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Medical Research
Let us not forget that progress is an optional goal, not an unconditional commitment, and that its tempo in particular, compulsive as it may become, has nothing sacred about it. Let us also remember that slower progress in the conquest of disease would not threaten society, grievous as it is to those who have to deplore that their particular disease be not yet conquered, but that society would indeed be threatened by the erosion of those moral values whose loss, possibly caused by too ruthless a pursuit of scientific progress would make its most dazzling triumphs not worth living.
Introduction
Legal discourse surrounding the regulation of medical research has attempted to resolve the tension between the societal need for medical progress and the welfare of its participants. While a number of ethical implications related to the use of persons in medical studies have been raised, other groups who have previously been omitted from such research, such as pregnant women and homosexuals, are now demanding inclusion in such work. The subject/participant dichotomy is raised however when vulnerable populations become involved in medical studies.
Researchers have described their work as part of a search for the Holy Grail. The nature of the work then becomes paramount and more importantly, the association of experimental research as divine or god-like has the potential to raise ethical concerns. As stated in a legislative comment of EU Clinical Trials, More than 50 per cent of people who suffer from severe head injury die or remain seriously disabled for the rest of their lives, and more than 90 per cent die following an out-of-hospital cardiac arrest.Research to develop and test drugs, devices and new therapeutic strategies could significantly change this. The blind association between medical research and its potential for miraculous results can result in uncertainty in the context of subject welfare.
The following analysis will discuss issues of voluntariness and consent among vulnerable subjects, with a focus on terminally ill patients. It will be demonstrated that this group, as a result of their health status, has become the forced subject of medical research studies. The first two sections will examine the theoretical and legal questions surrounding the human body as property, as well as explore the historical basis behind the societal need to eliminate illness. Forced human experimentation in the name of scientific progress will then be detailed, followed by a legal discussion of regulation procedures. In the final part the flaws in current research methods will be exposed.
I. The Human Body
Body as Property
While the individual is believed to have personal ownership over their own body, theorists have debated as to whether the body is property and what, if any rights, an individual has over it. In the context of medical research then, the question remains whether there is an obligation on individuals to volunteer their bodies in the interest of scientific progress. The utilitarian view, which seeks to maximize positive benefit, argues that the risks associated with untested medical research is outweighed by the potential for knowledge gained. The Social Contract theory also advocates for the willing participation of individuals for the greater public good, while Kantian moral theory argues that persons should not be used as a means to an end.
Regardless of the philosophical view chosen, the traditional common law rule has been that the human body cannot be property. Therefore while the individual does not have legal ownership, the law does guarantee certain rights towards one's body.
Bodily Integrity
The right to bodily integrity or the protection against unwanted, unconsented touching, has been sanctioned by the criminal law. The courts have upheld the principle of individual autonomy confirming that the individual has a right to control what happens to their body. In Collins v. Wilcock, Goff LJ states that The fundamental principle, plain and incontestable, is that every person's body is inviolate, it has long been established that any touching of another person, however slight, may amount to battery.
Without express or implied voluntary consent, any physical contact, treatment or procedure that involves an invasion of a person's bodily integrity is unlawful and actionable under the common law. Despite this assertion, the law of bodily integrity has been violated without punishment. This can be traced to historical views towards health.
II. Traditional Approaches Towards Health
In spite of the importance attached to personal autonomy by the legal system, situations arise in which it is considered legitimate to limit these rights for the public good. The World Health Organization (WHO) defines health as a state of complete physical, mental and social well-being, not merely the absence of disease or infirmity. Public health which refers to the well-being of the community as a whole is more broadly defined as what we as a society do collectively to ensure the conditions in which people can be healthy. It is important to recognize that in seeking to protect public health, individual human rights can be justifiably limited. Public health has thus become synonymous with limiting the rights of the few for the benefit of society as a whole.
The principle that certain rights must be restricted in order to protect the community has been codified in the Universal Declaration of Human Rights (UDHR), in which article 29(2) states that limitations are considered permissible to secure due recognition and respect for the rights and freedoms of others and of meeting the just requirements of morality, public order and the general welfare in a democratic society. In the United States Supreme Court decision, Jacobson v. Massachusetts, the court held that upon the principle of self-defense, of paramount necessity, a community has the right to protect itself against an epidemic of disease which threatens the safety of its members. With public health advocating for the promotion of community welfare, the extent to which it seeks to fulfill its objectives can lead to unjustifiable violations of bodily integrity.
III. Human Experimentation
The most infamous case of medical research on human subjects undoubtedly occurred at the hands of the Nazi doctors during the Second World War.
Nuremberg Doctors
Between 1939 and 1949, experiments were undertaken on primarily healthy subjects at various concentration camps throughout Europe in the alleged interest of medical science. As expressed by counsel for the prosecution in the aftermath of the Nuremberg Doctor trial (Doctor Trial);
It is well known that malaria, epidemic jaundice, and typhus were among the
principal diseases which had to be combated by the German Armed Forces and by German authorities in occupied territories. To some degree, the therapeutic pattern outlined above is undoubtedly a valid one and explains why the Wehrmacht, and especially the German Air Force participated in these experiments. None of the victims
of the atrocities perpetrated by these defendants were volunteers, and this is true regardless of what these unfortunate people may have signed before their tortures began.
Having found the physicians guilty of unethical medical practices, the court implemented the Nuremberg Code (Code), which established 10 principles regarding the use of human research subjects in medical experiments. It is important to note that the primary justification given by the Nuremberg doctors for their actions was to further the progress of medical science. Although this was ultimately rejected by the court, justifying medical research in the interest of scientific progress has been used in contemporary contexts as well. At the time, the Doctor Trial was unique in its forcible use of primarily healthy human subjects. While this may have been legally sanctioned, terminally ill patients became test subjects in a series of experiments and were actively recruited as a result of their health status as evident in the Tuskegee study.
Tuskegee Syphilis Experiment
Between 1932 and 1972, the United States Public Health Service (PHS) conducted an experiment on more than 300 syphilitic black men. Researchers never disclosed the name of the illness to the participants and instead the men were informed that they were being treated for bad blood. The physicians involved in the study however, had no intention of curing the disease. According to medical researcher Dr. Wenger, As I see it we have no further interest in these patients until they die. Autopsies served as the primary method of data collection and thus participants in the Tuskegee study never received any medical treatment.
The purpose of the study was to determine the effects of syphilis on different racial groups. The knowledge gained is tenuous in its actual potential to treat the disease. Although the scientific merit of the study was defended by the PHS, assistant chief of the Venereal Disease Branch Dr. Lucas concluded in 1970 that nothing learned will prevent, find, or cure a single case of infectious syphilis or bring us closer to our basic mission of controlling venereal disease in the United States.
By the end of the experiment, more than100 men were dead. To persuade the community to support the experiment as fundamental in the progress of medical research, it has been admitted by Dr. Clark that it was necessary to carry on this study under the guise of a demonstration and provide treatment. Other experiments undertaken during the Cold War also involved the recruitment of terminally ill patients, however these subjects were used as disposable body parts to test new medical techniques, rather than to study their illness as was premised in the previous case.
The Cold War Radiation Experiments
For thirty years between 1940 and 1970, government sponsored experiments were undertaken on more than 700 American subjects to test the effects of radiation exposure on the human body. The information was elicited to determine suitable treatment for workers and scientists exposed to plutonium during the military effort. The experiment thus consisted of infecting terminally ill patients with plutonium or uranium deposits. The subjects were not told the purpose of the study, either at the time of exposure or during follow-up.
The first experiment funded by the Atomic Energy Commission (AEC), involved injecting terminally ill patients, who were allegedly suffering from brain tumours, with uranium. The majority died within 2 months and there is no evidence of consent by any of the parties. The published report of the experiment concluded that of the common laboratory animals, man appears to correspond most closely to the rat in regard to intravenous tolerance to uranium.
The argument has been raised by jurist George J. Annas, that the subjects chosen for the experiment were used because they were ultimately a captive audience. Consent procedures were ignored due to the belief among researchers, that terminally ill patients could not be hurt physically because of impending death. The purpose of the study was also largely questioned by an advisory committee who concluded that if the true intent of the study was to examine the impact of chemical therapy on brain tumours, one of the patients had no such ailment. Furthermore there was no evidence to suggest that subjects would benefit from the study in any capacity. Despite the committee concluding a lack of informed consent, the experiment was not rejected in its entirety. The use of terminally ill patients in research studies shifted in the following experiment.
Cincinnati Whole Body Experiment
The Cincinnati Whole Body Radiation Experiment demonstrated that the immanent death of terminally ill patients was no longer sufficient justification for using this group as research subjects. The experiment, conducted between 1960 and 1971, was financed by the U.S. military and involved 88 advanced cancer patients, to examine the effects of radiation on the human body. The research study was promoted under the guise of palliative cancer therapy by the researchers who claimed that it would improve the treatment and management of the illness and potentially improve chances of survival for patients with advanced cancer, for whom, according to radiologist Eugene Saenger, there was no better alternative.
It was alleged that all patients gave informed consent, however none of the subjects were told of the risk of death or other side-effects. A committee undertaking a review of the experiment in the aftermath concluded that the research methods undertaken were unethical and contrary to patient welfare. Failure to inform the subjects of potential risks and disguising research under the pretext of treatment was inherently misleading.
IV. Legislative Framework
Following the Doctor Trial, the United Nations adopted the UDHR in order to physically document the fundamental freedoms guaranteed to all persons. Article 5 of the UDHR states that no one shall be subjected to torture or to cruel, inhuman or degrading treatment or punishment, and article 7 of the International Covenant on Civil and Political Rights expands on this statement by specifying that no one shall be subjected without his free consent to medical or scientific experimentation.
Questions surrounding the ethics of using human subjects in medical experiments also led to the formation of the World Medical Association (WMA) in 1946. However rather than enhancing subject welfare, the WMA focused more on the rights of physicians. The adoption of the 1964 Declaration of Helsinki (Declaration) minimized physician responsibility and informed consent procedures. The Declaration also divided research into two streams; therapeutic research, where non-traditional techniques are tested in order to determine the most effective medical treatment, and non-therapeutic research, intended to further medical knowledge rather than to benefit the participant. Therapeutic research clearly identified the participant as a patient and consent requirements were not as extensive.
The governance of medical research particularly in the UK has been limited in terms of legal authority and regulation has been merely persuasive in its policies. However, despite the emergence of separate domestic and international principles relating to ethical medical practice, a common theme emerges in all of them as discussed by biomedical ethics professor Baruch Brody. He argues that procedurally, research proposals need to be approved in advance by an independent research committee to ensure that ethical research practices are followed. Consent must also be obtained from the subject, risks minimized and in proportion to potential benefit. Subject selection must also be inclusive and the protection of privacy and confidentiality issues maintained.
While patient welfare remains the ultimate goal of all these policies, flaws are increasingly evident in regulation mechanisms, supporting the view that while terminally ill patients may not be as blatantly recruited for medical experiments as in the past, they are still being 'conscripted' through other means.
V. Concerns
Informed Consent
The Belmont Report, implemented in 1978 solidified the need to obtain consent in medical research studies and placed the onus on the researcher to obtain consent from human subjects. The modern informed consent doctrine is thus meant to ensure patient welfare by preserving the principle of bodily integrity. In the UK, regulatory bodies have issued guidelines requiring valid consent from subjects participating in medical research.
Despite an expectation on the part of researchers to obtain informed consent from participants, this process is inherently plagued with complications. Subjects with terminal illnesses, who believe they have no other alternative and who are desperate because of their health status, are unable to provide true consent. Terminally ill patients can also be offered questionable remedies under the pretext of therapy and the lack of treatment possibilities leads those afflicted to accept any available medical assistance, even those posing significant risks to participants. Terminally ill patients are more likely to confuse research with treatment, further negating informed consent. Additionally, an overemphasis on the benefits of participation fails to recognize the inherent risk in experimental research and that such methodology rarely benefits subjects. Because the informed consent process is linked to the research descriptions provided to potential subjects, language also has the potential to mislead.
Language
Actual understanding of the research material by the subject has always been an implicit requirement of the consent process. In his study of scientific research proposals, Professor Katz discovered that there was increasing ambiguity in describing the true nature of the subject's role in research studies; which ultimately was as a participant in medical experimentation. He notes that the purposes of the experiments were confounded by deceptive language choices which led participants to assume they would be receiving medical treatment. Of 93 studies examined by Katz, 41 were found to pose significant risk and of these Katz identified 75 percent that raised serious ethical concerns. On examining the informed consent process, Katz was amazed by the-
lack of disclosure in randomized clinical trials about the different consequences to patient-subjects' well being if assigned to one research arm or the other; the administration of highly toxic agents, in the scientific belief that only the knowledge gained from total therapy will eventually lead to cures, but without disclosure of the impact of such radical interventions on the quality of life or longevity.
The term medical study was a popular language choice used by researchers to mislead subjects as it was found to arouse minimal suspicion from potential participants when used to describe an experiment. Evidence of deception in depicting experimental treatment with therapy, is evident in Phase I drug studies undertaken with terminally ill cancer patients. Despite the Food and Drug Administration regulations specifying the non-therapeutic value of the work, researchers with the National Cancer Institute still refer to them as potentially therapeutic.
The deception problem for terminally ill patients is that any offer of medical assistance can be construed as potentially beneficial. There has been no evidence to suggest that the use of chemotherapy in Phase I studies has produced any substantial therapeutic advantage to patients. The prevalence of deceptive practices used by researchers has led 94 percent of investigators to concede that patients enrol in Phase I studies mostly for the possible medical benefit above all other reasoning.
Conclusion
As stated by author and former editor Franz Ingelfinger, the thumb screws of coercion are most relentlessly applied to the most used and useful of all experimental subjects, the patients with disease. The use of terminally ill patients in medical research has incited debates regarding the ethical and scientific implications of such work. While research into unknown illnesses has the potential to further medical knowledge, the issue remains whether particular research groups should be included in experimentation.
Evidence of past unethical research practices has led to greater regulation procedures in order to minimize risk and to protect potential participants. Legal authority, particularly in the UK is extremely lacking and different variables, such as language and issues with informed consent, are active concerns in the recruitment of vulnerable groups.
While the argument may be advanced that terminally ill persons willingly participate in medical research, due to the lack of coercion from medical researchers, desperation and misleading information are likely strong factors in their overall decisions. It is apparent that in contemporary society, as clearly expressed by Annas, now combating disease has itself become a war as we speak of a war on cancer and a war on AIDS. And in that war, patients, especially terminally ill patients, are conscripted as soldiers. While the method through which this occurs has changed, the premise has not. The underlying assumption is the restriction of basic individual rights of the few for the benefit of society as a whole.
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