Military Personnel as Research Subjects
MILITARY PERSONNEL AS RESEARCH SUBJECTS•••
A key ethical issue in the use of military personnel as research subjects is whether individuals in the armed services are free to accept or decline participation in research. Voluntary participation has been recognized as an essential requirement for ethical human experimentation; it is the cornerstone of the Nuremberg Code, issued in 1947 as part of the prosecution of Nazi physicians. Some bioethicists have expressed concerns that military discipline, with its emphasis on following orders and the chain of command, may constrain an individual's ability to make uncoerced decisions about participation in research. It is not clear, for example, how participation in a research study differs significantly from other hazardous duties expected of military personnel.
Negotiating the balance between respect for individual autonomy and the needs of the military is more problematic when nations are at war. During World War II, the medical needs of the military were invoked to justify the experimental use of vaccines and drugs in military populations, as well as nontherapeutic research on conscientious objectors, orphans, prisoners, and the mentally ill. Nearly 60,000 American military personnel were recruited through "lies and half-truths" into secret tests of mustard agents (sulfur and nitrogen mustard) and Lewisite (an arsenic compound) (Pechura and Rall). In the Persian Gulf War of 1991, the military's decision to seek a waiver of its own regulations about informed consent for the administration of investigational drugs and vaccines to American servicemen and servicewomen prompted controversy between critics who condemned this deviation from the Nuremberg Code and supporters who argued that the principle of preventing unnecessary harm to military personnel made the decision necessary (Howe and Martin; Annas and Grodin). These issues, which have received little sustained analysis, require greater attention from bioethicists.
Historical Use of Military Subjects
Historically, the armed forces have provided both unique opportunities and special needs for the study of human health and disease. "He who would become a surgeon," observed the Greek physician Hippocrates, "should join the army and follow it" (Hume, p. 78). Early efforts in disease prevention and treatment reflected the practical concerns of maintaining military personnel in good condition. One of the earliest clinical trials involving human subjects was conducted by the Scottish naval surgeon James Lind (1716–1794), who administered six different treatments to twelve sailors suffering from scurvy, and observed the beneficial effect of oranges and lemons in recovery from the disease (Carpenter).
Traumatic injuries from guns and other weapons have provided distinctive opportunities for military physicians to study human anatomy and physiology. In the 1820s, American army surgeon William Beaumont investigated the process of human digestion in a live subject after his repeated efforts failed to close the gunshot wound to French–Canadian trapper Alexis St. Martin's stomach. Beaumont developed an employment contract with his research subject, who agreed to allow physiological experiments in exchange for room, board, and wages. Beaumont also persuaded the trapper to enlist in the U.S. Army, giving the physician more complete control of his subject and rendering St. Martin's "faithless absconding" subject to military law (Numbers).
The rise of experimental science and the germ theory of disease in the late nineteenth century increased experimentation involving human beings. The Medical Department of the U.S. Army expanded its efforts to control infectious diseases, the major cause of mortality in the military before World War II. All U.S. Army commanders were directed to cooperate with the Medical Department to secure volunteers for experimental inoculations or other medical investigations approved by the War Department (Dow). Both the British and the American armed forces conducted experiments with newly developed vaccines for typhoid fever and other diseases (Tigertt). The introduction of aviation and its rapid development after World War I accelerated military research with human subjects (Pitts).
Introduction of Participant Consent
The shift from therapeutic experiments to nontherapeutic research in the early twentieth century fostered more formal arrangements with research subjects. In 1900 Major Walter Reed and members of the U.S. Army's Yellow Fever Board adopted the first written agreements between research subjects and experimenters. The Spanish immigrants who participated signed contracts that described compensation for subjects (civilians received $100 in gold and an additional $100 if they contracted the disease) and identified some of the risks of participation (Lederer). American physicians working in the Philippines followed Reed's example; prisoners in Manila's Bilibid Prison signed agreements written in their own dialect for medical research studies (Chernin; Lederer). During World War I, some physicians continued the policy of having written agreements with American soldiers who participated in infectious disease research (Sellards).
The success of the yellow fever research gained public approval for human experimentation. Public reaction to the research-related deaths of Army nurse Clara Maas and two Cuban volunteers, however, led the surgeon general to suspend the Army's work on a yellow fever vaccine in 1902. Most published reports of military medical research emphasized the voluntary nature of participation. References to cash payments and better duty assignments raised questions about the pressures to volunteer. In principle, American military personnel, although required to undergo standard medical procedures to enhance their military fitness, retained the right to refuse participation in medical experiments (Johnson).
The advent of World War II spurred massive changes in the organization and funding of medical research. The Committee on Medical Research, part of the Office of Scientific Research and Development, sponsored clinical research projects on an unprecedented scale. Pressures to find solutions for military medical problems encouraged investigators to conduct numerous trials with human subjects. As historian David J. Rothman has observed, the arguments that were used to justify sending men into combat were also invoked to sanction the use of conscientious objectors and civilians—prisoners, orphans, the retarded, and the mentally ill—in nontherapeutic research for military needs.
The wartime research ethos continued into the Cold War era. Both military and civilian researchers increasingly used human beings in experiments with little regard for the principles of consent and voluntary participation elaborated in the Nuremberg Code, or in the regulations governing research adopted by the secretary of defense in 1953 but classified as top secret until 1975 (Annas, Glantz, and Katz). During the Cold War, some 250,000 men and women were exposed to radiation as part of state-sponsored nuclear testing in Nevada and the South Pacific. In the early 1950s the American military conducted indoctrination and panic studies on troops at atom bomb tests (Moreno). Between 1955 and 1967, the U.S. Army and the Air Force supported more than eighteen research projects on the effects of hallucinogenic drugs on human performance in the United States and Canada (Annas and Grodin). Many of the nearly seven thousand servicemen who participated in drug tests at the Army Chemical Center at Edgewood Arsenal, Maryland, apparently received little information about the risks they incurred as a result of their participation in lysergic acid diethylamide (LSD) studies. Army investigators similarly failed to inform the more than one thousand participants about risks they incurred in tests of various nerve gases (Downey).
Amid the public condemnation of the LSD studies and the exposure of large numbers of servicemen to harmful radiation in the race to develop an atomic arsenal, the U.S. Army, Navy, and Air Force revised policies for research involving military personnel. In 1972 the American military banned all tests of nerve gases involving human subjects, and in 1974 issued new regulations for research on military personnel. In 1983, U.S. Department of Defense Directive 3216.2, "Protection of Human Subjects in DoD-Supported Research," established a uniform policy for research involving human subjects throughout the Department of Defense. In addition to adhering to the regulations for the protection of human subjects of the Department of Health and Human Services, the guidelines charged the military chain of command to ensure that the fundamental rights, welfare, and dignity of human subjects be protected to the maximum extent possible (Winter). Research involving American military personnel received greater scrutiny in the 1980s (Howe, Kark, and Wright; Maningas). Some military research subjects have received compensation for injuries they sustained in tests conducted without their knowledge.
New Complications in Military Research
Biological and chemical weapons pose some special problems for military personnel. Nations have approached the search for effective protections against these weapons in different ways. Whereas the American military discontinued the testing of toxic chemicals on human beings, the British Ministry of Defense continued to test antidotes for nerve gases on volunteer soldiers. Critics of the experimental exposure of soldier volunteers to nerve gases have cited safety concerns, as well as doubts that soldiers were "capable of giving full and informed consent to participate in complex toxicological experiments" (Mason, p. 30). Other North Atlantic Treaty Organization (NATO) countries have conducted similar testing of protective gear and drugs against nerve gas and a wide variety of other chemical weapons.
The threat of chemical and biological weapons in the Persian Gulf War in 1991 led the U.S. Food and Drug Administration (FDA) to grant the Department of Defense's request for a waiver of federal informed-consent regulations for administering investigational drugs and vaccines to troops stationed in Kuwait. Although the threat of chemical weapons did not materialize, the successful waiver of informed consent raised distinctive issues for military physicians. In the absence of informed consent, should a military physician follow orders and administer an investigational drug? Another related question for the military physician is whether his or her primary responsibility is the welfare of an individual patient or the success of a military mission (Howe; Annas).
Issues posed by research on military personnel are complex. As bioethicist George Annas has argued, these issues require critical attention in peacetime, since they are "not susceptible to rational analysis in wartime" (Annas, p. 773).
susan e. lederer (1995)
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