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Introduction
Nowadays, significant restrictions are imposed on the participation of prisoners in scientific research, and these restrictions are the result of the disturbing history of inhumane and unethical experiments. At the same time, prisons do contain the population that is often suffering from diseases that still have no cure. Therefore, involving them in drug testing can bring positive results for themselves and the community.
This paper reviews the events that led to the introduction of restrictions and considers the positions of their opponents and proponents. The paper uses two peer-reviewed articles, a book from a reputable publisher, two websites (one governmental and one belonging to a professional medical organization), and two articles from the New York Times. New legislation is described by the most recent source, but the historic part uses less contemporary materials. I conclude that we are not ready to lift the restrictions, but the improvement of the quality of life in prisons and the control over ethics in research might allow us to consider changes.
History of the Issue: Dr. Kligman
Dr. Albert M. Kligman was an outstanding scientist. He described human hair cycle and the acne development, discovered the beneficial effects of tretinoin (the ingredient of remedies for acne and wrinkles), and found treatments for poison ivy effects. Moreover, he made dermatology scientific in nature and sponsored the University of Pennsylvania’s dermatology department with the help of the money that his cosmetics discovery generated (Gellene, 2010). Unfortunately, this success was based on abusive, unethical experiments that were run at Holmesburg Prison in Philadelphia between 1951 and 1974 (Urbina, 2006). The prisoners who had been experimented upon in the 1960s kept reporting skin problems like blisters and rashes in the 2000s (Reiter, 2009). The inmates did not only test shampoos and tretinoin (which caused wounds and sores as the right dosage was sought for); they were also exposed to a variety of harmful (radioactive, toxic and hallucinogenic) substances and infections, which were of interest for pharmaceutical companies and governmental bodies (Gellene, 2010, para. 10-12). As a result, Dr. Kligman left another trace in our history: the scandals related to his experiments led to the development of federal human experimentation restrictions that were introduced in 1976 (Reiter, 2009) and nowadays can be found at the National Institutes of Health (2016) website in their updated version.
Admittedly, Kligman’s studies were not the only ones that had caused public outrage. Between 1944 and 1975, the US Government was involved in chemical weapons testing and radioactive exposure studies (The Physicians Committee for Responsible Medicine, n.d.); the Tuskegee Study that was carried out between 1930s-1970s involved infecting Alabama black males with syphilis and not treating them to study the development of the disease (Urbina, 2006, para. 4). However, the Holmesburg Prison was unique in demonstrating the vulnerability of inmates, which led to the restrictions aimed at protecting them.
The restrictions also had an adverse effect: because of them, even beneficial research was stopped (Gellene, 2010, para. 16). Nowadays, prisoners are supposed to be available only for “non-intrusive, low-risk, individually beneficial research” (Reiter, 2009, p. 502), and the studies are to be controlled and supervised by the representatives of the Office for Human Research Protections (National Institutes of Health, 2016, para. 10).
Agreeing with Dr. Kligman
Despite the limitations, medical experimentation in humans is still necessary: any drug must be tested on a sufficient number of human subjects before it can be used in healthcare (Urbina, 2006). As a result, the population of prisons becomes very attractive to scientists, especially since the number of people suffering from the diseases like AIDS, the treatment for which is still being developed, is quite large among inmates. In fact, scientists keep finding loopholes for using prisoners for tests. An example is the experimental Prometa program that was carried out between 2006 and 2008 to find addiction treatment. Prisoners could be directed to take part in Prometa if they were found to possess drugs, even though none of the treatment prescriptions had received proper approval (Reiter, 2009, p. 503).
This fact hardly testifies to the development of ethical practices in the modern scientific community, but hypothetically, an ethical research is not expected to carry significant risks. Moreover, its benefits are supposed to be immense for the entire population of the planet, including the inmates, who, as was stated, often suffer from diseases that the modern medicine only seeks to cure (The Physicians Committee for Responsible Medicine, n.d.). Consequently, the scientific community proceeds to attempt to lift the prisoner participation restrictions (Urbina, 2006).
Disagreeing with Dr. Kligman
Prison inmates are admittedly a vulnerable population, and when considering the changes in regulations, it is necessary to focus on whether they might benefit in the end. Supposedly, new drugs should be able to treat AIDS more effectively, but the idea that the newest drugs will become accessible to HIV-positive prison inmates causes serious doubt (Urbina, 2006). In fact, it is most likely that the price of such treatment or cure will be prohibitive. The issue of money involved in research also endangers the ethical conduct. Dr. Bernard Ackerman, who had worked with Dr. Kligman, states that the studies in the Holmesburg Prison were turned into a business (Urbina, 2006, para. 19).
It is not surprising that people were regarded as the means of achieving an aim. One might argue that they had expressed consent and even volunteered for the procedures, but it should be pointed out that consent is especially dubious when a prison is involved (National Institutes of Health, 2016). Nowadays, it is a requirement to provide the documents in the language that a person knows (Lo, 2010, 46-50), but even this fact cannot guarantee that the person who is not acquainted with science is capable of understanding the possible consequences. Even outside the prison, consent is often considered just a bureaucratic procedure or even “responsibility exemption,” which affects the effectiveness of fulfilling its aims: that is, informing, and ensuring the freedom of choice (Takahashi, Ramos, Pinheiro-Neto, Miziara, & Oliveira, 2011). In prison, concerns can be raised with respect to coercive prices of participation, and the problem of the low quality of life (including inefficient medical care), the improvement of which can become a coercive element (Urbina, 2006).
In general, as pointed out by Reiter (2009), the arguments that are used for the experiments that involve prisoners presuppose “a base level of acceptable conditions in prison and ethical motivations among researchers” (p. 565). If a means of guaranteeing these two aspects are found in the future, lifting the restrictions on prisoner involvement in research may be considered. Until then, it is hardly a possibility.
Conclusion
The history of prisoner involvement in research is extremely disturbing. The arguments that are being made in favor of lifting the restrictions imposed on prisoner participation in studies are concerned with the potential benefits that the society can gain from the discoveries. Opponents of changes in the legislation point out the questionable nature of informed consent in prison and emphasize the fact that prisoners are unlikely to benefit from the discoveries. It can be concluded that given the current level of control over the studies, the inefficiency of informed consent, and the quality of life in prisons, the restrictions imposed on prisoner participation in research cannot be lifted at the moment.
References
Gellene, D. (2010). Dr. Albert M. Kligman, Dermatologist, Dies at 93.The New York Times. Web.
Lo, B. (2010). Ethical issues in clinical research. Philadelphia, PA: Wolters Kluwer Health/Lippincott William & Wilkins.
National Institutes of Health. (2016). Research Involving Vulnerable Populations. Web.
Reiter, K. (2009). Experimentation on Prisoners: Persistent Dilemmas in Rights and Regulations. California Law Review, 97(2), 501-566. Web.
Takahashi, M., Ramos, H., Pinheiro-Neto, C., Miziara, I., & Oliveira, R. (2011). Current outlook of ethics in research with human subjects.Brazilian Journal Of Otorhinolaryngology, 77(2), 263-266. Web.
The Physicians Committee for Responsible Medicine. (n.d.). Human Experimentation: An Introduction to the Ethical Issues. Web.
Urbina, I. (2006). Panel Suggests Using Inmates in Drug Trials.The New York Times. Web.
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