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Human Experimentation

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TOPIC #4: Human Experimentation
PRO: Prisoners should be allowed to participate in human research
CON: Prisoners should not be allowed to participate in human research

History and definitions Dating back to 1965, seventy-five prisoners at Holmesburg prison in Pennsylvania were purposely exposed to a poisonous agent. This study was conducted to determine the effects of dioxin, a potentially harmful substance. Dermatologist Dr. Albert Kligman, exposed prisoners to a dosage 468 times greater than the required dosage for the experiment. All evidence has been destroyed; however, participants are still experiencing dermatologic issues. As a result of research and experiments like these conducted in prisons, the Department of Health, Education and Welfare terminated the use of prisoners as subjects. Shortly after, the federal government passed strict guidelines limiting the scope of experimentation among prisoners. These guidelines passed, codified at Title 45 of the Code of Federal Regulations, in 1978. Although prisoner research has been outlawed decades ago, it is far from over (Reiter, 2009). Certain guidelines are in place to protect human subjects in research. “The Common Rule” provides for the proposed research to be reviewed by the institutional review board (IRB) in addition to requiring informed consent. A review body, known as the Institutional review board (IRB) was established to protect the natural rights and welfare of persons subjected to scientific research (Institutional). Birthed from the National Research Act of 1974, the U.S. Department of Health and Human Services states that the Belmont report “is a statement of basic ethical principles and guidelines that should assist in resolving the ethical problems that surround the conduct of research with human subjects” (1979, para. 2). “Prisoner” is defined as any individual who is detained in a correctional facility or other facility as a result of committing a crime. The same holds true for individuals awaiting arraignment or sentencing (Pope, 2007). The questions remain, do prisoners have rights and should they participate in human research? Prisoners are among the most underserved population in the nation. Oftentimes, individuals take for granted their right to autonomy, privacy and liberty. In correctional facilities these rights are limited. Because of these limitations, the Department of Health and Human Services Office for Human Research Protections commissioned the Institute of Medicine to review the research conducted involving prisoners. The institute founded five critical actions which provided protection for the prisoners. Prisoners are vulnerable to research more so than the general population because of their accessibility, cost effectiveness, vulnerability and because correctional facilities are inundated with people with communicable diseases, HIV, AIDS, and hepatitis C. If participation is voluntary it may or may not be out of desperation for adequate healthcare. Some research may have the potential to improve living conditions or improve overall health, if high ethical standards are adhered (Pope, 2007)
PRO: Prisoners should be allowed to participate in human research Researchers and scholars that advocate for human research on prisoners base their arguments on the prisoner’s right to healthcare. Legal scholar Sharona Hoffman argues that if treatment is only available through experimental clinical trials, then it is the prisoner’s constitutional right to be afforded the opportunity for treatment: Especially in AIDS patients because treatment is only available through clinical trial. Hoffman argues that Due Process considerations coupled with the Eighth and Fourteenth Amendments, may mandate research involving prisoners when life-saving treatments are produced (Pacquerella, 2002). Celebrated philosopher and medical ethicist, Lynn Pacquerella, asserts that While the courts have failed to take a position on the constitutional rights of inmates to participate in clinical trials, if an inmate cannot be denied the right to receive a life-saving heart transplant under the right to health care, then it would seem illegitimate to deny inmates access to potentially life-saving treatment when that treatment is the only option. (p. 11) Prisoners have a constitutional right to exercise their autonomous choice to participate in such trials. Although autonomy is limited due to incarceration, it should be expressed if the opportunity is presented. Going beyond constitutional rights, the contemporary code of decency suggests that if there is a chance that prisoners with life threatening diseases, can be alleviated of pain or have death delayed through therapeutic treatment, than decency should be upheld (Pacquerella, 2002). Because of research done in the past, where ethical questions arose, there are rules and guidelines in place to prevent the abuse of prisoners. Advocates say that, in certain instances where the risks for general participants are equivalent to those of prisoner participants, and the risks were approved and accepted by general participants then prisoners should not be restricted in order to protect them from abuse (Pacquerella, 2002).
Prisoners should not be allowed to participate in human research argument. Generally, research participants are offered incentives as compensation for their time. In a correctional facility incentives may include, cash, more suitable living quarters and a reduced sentence. The American Medical Association (AMA) claims that such rewards defeat the purpose of punishment. It was prior to the 1960’s that the AMA viewed prisoners as “slaves of the state” with no rights. As a result of this, coinciding with the civil rights movement, the concept of prisoner’s rights led to the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research investigating prisoner research (Pasquerella, 2002). In order to fully participate in research, the participant must give autonomous consent without any outside influence. Those that argue against human research among prisoners suggest that prisoners are unable to give consent because they are easy to coerce and manipulate. Prisoners may believe that if they participate, then they would earn special rights and privileges within the facility, earn ‘cool points’ with the staff which would in turn influence their eligibility for early release (Pasquerella, 2002).
3 ethical theories or principles Three ethical principles that are addressed within the topic of human research among prisoners are: the ethics of respect, beneficence, and justice. The ethics of respect for persons is just that; respecting a person’s individuality and autonomy. Philosophers, Immanuel Kant and John Stuart Mill substantiate that “autonomy, human dignity, and respect for person” are inseparable (Pacquerella, 2002, p. 3). According to Kant, humans have the ability to rationalize and act in accordance with our capacity to be moral. The idea of respecting autonomy requires giving individuals the opportunity to choose for themselves and choose what happens to them as well (Pacquerella, 2002). Mill regarded autonomy as related to respect for persons. As a utilitarian, he believed that an act is morally correct if it provides the greatest good for the greatest number. Mill also believed that happiness and well-being is based on respecting one’s autonomy. According to Mill, restrictions on autonomy are acceptable only when harm is prevented. Both Kantian and Millian perspectives are the foundation established to guarantee truly voluntary participation.
To meet the conditions of informed consent necessary for upholding the principle of respect for persons, (1) the prison living conditions should not be so substandard as to be coercive, (2)
Prisoners should be able to understand what is presented to them and (3) research participation should not be included during parole (Pacquerella, 2002). It is difficult to establish trust in a correctional facility. Beneficence is based on trust. Even prisoners are entitled to some form of beneficence. In a normal healthcare setting, the patient trusts that they are a priority to their provider. The physician should always act with compassion and consider the patient’s needs at all times (Morrison, 2011) In accordance with the ethics of justice, it is not justifiable to further burden an already burdened population by absorbing the costs of research which only benefits a small population. Because of this, research on prisoners has been limited to those purposed to directly benefit the subject and to those that are directly related to the entire prison population. Examples of such research include: events and processes related to confinement, criminal behavior, and “studies on conditions that disproportionately impact the prison population” (Pacquerella, 2002).
PRO or CON? In the world of research, there have been strides in its evolution. We are no longer in an era where prisoners are used as test subjects for non-therapeutic treatments. In the instance where prisoners would be used as lab rats, I would have to argue against it, due to virtue ethics, ethics of respect, ethics of duty and justice. On the other hand, if there is a treatment available for an incurable ailment, anyone who has that ailment should be entitled to treatment. It is up to the judicial system to decide fair punishment for the crimes that prisoners commit. As they carry out their sentence, it is not up to anyone else to decide if they should suffer more. With the current rise in morbidity rates in correctional facilities, I think it is important to begin clinical trials there. In order for a clinical trial to truly be scientific in nature, the data set must be diverse and it must reflect minorities, women and many others-to avoid any stigmatization. I am in accordance with those that support research testing among humans because it is their natural right.
References
Institutional review board. (n.d.). In Mayo Clinic Definition of Terms. Retrieved from http://www.mayo.edu
Morrison, E. E. (2011). Ethics in health administration. Sudbury, MA: Jones and Bartlett.
Pasquerella, L. (2002). Confining choices: should inmates' participation in research be limited?. Theoretical Medicine And Bioethics, 23(6), 519-536.
Pope, A., Gostin, L. O., Gostin, L. O., Vanchieri, C., & Pope, A. (2007). Ethical considerations for research involving prisoners / Committee on Ethical Considerations for Revisions to DHHS Regulations for Protection of Prisoners Involved in Research, Board on Health Sciences Policy, Institute of Medicine of the National Academies ; Lawrence O. Gostin, Cori Vanchieri, and Andrew Pope, editors. Washington, D.C. : National Academies Press, c2007.
U.S. Department of Health & Human Services. (1979). The Belmont Report. Retrieved from http://www.hhs.gov
Reiter, K. (2009). Experimentation on Prisoners: Persistent Dilemmas in Rights and Regulations. California Law Review, 97(2), 501-566.

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