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It is well-established that incarcerated people suffer disproportionately from low literacy and health-related conditions that can affect cognition. Despite this, modified informed consent processes are not required by federal guidelines.
“The prison system in America is deeply, profoundly, unfixably unethical. How you do ethical research in such a system is always a quandary,” says Nancy Neveloff Dubler, senior associate at the Montefiore-Einstein Center for Bioethics and professor emerita of bioethics at the Albert Einstein College of Medicine, both in Bronx, NY. Dubler co-authored The Ethics and Regulation of Research with Human Subjects.
Prisoners arguably can provide consent to research in the same way they provide consent or refusal of medical care. “On the other hand, if the inducements are very great, it’s an unfair position to put the inmate in,” says Dubler, noting the long history of unethical research practices involving incarcerated subjects. “Prisoners were used to test and develop random things, and would be promised a better place to live or better food,” says Dubler.
The Common Rule was designed to prevent such research. The regulations permit only certain types of research on prisoners, including:
• research that is solely the study of the possible causes of incarceration and of criminal behavior, provided that the study presents no more than minimal risks and no more than inconvenience to the subjects;
• research on prisons as institutional structures;
• research on conditions particularly affecting prisoners as a class, such as drug addiction or vaccine trials for hepatitis;
• research on practices of innovative or accepted interventions that have the intent or probability of improving the health of the subject.
“This means that you can’t use prisoners to test new drugs simply because they are useful, you know where they are, you can come back to them, and they’re convenient,” says Dubler.
Drugs being tested have to, in some way, relate to the population that is being studied. For example, anonymous surveys of one detoxification unit revealed that over half of inmates were HIV-positive, says Dubler: “Clearly, this was an issue that you could study in the prison population, with proper safeguards.”
However, in a prison setting, it’s not possible to distinguish between refusal of care and denial of care, says Dubler: “It’s a very complicated setting in which to provide care, which makes it a super complicated setting in which to do medical research. The other problem is that prisons are basically untrustworthy settings.”
When someone does not show up for an appointment, researchers have no way of knowing if it’s because that person chose not to come, or whether a guard prevented him or her from coming. “Prisons are not places of transparency, and they’re settings in which prisoners are used often to their own detriment, but sometimes for their benefit,” says Dubler. “This makes it a quite complicated area.”
Mitigating potential conflicts of interest is a thorny ethical challenge if research participants are incarcerated.
“It’s possible that the researcher, the researcher’s university, and the correction facility are all funded by a single source,” says Alina Bennett, MPH, PhD, a postdoctoral fellow at McGovern Center for Humanities & Ethics at University of Texas Health Science Center at Houston.
Bennett offers a hypothetical to illustrate the complexity of conflicts of interest. A highly infectious agent, “Hepatitis Z,” is quickly spreading among certain prison populations who share a behavioral exposure. If left untreated, it can cause liver failure or hepatocellular carcinoma. A significant percentage of inmates are infected, despite the fact that the virus is almost nonexistent in the general population. While the standard of care is a liver transplant, this is not financially feasible in the prison setting.
In this scenario, a researcher at a state-sponsored university working on a potentially curative therapy approaches the institutional review board seeking approval for a prisoner-only study. This researcher believes that prisoners are suffering from this virus’s complications at much higher rates than others and thus, the study ought to prioritize therapy for inmates over therapy for nonincarcerated people.
“On the face of it, this situation might not ring any alarm bells,” says Bennett. “However, an inherent conflict of interest exists concerning what is responsible for the problem and what is responsible for the solution.”
One issue is that the state bears responsibility for prisoners being exposed to the virus in the first place. The state also benefits from access to a relatively static pool of human subjects who are newly diagnosed, yet are denied the standard of care by the state. Lastly, the state stands to benefit from the development of a drug should the trial be successful.
“Because the state will benefit both during the study and potentially after its completion, the ethical justifiability of this work hinges on the successful efforts of the correctional facilities to stop the creation of newly eligible human subjects for this state-run trial,” says Bennett.
Simple disclosure is not sufficient. In this scenario, securing a person’s informed consent requires a two-step process.
“The first step is that the study team must recruit decision scientists,” says Bennett. Decision science is a growing field that focuses on supporting patients facing complex decisions. The consent process must inform patients about not only the study, but also the relationships between the state, the researcher, the institution, and the correctional facility.
“Participants must understand that an entity might benefit from a successful discovery — which was made possible because the entity did not honor their obligation to protect prisoners from infectious diseases,” says Bennett.
The second step is to design a decision aid. The decision scientists will assess the decision that is facing potential study participants, and will create an evidence-based decision aid that meets — and far surpasses — all federal guidelines concerning consent. “These aids can take a variety of forms, such as an iPad application, a webpage, or a document,” says Bennett.
Lastly, knowledge checks are performed during the use of the aid, and afterward.
“These conversations take a neutral, nondirective tone, so that the patient will remain free of influence as they make an informed decision,” says Bennett.