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Should COVID-19 vaccine testing be done on prisoners? Some researchers say we should ask them.

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September 4, 2020 by Hannah Critchfield
Source: North Carolina Health News

Is it time to reconsider restrictions on using prisoners in medical experiments? Some experts say we should ask incarcerated people themselves.

By Hannah Critchfield 

As the COVID-19 infection toll inside United States prisons and jails reaches 100,000, some researchers are wondering if it’s time to reconsider bans on using prisoners in medical trials, such as the vaccine trials currently underway across the country.

Though often in the center of the discussion of a contentious topic, prisoners have had little input into the conversation. The researchers say it’s time to ask prisoners what they might want.

In the past, prisoners were used as medical study subjects, sometimes against their will. Prisoners were paid hundreds of dollars — far more than what a person normally receives doing prison labor, even today — to undergo studies involving everything from the toxic substance in Agent Orange, dioxin, to Johnson & Johnson bubble bath products (which reportedly led one prisoner to break out in painful blisters) to skin viruses like herpes.

Since 1978, however, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research has heavily restricted most research involving incarcerated people. The regulations followed reports of widespread abuse in drug and vaccine testing on prisoners in places like Holmesburg Prison in Philadelphia, where inmates were exposed to radioactive, carcinogenic and hallucinogenic chemicals without independent oversight or obtaining informed consent.

“I was in prison with a low bail,” former Holmesburg prisoner Leodua Jones told Executive Intelligence Review in 1999. “I couldn’t afford the monies to pay for bail. I knew that I wasn’t guilty of what I was being held for. I was being coerced to plea bargain. So, I thought, if I can get out of this, get me enough money to get a lawyer, I can beat this. That was my first thought.”

An exposé of the prison experiments in 1974 came on the coattails of the public’s discovery and the subsequent shutdown of the Tuskegee Study of Untreated Syphilis in the Negro Male, a 40-year study commissioned by the U.S. Public Health Service in which researchers withheld and concealed the existence of widely available, effective treatment for syphilis from its all-Black participants in order to study the long-term effects of the disease.

“You can make a strong argument that Holmesburg was as bad, if not worse,” said Allen Hornblum, who worked as a literacy instructor at the prison at the time and later wrote the book Acres of Skin about the experiments. “Because it’s not happening in the backwoods of Alabama, it’s happening in the third-largest city in the nation. A city loaded with universities, and medical schools, and very sophisticated people. Yet nobody seemed bothered or perturbed by it.”

In the time of pandemic 

Today, research in correctional settings is only permitted in limited conditions. Two of the categories of potentially permissible research are “research on conditions particularly affecting prisoners as a class” and “research on practices intended and deemed likely to improve the health or well-being of participants.”

Federal law requires that the secretary of the U.S. Department of Health and Human Services must convene a panel of experts before any trial takes place, a barrier that drastically reduces the likelihood that studies of this kind would occur.

With present regulations, vaccine trials for COVID-19 will not include currently-incarcerated people. But the novel coronavirus has ravaged the very places where incarcerated people live, leading some researchers to ask if now is the time for convening a DHHS panel. Inmates are more likely to contract COVID-19 than the general population, and to have chronic conditions that increase risk of severe illness from the virus, such as diabetes and heart conditions.

Outbreaks have ravaged North Carolina prisons, infecting thousands and killing 10 in the state correctional system alone. The facilities have been likened to petri dishes for the virus, as incarcerated people are housed in close, crowded conditions that make it difficult to social distance.

In a report released earlier this month in the Journal of the American Medical Association, health experts from the schools of medicine at Yale, Johns Hopkins and the University of North Carolina asked DHHS to consider if a Phase 3 vaccine trial for COVID-19 might meet the criteria for study of a condition “particularly affecting” prisoners.

“We’re just calling into question whether we’re taking away the agency of people who are in these settings,” said Lauren Brinkley-Rubinstein, a public health researcher at UNC-Chapel Hill and co-author of the report. “A majority of cluster outbreaks in this country are happening in these settings, and so why wouldn’t you give people that live there the option of participating or not?”

Trial participation would need to be voluntary, according to the authors, and couldn’t be tied to any condition, such as release from incarceration or special treatment

It would also require approval from an Institutional Review Board, those bodies that oversee the ethics of drug trials, that would need to include a prisoner representative.

Prisoner participants shouldn’t make up more than 50 percent of the test subjects to avoid exploitation and would need to be adequately briefed on risks, including “potentially the unique risks in the correctional health system of obtaining aftercare.”

“What we tried to communicate in that article is not that we definitely should be doing [correctional testing],” said Brinkley-Rubinstein. “But we tried to create a framework that could be used, if we were to consider it, that tries to center the voice of people who have been incarcerated.”

Oversight and equitable access

Clinical vaccine trials involving incarcerated people must ensure their correctional facilities have the resources to provide adequate treatment for vaccine complications, as well as funding for an incarcerated person’s aftercare in a community setting upon release.

The report also emphasizes that clinical trials should guarantee that incarcerated people have universal access to vaccines once one is proven successful. They also call for the federal government to pass legislation guaranteeing this universal access.

“I think once vaccines are proven that they work, the first places they should be deployed are nursing homes, prisons and jails,” said Brinkley-Rubinstein. “So that’s a part of [considering research with incarcerated people] too — if we are to do that, we need to understand how best to implement vaccine programs in the settings.”

The authors emphasize the need for a Federal Oversight Board in addition to an IRB, regardless of whether the trials are funded by the U.S. government, to monitor any clinical COVID-19 trials in prisons and jails.

Is consent possible behind bars?

Still, some people like Hornblum, the former Holmesburg worker, remain skeptical about whether it’s possible to ethically implement any medical trial behind bars.

“A lot of people in high positions do not want to ruffle the feathers of the medical-industrial community,” he said. “Can you imagine what ‘federal oversight’ would be with the Trump administration?

“I see the argument that is being made, and there is merit to it,” Hornblum added. “But I’m not just an academic who has read this in a journal, I witnessed it. I saw the lies, I saw the deceit. I saw inmates trusting their doctors, who were from an Ivy League institution, yet people were being damaged on an industrial scale.

“When it can happen at prison in a major sophisticated city, just think what can happen in smaller-scale facilities.”

Central to this debate is the issue of free and informed consent.

Some researchers believe that a person who cannot leave their present environment due to incarceration cannot truly give “informed consent” — that incarceration itself is too great a power dynamic to surmount. Many cite the Nuremberg Code, a set of research ethics principles drafted in the aftermath of the Nuremberg Trials at the end of World War II.

“Prisoner testing flies in the face of the first principle of the Nuremberg Code, which argues that if you’re confined or in a facility that lacks freedom, if you can’t walk out, you should not be used as a test subject,” said Hornblum.

‘A million ethical landmines’

Brinkley-Rubinstein conceded that there would be “a million ethical landmines” to navigate in vaccine trials inside prisons and jails.

“I do think the entire critique of whether it should happen or not really rests on that power dynamic, and that can manifest in a million different ways,” she said. “It would take a lot of time to figure out how to do it well.”

But the authors of the JAMA report said a blanket bar on research involving prisoners lacks nuance — in this moment, researchers must ask if it’s also unethical to not allow incarcerated people to participate.

“While the history of clinical trials in US prisons suggests that there is potential and opportunity for coercion in correctional settings, research on this issue in the contemporary era is limited,” the report states, noting that while prisoners need protection from coercion and exploitation, respect for prisoners requires “recognition of their autonomy in decision-making.”

“An ethical position that could be considered is that because of the epidemiology of this disease, it may be unethical to not provide clinical trial opportunities to these groups,” it adds.

“There are definitely places in which I would be terrified if they tried to do something like this,” said Brinkley-Rubinstein, who researches addiction treatment for incarcerated people in North Carolina, Rhode Island and Pennsylvania facilities. “But I think there are some systems, like Rhode Island’s, that are primed for this and have demonstrated their ability to properly take care of people in their custody.

“It’s context dependent, and lots of different voices should be at the table,” she added.

Considering the inclusion of incarcerated people in vaccine testing, according to Brinkley-Rubinstein, would signal a shift away from what she called “patriarchal” ideas about prisoners in research.

“We [on the outside] may all agree that this could never ethically happen in these settings, but like it’s not for us to decide,” Brinkley-Rubinstein said. “There needs to be this paradigm shift where people who have lived in those settings, and experienced the risks to their health from COVID, get to decide if this is a prevention activity that they want to engage in.”

Is it ethical to include unknowing people in medical experiments in or out of jail? Informed consent is not always received by people not in prison. What is the difference? Would you recognize health care fraud when you see it?

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