codes of ethics, ethics, history, informed consent, research subjects



  1. Layman, Elizabeth J. PhD, RHIA, CCS, FAHIMA


Health care supervisors and managers may participate in ethical discussions and serve on ethics committees in their health care organizations. To aid them in their participation and service, this article expands upon the knowledge of ethics that they obtained in their academic training. The article provides readers with a common language based on frequently cited cases and key documents. The article traces a brief history of human experimentation, describes ethical breaches in the United States, and summarizes key documents guiding current thought on informed and voluntary consent. The article concludes with 3 common misconceptions that health care supervisors and managers will want to avoid in ethical discussions and ethical decision making. Health care supervisors and managers will be prepared to meaningfully contribute to the discussion of ethical issues and to the resolution of ethical problems in their health care organizations.


Article Content

THIS ARTICLE PREPARES health care supervisors and managers to contribute to discussions of ethics in their health care organizations. Representing a variety of backgrounds, these health care supervisors and managers will be able to participate in the processes of their organizational ethics committees. Unfortunately, history demonstrates that ethical behavior cannot be assumed. Moreover, technology is advancing faster than our philosophical understanding of its implications. Thus, in academic curricula, the history of ethical breaches may be abbreviated to discuss current topics with the intention of preventing future breaches. The breadth and depth of historical discussions may be only the origins of informed consent, such as the Nuremberg Code1 and the US Public Health Service Syphilis Study, more commonly known as the Tuskegee Syphilis Study.2 To emphasize the need for continued attention to the study of ethics and ethical codes, this article expands upon health care personnel's academic preparation in ethics.


The study of ethics is an element in the health disciplines' academic curricula. This study is often mandated by the accrediting standards for academic programs (Figure 1). These accrediting standards use terms and phrases, such as ethics, professionalism, professional standards, professional ethics, ethical practice, and professional values.

Figure 1 - Click to enlarge in new windowFigure 1. Representative examples of curricular standards on ethics.
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The health disciplines have ethical codes. The establishment of these codes has evolved over time, with the Hippocratic Oath of medicine being the first. The ethical codes of nursing and allied health have emerged with the professionalization of these disciplines. The health disciplines' professional associations maintain and apply these codes of ethics (Figure 2). These codes of ethics may also be known as codes of conduct or statements of ethics and professional conduct.

Figure 2 - Click to enlarge in new windowFigure 2. Representative list of ethical codes.
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In the health disciplines' academic curricula, the underlying principles of ethics and ethical codes are studied, such as justice, fidelity, honesty, and autonomy. Then, the individual standards of the codes are discussed with examples of modern-day behaviors, both appropriate and inappropriate. Common topics include obtaining informed consent, maintaining confidentiality, and applying models of ethical decision making. Finally, the study concludes with discussion of suitable courses of action for breaches of ethics within the structure of the professional organization.


Expanding this study and preparation, this article first traces a brief history of human experimentation. Throughout history, researchers have used human subjects to assess therapies and to advance medical knowledge.3 However, human experimentation, improperly conducted, is an ethical breach. Specifically, ethics are breached when researchers experiment on humans without their knowledge or informed consent. Second, the article through a review of the literature provides information about human experimentation in the United States. Frequently cited cases of ethical breaches in the use of human subjects are summarized. Many of researchers who conducted unethical experiments on humans were physicians. Third, the key documents in the evolution of protections for US human subjects are described. Finally, the article addresses common misconceptions of which health care supervisors and managers should be aware during discussions of ethical issues in health care organizations.



Human experimentation is anything done to individuals to learn how it will affect them.4 The main objective of human experimentation "is the acquisition of new scientific knowledge rather than therapy."4(p164) Human experimentation is also differentiated from therapy because human experimentation may be conducted on healthy individuals, sometimes actually inducing disease.4 A form of human experimentation is self-experimentation or autoexperimentation. Self-experimentation is when researchers use themselves or their family members, colleagues, or students, as subjects.5


Human experimentation has a long history.4 To provide a general frame of reference, a few examples of human experimentation from history will be discussed. In Alexandria, in approximately 300 BCE, Herophilus both dissected and vivisected (dissections of living beings) humans to learn and teach anatomy.6-8 Theophanes, writing between 810 and 814 CE, described a human's vivisection.9 According to Theophanes, physicians in Constantinople had vivisected a prisoner from pubis to chest to understand anatomy and thus to improve treatment.9 In the early 1800s, Hamilton, a Scottish physician in the British Army Medical Department, described an experiment on bloodletting. The subjects of the 1809 experiment were 366 soldiers fighting in the Peninsular War in Portugal. In the experiment, Hamilton and another physician did not use bloodletting, whereas a third physician did.10



Human experimentation occurred in the United States, similar to its history in Europe and the Middle East. In the early and mid-1800s, few individuals expressed concern for the subjects of human experimentation. At the time, the emphasis was the glory of science and the "march of knowledge."11(p119) Concerns, though, about the ethics of human experimentation existed in the United States before World War II. For example, in 1916, the American Medical Association considered amending its ethical code to include a standard about human experimentation, such as requiring consent.5 However, this amendment was not adopted.5 In addition, court cases in the 1930s established the principle of informed consent, although the principle was not widely applied.12,13 Finally, some researchers believed that 2 conditions made human experimentation acceptable: prior experiments on animals and self-experimentation.5,14 However, many research studies in the United States did not conform to these conditions.5 Thus, prior to World War II, few formal guidelines existed for researchers conducting experiments on humans.5


The research on yellow fever has long been the ideal model for research on human subjects in the United States. Walter Reed and his 3 colleagues, Jesse Lazear, James Carroll, and Aristides Agramonte, conducted research on yellow fever in 1900 through 1901. In late 1900 and early 1901, the team investigated whether yellow fever was transmitted by mosquitoes. The team conducted a series of experiments on humans because earlier experiments on animals had been unsuccessful. In previous research, inoculating animals to infect them had failed many times.15 In August 1900, at Columbia Barracks, a US military base near Havana Cuba, Carroll and Lazear allowed mosquitoes to bite them.16 From this autoexperimentation, both developed yellow fever, Lazear's case being fatal on September 25, 1900.16 Agramonte was a Cuban scientist who had worked in Reed's research laboratory in the United States.16 He had acquired immunity to yellow fever as a child.15,16 Beginning in November 1900, Reed conducted a structured series of experiments at Camp Lazear, a quarantined research station on the Columbia Barracks.16 The 22 volunteer subjects consisted of 12 US Army personnel, 1 non-US Army personnel, and 9 recent Spanish immigrants to Cuba.15,16 Of the 22 volunteers, the 4 immune subjects were the control group and the remaining 18 nonimmune subjects were the experimental group. There were 4 series of experiments in which inoculations and mosquitoes were tested as means of transmission of yellow fever. The 4 series of experiments resulted in 14 cases of yellow fever; all the subjects recovered. In the United States, the yellow fever research is the ideal model for research on human subjects for 2 reasons. Animal experimentation preceded human experimentation, and contributing to the renown of the yellow fever research, some members of the team subjected themselves to autoexperimentation. Contrary to myth, Walter Reed did not subject himself to autoexperimentation.17 Reed did not inoculate himself because George Miller Sternberg, surgeon general of the Army, either ordered or strongly advised Reed not to experiment on himself because of his age of 49 years.15,16 Second, notably, Walter Reed obtained signed informed consent for the potential subjects. The subjects (or their designee in case of death) were paid $100 in American gold and an additional $100 in American gold should they contract yellow fever.15 Thus, since the early 1900s, the yellow fever research has been set forth as the standard in human experimentation. Finally, until the mid-to-late 1960s, the moral rectitude exhibited by the yellow fever researchers justified self-regulation of biomedical research and deterred its regulation.17


In 1966, in a pioneering article, Beecher18 questioned this moral rectitude. With the "enormous and continuing increase," 624-fold, in federal funding between 1945 and 1965, the number of experiments using human subjects increased after World War II.18(p1355) Beecher18 raised awareness that subjects were not informed of the risks and that many subjects were not even informed of their status as experimental subjects.18 Beecher's18 article cited 22 instances of ethically questionable human experiments, many at leading universities19. Beecher compiled his list of ethically questionable human experiments from published research. His original list had 50 instances, but for reasons of space, he reduced the list to 22 examples (Figure 3). The following chronology of selected human experimentation shows how researchers neither met the conditions of acceptability nor conformed to the ideal model set by the yellow fever research.

Figure 3 - Click to enlarge in new windowFigure 3. Beecher's list of unethical or questionably ethical experiments reported in the literature.
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1800s to 1920

Experiments on human subjects were conducted in the United States from its early history. Often, these experiments were conducted on persons of lower socioeconomic classes.11 Given society's acceptance of social classes in the 19th century, there was little criticism.11


Beaumont conducted several experiments on gastric and digestive physiology between 1823 and 1833.11 His subject was St Martin, a French-Canadian voyageur working in the United States. St Martin had been shot across the abdominal wall with a resulting chronic gastric fistula.11 Beaumont used the fistula to administer and insert various solutions and objects.11 He then observed physiological processes, such as digestion times.11 Expressing his dislike for his role, St Martin periodically disappeared.11 In 1832, to secure his experimental subject, Beaumont signed St Martin to a 1-year contract. Per the contract, St Martin was to "obey, suffer and comply with all reasonable and proper orders or experiments" for $150 and room, board, and clothing.11(p117) In 1833, St Martin went home to Canada, never to return to Beaumont's care.11 The difference in social status and wealth makes Beaumont's use of St Martin ethically questionable.


Between 1842 and 1846, Long, a physician, and Morton, a dentist, conducted experiments on humans. Working independently, they were each experimenting with potential anesthetic agents.20,21 In March 1842, Long removed a tumor from a patient's neck, successfully anesthetizing the patient with ether.20 Long did not publicize his experiment until December 1849, after reading several other writers' accounts of ether's use.20 In a letter to editor of the Medical Examiner, he explained that his "very laborious country practice" prevented him from publishing his findings earlier. In 1845, demonstrating at Harvard Medical School, Morton was unsuccessful in controlling a patient's pain while extracting a tooth.21 However, in 1846, at Boston's Massachusetts General Hospital, Morton successfully eliminated a patient's pain during neck surgery using sulfuric ether.21


J. Marion Sims is known as the father of gynecology.22 He invented a treatment for vesicovaginal fistula, a common condition in the 1800s.22 Vesicovaginal fistula is an abnormal tract between the bladder and the vagina caused by an obstructed obstetrical delivery. The abnormal tract allows urine to continuously flow into the vagina. From 1845 to 1849, Sims experimented on black slaves to develop his surgical treatment.23,24 The first surgeries were performed without anesthesia as the use of ether was still little known and controversial.24 One slave with both a vesicovaginal fistula and a rectovaginal fistula underwent 30 surgeries to repair the holes among the bladder, rectum, and vagina.24 In the 1850s and 1860s, Sims performed surgeries on poor, female Irish immigrants.22 The lack of autonomy of vulnerable populations, such as slaves and impoverished people, casts doubt on the voluntariness of their consent.22


In 1911 and 1912 at the Rockefeller Institute in New York City, Noguchi was working to develop a syphilis skin test similar to the tuberculin skin test.25 The subjects were recruited from clinics and hospitals in New York.26,27 In the experiment, Noguchi injected an extract of syphilis under the subjects' upper arm skin.25 Skin reactions varied among healthy subjects and syphilis patients by the disease's stage and its treatment.25-27 Of the 571 subjects, 315 had syphilis.26 The remaining subjects were "controls" who did not have syphilis and were orphans or hospital patients.25-27 The hospital patients had nonsyphilitic diseases, such as malaria, leprosy, tuberculosis, and pneumonia.25,26 Finally, of the controls, 46 were normal individuals, mostly children between the ages of 2 and 18 years.25,26 Critics at the time noted that Noguchi violated the rights of orphans and hospital patients.25


Goldberger and Wheeler,28 in 1915, studied pellagra to determine its cause. Unknown at the time, pellagra is a nutritional disorder caused by a deficiency of niacin (a B complex vitamin). Pellagra can involve multiple body systems, including skin, gastrointestinal, neurological, and psychological. Goldberger and Wheeler28 believed that they could produce pellagra in people by controlling their diet because previous related studies had shown higher rates of disease in people with certain diets. Therefore, with the assistance of the Mississippi governor, Goldberger and Wheeler28 controlled the diet of 11 healthy prisoners. In return for participating in Goldberger and Wheeler's study,28 Mississippi's governor offered the prisoners a pardon. For 61/2 months, the prisoners were fed the experimental diet, consisting mostly of grains, such as white wheat flour, corn meal, hominy grits, white rice, sweet potatoes, cabbage, collards, turnips, and turnip greens. Of the 11 prisoners, 6 developed pellagra rashes after 5 months. Thus, Goldberger and Wheeler28showed the cause of pellagra to be diet. The ethical concern is whether the participation of prisoners can ever be truly voluntary.


1921 to 1974

The US Public Health Service Syphilis Study, more commonly known as the Tuskegee Syphilis Study, was conducted from 1932 through 1972.2 The 399 African-American male subjects had syphilis.29 The men came from poor, rural counties around Tuskegee, Alabama.2,5 The stated purpose of the study was to obtain information about the course of untreated syphilis.5 Although initially short term, after 6 months the study was modified into a "death as end-point study."5(p225) The medical researchers did not tell the men that they had syphilis. Instead, the researchers led the men to believe that they were receiving special treatment from the US Public Health Service for their "bad blood."29 In fact, the men did not receive the period's conventional treatments for syphilis; the men received only vitamins and aspirins to deceive them into thinking they were receiving treatments.2 Moreover, the medical researchers acted to prevent the men from receiving treatments by tracking them to other public health departments, by intervening with local physicians, and by preventing them from being drafted into military service (drafted soldiers being routinely treated).2,29 Also, the Public Health Service continued the study after the advent of penicillin in 1940s.29 Finally, many of the men's wives were infected, and their children were subsequently born with congenital syphilis. The Public Health Service Syphilis Study ended only in 1972 after public outcry and congressional hearings.2


Prisoners are a vulnerable population because the mere status of being incarcerated casts doubt on the voluntary nature of their consent.30,31 Beecher31 explains that ordinary people do not willingly risk their health. Thus, subtle coercion may occur when people, such as patients and prisoners, consent to procedures that will harm them.31 However, in the 1940s through the 1960s, prisoners were often subjects in research studies.5 For example, in 1943, 241 federal male prisoners at Terre Haute Federal Penitentiary were injected with various strains of the gonococcus bacteria.5 In this federally sponsored research, the prisoners received $100, a certificate of merit, a letter of commendation for their parole boards, and a promise of treatment should they contract gonorrhea.5 Also during World War II, more than 1,300 prisoners at 4 US prisons had been part of research studies on malaria. These prisoners also received $100.5 Only in the 1970s did the United States discontinue wide-scale experiments on prisoners.5


Sponsored by several US federal agencies, researchers conducted radiation experiments on human subjects between 1944 and 1972.32 In total, there were approximately 4,000 human radiation experiments.33 Representative examples of these 4,000 experiments are listed and described in a special report to President Clinton.33 The report is organized in chapters by type of human radiation experiment, such as research on sick patients, children, prisoners, and atomic veterans.34 Authors of the report and other writers described several ethically questionable experiments.


In the late 1940s through early 1950s, at the residential Fernald School, 32 mentally retarded children were fed radioisotopes in the milk for their breakfast oatmeal.13,32 The purpose was to study the effect of oat cereals on the absorption of the milk's calcium.13 Researchers, with the collusion of the school's administrator, had essentially tricked the children's parents into giving consent by describing the activity as participation in a "science club."32 Also, at the school, another 17 mentally retarded children were fed radioactive iron to learn about iron absorption in the body.13 Occurring between 1945 and 1971, other examples include (1) injecting 18 terminally ill patients with high doses of plutonium to learn whether the human body absorbed it, (2) injecting 6 hospital patients with uranium salts to determine the dose required to produce renal injury, and (3) exposing the testicles of 131 prisoners to x-rays to study the effects of radiation on the production of sperm.13


In the 1950s, Gardner and Dukes35 experimented on female patients at a volunteer clinic.36 Fifteen infection-free patients were inoculated with bacterium from the vaginal discharge of infected patients. Of the 15, 11 developed Haemophilus vaginalis vaginitis. According to the researchers, "Some of these patients were allowed to go untreated for as long as 4 months, none showed spontaneous cure or alteration in the clinical picture."35(p968) In the published article describing the experiment, no mention is made of informed consent.36


In the mid-1950s, there were about 6,000 residents at Willowbrook State School in New York.37 Of the residents, 77% were severely or profoundly mentally retarded, 64% could not feed themselves, 60% were not toilet trained, 39% were nonambulatory, and 30% had seizures.37 Hepatitis was endemic at the institution, with an annual attack rate of 25 per 1,000 for children and 40 per 1,000 for adults.37 Beginning in 1956 and for the next 20 years, researchers conducted an experiment at the school to learn more about the natural course of hepatitis and its prevention.37 The experiment exposed newly admitted children to the Willowbrook strain of the hepatitis virus.37 Consent to the experiment was obtained from the children's parents prior to their admission, at first through individual meetings and then through group meetings.37 However, the consent was deceptive because it was worded to read as though the children were receiving a vaccine against the virus rather than being infected with the virus.38 Using manipulation and deceit disregards the rights of subjects and is ethically problematic.


In 1963, at Jewish Chronic Disease Hospital, 3 physicians experimented on 22 chronically ill and weakened patients.29,39 The physicians injected live cancer cells beneath the patients' skin to measure the patients' ability to reject foreign cells.29,39 The patients were told that the injections were a test of their resistance to disease.39 They were not told that the injection was a part of a research study.39 Nor were the patients told that the injection was unrelated to any treatments for them.39 In terms of ethical breaches, the physicians did not clearly and simply inform any of the patients that the injections were unrelated to their treatment and were part of an experiment.29,39


1975 to Present

From 1988 through 2000, drugs for the treatment of AIDS were tested on children in foster care. An investigation conducted by Associated Press found that foster children in at least 7 states were involved in more than 48 government-funded studies of various AIDS drugs. The children had HIV, and the studies allowed the children to receive AIDS drugs not yet on the market. Often, the researchers did not adhere to federally mandated protections for vulnerable populations, such as advocates for foster children. In terms of representative numbers, 465 foster children in New York City and 200 foster children in Illinois were in the pediatric AIDS drug studies.40,41


In 1996 at the University of Rochester Medical Center, a healthy volunteer died undergoing bronchoscopy as part of an experiment. The volunteer was a 19-year-old nursing student at the university. The experiment investigated the relationship between airborne chemicals and lung cancer.42 Researchers did not follow approved protocols, and a maximum dose of the topical anesthesia for a healthy subject, lidocaine, was not established. Lidocaine toxicity was the cause of the student's death.


Gelsinger was 18 years old with a genetic disorder that affected his ability to metabolize nitrogen.43 "Relatively fit," Gelsinger's disorder could be managed through diet and drugs.43,44(p2244) In September 1999, as part of a gene therapy trial, a viral vector carrying the gene was infused directly into Gelsinger's liver through a catheter.43,45 Gelsinger received a "massive dose" of the vector; the highest dose of the 18-subject trial.44(p2244) Four days after the infusion, Gelsinger died of multisystem organ failure.46 Of note, in the consent, the researchers omitted information that monkeys had previously died of toxicity from the treatment.43 The researchers also did not adequately evaluate Gelsinger prior to the trial; pre-erythroblast cells in his bone marrow were depressed, possibly caused by another genetic disorder or a viral infection.43,44 Moreover, the researchers deviated from their protocol as approved by the Food and Drug Administration.43,44 Gelsinger's ammonia levels were 30% to 60% higher than the protocol's criterion of eligibility.43,44 Thus, in this case, information necessary for informed consent was withheld, and the potential risk exceeded the potential benefit.


In 2001, 24-year-old Ellen Roche, a healthy volunteer, died as a result of an experiment.47 The experiment's purpose was to study airway hyperresponsiveness in asthma by experimenting on the normal airways of healthy volunteers. In the research protocol, the healthy volunteers inhaled hexamethonium bromide, a neurotransmission blocker. Roche was the third subject in the experiment. The first subject developed shortness of breath and a dry cough. Five days after inhaling the hexamethonium bromide, Roche was hospitalized. Approximately 1 month later, Roche died of progressive hypotension and multiorgan failure; autopsy showed diffuse alveolar damage.47 At question is the consent form, which described hexamethonium bromide as a medication. In fact, the Food and Drug Administration removed hexamethonium bromide from the US market in 1972 after it was shown ineffective in the treatment of hypertension.47 The hexamethonium bromide used in the study was specifically labeled, "For laboratory use only, not for drug, household, or other uses."47(p717) Thus, the statement in the consent, that hexamethonium bromide was a medication, was false. A healthy volunteer was put at risk for a nontherapeutic experiment, and her safety was not protected.



Contemporary beliefs that human beings need protection during experiments evolved over time. In the 1700s and 1800s, the United States had a class system that allowed indentured servants and slaves. Lower classes were considered socially inferior and not worthy of the same ethical considerations as other citizens.11 As Numbers11 noted, "In a nation that still tolerated involuntary servitude and even slavery, it is hardly surprising that [the use of humans] for scientific purposes elicited little criticism."11(pp 133,134) In addition, the doctor-patient relationship was insufficient to protect humans from research transgressions.48 Finally, though, beginning in the early 1900s and extending through the second half of the 20th century, events changed opinions. Key documents that advanced protections for human subjects are listed in Table 1.

Table 1 - Click to enlarge in new windowTable 1. Key documents underpinning ethical treatment of human subjects

Nuremberg Code

In the United States, current thinking about safeguarding the rights of human subjects began with the Nuremberg Code.19,49 The trials at Nuremberg began in 1945 with an international military tribunal for the captured Nazi leaders. Extending through 1949, subsequent trials were conducted by individual countries, such as the US Military Tribunals (also called American Military Tribunals). Tried at the 12 US Military Tribunals were Nazis from various industries, such as law, finance, manufacturing, and medicine.49 At the US Military Tribunal-Doctors' Trial, 23 scientists, 20 of whom were physicians, were charged with committing war crimes in the conduct of their medical experiments.49 These medical experiments included subjecting civilian prisoners to hypothermia, castration by x-rays and intrauterine injections, high-altitude conditions by decompression chambers, injection of typhus and malaria, bone transplantation, and introduction of bacteria into wounds.12 The Nuremburg Code was the set of principles used to judge the 23 Nazi scientists.19,50 Thus, the Nuremberg Code evolved from the trial documents of the US Military Tribunal-Doctors' Trial. The Code comprised 10 basic requirements for conducting human experimentation.19 Included within the 10 principles are the concepts of (1) voluntary consent, (2) the subject's right to end participation, and (3) the anticipated human benefit to exceed the potential degree of risk.19 The code became an international statement that human participation research must be voluntary and with informed consent.


Declaration of Helsinki

The Declaration of Helsinki is a guide to physicians conducting biomedical research. The Declaration of Helsinki emerged from statements generated by the World Medical Association. The World Medical Association was established in 1947. At its second assembly at Geneva in 1948, the organization issued a contemporary restatement of the Hippocratic Oath.12 At its assembly in Rome in 1954, the organization promulgated "Principles for Those in Research and Experimentation." The principles included many of the same concepts as the Nuremberg Code. Beginning in 1961, the ethical committee of the World Medical Association drafted conclusions from its study of human experimentation.12 In 1964, the final version of these conclusions was accepted by the assembly at Helsinki. Known as the Declaration of Helsinki, the formal name of the declaration is the Code of Ethics on Human Experimentation of the World Medical Association.12 The Declaration made 2 important distinctions regarding human experimentation; it differentiated (1) ethical and legal requirements and (2) therapeutic and nontherapeutic experiments.51 As a document issued by a physicians' organization, the Declaration of Helsinki influenced the development of similar codes worldwide.51 In the United States, several medical associations, including the American Medical Association endorsed it.4


National Research Act, Public Law 93-348

Congress passed the National Research Act in 1974. Origins of the Act can be traced back to the early 1950s. In 1953, the Medical Board of the Clinical Center of the National Institutes of Health mandated that clinical research committees review clinical projects involving unusual hazards.52,53 In 1966, the Public Health Service required that researchers' "institutional associates" review their clinical research.53 The National Research Act of 1974 has 2 important aspects. First, the act required that a local oversight committee with lay members review research on human subjects. Second, as a response to the reports of contemporary ethical transgressions, such as the Tuskegee Study, the act also created a National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.48 The charge of the commission was "to identify the basic ethical principles that should underlie research on human subjects, develop guidelines for such research, and make recommendations to the Secretary of Health, Education and Welfare" (now known as Health and Human Services).54(p14) Thus, with the National Research Act, all federally funded research required oversight from institutional review boards (IRBs).


Belmont Report

The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research issued 5 reports concerning safeguards for human subjects. The first 4 reports addressed safeguards for special groups, human fetuses, prisoners, mental patients, and children.53 The final report was the Belmont Report in which the commission summarized the basic ethical principles underlying research on human subjects. These underlying principles are respect for persons, beneficence, and justice.55 From these underlying principles come the requirements for informed consent, anticipated benefit greater than potential risk, and fair selection of subjects.55 As a set of guiding beliefs underpinned by ethical principles, the Belmont Report greatly influenced the development of bioethics in the United States.56



Health care supervisors and managers should be aware of misconceptions in ethical decision making. Awareness may assist health personnel to avoid these fallacies when making ethical decisions. Three common misconceptions are ethical relativism, overreliance on the protections accorded by IRBs or human subjects committees, and dependence on truisms.


Ethical Relativism

Ethical relativism is the belief that moral values depend upon social, cultural, historical, or personal contexts. In ethical relativism, there are no objective standards or universal truths for moral behavior. In ethical relativism, excuses are made, such as "It was a different world then" or "We can't judge the past by contemporary standards."32(p26) For example, some writers used ethical relativism to justify Sims' use of female slaves for surgical experimentation.22,24 Thus, in this flawed perspective, ethics becomes based on context. Buchanan,32 though, explains that this perspective denies the existence of human rights also known as the ethical principle of sanctity. Our sanctity is based on just being human. Therefore, how we are treated as humans is independent of context; our sanctity is not dependent on the time or place in which we live.32 Individuals deserve to be treated well and with respect just because they are humans, not because they live in a particular time or place.


Overreliance on Protections Accorded by Institutional Review Boards

Institutional review boards also known as human subjects committee are bodies that provide oversight for research studies conducted within institutions. Over the last 30 years, they have been very successful in ensuring that researchers conduct well-designed research studies and that they obtain informed consent.57 However, as local bodies, they have limitations. First, patient-consumers' demand for new experimental treatments has overridden the protections of informed consent. Patient-consumers, no longer suspicious of the risk of experimental treatments, want to obtain these experimental treatments, believing that these treatments may be the most advanced and therapeutic. Patients with AIDS were the first to demand experimental drugs; now, other patients with other conditions, such as Alzheimer disease and Parkinson disease, are making similar demands.57,58 Second, members of IRBs assess the quality of the scientific protocol; they do not assess the research's potential implications for policy or society.57 Thus, an IRB approved a research protocol for experiments that underpinned human cloning.57 The members of the IRB had not assessed the moral and societal ramifications of this medical technology.57 Finally, the procedures of IRBs do not make publicly visible the development of paradigm-shifting technologies. Thus, these new technologies, which have implications for public policy and law, are not submitted to public scrutiny and debate about their desirability.57


Dependence on Truisms

In dependence upon truisms, persons put excessive faith in the truth of common sayings, such as "for the public good," "in the general interest," or "society cannot afford it." Although these sayings often contain a germ of truth, ethical issues are too complex to resort to simple axioms. For example, persons are often asked to relinquish individual rights for the public good. People with infectious diseases are quarantined; they have relinquished the right of free movement. However, as Jonas59 states, "I cannot be required to die for the public good."59(p225) Furthermore, society can afford deaths at a normal rate of incidence, and in fact, deaths are necessary to avoid overpopulation.59 What society cannot afford are pandemics, such as the Black Death in the Middle Ages or excessively high or low birth rates. These instances do imperil the future of the society. Only in these cases can extraordinary measures be sought. Thus, rather than depending on truisms, health care supervisors and managers must critically weigh opposing ethical principles, striving to achieve a delicate balance between individual rights and societal rights.


While participating in ethical discussions in their health care organizations or serving on an ethics committee, health care supervisors and managers can contribute to the quality of the ethical decision making by avoiding these common mistakes. Moreover, they can assist other health personnel in avoiding these misconceptions as well.



The article armed health care supervisors and managers with tools to address ethical issues in their health care organizations. In today's health disciplines' academic curricula, attention to current ethical problems often takes precedence over reflecting on the past. This article provides health care personnel with information on allusions and references commonly used during discussions of ethics. Armed with this knowledge, health care supervisors and managers can meaningfully contribute to the deliberations of ethical issues and to the resolution of ethical problems in their health care organizations.


Human experimentation advances knowledge of medicine and science. The medical and scientific bodies of knowledge would be much smaller without the knowledge gained from experiments on human subjects. Human experimentation involves investigations of therapies for patients with the disease, experiments on healthy volunteers, and researchers' autoexperimentation. Human experimentation is often necessary because animal research cannot answer all questions about human responses. However, it is paramount that, for all people, the ethical principles of autonomy, sanctity, and justice are preserved and protected. Thus, informed consent and genuine voluntary consent, free of deception and subtle coercion, are critical.


Ethical errors have occurred in the United States. Through a review of the literature on ethical breaches in the United States, this article exposed health care supervisors and managers to a focused history of sentinel events in bioethics in the United States. Described in the article are several cases of ethical errors chronicled in the literature. The article also provided a basic list of key documents on ethics. These documents advanced the thought about the ethical underpinnings of the protection of human subjects.


Ethicists and other health personnel frequently cite these cases and documents in their discussions of ethical problems. Awareness of this lexicon of cases and key sources increases the ability of health care supervisors and managers to effectively participate in ethics and oversight committees of their health care organizations.




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2. Reverby SM. More than fact and fiction: cultural memory and the Tuskegee Syphilis Study. Hastings Cent Rep. 2001;31(5):22-28. [Context Link]


3. Green FHK. The clinical evaluation of remedies. Lancet. 1954;264(6848):1085-1091. [Context Link]


4. Bowker WF. Experimentation on humans and gifts of tissue: articles 20-23 of the Civil Code. McGill Law J. 1973;19(2):161-194. [Context Link]


5. Baader G, Lederer SE, Low M, Schmaltz F, Schwerin AV. Pathways to human experimentation, 1933-1945: Germany, Japan, and the United States. In: Sachse C, Walker M, eds. Osiris, 2nd Series, Volume 20, Politics and Science in Wartime: Comparative International Perspectives on the Kaiser Wilhelm Institute. Chicago, IL: University of Chicago Press; 2005:205-231. [Context Link]


6. Burton JL. A bite into the history of the autopsy: from ancient roots to modern decay. Forensic Sci Med Pathol. 2005;1(4):277-284. [Context Link]


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