Within healthcare and medical research, certain groups of people are offered special services and protections because they are considered vulnerable. Vulnerable populations include children, persons with mental disabilities, women who are pregnant, and prisoners. The CIOMS International Ethical Guidelines for Biomedical Research define ‘vulnerable persons’ as “those who are relatively (or absolutely) incapable of protecting their own interests. More formally, the may have insufficient power, intelligence, education, resources, strength, or other needed attributes to protect their own interests.
Therefore, there are detailed guidelines that are designed to protect the rights and welfare of any vulnerable persons by requiring justifications for involving such individuals in research. It is essential for healthcare workers and researchers to identify subjects as vulnerable or not to make sure that resources are properly allocated to ensure that special protections and benefits are given to those who need it (8). There has been a long struggle to define vulnerability, which has led to arguments about its value as a factor in the distribution of resources an it’s appropriateness as a guiding principle in bioethics.
History of the use of Prisoners The abuse of the use of humans in research in recent history has made it evident for the need for a code of ethics protecting human research subjects. Both Nazi Germany and the Imperial Japanese Army took advantage of the poverty, defenselessness, and dependency of others by using the latter to serve their own needs without adequate compensation for these disadvantaged individuals or groups (6). When Adolf Hitler came to power, he implemented a series of laws promoting racial segregation and the protection of the “Arian race”.
These laws were created in partnership with a portion of the German medical community. One of the first laws that was enacted was called the Sterilization Act. This called for the sterilization of subjects with certain medical and mental disorders in order to remove the genetic abnormalities that caused these conditions from the gene pool, thereby purifying and improving the “German race. ” The scientists involved in implementing these laws argued that they were performing these procedures “for the benefit of the nation and the health of subsequent generations, and not for the individual patient.
They believed they were part of a ‘holy mission’, which would benefit society as a whole. (5) In addition to the Sterilization Act, the German medical community was involved in the implementation of the Nuremburg Laws, which were encated for the purpose of the “purification of the blood of the German people. (5) The involvemtn of the medical community in employing these laws demonstrates the relaxation of ethical principles. These laws required that couples undergo premarital medical examinations in order to prevent the spread of ‘racially damaging diseases’.
In addition, as the war was approaching the Germans needed to free up hospital beds for wounded soldiers, and thus, the medical community was instructed to perform euthanasia on any incurable patients. This program was eventually extended to include the extermination of those who constituted a threat to society; those with links to criminals, behaved antisocially, prostitutes, drifters, and homosexuals. This practice of mass extermination served as the model for the “Final Solution”, which was to wipe out an enormous number of Jewish people.
In addition to these methods of eradication, the German medical community played a large role in more covert procedures that took places in healthcare institutions. These included killing patients though malnutrition, inducing hypothermia by turning off the heat during the winter, and injecting subjects with drugs in order to speed up the death process. (5) Probably one of the most concerning displays of the connecting between the German doctors and the Nazis was the use of humans as research subjects, not only among the atrocities of the concentration camps, but also in the hospitals and universities.
In addition to Jews, gypsies, Slavs, homosexuals, and the physically and mentally disabled were recruited as ‘subjects’ for these horrific experiments. Just as they justified carrying out the Sterilization Act and the Nuremburg Laws, they also deemed the acts performed in hospitals as ok, saying that “if the sick have to die anyway, as a result of the assessment of one of my colleagues, why not make use of them while alive or after their execution for research? ” (5) Ethical Guidelines for the Use of Prisoners
As a result of these horrors and the exploitation in the use of prisoners as research subjects, ethical codes were written in an attempt to protect this population, in addition to other populations classified as vulnerable, from being mistreated and exploited. The various codes of ethics that have been drawn up demonstrate that when vulnerable groups, such as prisoners, serve as research populations, special principles and a heightened degree of care must be employed to deal with them. (7)
As a reaction to the atrocities carried out by the Nazi doctors and scientists in the field of human research that were revealed during the Nuremburg trials, the Nuremburg code was published in August of 1947. It was the first international code for research with human beings, and was based on the Hippocratic oath of “first do no harm. ” It was created to prevent and repetition of the calamity resulting from the extremely cruel attacks on human wellbeing and rights. It put forth rules that should govern the use of human beings for experimentation.
The need to obtain informed consent is emphasized, and it has since been regarded as the key issue of the protection of patients’ rights. The code consists of a declaration of ten principles, generally focusing on the protection of the rights of persons participating in medical research. It requires that in addition to the requirement for researchers and clinicians to protect their patients’ rights, the subjects themselves also actively participate in their own protection.
Though the Nuremburg Code has not been officially implemented in any nation or medical association, it has had a huge impact on the area of human rights and bioethics. Since its fundamental requirement of informed consent has been accepted all over the world, it has been preserved within multiple international laws regarding human rights. (5) In 1964, the Eighteenth World Medical Assembly meeting in Helsinki adopted an ethical code to help guide doctors and researchers who conduct medical research involving human subjects, and has been amended several times in attempt to stay current.
The Declaration of Helsinki developed the ten principle first addressed in the Nuremburg Code and tied them to the Declaration of Geneva, a statement of a physician’s ethical duties. Thus, it has many things in common with the Nuremburg Code, the most essential of which is the requirement for informed consent. However, they do have their differences. First, the Declaration of Helsinki points out that some, but not all, medical research is combined with medical care. Consequently, it puts forth a set of principles for medical research combined with medical care or therapeutic research.
Second, while the Nuremberg Code does not address research on subjects who are unable to provide informed consent, the Helsinki Code addresses such research, stating the ethical acceptability under certain conditions of “proxy consent. ” Despite the Declaration of Helsinki not being regarded as a binding instrument in international law, it is significant because it was the first major effort of the medical community to regulate research itself (5). Federal Regulations to protect human subjects in research were established in 1974 and adapted in 1981.
They were then revised in 1991 as the US Code of Federal Regulations for the Protection of Human Subjects, also known as the Common Rule. However, unlike other ethical guideline, it does not define vulnerability. Instead, it provides special protections for ‘particularly vulnerable populations’. These include pregnant women, fetuses, neonates, children, and prisoners. (4) These regulations define research as a ‘systemic investigation’ designed to advance or add to ‘generalizable knowledge. ’ This includes research development, testing, and evaluation.
Current Literature on the Use of Prisoners Lawrence Gostin, in his article entitled Biomedical Research Involving Prisoners, discusses the ethical values and legal regulations regarding research studies that involve prisoners. He mentions that many companies, including the US Army and major pharmaceutical companies, performed a wide variety of research on prisoners up until the early 1970s due to their easy accessibility, vulnerability, and captivity. In many cases researchers did not obtain informed consent and failed to treat the prisoners properly for the pain they endured.
Ultimately, in the mid 1970s research of this kind declined due to publicized knowledge of the exploitation of prisoners. Federal regulations that protected human subjects were adapted several times and came to be known as the Common Rule. In recent years the amount of prisoners in correctional facilities has greatly increased. Thus, correctional facilities are overcrowded and many inmates are subject to inadequate treatment including limited access to services and health care. In addition to their poor health and low socioeconomic status, prisoners are considered vulnerable due to their limited liberty and autonomy.
They may not be capable of providing informed consent and may not have a practical expectation of privacy within prison settings. In this environment, prisoners may not be capable of meaningfully choosing between participating in research and not participating (Gostin, 738). A compromise between promoting beneficial research and protecting prisoners is difficult to achieve and is politically controversial. The author suggests a few proposals that he believes solve this difficulty. Firstly, he suggests that the definition of prisoner be extended to include all individuals whose autonomy and liberty are limited by the justice system.
Next, he recommends that all research on prisoners be regulated consistently, irrespective of the source of funding, supporting agency, or type of correctional facility. The third proposal is to create a national database for prisoner research. This would ensure greater accountability, provide a method for measuring the success of research projects, and assist the implementation of beneficial research findings to prisoner populations. In his article entitled Against Risk-Benefit Review of Prisoner Research, Eric Chwang discusses the some of the weaknesses of the Common Rule.
He mentions the recommendations of the Institute of Medicine’s Ethical Considerations for Research Involving Prisoners. The suggested five changes to the current United States regulations on prisoner research. These are 1) to broaden the definition of “prisoner”, 2) to guarantee universally and consistently applied standards of protection, 3) to move from a category- based to a risk-benefit approach to research review, 4) to revise the ethical framework to include collaborative responsibility, and 5) to improve systematic oversight of research involving prisoners.
The IOM report maintains that the category-based constraints stated in the Common Rule are lacking since they are subject to interpretation and do not attend to actual prisoner vulnerabilities. Thus, the IOM report recommends that the category-based constraints be replaced with risk-benefit constraints. However, the author disagrees and thinks the Common Rule and IOM recommendations should be combined into an ethical framework.
He suggests that additional risk-benefit restrictions on research are redundant and that the current Common Rule regulations excluding category-based constraints, but compounded with the IOM’s four other recommendations, guarantee that prisoner research is as ethical as non-prisoner research. Chwang argues that the reason for the IOM’s insistence on risk-benefit constraints is that the IOM compares the vulnerable population of prisoners to the vulnerable population of children, for whom research is regulated on the basis of risk-benefit restrictions.
However, while children are not competent to give rational consent and rely on adults to determine whether or not they should serve as subjects in research, most prisoners are adults and can thus make rational decisions about participation in research (Chwang, 15). Chwang claims that even though the implementation of risk-benefit restrictions was designed to solve certain problems inherent to prisoners, there are several reasons why it was not successful in its attempt. First, risk-benefit constraints seem appropriate because they protect against the lack of autonomy inherent to prison life due to prisoner’s lack of freedom.
They live in a coercive environment in which their lives are highly regulated, and therefore it can be argued that prisoners cannot freely choose whether or not to participate in research. However, while it seems that prisoners living in a coercive are completely “unfree”, meaning all of their decisions are made under pressure, then this is claim is false. Even though in this coercive environment many of prisoners’ decisions are subject to interference, this does not necessarily mean that every choice they make is subject to coercive interference.
Another argument is that even prisoners can make some free choices the choice to participate in research will always be coerced. Yet, coercion is prohibited by the Common Rule, which applies to research with all populations. In addition, risk-benefit constraints do not alleviate these concerns about coercion since passing the research through a risk-benefit filter would not make it any more ethical to coerce prisoners into participating in research. The author suggests that the right response is to ensure that the research study is not coercive to begin with.
The solution is not to add a risk-benefit analysis to the process; the solution is to make certain that the constraints already established for research are followed. In addition to risk-benefit analysis not being a suitable solution for the problem of coercion it is not a solution for the problem of undue inducement. Undue inducement is an incentive to participate in research that inappropriately influences the subject to enroll. Though prisoner research seems susceptible to undue inducement, this concern is not resolved by additional risk-benefit constraints.
Firstly, the IOM report is concerned with risk-benefit analysis because it wants to guarantee that the benefits of prisoner research are great enough to offset the risks. Yet, it does not mention the danger of undue inducement as a motivating factor for its suggestion of risk-benefit restrictions. Also, undue inducements are no more problematic for prisoners than they are for the general population. Therefore, it is essential that the constraints already in place are strictly followed, not the addition of new constraints.
Finally, while additional risk-benefit restrictions might seem to help solve the issue of exploitation of prisoners, they in fact do not. This is partly due to the fact that calculating the degree of exploitation is controversial. In order to eliminate exploitation, we would have to figure out not just whether the benefits of participation outweigh the risks, but rather we would also have to figure out whether the net benefits are high enough. This may depend on comparing those benefits to the benefits to the researcher and to society.
We would therefore require an expected benefit calculation. This idea that we must guarantee that the distribution of benefits is not exploitative is not part of the IOM report’s suggestion. Even if they did incorporate this calculation, it would still be problematic since the calculation can yield incorrect results. In addition, exploitation is a problem for all research, not just for research involving prisoners. Exploitation should be prohibited and more rigorous guidelines should be implemented for all research. Thus, we do not need additional restrictions for prisoner research.
What is needed is better supervision to guarantee that more general constraints, which apply to all research, are followed. David Thomas, in his article entitled Prisoner Research- Looking Back or Looking Forward, discusses the issue of what he calls “prisoner’s right to research”, which refers to the concept of a prisoner’s right to participate as a subject in medical research. The author argues that this issue has been rarely addressed. While the IOM recommendations advocates for prisoners and allows research on prisoners, it does not advocate for the concept of a prisoner’s right to research (Thomas, 23).
There are a variety of therapies in current medical care that change with great speed. Unlike a non-incarcerated person who has readily available access to therapies and receive treatment if needed, in a prison environment the only way to gain access to these therapies is to participate in a clinical trial. Thus, refusing prisoners the advantages of modern therapies would be equivalent to restricting their rights due only to their incarceration. Forms of imprisonment that extend beyond humane confinement may defy the ban against cruel and unusual punishment.
In addition, denying incarcerated persons therapy by virtue of their incarceration creates an unequal state of affairs that imposes upon the essential issue of justice (Thomas, 25). Research involving prisoners with suitable protections that give prisoners the accepted standard of care should not be denied. In addition to the IOM recommendations, Julio Arboleda-Florez, in his article The Ethics of Biomedical Research on Prisoners suggests other rules to ensure the protection of prisoners involved in research. He first recommends that external rewards should not be used as inducements to participate in research.
Medical care, healthy food, reduction in sentence, or an increase in visiting hours should not be used to persuade prisoners to be involved in research. Next, he suggests that therapeutic research should be distinguished from nontherapeutic research. This is necessary so that prisoners will not be denied eventual health benefits that could result from involvement as a subject in research. The author also insists that the Institutional Review Board must have a role (Florez, 516). Finally, he proposes that increased external governance should be introduced. This is due to the trouble that results from lack of oversight.
Ethical Analysis of the Use of Prisoners As can be seen from the literature previously discussed, there has been an ongoing debate regarding the ethical issues surrounding the use of prisoners as subjects of research studies, and the proper course of action to take in order to ensure prisoners’ protection from exploitation and coercion while at the same time maintaining their autonomy. According to the various codes of ethics, the requirement to protect the autonomy of persons with diminished capacity is linked to the ethical principle of respect for persons.