapon to do so, is simply the wrong use of medi-
There seems to be a prevailing attitude among cine and medical research, because it turns the
certain scientific circles that if the military is fund- medical researcher into a weapons developer. Fur-
ing research, there must inherently be something thermore, such an example clearly demonstrates the
nefarious about its conduct. The military has contrib- point regarding the issue of social responsibility and
uted to this perception in the past by conducting the consequences of research. No person, operat-
unethical research. The lysergic acid diethylamide ing in any capacity, ought to be compelled to act in
(LSD) studies (which were discussed in detail in such a way as to violate personal conscience or moral
Chapter 17, The Cold War and Beyond: Covert and obligations. Nor should medical professionals use
Deceptive American Medical Experimentation) for medical knowledge for the expressed purpose of
example, are clearly unethical judged by the stan- endangering or destroying life.
dards of the day regarding the lack of informed Indeed, there are two parallel issues that emerge
consent from research subjects. Even though these regarding the ethical legitimacy of biomedical re-
experiments were not medical protocols, military search. Returning to the principle of  do no harm,
medical research tends to be painted with the same there is a distinction to be made between research that
broad brush of suspicion based upon a lapse of ethi- has benevolent ends and research that has nonben-
cal judgment from the past. evolent ends. Medical professionals ought to stay in
There is a line, be it distinct or vague, between the business of healing and not hurting, which in-
justifiable and unjustifiable biomedical research and cludes not participating in or contributing to weap-
the use of these data for purposes that violate the ons research and development. However, there is
integrity of the medical community. Such a possi- also a need to establish a clear distinction between
bility exists for all medical data, not just data from offensive and defensive goals within the realm of
military medical research.27,28 More problematic are biomedical military research. Even though this is
those protocols designed in other than biomedical not an ideal world, preserving the ethical integrity
programs that require the participation of medical of biomedical research and providing for the wel-
personnel to validate the data. For example, while fare of military personnel ought not be competing
enhancing the lethality of a particular weapon, de- or mutually exclusive goals. Both can be done and
velopers may request the participation of biomedi- both should be done.
THE ETHICAL CONDUCT OF RESEARCH
 Research is a complicated activity in which it is infamous Tuskegee syphilis studies and the more
easy for well-meaning investigators to overlook the recent revelations of radiation studies conducted by
interests of research participants to the detriment of the US Department of Energy (discussed in Chap-
the participants, scientists, science, and society. 29(p1) ter 17 of this volume), breaches in conduct exist.
Upholding the ethical principles of biomedical re- Such conduct has led to the promulgation of the
search is part of the intricacies of the entire research Nuremberg Code, The Declaration of Helsinki, the
enterprise. The breaches of ethical principles, be Belmont Report, and a host of federal regulations
they intentional or unintentional, are replete in the in an attempt to provide clear guidelines regarding
historical literature.30 34 From the Nazi doctors (dis- the ethical conduct of biomedical research.
cussed in Chapters 14 and 15 in this volume) to the These efforts notwithstanding, while scientific
545
Military Medical Ethics, Volume 2
research continues to produce substantial social 3. Identification of consequences: a risks and
benefits, it continues to pose vexing ethical ques- benefits analysis must be conducted. Ethical
tions regarding the protection of human subjects, research adjusts procedures to ensure privacy,
the use of nonhuman animals, and expanding study confidentiality, minimized risks, and maxi-
populations to include women and minority groups. mized benefits;
Military biomedical research is not immune to these 4. Selection of subjects: the subjects must be ap-
questions. Hence there is a need to consider how propriate for the purposes of the study, rep-
each of these issues impact, in an ethical sense, the resentative of those who will benefit from the
conduct of biomedical research in the military. research, and appropriate in number;
5. Voluntary informed consent: voluntary
Criteria for Conducting Ethically Responsible means freely, without threat or inducement.
Research Informed means the subject knows what a
reasonable person in the same situation
The National Commission for the Protection of would want to know prior to granting con-
Human Subjects in Biomedical and Behavioral Re- sent. Consent means an explicit agreement to
search conducted hearings on the ethical problems participate; and
in human research from 1974 to 1977. The mission 6. Compensation for injury: the researcher is re-
of this panel as outlined in its summary statement, sponsible for what happens to a research sub-
was, in part, to ject. Federal law requires that subjects be in-
formed regarding compensation for injury,
conduct a comprehensive investigation and study but the law does not require compensation.
to identify the basic ethical principles that should
underlie the conduct of biomedical and behavioral
The application of the general principles and
research involving human subjects.8
norms stated above often narrow specifically to
three fundamental requirements: (1) informed con-
The recommendations of the panel were later codi-
sent, (2) risk and benefit assessment, and (3) the
fied into public law.35 The fruit of the National
selection of subjects of research. Of these three areas,
Commission s labor appears in The Belmont Report.8 informed consent (deriving from the Nuremberg
The three basic principles, intended as succinct
Code, 1947) is the most contentious regarding the
guidelines to govern the use of human subjects in
use of soldiers as subjects in research. Why is in-
research, include8(PartB):
formed consent important? What does it entail? Is
consent different from mere approval? The answers
1. Beneficence: maximize the good outcomes
to these questions are found in the federal regula-
while avoiding or minimizing unnecessary
tions written to address these situations.
risk, harm, or wrong;
2. Respect: protect the autonomy of persons,
Informed Consent
with courtesy and respect for individuals as
persons (as ends in themselves and not mere
Although the importance of informed consent is
means); and
generally unquestioned,36,37 there is controversy
3. Justice: ensuring reasonable, nonexploitive,
over whether it is possible to actually obtain truly
and carefully considered procedures and their
informed consent from a research participant. Gen-
fair administration fair distribution of risks
eral agreement exists regarding the three basic ele-
and benefits among persons and groups.
ments in the consent process: (1) information, (2)
understanding, and (3) voluntariness. The aspect
These three principles are the foundation for the
of information requires full disclosure by the inves-
following six norms that govern the ethical conduct
tigator including a statement of the purpose of the
of research29(p19):
research, description of foreseeable risks and dis-
comfort, description of benefits, a disclosure of al-
1. Valid research design: valid design yields cor- ternative procedures, statement regarding confiden-
rect results taking into account relevant tiality of the records, explanation of compensation
theory, methods, and prior studies; and medical treatment for injuries resulting from
2. Competence of the researcher: the investiga- participation, a point of contact regarding the rights
tor must be capable of conducting various of the research volunteer, a statement regarding the
procedures in a valid manner; voluntary nature of the participant, and any addi-
546
Medical Ethics in Military Biomedical Research
tional information regarding the findings of the re- tive exists for subjects to participate in research. At
search, withdrawal criteria, or circumstances by some juncture the potential exists to cross the line
which the investigator can terminate the participa- from benefits and appropriate incentives to decep-
tion of the research volunteer. tion and coercion. If this aspect of  mitigated coer-
How well a research subject understands or com- cion associated with medical research cannot be
prehends information relevant to the research is justified, then the use of soldiers in biomedical re-
dependent upon a number of factors. Because com- search is unethical.
prehension is often a matter of how the investiga-
tor conveys information to the research volunteer, Is It Ethical to Conduct Research on Soldiers?
the investigator needs to tailor the informed con-
sent process to each individual based upon the There are several issues at stake in what amounts
subject s intelligence, maturity, language level, and to the fundamental question of this section. First,
other special aspects of the participant. If necessary, and perhaps foremost, is the issue of the ethical sta-
a third party is part of the process to assess the un- tus of soldiers. When a person joins the military,
derstanding of the research participant. Printing the individual incurs unique obligations to the
consent forms in the native language of the subject country and to other service members. These obli-
may be necessary as well as providing interpreta- gations cause a shift in the ranking of usually ap-
tion for those subjects who may not be able to read plicable ethical priorities. By joining the military,
the consent form. On the face of it, using a subject individuals implicitly agree to subordinate their
who cannot read a consent form sounds, in and of autonomy for the sake of accomplishing the mili-
itself, ethically suspect. Such practice is acceptable tary mission. Service members also agree, implic-
regarding children and may be acceptable in other itly, to risk personal injury or loss of life if need be
instances as well. The key component is the aspect in compliance with lawful orders of their superi-
of comprehension. Regardless of how the informa- ors. This implicit consent applies not only in direct
tion is conveyed and the level of comprehension warfare but in preparations for war as well. None-
obtained, investigators are responsible for ensuring theless, even though service members voluntarily
that the subject comprehends all the information. allow themselves to be treated as a means in some
The aspect of voluntariness of consent that dif- instances, the military has an obligation to protect
fers from mere approval is the element of rights the interests and welfare of soldiers consistent with
conveyed upon the volunteer in the consent pro- accomplishing the military mission. The extent to
cess. This element requires conditions free from which this reciprocal relationship functions varies
coercion and undue influence. in times of peace and war, and the willingness to
protect the autonomy of soldiers is mitigated in di-
Coercion occurs when an overt threat of harm is
rect proportion to the perceived threat to national
intentionally presented by one person to another
interests.
in order to obtain compliance. Undue influence, by
Although service members subordinate autonomy
contrast, occurs through an offer of an excessive,
relative to accomplishing a wartime mission, this
unwarranted, inappropriate or improper reward or
does not mean that individual autonomy should be
other overture in order to obtain compliance.8(PartC)
compromised regarding medical research even
Perhaps the least understood aspect of gaining in- medical research that has direct impact on soldiers
formed consent is the communication process that and the military mission. With regard to medical
takes place between the investigator and the research research, soldiers are still entitled to full autonomy
subject. Failing to understand the nuances of body and due the requisite consideration regarding their
language, general attitude and friendliness, or gen- use in research as that provided to civilians. Con-
eral empathy for the research subject are some fac- sequently, the DoD policy for the conduct and re-
tors that can contribute to the perception of coercion. view of human subjects research, which applies to
The aspect of voluntariness is absolute concern- all elements of the DoD and its contractors and grant-
ing informed consent in the same way that informed ees,  requires that the fundamental rights, welfare,
consent is absolute to the conduct of ethical re- and dignity of human subjects in DoD-supported
search. Consequently it is reasonable to ask whether research be protected to the maximum extent pos-
soldiers can ever provide true voluntary consent. sible, and establishes this as a responsibility of the
The aspect of coercion is problematic in that an ele- military chain of command. 38(p9)
ment of coercion tends to exist in research on a slid- The Department of Defense adheres to all pro-
ing scale. That is to say that some element of incen- tections established by the federal government to
547
Military Medical Ethics, Volume 2
include: Department of Defense 32 CFR 219; Depart- faction of knowing they are making a unique con-
ment of Health and Human Services 45 CFR 46; the tribution to the welfare of other soldiers. Many see
Food and Drug Administration 21 CFR 50 and 56; their efforts as a unique sacrifice and service to their
and Department of Defense 10 USC 980, which re- country, and these soldiers view their participation
quires: (a) the informed consent of the subject in as voluntary. The military maintains a database of
advance; or (b) in the case of research intended to the names of all its test subjects participating in
be beneficial to the subject, the informed consent greater-than-minimal-risk studies for 75 years. The
of the subject or legal representative of the subject requirements of the protocol approval process for DoD
is obtained in advance. In essence, if an individual biomedical research preserves the key aspects of au-
cannot give his or her own consent, investigators tonomy and informed consent in times of peace and
cannot enroll the person into a nontherapeutic (ie, war. Consequently it appears that these individuals
of no benefit to the subject) study. Quite simply, the voluntarily concede their autonomy by virtue of be-
answer is  no to the question  Are there ethical ing in the military, that such concession of autonomy
exceptions for military medical research? concern- is justifiable, and the spirit as well as the intent of the
ing the corpus of historical and contemporary informed consent process is not compromised.
guidelines of medical research (levels of risk,
Practicality and American Moral Ideals
voluntariness, informed consent).
As straightforward as this analysis seems to be,
The voluntary consent of the human subject is ab-
given the DoD s own stated policy, there is still con-
solutely essential. This means that the person in-
siderable concern over the application of these stan-
volved should have legal capacity to give consent;
dards particularly in the area of informed consent.
should be so situated as to be able to exercise the
There are those who may argue that given the coer-
free power of choice, without the intervention of
cive nature of the military, soldiers are incapable of
any element of force, fraud, deceit, duress, over-
providing voluntary consent in the purest sense of
reaching, or other ulterior form of constraint or
the term. If this is the case, and unless there are jus- coercion; and should have sufficient knowledge
and comprehension of the elements of the subject
tifiable exceptions to the ethical criteria for military
matter involved as to enable him to make an un-
medical research, then it would be unethical to use
derstanding and enlightened decision.& The duty
soldiers as research subjects. Is it necessarily true
and responsibility for ascertaining the quality of
that simply because the military is inherently coer-
the consent rests upon each individual who ini-
cive that soldiers lose their autonomy and hence the
tiates, directs or engages in the experiment. It is a
ability to provide voluntary informed consent?
personal duty and responsibility which may not be
First, it is necessary to understand that soldiers
delegated to another with impunity.40(Art1)
have the desire to participate in military biomedi-
cal research. In fact, some soldiers volunteer to be The Nuremberg Code makes no distinction be-
part of a unique program designated specifically tween peacetime and the exigencies of war regard-
for use as research volunteers.39 These soldiers are ing the requirement for informed consent of an in-
recruited directly from their advanced individual dividual prior to participating in research. This
training programs for the sole purpose of volun- point is particularly troubling given the findings of
teering for various biomedical research protocols. the Advisory Committee on Human Radiation Ex-
Even though these soldiers need never volunteer periments,41 a panel created by the Clinton Admin-
for a study during their tour of duty with the Mili- istration to investigate reports of unethical and pos-
tary Research Volunteer Program, their mere par- sibly life-threatening experimentation on human
ticipation makes them vulnerable to exploitation subjects. The Committee discovered that tens of
and the military needs to guard against the poten- thousands of service members were exposed to ra-
tial for abuse. Nonetheless, many soldiers do vol- diation in research without their consent.
unteer by choice for a variety of studies based on The examples of the radiation research42 and the
the written protocol that describes the research infamous LSD43 studies occurred prior to the rigor-
methodology and possible side effects of the study. ous screening and protocol review process of today.
More importantly, these soldiers may withdraw Moral hindsight allows the privilege of criticizing
from any study, at any time, without fear of reprisal and, when necessary, condemning immoral prac-
from their superiors or the investigators. tices of the past. Nonetheless, the radiation experi-
For many of these soldiers, participating in medi- ments and LSD studies conducted on military per-
cal research is a matter of pride and the self-satis- sonnel without their informed consent did occur
548
Medical Ethics in Military Biomedical Research
after the adoption of the Nuremberg Code of 1947 asphyxiation. Additionally, Iraq was known to have
and the top-secret rules adopted by the DoD in an arsenal of biological weapons that work by
1953,44 which required researchers to inform human spreading disease. Anthrax and botulism are typi-
subjects of health risks associated with radioactive, cal biological agents that can be delivered on the
chemical, and biological warfare experiments.45 battlefield by bombs, missiles, and rockets.
There is no ambiguity in the requirements of the Prior to commencing Operation Desert Storm
Nuremberg Code regarding voluntary consent. (ODS), the combat phase of the Persian Gulf War,
Consequently, the researchers involved in these the DoD sought and obtained a one-time waiver of
protocols failed in their duties and responsibilities informed consent requirements (known as Rule
owed to the victims of their research. 23[d]) for the use of investigational drugs and vac-
As disturbing as these examples appear regarding cines on American forces serving in the Persian
the outright disregard for the rules and guidelines Gulf. The Food and Drug Administration (FDA)
of human research, they are clearly distinguishable defines investigational drugs as those not approved
from the more perplexing problem of trying to draw for use by the general public. Until 1987, the use of
distinctions between medical research and medical investigational agents was permitted solely for re-
practice and the need to determine whether mili- search purposes. The FDA modified this rule ap-
tary personnel have been treated as uninformed proving the use of investigational agents to treat
research subjects. The advances in medical technol- life-threatening conditions where no comparable
ogy and therapeutic treatments have blurred the drug or therapy is available. Changes not with-
distinction between therapy and research. This standing, the FDA requires physicians to obtain a
fuzzy line of demarcation applies in the military and patient s informed consent before using an investi-
has potential for ethical conflict as one seeks to pro- gational drug for therapy.46 In persuading the FDA
tect the rights of military personnel from unethical to waive their requirements on the use of investi-
practices regarding their use as human subjects. gational agents, the DoD argued that in the exigen-
cies of war obtaining solders informed consent was
The Persian Gulf War Experience  not feasible. 47 This case study highlights many
issues, the least of which includes where to draw
The history of research with soldiers demon- the line between medical practice and medical re-
strates a prevailing attitude that when a threat to search. The FDA approval of the informed consent
the nation s security appears imminent (as was the waiver rekindled discussion of how to make a dis-
case of nuclear war in the 1950s and the fear of ly- tinction between therapy and research but also
sergic acid diethylamide [LSD] use on American raised the specter of the Nazi doctors namely, did
personnel in the 1960s), the requirements of in- the DoD make guinea pigs out of US military per-
formed consent and review approval represent im- sonnel serving in the Persian Gulf War?48 52
pediments to national security the urgency of the There are two basic positions regarding the use
situation demands the conduct of these studies. of investigational drugs and the informed consent
Such a rationale has been used to justify egregious waiver approval as it applied to military members
abuses of autonomy and respect for human welfare during the Persian Gulf War. The major point of con-
in clear cases of research when such a defense is tention hinges on whether the use of investigational
unjustifiable. agents by the military in this one-time occurrence
The Persian Gulf War added a new dimension to constitutes medical research or medical treatment.
the issue of protecting military members not only Presumably if the intended use is for research, the
from abuses of research mentioned previously but waiver is unethical as opposed to medical treatment
from the imminent prospect of facing chemical and where the exigencies of war provide justification to
biological weapons. Chemical weapons comprise a waiving consent with the purpose of protecting sol-
broad spectrum of devices that include lethal agents diers from chemical and biological weapons.
(nerve, blood, blister, and phosgene), incapacitat-
ing agents (so-called tear gas agents), smoke, and The Research Point of View
herbicides. Nerve agents, a particular threat from
the Iraqi arsenal, attack a person through the skin The first position contends that the military in-
inhibiting the action of the enzyme cholinesterase. tent for using investigational agents was to conduct
Inhibition of cholinesterase causes violent muscle medical research. Consequently, the Nuremberg
contraction in the victim with death resulting from Code would prohibit the use of these drugs on sol-
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Military Medical Ethics, Volume 2
diers who did not provide informed consent. More ing point for this discussion. According to the Re-
recently, the Department of Defense Authorization port, the term practice refers
Act (1985) also prohibits the military from conduct-
ing research on humans unless it has obtained the to interventions that are designed solely to enhance
the well-being of an individual patient or client and
informed consent of the subject in advance. This
that have a reasonable expectation of success. The
prohibition even extends to research intended to be
purpose of medical or behavioral practice is to pro-
beneficial to the subject. Consequently, those who
vide diagnosis, preventive treatment or therapy to
hold this position view the waiver of informed con-
particular individuals.8(PartA)
sent as patently unethical. A moderated position of
this view concedes the intent of the military as one
The term research, by contrast,
of medical practice but insists that in the use of in-
vestigational agents, even when there is evidence
designates an activity designed to test an hypoth-
that a derived benefit from their use exists, such a
esis, permit conclusions to be drawn, and thereby
benefit does not automatically transform what is
to develop or contribute to generalizable knowl-
experimental into therapy. If this were the case, then
edge (expressed, for example, in theories, prin-
the informed consent process could simply be cir-
ciples, and statements of relationships).8(PartA)
cumvented by redefining these activities. In either
case, the argument upholds the absolute of in-
The Report goes on to further clarify departures by
formed consent in research activities. Advocates of
physicians from standard or accepted practice, but
this view believe the use of investigational agents
such departures from standard practice do not, of
constitutes research. Therefore, the use of these agents
themselves, constitute research.
with a waiver of informed consent is unethical.
The fact that a procedure is  experimental, in the
The Practice Point of View
sense of new, untested or different, does not auto-
matically place it in the category of research.8(PartA)
Those who condone the waiver of informed con-
sent articulate a position that argues the use of inves- The use of investigational agents by the DoD for
tigational agents as a preventive treatment against preventive treatment against biological and chemi-
biological and chemical weapons is not medical re- cal warfare agents was new and untested. One of
search. The DoD was attempting to use these agents the agents, pyridostigmine bromide (PB), is ap-
in what was considered an immediate  life-threat- proved by the FDA for therapeutic use for a differ-
ening situation to protect the lives of military ent purpose than as a pretreatment chemical agent
members from the effects of biological and chemi- antidote. Consequently, the DoD was compelled by
cal weapons. This use is within the scope of the US law to file a new investigational drug application
Food and Drug Administration s (FDA) regulation for an already approved FDA drug. FDA approval
on investigational drugs.53 The principle of prevent- requires safety and efficacy testing in both animals
ing unnecessary harm (nonmaleficence) to military and humans. Safety and efficacy data exist in ani-
members overrides all other principles in this view, mal studies for PB use as a chemical agent pretreat-
even the prerogative of soldiers to make their own ment. Only safety data exist for this use in humans
decisions regarding medical treatment (autonomy). because efficacy testing would require exposing
Because the use of these agents was intended as a human subjects to a nerve agent. This activity is
preventive therapy and not research, and because unethical under existing human use review board
the military already has precedent to impose medi- standards. Therefore, the FDA cannot grant com-
cal therapies on military members to ensure mis- plete licensure for the use of this drug as a chemi-
sion accomplishment, the action regarding the use cal nerve agent pretreatment.
of investigational agents in this context was not At this juncture the issue becomes how to gain
viewed as unethical by the FDA or DoD leadership. approval to use these investigational agents even
though they lack full approval status. Having con-
The Distinction Between Research and Practice ducted risk-benefit analysis, given the best intelli-
gence data regarding the Iraqi intent to use biologi-
The Persian Gulf War example provided the op- cal and chemical weapons, and lacking any current
portunity to examine the conceptual distinction pretreatment standard of care for exposure to nerve
between medical research and medical practice. The agents, soldiers faced a greater risk from these
Belmont Report addresses this issue and is the start- weapons unprotected than they did from receiving
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Medical Ethics in Military Biomedical Research
the investigational drugs. Now the issue shifts to training and preparing for their wartime missions.
the appropriateness of requiring soldiers to take The success of small unit tactics depends upon unit
drugs known to be safe without the option of in- members being able to perform their assigned tasks
formed consent. The military could have allowed when called upon to do so. Unprotected soldiers
soldiers to take these drugs voluntarily. The DoD suffering injury from chemical and biological agents
argued, however, that to allow soldiers to refuse to become liabilities to the welfare of their unit mem-
take the drugs would needlessly risk their lives and bers when they are unable to perform their assigned
the lives of their protected compatriots: role. Ultimately, the success of the overall mission is
potentially jeopardized. If there is a derived benefit
Our planning for Desert Shield contingencies has
from taking these investigational agents and some
convinced us that another circumstance should be
members fail to accept this benefit, the negative ef-
recognized in the FDA regulation in which it would
fects of biological and chemical weapons not only
be consistent with the statute and ethically appro-
impacts on those members not protected but de-
priate for medical professionals to  deem it not fea-
grades the capability of the entire unit and ultimately
sible to obtain informed consent of the patient
the welfare of the other unit members. Although
that circumstance being the existence of military
some may argue that requiring military personnel
combat exigencies, coupled with a determination
to sacrifice their autonomy is morally indefensible,
that the use of the product is in the best interest of
the individual. By the term  military combat exi- such a sacrifice has justification based on the prin-
gencies, we mean military combat (actual or
ciple of duty.
threatened) circumstances in which the health of
the individual, the safety of other personnel and
Summary
the accomplishment of the military mission require
that a particular treatment be provided to a specified
The protection of military personnel from the
group of military personnel, without regard to what
inherent risks of medical research and from inno-
might be any individual s personal preference for no
vative, new, and unproved practice is of paramount
treatment or for some alternative treatment.47
importance. Those who serve in defense of their
The Dilemma of Choice country have a heightened sense of duty to their
comrades-in-arms and to the nation. Those who
Earlier in this discussion the conclusion was drawn exercise command authority over military person-
that there are no exceptions to the right of informed nel have an obligation to protect the rights, dignity,
consent to participate in research. One can argue and autonomy of their subordinates to the extent
that even the use of a new, unproved therapy should possible without jeopardizing the military mission
not be imposed on soldiers without their consent. Can or the welfare of military personnel as a whole.
the Persian Gulf War example the use of unproved There exists an ethical framework and criteria by
therapy (given it is consistent with the criteria of which medical research can be conducted that pre-
The Belmont Report) provide a qualified exception serves the ethical status of military members. Mili-
in the context of actual or threatened combat? tary personnel have the prerogative to volunteer for
The basic responsibility of the FDA is to protect research and to deny them this privilege can poten-
the American public (to include military members) tially violate their personal autonomy. The experi-
from unsafe and ineffective drugs. A problem arises ence in the Persian Gulf War and Rule 23(d) illustrates
when a drug passes safety testing but criteria for the difficulty of making choices that satisfy the de-
testing efficacy are beyond the bounds of ethical mands of competing ethical principles and the po-
conduct. Which is more harmful: (a) to withhold the tential for blurring the distinction between research
potential benefit or (b) risk facing the life-threaten- and therapy. Significant to the Persian Gulf War is
ing situation without protection? One might readily the need to acknowledge the risk associated with
answer that no protection produces a greater risk. the use of unproved therapies. When the DoD finds
Does that mean that the use of the drug is required it necessary to seek another waiver for the use of
or should soldiers be allowed to choose voluntar- investigational agents in times of war, careful and
ily? The answer to this question depends upon comprehensive study of military members who take
whether military members have a duty to subordi- these agents is a moral imperative. The mysteries
nate individual self-interest for the good of the of Gulf War illnesses suggest that the military
many. The success of a military mission depends should do a better job of obtaining information re-
upon unit cohesion, trust, and interdependence of garding side effects and illness that may stem from
unit members. Military units spend countless hours the agents themselves or effects of the agents com-
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Military Medical Ethics, Volume 2
bined with unique environmental exposures and tablished practices to informed consent exist, and
stress of the battlefield. Simply stated, the military military personnel later suffer from medical condi-
needs to devise a more effective method for record- tions linked to the use of investigational agents ad-
ing and sorting medical information on the battlefield, ministered without informed consent, then they
particularly when it requires waivers from standard ought to receive just compensation and the record trail
legal and ethical practices in medical research or to support such claims ought to be available, exigen-
therapy. This point suggests that if exceptions to es- cies of combat notwithstanding.
ETHICS AND THE ISSUE OF ANIMAL EXPERIMENTATION
More than the other topics of this chapter, the equality and rights of animals.54,55 The moral equal-
use of animals in research is as much a social and ity position advocates rights in the sense of human
political question as it is a philosophical one. With rights where it follows that the use of animals by
few exceptions the voices in this debate are volatile humans constitutes a moral wrong. The logical
and intractable, expressing virtually no hope of starting point to determine whether it is ethical to
reaching common ground or compromise. Conse- use animals in research begins by determining
quently it is imperative to examine the arguments whether it is ethical for humans to use animals for
with the intent of gaining understanding of the ethi- any purpose. Many critics of animal research assert
cal stakes from both sides of this debate. the right of nonhuman animals to be treated as ends
There exists the presumption that most people in themselves. If one holds the position that it is
want to  do the right thing regarding actions to wrong for humans to use animals for any purpose
fellow humans and nonhuman animals. With this then there is no moral distinction to make between
presumption comes the recognition of the value of justifiable and unjustifiable use of nonhuman ani-
biomedical research in advancing cures, treatments, mals in research. There is no middle ground, no
and prophylaxis enhancing quality of life (even basis for mediation, no common principle by which
though some opposed to animal research deny such antagonists in this debate can reach consensus.
value). Value is ascribed to medical research because Logical consistency demands that using animals for
of the good that it adds to human life. Advocates of food, clothing, sport, entertainment, and education
animal research support its practice because they also violates the so-called rights of animals. If, how-
view the value of human life greater than nonhu- ever, one concedes that not all uses of animals for
man animal life. One can hold this position with- human needs are unethical, the debate narrows as
out denying that nonhuman animal life has value, to why using animals in research is morally wrong
only that human life has greater value. As a soci- but other uses are morally permissible.
ety, however, the United States is becoming more
ambivalent over the use of animals to gain medical Animal Suffering vs the Primacy of Human Life
advances at the expense of nonhuman animals, using
lower animal life models or computer modeling as One might easily suggest, as many do, that the
alternatives. The source of this ambivalence may stem main problem with using animals in research is the
from emotionally charged rhetoric, or the desire to suffering inflicted upon them.56 Advocates for ani-
be more sensitive to creatures who can experience mal rights have framed the antivivisection debate
pain, suffering, and lost preferences, or possibly a as one depicting all animal research as cruel, un-
paradigm shift of viewing nature as a cosmic unity. necessary, and unscientific as opposed to distin-
This ambivalence might also stem from the realiza- guishing between the humane and inhumane use
tion that a concept of speciesism is valid in regard of animals. Hence the fundamental value argument
to the treatment of nonhuman animals, pricking in this context places the research community in a
moral consciousness beyond caring about the wel- position of upholding the primacy of human life
fare of animals to affording them rights. over animal life. If animals have moral equality with
humans then one cannot help but question, as do
The Moral Status of Animals many who favor vivisection, as to the matter of pri-
ority when defending the rights of animals on the
The position one chooses to embrace regarding issue of suffering. For example, the use of animals
the use of animals in research derives from whether for food and clothing probably exceeds biomedical
or not one has a fundamental belief in the moral research by higher than a thousand-fold. Further-
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Medical Ethics in Military Biomedical Research
more, the majority of animals used in research are animals that derive from their inherent moral worth.
mice and rats. This dichotomy or, less charitably, This argument requires a conceptual definition of
logical contradiction has led many people to con- inherent value. Antivivisectionists conceive (in
clude that animal research is merely a target of op- minimal properties) sentience, purposiveness, and
portunity an issue easily isolated from main- the capacity to feel pain to be sufficient to afford
stream animal use, namely hunting, domestic pets, animals moral status. One criticism of these crite-
and the food and clothing industries. ria is that they are not sufficient. The necessary trait
It is not possible to conclude, however, from the to confer moral status on a living entity is moral
preceding discussion that the use of animals in re- autonomy the capacity to make moral choices.
search and related suffering they might incur, is Because this trait is lacking in nonhuman animals
automatically justifiable simply because their use they deserve less or no moral consideration. One
for other purposes is condoned. Many animals have attacks this criticism by pointing out that humans
 expressed preferences and the ability to pursue lack, at various times, the capacity to function as
those preferences. Consequently animals should not moral agents (ie, a baby; a senile, demented, or re-
be treated as mere objects. Animal lives count for tarded person; a comatose patient) yet their moral
something as does their ability to feel pain and to value is still regarded. Likewise sentient animals
suffer. On balance one has to consider whether the should be afforded equal consideration and their
pain an animal might experience in research is jus- well-being should not be disrupted.58
tified given the magnitude of benefit derived. Hence If this argument is sound (if its premises are true
one returns to the question at hand: Are humans and the conclusion follows from the premises), then
ethically justified in the use of animals either in humans incur fundamental duties regarding their
general or specific instances, and if so, what ethical actions toward animals. These duties derive from
obligations apply to researchers who use nonhuman the respect or moral concern they are now obligated
animals in their research? Surprisingly, there ap- to afford to animals but are in conflict with the
pears to be no consensus among philosophers in consequentialist (utilitarian) view. A consequentialist
applying ethical theories to answer these questions. may well agree with the concept that animals have
There is indication, however, that even arguments moral worth but reject the absolute view of violat-
for complete abolition of animal research do not ing that worth when doing so maximizes the great-
completely exclude exceptions for valuing human est benefit balanced against the harm to an animal.
life as greater than nonhuman animal life.57 Most researchers are likely to be utilitarian in their
view of using animals in research. Even Peter
Application of Ethical Theory Singer, viewed by many as the founder of the ani-
mal rights movement, concedes the use of animals
The major ethical theories are versions of (a) te- as research subjects could be justified if it produced
leological or consequentialist views the basic more utility than disutility.54 His major claim is sim-
theory of this type is generally known as classic ply that it is wrong to give less consideration to the
utilitarianism or (b) deontological views focusing suffering of an animal than one would give to the
on the inherent rightness or wrongness of an ac- similar suffering of a human being. This claim does
tion irrespective of the good (bad) consequences not support the abolition of animal research. It only
that result from doing an action. Closely akin to the compels the researcher to demonstrate (from a utili-
deontological view is the rights-based account of tarian calculation) that the good to be derived from
moral obligation that emphasizes the notion of re- the animal s suffering outweighs the evil of the suf-
spect and justice that reflect upon a particular moral fering. If one accepts the aggregate benefit of using
judgment as right or wrong. Finally the contractarian animals for medical cures, especially when a particu-
view espouses ethical obligations forged from mu- lar protocol involves no pain to the animals, there
tual agreement of consenting parties who function can be little left to worry about in the utilitarian
as moral agents. calculation. One criticism of this view is that the per-
The animal rights proponent fundamentally ceived benefits of an experiment are in doubt until
opposes the use of animals by humans based on the after the experiment has run its course. If there is no
belief that animals have inherent value. If animals benefit, then only retrospectively can it be concluded
have inherent value (moral equality), then regard- that the animal s loss produced no aggregate benefit.
less of the good humans can derive from their use, This view still grants some moral status to animals
it is morally impermissible to violate the rights of and places an obligation on researchers to develop
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Military Medical Ethics, Volume 2
well-designed protocols using the lowest form of save human lives, then it would be justified in ei-
animal model suitable to validate the scientific hy- ther of Regan s principles to harm the animal, even
pothesis. Consequently one considers the welfare to the point of death, to produce the vaccine. There-
of animals without having to take the extreme po- fore, even someone like Regan, a complete aboli-
sition of an animal rights advocate. tionist of animal research, who advocates a moral
rights position, would have to concede that at least
A Definitive Rights Position some medical research with animals is morally per-
missible (justified).
Regan presents a clearly articulated position in
The Case for Animal Rights.59 Regan s position re- Summary
volves around a fundamental right the right not
to be harmed on the grounds that doing so benefits What is interesting about the preceding compari-
others. This position is in distinct contrast to the son of the utilitarian and rights positions is that in
classic utilitarian. Harm in Regan s view is the loss either case, whether one accepts the moral equality
of the capacity to form and satisfy desires. For any claim or subscribes to the view that humans have
living thing that can form and satisfy desires, the greater capacity to satisfy desires, both views jus-
ultimate harm is death the complete loss of one s tify at least some medical research. Consequently
ability to form and satisfy those desires. As to the the question then becomes a matter of deciding
issue of delineating a list of which animals are ca- which experiments are justifiable and which are not.
pable of forming desires, Regan is reluctant to This question becomes more a matter of oversight
 draw lines. He is quite satisfied that at least mam- and regulation than the outright prohibition of ani-
mals and birds have this desire but will admit that mal research. This debate has increased the burden
humans have this capacity to a greater degree than for scientists to justify their use of animals but in
other mammals and birds. Consequently, Regan so doing has benefited the animals and contributed
postulates that if four humans and a dog are in a to better science.
lifeboat that can support only four occupants, none In considering the proponent and opponent posi-
of the humans should be harmed because each tions of animal research the views can be summarized
stands to lose more than the dog. Regan calls this in the context of competing ethical theories and in-
scenario the application of the  worse-off prin- terests. From both a teleological and deontological
ciple. Because a human being s capacity to form and perspective there are reasonable arguments to jus-
satisfy desires is greater than that of any nonhu- tify the use of animals in research. Both perspec-
man animal, a human stands to lose more in death tives provide ethical principles by which to consider
than the dog. Harming any of the humans is any justification for animal research: comfort, well-
avoided because they stand to lose more than the being, pleasure, sentience, and purposiveness. Al-
dog. Peter Singer believes that this conclusion dem- though researchers may be able to move away from
onstrates an inconsistency in Regan s position.54 animal use with emerging technology, at least for
Regan also formulates a rule of action called the the present their use is still required. Hence the
 miniride principle. In this view, there is an at- question is less about the ethics of animal research
tempt to minimize the overriding of an individual s and more about the ethics in animal research. Re-
rights. In this way one is not using a utilitarian view searchers should use animals with good reason.
of aggregate happiness but rather is focusing on the Protocols must adhere to sound experimental de-
individual. Thus, in Regan s mind, utilitarian rea- sign and subscribe to the ethical and legal codes of
soning is avoided. The problem is that in applying conduct relevant to the care and use of animals in
the miniride principle the same conclusions are research. Most significantly, researchers must take
derived as when the principle of utility is applied. great strides to reduce the pain and suffering in-
Regan simply wants to emphasize focusing on the flicted on animals in the conduct of research. Finally,
individual and minimizing any overriding of the as a society there ought to be a commitment to de-
animal s rights as opposed to focusing the aggre- veloping alternatives to animal use when such al-
gate happiness produced by the principle of utility. ternatives will produce credible scientific results.
Critics suggest that Regan, in his formulation of Military research may present a problem regarding
these moral principles, fails to establish standards the development of alternatives to animal research.
that support the total abolition of animal research.60 One example is the need to conduct physiologic
Hypothetically, if it were known with certainty that studies regarding methods to combat biological
an experiment could produce a vaccine that would and chemical weapons. Data obtained from ani-
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Medical Ethics in Military Biomedical Research
mal studies indicated the safety and efficacy of the analysis does not support a complete prohibition
nerve agent antidote used by the US military dur- of animal research. Application of ethical parameters
ing the Persian Gulf War. Given that the goals of might well suggest that animal use in military bio-
military biomedical research are directly linked to medical research has greater justification than ci-
enhancing the well-being and reducing the suffer- vilian research as military research consistently
ing of military personnel, most Americans would aims at reducing significant human suffering and
accept the use of animals in this research as ethi- death produced by the weapons of modern warfare.
cally justifiable. Consequently, the issue narrows to In many instances, animal studies are the only way
defining how much animal use is justified in serv- to verify the harm that exists to military personnel
ing the aims of military biomedical research. To this from various weapons, but animal studies are also
end, military researchers face the same ethical con- necessary to study the effects of American weapon
cerns as civilian researchers in mitigating animal systems and military material on American person-
suffering for the benefits derived to improve the nel. To this end, military biomedical research needs
human condition. Ethical analysis provides guide- to consider the ethical requirements of conducting
lines to govern animal care committees for the hu- good science while considering the humane treat-
mane care and use of laboratory animals. This same ment and welfare of laboratory animals.
MILITARY WOMEN S RESEARCH PROGRAM
A national agenda is forming on women s health In the 1990s several programs were instituted to
that focuses on the previous lack of female subjects redress this problem.64,65 In 1994, the Congress es-
in research; the lack of funding for research of tablished the Defense Women s Health Research
women-unique diseases; the need to improve ac- Program (DWHRP) to  address the critical health
cess to healthcare for women; and the desire to im- and performance issues impacting women in the
prove preventive care for women. The problem of military. 65 There were two main components of the
specific data gaps related to women s health issues research programs: (1) those utilizing institutions
has already received national attention. The Gen- that are part of an agency or activity of the DoD or
eral Accounting Office issued a report in June 1990 other US military service department (the intramu-
demonstrating that despite federal policy dating ral program) or civilian institutions that would col-
back to 1986, women continue to be excluded in laborate with military institutions; and (2) those
biomedical research populations.61 As recently as utilizing agencies outside the government, both for
June 1994, the National Institutes of Health (NIH) profit and nonprofit, both public and private (the
issued new guidelines to enhance medical research extramural program).
standards to include more women and minorities The intramural research program solicited re-
in research studies. Not only are women and mi- search proposals in the following four areas: (1)
norities to be included but their subpopulations are major factors affecting the health and work perfor-
to be noted and numbered.62,63 mance of military women; (2) psychological and
The efforts to overcome data gaps created by pre- health issues resulting from the integration of
vious policies have significant relevance for mili- women into a hierarchical male environment or re-
tary women. The US military deployed nearly lated women and men living and working in close
40,000 women to Southwest Asia during the Per- quarters; (3) health promotion and disease preven-
sian Gulf War. Throughout this deployment signifi- tion; and (4) access to delivery of healthcare. The
cant female soldier health and performance issues extramural program solicited research proposals in
surfaced in the areas of occupational and environ- four areas related to the intramural research: (1)
mental health hazards, psychosocial and posttrau- operational effectiveness for mission accomplish-
matic stress illness, clinical safety and efficacy of ment; (2) health promotion and disease prevention;
licensed and investigational pharmaceutical and (3) psychological health and well-being; and (4)
biological products, and preventive health and sus- access to and delivery of healthcare. By fiscal year
tained duty performance. Similar to the civilian 1995 a total of 66 research programs had been
medical community, there are scant research stud- funded for the intramural and extramural pro-
ies of military relevance that focus on women- grams. Similar levels of research activity will likely
unique health problems and military women are continue well into the future to redress the prior
excluded disproportionately to their male counter- lack of research into issues pertaining to the health
parts as research subjects. of women serving in the military.
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Military Medical Ethics, Volume 2
THE PROBLEM OF EXCLUSION
Various articles have been written exploring the offered as a way of protecting minorities from these
problem of exclusion.66,67 The fundamental issue, past practices of exploitation. Thus the principle of
having already identified probable causes for a gen- beneficence is upheld in the sense that excluding
der bias in healthcare, is to recognize the ethical im- minorities from studies protects them from the pos-
perative for correcting recognized deficiencies. One sible harm of exploitation. This explanation fails to
aspect of ethical analysis is to determine whether consider that the harm of exploitation is a product
there exists sufficient ethical justification for a par- of failing to adequately inform the research subject
ticular practice, namely an exclusion policy toward of the inherent risks to research participation. In-
women in medical research and treatment protocols. formed consent is supposed to mitigate against ex-
Given the basis for biomedical research to obtain ploitation. The paternalism of  protecting minori-
generalizable data for improving health and treat- ties is a subtle form of unjust discrimination and
ment, one must ask whether exclusion practices applies protectively only in the case of nonclinical
violate the principle of beneficence. The application investigations. In clinical investigations, exclusion
of beneficence suggests that research practices and paternalism possibly deny minorities the ben-
should maximize benefit and minimize harm. To efits of the research. Hence, the real issue is not a
violate this principle the practice of exclusion must matter of  protecting minorities from harm but
cause harm or diminish expected benefits. Applying allowing them to participate as equals in the re-
this principle to the practice of excluding women search enterprise with full knowledge of the risks
from research protocols, several harms are evident. so they may also derive the benefits of the research
First, the physiological differences between men outcomes. Therefore, a practice of exclusion lacks
and women make it inappropriate to simply gener- ethical justification in relationship to the principle
alize findings from research conducted on male of beneficence.
subjects. For instance, a variety of male-only studies One must not judge too harshly the failure of the
for heart disease, cholesterol, and asthma medication position that exclusion protects minorities from
led to treatment alternatives actually detrimental exploitation in the research process. The backlash
to women s health. Even though one can argue the of Tuskegee and similar studies not only led to a
need for uncomplicated data from a homogeneous paternalistic view of protecting minorities but also
test population, this scientific requirement (or ex- caused a reluctance on the part of minority groups
pediency perhaps) does not justify conducting stud- to participate in the scientific enterprise. Both of
ies on all male groups. During the Persian Gulf War, these trends fail to uphold the principle of benefi-
female soldiers received the same dosage rates of cence. Additionally, the exclusion practice in seek-
pyridostigmine bromide, a nerve agent pretreat- ing to do good (granted a charitable interpretation)
ment antidote, as their male colleagues. Testimony violates the principle of justice. Current ethical prac-
during the Senate hearings on illnesses associated tices in research, based on the principle of justice,
with service in the Persian Gulf suggested physiologi- require a fair and equitable distribution of burdens
cal differences in men and women could affect safe and benefits giving people what they deserve
dosage levels for women causing various side-ef- (benefits) mitigated against the amount of their in-
fects and a possible connection to unexplained ill- volvement in the process (risk-taking). An exclu-
nesses in women who had served in the Persian sion practice cuts two ways in violating the prin-
Gulf War. Consequently, studies conducted with- ciple of justice. First, medical research is subsidized
out female test subjects may lack the very scientific with tax dollars. If a segment of the population fi-
merit the study was initially designed to support. nancially supports the research enterprise and then
These obvious harms aside for the moment, one cannot benefit from its outcomes, such a practice
explanation offered in the past to defend exclusion violates the justice principle. Likewise, if a segment
practices is that such practices actually prevent of the population benefits from research but does
harm to women and other minorities simply be- not accept the associated risks, be they physical or
cause they are minorities. The early history of bio- financial, this practice also violates the principle of
medical research in this country is replete with the justice. Consequently the requirement to expand
exploitation of disadvantaged groups as research protocols to include women satisfies both aspects
participants. The infamous Tuskegee syphilis study of the justice principle.
stands as a permanent fixture to these unethical Another consideration used to justify exclusion
abuses. Consequently, exclusion practices might be of women from studies is the possibility of a woman
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research participant getting pregnant during the Much is being done to correct the previous gen-
study resulting in harm to the unborn child (com- der bias in research selection. The military medical
monly referred to as unforeseeable teratogenic risk). research programs are expanding to cover women-
The principle of nonmaleficence (avoid causing unique problems associated with military duty and
harm) is the ethical principle ofttimes used in this job performance. Most notably perhaps was the cre-
defense. Military research protocols and the accom- ation of a DoD breast cancer research program in
panying informed consent require special counseling 1993. Congress directed the Army to execute a
for fertile women volunteers regarding the hazards breast cancer research program based upon a num-
of birth defects and miscarriage should pregnancy ber of factors. The major effort came from a highly
occur in the course of the study. Researchers funded visible lobbying effort by the National Breast Can-
on DoD dollars must inform women of the need to cer Coalition, a grass roots advocacy effort to eradi-
use birth control during the study. Pregnancy is of- cate breast cancer, seeking congressional funding
ten used as an exclusion criteria to withdraw for the breast cancer program at the National Can-
women subjects from a study. Given these condi- cer Institute (NCI). The US Congress responded by
tions, complete exclusion from the onset of a study directing $210 million to the US Army Medical Re-
may be too general and broad a practice. Even search and Development Command (which later
though precaution is clearly warranted to avoid became the US Army Medical Research and Mate-
potential harm to an unborn child (and one can riel Command) to create a breast cancer program.68
debate whether enforced contraceptive use is too The overall objective of this funding is to promote
strong a precaution), a real harm is created by sim- research directed toward reducing the incidence of
ply excluding women with the ability of conceiv- breast cancer, increasing survival rates, and improv-
ing children. The key to mitigating risk with fertile ing the quality of life of those diagnosed with the
women subjects is to determine the degree of risk disease. This program extends beyond the tradi-
each protocol actually presents to a developing tional military medical research mission and is in-
child the greater the risk, the more exclusive the dicative of the strides being taken to correct past
selection criteria could be for fertile women. Still practices. Still the lesson to learn is that it is neces-
this parameter need not mean total exclusion. Not sary to stay vigilant to uncover other biases in medi-
all fertile women are sexually active nor would be cal research and healthcare as yet undetected.
necessarily so while participating in a study. Finally, now that the research community is ex-
Past research practices of exclusion should not panding its horizon to include women-unique stud-
be construed as intentionally seeking to discrimi- ies, women must be willing to become active partici-
nate against women. The lack of enlightened sensi- pants in the research process. What must be guarded
tivity and thinking in this area is more likely attrib- against in the developing process of a women s
uted to convenience, saving money, simplifying the health agenda, however, is that whatever biologi-
design of protocols, and simplifying logistical re- cal and physiological differences might be discov-
quirements to accommodate both sexes during the ered do not become a means to perpetuate unjust
conduct of a study. The fact remains that there ex- discriminatory practices in employment and career
ists a gender bias in selecting research subjects and paths. This is perhaps unlikely, but a word of cau-
this bias is harmful to the welfare of women. Value tion is prudent when the study of environmental,
judgments have been made in American society physiological, and nutritional aspects of women s
about practices that cause harm they are unethi- health specifically related to military duty is begun.
cal. Hence because exclusion practices cause harm, Such differences, by themselves, ought not be used
or at least have been demonstrated to cause harm, to exclude women from such service. Instead, ways
exclusion practices are unethical. to solve these various problems should be explored.
CONCLUSION
The ultimate mission of military medical research not only for soldiers but for the greater society as
is to provide preventive and therapeutic products well. The US Army Medical Research and Materiel
for the welfare of the soldier. To this end military Command has been managing and administering
medical research must remain committed both in a targeted appropriations to the Department of De-
professional sense and an ethical one. Military fense from Congressional direction since 1992. Ap-
medical research is a noble enterprise with a long propriations totaling in excess of $1.1 billion for
history of significant contributions to healthcare, breast cancer, women s health issues, and other
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specified programs highlight key aspects of military among research participants, scientists from various
medical research with a clear vision committed to disciplines, consumer advocate groups, leading
ethical aims of improving quality of life. These pro- government, academic, and private organizations
grams are managed by skilled, multidisciplinary are all partnering to ensure unique issues and gaps
teams of military and civilian scientists and clini- in medical knowledge no longer exist. Expanding
cians. The National Academy of Sciences and the the opportunities for gender specific research is only
Institute of Medicine have participated in program one facet of the program that lends credence to the
reviews and development seeking to substantiate fact that times have changed and that program de-
the ethical and scientific credibility of these pro- velopment and funding target these specific gaps and
grams. These programs received strict review of remedy the failures of the past. The growth of mili-
Congressional oversight committees and are com- tary medical research is not only a good thing for the
mitted to public accountability in the investment military but for society as a whole. The growth of ethi-
of funds to address the research needs of targeted cal awareness toward the use of medical research for
diseases. the benefit of society and preserving the very core of
Unlike the past, stakeholder participation is at the healing professions caring, compassion, and the
the very heart of the implementation strategy of relief of suffering continues as a necessary and es-
these research programs. Open communication sential component of these research programs.
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