Elizabeth Parker, Class of 2021
Utilizing human subjects in research is common, and most products that are on the market today went through significant human testing before they were approved for sale. Although regulations for human testing have become stricter in recent times, there is a long and dark history of unethical human testing in medicine. Several major contributions to current medicine have come from less than ideal experiments, and countless victims have suffered unwillingly in the name of science. Occurrences like the testing of syphilis on African Americans in the Tuskegee Experiment are discussed frequently, but many other instances of unethical testing go generally unacknowledged in the medical community.
Ethical issues in human research typically arise in relation to population groups that are vulnerable to abuse ("Human Experimentation: An Introduction to the Ethical Issues”). As has been seen in other experiments with ethical violations, marginally underprivileged groups are at an elevated risk for exploitation as a result of their position. Monetary incentives are less likely to be turned away by populations that are suffering economically. In addition, these groups are more susceptible to abuse and cruelty as a result of their decreased societal positions and the lack of regulation and protection for these communities.
One such experiment occurred in 1951 when Dr. Albert M. Kligman, a dermatologist at the University of Pennsylvania and future inventor of Retin-A, began experimenting on inmates at Philadelphia’s Holmesburg Prison ("Studying prison experiments research”). Dr. Kligman was brought into the prison to address an outbreak of athlete’s foot and as he later told a newspaper “All I saw before me were acres of skin. It was like a farmer seeing a field for the first time.” Over the course of 20 years, inmates at the prison willingly allowed the doctor to conduct experiments on them and test various products such as hair dyes, detergents, liquid diets, eye drops, and skin creams, all of which were experimental and not yet approved for human use. Dr. Kligman also reportedly injected 70 of the prisoners with dioxin, which is an extremely toxic chemical that is found in Agent Orange, herpes, and staphylococcus ("Acres of Skin: Human Experiments at Holmesburg Prison; A True Story of Abuse and Exploitation in the Name of Medical Science”). All of Kligman’s research was public and did not receive any opposition until much later, when former criminal justice official Allen M. Hornblum exposed the ethical issues that surrounded the prison experiments.
The Holmesburg Prison Experiment exposed critical holes in regulation of human experimentation. "I began to go to the prison regularly, although I had no authorization," Kligman said in a 1986 history of Penn's dermatology department. "It was years before the authorities knew that I was conducting various studies on prisoner volunteers. Things were simpler then. Informed consent was unheard of. No one asked me what I was doing. It was a wonderful time” (The Baltimore Sun). The prisoners involved in the experiment were all given monetary compensation, which served as a tool to further control them, given that prisoners have very few opportunities to earn money. In a personal interview, Holmesburg said: "It was chilling to be in a totalitarian atmosphere, which a prison is, and to see minorities – the prison was about 85 percent black and there were very few high school graduates – to see all of these people involved in some medical experiment about which they had a minimal amount of information." In addition, the prisoners were unable to properly give consent to the experimentation because their lives are completely controlled by others. The large risk of coerciveness is what inspired the Belmont report to rule out experiments with this vulnerable population.
As a result of ethical violations conducted in clinical research, the Belmont Report was created. Its primary purpose is to protect participants in clinical or research trials and it states that experiments must follow basic ethical principles of beneficence, justice, and respect for persons (“A Brief Review of the Belmont Report”). Furthermore, the National Institute of Health (NIH) has since implemented a system of regulations that are in place to protect the subjects and ensure ethical procedures. According to the NIH, a section of any grant application must include a section labeled “Protection of Human Subjects” and must have a detailed plan that describes the risks involved in the experiment and the potential benefits in order to conduct a risk assessment. The implementation of these regulations and ethical guidelines has helped prevent experiments like the Holmesburg Experiment, but unethical experiments still occur in the medical field and the targets are primarily disadvantaged groups.
More recently in 2006, an influential federal panel of medical advisors suggested using prisoners once again for medical experimentation. When speaking to the New York Times one supporter of the proposition, a Washington lawyer, said “With the help of external review boards that would include a prisoner advocate,” Mr. Bronstein said, “I do believe that the potential benefits of biomedical research outweigh the potential risks.” Under current regulations that were established in 1978, prisoners are allowed to participate in biomedical research under the government only if the experiment poses “minimal risk.” This new issue of whether or not prisoners are an underutilized resource in research will be one that future scientists will have to grapple with.
The prison population has quadrupled in the past 30 years and there are currently 2 million people incarcerated in the United States. Many argue that because the prison population is disproportionately comprised of people of color, research studies are unable to accurately represent those populations in studies (The New York Times). They also argue that because these populations are affected in greater amounts from diseases like hepatitis C and HIV, increased research on inmates could ultimately benefit them.
Opposers to this proposition reference the limited rights of prisoners, which the government has classified as a “vulnerable population.” Inmates are at increased risk because of their financial perks. Not only are they less expensive than chimps, but they also have less government protections. Researchers are required to track and document every dog, chimp, and hamster used in research trials but there is no federal law that requires the same for humans (“The Pros and Cons of Clinical Trials on Prisoner”). The singular protection that prisoners have is located in Subpart C of the Common Rule and it only applies to federally funded research. Exploitations of prisoners are made easier by state regulations which differ by region and allow various degrees of experimentation on inmates.
The demand for human test subjects has grown so much that a fairly new sector called the contract research industry has emerged with the sole purpose of recruiting volunteers to participate in research trials. The global healthcare contract research organization is expected to be worth $54.7 Billion by 2025. In a technologically advanced society with the constant scientific innovations, the need for human test subjects has never been greater, which has resulted in this current debate over the ethics of using prisoners once again.
The relevance of these experiments is indisputable, and by increasing awareness about them it challenges current scientists and members of the medical community to think critically about ethical issues surrounding the field. How far are we willing to go in the name of science? And at whose disposal?
References
1. Compensation for Incarcerated Research Participants: Diverse State Policies Suggest a New Research Agenda. (n.d.). Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2741529/
2. Goodman, H. "Studying prison experiments Research: For 20 years, a dermatologist used the inmates of a Philadelphia prison as the willing subjects of tests on shampoo, foot powder, deodorant, and later, mind-altering drugs and dioxin." 12 Oct. 2018, www.baltimoresun.com/news/bs-xpm-1998-07-21-1998202099-story.html.
3. Healthcare CRO Market Size Worth $54.7 Billion By 2025 | CAGR: 6.6%. (n.d.). Retrieved from https://www.grandviewresearch.com/press-release/global-healthcare-cro-market
4. Hornblum, Allen M. Acres of Skin: Human Experiments at Holmesburg Prison. Routledge, 2013.
"Human Experimentation: An Introduction to the Ethical Issues." Physicians Committee for Responsible Medicine
Ethical issues in human research typically arise in relation to population groups that are vulnerable to abuse ("Human Experimentation: An Introduction to the Ethical Issues”). As has been seen in other experiments with ethical violations, marginally underprivileged groups are at an elevated risk for exploitation as a result of their position. Monetary incentives are less likely to be turned away by populations that are suffering economically. In addition, these groups are more susceptible to abuse and cruelty as a result of their decreased societal positions and the lack of regulation and protection for these communities.
One such experiment occurred in 1951 when Dr. Albert M. Kligman, a dermatologist at the University of Pennsylvania and future inventor of Retin-A, began experimenting on inmates at Philadelphia’s Holmesburg Prison ("Studying prison experiments research”). Dr. Kligman was brought into the prison to address an outbreak of athlete’s foot and as he later told a newspaper “All I saw before me were acres of skin. It was like a farmer seeing a field for the first time.” Over the course of 20 years, inmates at the prison willingly allowed the doctor to conduct experiments on them and test various products such as hair dyes, detergents, liquid diets, eye drops, and skin creams, all of which were experimental and not yet approved for human use. Dr. Kligman also reportedly injected 70 of the prisoners with dioxin, which is an extremely toxic chemical that is found in Agent Orange, herpes, and staphylococcus ("Acres of Skin: Human Experiments at Holmesburg Prison; A True Story of Abuse and Exploitation in the Name of Medical Science”). All of Kligman’s research was public and did not receive any opposition until much later, when former criminal justice official Allen M. Hornblum exposed the ethical issues that surrounded the prison experiments.
The Holmesburg Prison Experiment exposed critical holes in regulation of human experimentation. "I began to go to the prison regularly, although I had no authorization," Kligman said in a 1986 history of Penn's dermatology department. "It was years before the authorities knew that I was conducting various studies on prisoner volunteers. Things were simpler then. Informed consent was unheard of. No one asked me what I was doing. It was a wonderful time” (The Baltimore Sun). The prisoners involved in the experiment were all given monetary compensation, which served as a tool to further control them, given that prisoners have very few opportunities to earn money. In a personal interview, Holmesburg said: "It was chilling to be in a totalitarian atmosphere, which a prison is, and to see minorities – the prison was about 85 percent black and there were very few high school graduates – to see all of these people involved in some medical experiment about which they had a minimal amount of information." In addition, the prisoners were unable to properly give consent to the experimentation because their lives are completely controlled by others. The large risk of coerciveness is what inspired the Belmont report to rule out experiments with this vulnerable population.
As a result of ethical violations conducted in clinical research, the Belmont Report was created. Its primary purpose is to protect participants in clinical or research trials and it states that experiments must follow basic ethical principles of beneficence, justice, and respect for persons (“A Brief Review of the Belmont Report”). Furthermore, the National Institute of Health (NIH) has since implemented a system of regulations that are in place to protect the subjects and ensure ethical procedures. According to the NIH, a section of any grant application must include a section labeled “Protection of Human Subjects” and must have a detailed plan that describes the risks involved in the experiment and the potential benefits in order to conduct a risk assessment. The implementation of these regulations and ethical guidelines has helped prevent experiments like the Holmesburg Experiment, but unethical experiments still occur in the medical field and the targets are primarily disadvantaged groups.
More recently in 2006, an influential federal panel of medical advisors suggested using prisoners once again for medical experimentation. When speaking to the New York Times one supporter of the proposition, a Washington lawyer, said “With the help of external review boards that would include a prisoner advocate,” Mr. Bronstein said, “I do believe that the potential benefits of biomedical research outweigh the potential risks.” Under current regulations that were established in 1978, prisoners are allowed to participate in biomedical research under the government only if the experiment poses “minimal risk.” This new issue of whether or not prisoners are an underutilized resource in research will be one that future scientists will have to grapple with.
The prison population has quadrupled in the past 30 years and there are currently 2 million people incarcerated in the United States. Many argue that because the prison population is disproportionately comprised of people of color, research studies are unable to accurately represent those populations in studies (The New York Times). They also argue that because these populations are affected in greater amounts from diseases like hepatitis C and HIV, increased research on inmates could ultimately benefit them.
Opposers to this proposition reference the limited rights of prisoners, which the government has classified as a “vulnerable population.” Inmates are at increased risk because of their financial perks. Not only are they less expensive than chimps, but they also have less government protections. Researchers are required to track and document every dog, chimp, and hamster used in research trials but there is no federal law that requires the same for humans (“The Pros and Cons of Clinical Trials on Prisoner”). The singular protection that prisoners have is located in Subpart C of the Common Rule and it only applies to federally funded research. Exploitations of prisoners are made easier by state regulations which differ by region and allow various degrees of experimentation on inmates.
The demand for human test subjects has grown so much that a fairly new sector called the contract research industry has emerged with the sole purpose of recruiting volunteers to participate in research trials. The global healthcare contract research organization is expected to be worth $54.7 Billion by 2025. In a technologically advanced society with the constant scientific innovations, the need for human test subjects has never been greater, which has resulted in this current debate over the ethics of using prisoners once again.
The relevance of these experiments is indisputable, and by increasing awareness about them it challenges current scientists and members of the medical community to think critically about ethical issues surrounding the field. How far are we willing to go in the name of science? And at whose disposal?
References
1. Compensation for Incarcerated Research Participants: Diverse State Policies Suggest a New Research Agenda. (n.d.). Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2741529/
2. Goodman, H. "Studying prison experiments Research: For 20 years, a dermatologist used the inmates of a Philadelphia prison as the willing subjects of tests on shampoo, foot powder, deodorant, and later, mind-altering drugs and dioxin." 12 Oct. 2018, www.baltimoresun.com/news/bs-xpm-1998-07-21-1998202099-story.html.
3. Healthcare CRO Market Size Worth $54.7 Billion By 2025 | CAGR: 6.6%. (n.d.). Retrieved from https://www.grandviewresearch.com/press-release/global-healthcare-cro-market
4. Hornblum, Allen M. Acres of Skin: Human Experiments at Holmesburg Prison. Routledge, 2013.
"Human Experimentation: An Introduction to the Ethical Issues." Physicians Committee for Responsible Medicine
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