Ethical Considerations for COVID-19 Vaccine Trials in Correctional Facilities | Infectious Diseases | JAMA | JAMA Network
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Viewpoint
August 17, 2020

Ethical Considerations for COVID-19 Vaccine Trials in Correctional Facilities

Author Affiliations
  • 1SEICHE Center of Health and Justice, Yale School of Medicine, New Haven, Connecticut
  • 2Section of General Internal Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut
  • 3Division of Infection Diseases, Johns Hopkins University School of Medicine, Baltimore, Maryland
  • 4Department of Social Medicine, University of North Carolina, Chapel Hill
  • 5Center for Health Equity Research, University of North Carolina, Chapel Hill
JAMA. 2020;324(11):1031-1032. doi:10.1001/jama.2020.15589

The first phase 3 coronavirus disease 2019 (COVID-19) vaccine trials began in July 2020. China, Britain, and the US have experimental vaccines ready to move into large-scale human testing. In the US, the Vaccine and Treatment Evaluation Units, HIV Prevention Trials Network, AIDS Clinical Trials Group, and HIV Vaccine Trials Network have merged resources into Operation Warp Speed, as each phase 3 trial is anticipated to enroll 30 000 participants. Recruitment for the first US trial involving the Moderna vaccine is targeting participants “at high risk of SARS-CoV-2 infection.”1 However, even though 39 of the 50 largest US outbreaks have occurred in correctional facilities and the case rate of SARS-CoV-2 infection in prisons (3521 per 100 000) has been 5.5 times higher than the general population,2,3 one key setting in which US investigators will not be recruiting participants for trials of COVID-19 vaccines are prisons and jails. This omission is an example of unintended consequences of well-intentioned policies.

History of Research in Prisons

In 1978, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research instituted a moratorium on research in correctional settings after decades of unethical studies that had enrolled incarcerated individuals into studies that involved testing of drugs and vaccines.4 At the time, incarcerated individuals were enrolled without informed consent or any federal oversight of studies. Studies that violated ethical standards and were explicitly exploitative of incarcerated individuals were stopped.5 Subsequently, the commission recommended that research involving prisoners that posed more than minimal risk, was not studying the process of incarceration, and did not directly improve the health or well-being of individual prisoners should not be conducted, unless the reasons for research were compelling. One salient example provided in the report was studies of viral hepatitis, which was highly prevalent among incarcerated individuals. Because of its concern for the ethical principle of justice in clinical research, the commission also indicated that the research would have to satisfy “conditions of equity.”4

In 2006, the Institute of Medicine (IOM) (now the National Academy of Medicine) revisited the issue at the behest of the US Department of Health and Human Services (DHHS).6 In its report, the IOM suggested updates to improve the ability of incarcerated individuals to participate in limited clinical studies, particularly those with minimal risk and interventions with demonstrated safety and efficacy, including phase 3 clinical trials. Despite these recommendations, the restrictions on research in correctional settings have not been changed.

Four categories of research are presently permissible in correctional settings (including randomized clinical trials): (1) minimal risk studies on possible causes, effects, and processes of incarceration and of criminal behavior; (2) minimal risk studies of prisons as institutional structures or of prisoners as incarcerated persons; (3) research on conditions particularly affecting prisoners as a class; and (4) research on practices that are intended and deemed likely to improve the health or well-being of participants.4 However, cumbersome regulations often make conducting scientific investigations challenging in these settings. Currently, federal regulation stipulates that the DHHS secretary must convene a panel of experts before such a trial takes place, thereby creating barriers to conducting clinical research in prisons and jails.

The COVID-19 pandemic provides justification to support reconsideration of the policy to systematically exclude correctional facilities from vaccine trials. Incarcerated individuals and correctional staff are at high risk for COVID-19,3 and correctional facilities are ideal settings for the spread of respiratory infections. Newly incarcerated individuals and correctional staff frequently enter and exit facilities, social-distancing measures are difficult or impossible to implement, and most correctional facilities are not built to handle large-scale outbreaks of respiratory infection or meet the long-term health care needs of individuals with COVID-19. Furthermore, incarcerated individuals have disproportionately high rates of chronic health conditions such as diabetes, hypertension, and cardiac disease, which are known risks for adverse COVID-19 outcomes and mortality. The death rate from COVID-19 among individuals in state and federal prisons is estimated to be 3 times higher than expected if the age and sex distributions of the US and prison populations were equal.3

Given these high exposure risks, a vaccine trial for COVID-19 could meet the criteria of the current DHHS regulations for “research on conditions particularly affecting prisoners as a class.”7 Any trial participation should be voluntary, not tied to any conditions of incarceration or release, and must include informed consent, highlighting the risks and benefits to participation, including the potential toxicities of the vaccine or lack of preventive benefit and potentially the unique risks in the correctional health system of obtaining aftercare. All trials must be approved by an institutional review board (IRB) that has a prisoner representative, and no trial could include more than 50% enrollment of incarcerated people to minimize the potential of exploitation. 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. Qualitative research with incarcerated people participating in clinical trials suggests that their perception of benefits and risks are no different than nonincarcerated participants, with the exception of the perceived benefit of accessing better health care through trial participation.8

Any vaccine trials that proceed must acknowledge this potential for coercion, but arguably prevention and treatment of COVID-19 are similarly constrained in the community setting in the US. While prisoners still need to be protected from the risk of coercion and exploitation, respect for prisoners also requires recognition of their autonomy in decision-making, even with true clinical equipoise. 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.

As COVID-19 vaccine trials have started enrollment, the DHHS secretary should convene a panel of experts to consider the inclusion of incarcerated people in phase 3 trials and consider the following recommendations:

  1. Obtain input from currently and formerly incarcerated individuals and those who work in corrections: The IOM report suggested the need for “collaborative responsibility,” whereby incarcerated people and correctional staff are involved in the design of research proposals and setting a research agenda. Vaccine trials should be person-centered and acknowledge the unique logistics of conducting research in correctional facilities without impeding good science or violating research ethics. In the longer-term, incarcerated people should also be part of revising regulations of clinical research in correctional facilities.

  2. Make racial equity a guiding lens: COVID-19 and incarceration disproportionately affect Black communities. One in 3 Black men will interface with the US prison system in their lifetime (this does not account for time in jail),9 making vaccine trial data from prisons and jails likely generalizable to the general population of Black men. Recruitment for vaccine trials in prisons and jails may improve participation of racial and ethnic minorities, thereby improving external validity of COVID-19 vaccine trials, which, as of yet, have disproportionately recruited White participants. Clinical trials conducted in the community should obtain permission to follow trial participants into correctional settings, as necessary, to help minimize loss to follow-up among minority participants.10

  3. Learn from history: The urgency of the current pandemic and of past and future respiratory pandemics may lead to the desire for quick, easier solutions. The present sense of urgency to find a vaccine makes it difficult to take time to support inclusive decision-making and consider long-term consequences. The need for quick results may minimize the interests of vulnerable populations.

  4. Ensure receipt of efficacious vaccines and care after the trial concludes: Many correctional settings are not well equipped to deal with screening for and treating COVID-19, much less aftercare following vaccine trials. Inclusion of incarcerated individuals in clinical trials must also include resources for correctional health systems to attend to vaccine complications and, once the trials conclude, universal access to these vaccines.9 Funding for aftercare, like any community setting, should be guaranteed by the study sponsor and universal access to vaccines proven to be effective and safe should be guaranteed by federal legislation, as there currently is no mandate to provide vaccines to those who are incarcerated.

  5. Convene a federal oversight board: Aside from the specific IRB processes outlined in the current regulations, a federal oversight board should be convened that monitors all COVID-19 vaccine trials conducted in correctional settings, regardless of whether the trials are funded by the federal government.

  6. Study implementation of vaccines in correctional systems: Implementing clinical trials in correctional facilities, especially in prisons where sentence lengths are typically longer than a year, could help to enable high levels of adherence and follow-up, including antibody testing. However, once efficacious and safe COVID-19 vaccines are developed, additional research will be needed to determine how best to administer and improve uptake of vaccines in correctional systems. In jails where the risk for COVID-19 is still high but the population throughput is much higher, effective strategies for follow-up within the facility and after release must be identified.

Conclusions

Incarcerated people and correctional staff are at high risk of contracting COVID-19. Federal regulations, formed in reaction to previous unethical experimentation, were established to protect incarcerated populations from future mistreatment. However, jails and prisons have become an epicenter of the current pandemic. With appropriate cautions and a person-centered approach, the US research community should revisit whether COVID-19 vaccine trials should include incarcerated individuals and correctional facility staff. Correctional settings present the opportunity to determine vaccine efficacy when trials are ethically conducted and perhaps to the benefit of the health of people who live and work there. Not revisiting the inclusion of these groups in COVID-19 clinical trials presents another set of ethical challenges.

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Article Information

Corresponding Author: Emily Wang, MD, MAS, Yale School of Medicine, Section of General Internal Medicine, 367 Cedar St, Harkness Building A, Ste 410A, New Haven, CT 06511 (emily.wang@yale.edu).

Published Online: August 17, 2020. doi:10.1001/jama.2020.15589

Conflict of Interest Disclosures: None reported.

Additional Contributions: We acknowledge Tino Negron, a member of the Yale Health Justice Lab, who provided critical input about recommendations put forward in this Viewpoint. He did not receive compensation.

References
1.
ClinicalTrials.gov. A Study to Evaluate Efficacy, Safety, and Immunogenicity of mRNA-1273 Vaccine in Adults Aged 18 Years and Older to Prevent COVID-19. Accessed July 14, 2020. https://clinicaltrials.gov/ct2/show/NCT04470427#contacts
2.
The COVID Prison Project. Accessed July 12, 2020. http://www.covidprisonproject.com
3.
Saloner  B, Parish  K, Ward  JA, DiLaura  G, Dolovich  S.  COVID-19 cases and deaths in federal and state prisons.   JAMA. Published online July 8, 2020. doi:10.1001/jama.2020.12528 PubMedGoogle Scholar
4.
US Department of Health and Human Services.  The National Commission for The Protection of Humans Subjects of Biomedical and Behavioral Research. US Dept of Health and Human Services; 1978.
5.
Lerner  BH.  Subjects or objects? prisoners and human experimentation.   N Engl J Med. 2007;356(18):1806-1807. doi:10.1056/NEJMp068280PubMedGoogle ScholarCrossref
6.
Gostin  LO, Blair  P, Cambra  S,  et al  Ethical Considerations for Research Involving Prisoners. Washington, DC: National Academies Press; 2006.
7.
Protection of Human Subjects. 45 CFR §46.303 (2020).
8.
Christopher  PP, Stein  MD, Johnson  JE,  et al.  Exploitation of prisoners in clinical research.   IRB. 2016;38(1):7-12.PubMedGoogle Scholar
9.
Nellis  A,  The Color of Justice: Racial and Ethnic Disparity in State Prisons. Washington, DC: The Sentencing Project; 2016.
10.
Wang  EA, Aminawung  JA, Wildeman  C, Ross  JS, Krumholz  HM.  High incarceration rates among black men enrolled in clinical studies may compromise ability to identify disparities.   Health Aff (Millwood). 2014;33(5):848-855. doi:10.1377/hlthaff.2013.1325 PubMedGoogle ScholarCrossref
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    6 Comments for this article
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    It's Time
    Evan Ashkin, MD | University of North Carolina at Chapel Hill, Department of Family Medicine
    Unethical and immoral research practices have taken advantage of and harmed people incarcerated in prisons and jails in the US and throughout the world. As the authors point out, necessary protections have been implemented in the US, but can have unintended consequences that impede research that can benefit prisoners and potentially improve health conditions while incarcerated.

    Academic medicine has failed to study effects on health of incarceration. Prior research showed that over a five year period of time the NIH spent less than 0.1% of its budget studying the relationship between health and incarceration. Structural racism and bias and
    stigma surrounding mental illness and substance use disorder have contributed to this abrogation of our responsibility to understand the devastating impacts of incarceration on the health of arguable our societies most vulnerable and marginalized people.

    It's time to take the actions enumerated by the authors to include people in jails and prisons in ethical Covid-19 vaccine research.
    CONFLICT OF INTEREST: None Reported
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    No to Research on Vulnerable Populations
    Dana Ludwig |
    In this Viewpoint the author writes "This omission is an example of unintended consequences of well-intentioned policies." I disagree. This is the intended consequence of the policy.

    Participation in any clinical trial is a risk to the subject. Otherwise we would not have clinical trials and would instead permit the widespread marketing of new drugs and biologics without testing. Given that there is a risk involved, it is ethically incorrect to ask for an incarcerated person to participate. They would naturally ask, "why are you asking me? Do I need this?" or "If I
    participate, will the parole board look more favorably at my next hearing?". It is not even correct for the sponsor to suggest to any subject: "we think this new product is your best chance". If that were true, subjects would line up from the around the entire country to take the new drug. Yet we know the untested drug could be ineffective or harmful and that's why we must do these trials, to limit the initial exposure to unknown toxicity. So telling the subject that the drug will likely help them is misleading and leads to the abuses that we have historically seen. The only good reason for a subject to participate in a trial is the desire to voluntarily contribute to the benefit of mankind and the community, knowing that he or she is taking a possibly significant risk. Prisoners can not freely volunteer with the implied coercion of their position.

    Historically, prisoners have been a research-subject-of-choice for many reasons. They are nearby and easy to contact. As in the case of Covid-19, they are at high risk of the disease for which the drug is indicated, and will make testing more "efficient". We must not let our investigators take advantage of these obvious benefits. The result will be a slippery slope to the abuses that have taken place too often to this population. Prisoners are paying their debt to society without having to incur additional extra-judicial punishment. If we really respect the prisoners and worry about their high risk as much as this article implies, make them first in line to receive the vaccine after it has completed clinical trials.
    CONFLICT OF INTEREST: None Reported
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    Overthinking Political Correctness is Harming the Incarcerated
    Kenneth Best |
    As stated, the incarcerated are at significantly greater risk of COVID-19 infection than the general population. It is in the best interest of the incarcerated to participate in trials that would directly benefit the incarcerated.

    If, somehow, there were a disease that only affected the incarcerated, then it would be impossible to test any remedy to that disease under the current thinking that the incarcerated should not participate in trials.

    Controls can be established that ensure proper supervision, segregation of duties, and safeguarding to minimize inappropriate study conditions. Appropriate oversight (auditing) can be established to verify
    that controls have been effective.

    Certainly, excluding the incarcerated from studies guarantees that there will be no exploitation. However, how many incarcerated will need to die while waiting for a vaccine to be developed without them?
    CONFLICT OF INTEREST: None Reported
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    The Ethics of Human Protection Regulations
    Walton Francis, MA, MPA, MPP | Self-employed Economist
    The authors are to be commended, but their proposal is too little and too late. Recruitment for Phase 3 clinical trials to prove the efficacy of more than a dozen COVID-19 vaccines is already underway. Creating a panel of experts in late summer or fall to deal with various ethical issues related to using prisoners as volunteers in vaccine trials would require months to establish and months to conduct. Opponents of reform would be vociferous and numerous. Before the dust settled the vaccines would already have been proved effective in the late fall and winter, and during the winter months would already have been used in major vaccination campaigns including, among others, high risk populations such as prisoners.

    This means that major life-saving opportunities would have been missed. Thousands or tens of thousands of prisoners could have participated in vaccine testing, and hundreds or thousands of cases and some number of deaths could have been prevented. Moreover, if prisoner volunteers could have shortened the time needed to assemble and complete large Phase 3 trials, availability of proven vaccines could have been accelerated by weeks or possibly months. The loss of these lives was an unethical outcome and a direct result of a regulatory scheme deliberately intended to make it all but impossible for prisoners to participate in research of value to them personally or to society at large, or both. As suggested by the authors, it was indeed unethical to not provide these clinical trial opportunities to prisoners. And it will forever be unethical because no sensible researcher is going to delay a clinical trial for a new cancer drug or new diabetes treatment to take months to jump through a burdensome regulatory hoop to debate including prisoners as subjects. (For the government to require such a hoop in order to consider using prisoners in all clinical trials would be far worse, adding delay to all trials when what is needed is to adopt reforms to reduce existing delays.)

    The current regulatory systems for participation of prisoners and other highly protected groups under regulations drafted decades ago need the same kinds of reforms applied to the main regulations protecting human subjects of research over the last several years. A proposed rule to abolish or substantially simplify those burdensome and red tape-ridden systems would allow all stakeholders and all experts to contribute their views on all foreseeable future situations, rather than limit review to one panel of experts and one situation that will be largely behind us before the experts opine. The ensuing final rule would, if sensible, remove unreasonable and burdensome prohibitions once and for all.
    CONFLICT OF INTEREST: None Reported
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    Remember Willowbrook State School?
    Leonard Glantz, J.D | Boston University School of Public Health
    It is surprising that the authors do not refer to the Willowbrook State School experiments. In the mid-1960s Willowbrook, located in Staten Island, NY, housed over 6,000 intellectually disabled persons in appalling circumstances. These grotesquely unsanitary conditions led to the infection of about 90% of residents with hepatitis A. The well-documented experiments by Dr. Saul Krugman at NYU included infecting residents with hepatitis to better determine the course of the disease and effectiveness of treatment. To justify these experiments, Krugman and his colleagues argued that most of the residents would contract hepatitis anyway, so the research would not harm them.

    These experiments have been virtually universally condemned as grossly unethical. One ethicist commented that if there was a hepatitis outbreak at Exeter, this would not be used as an excuse to perform experiments in which these students from elite families would be intentionally infected. Rather, the conditions causing the outbreak would be found and eliminated.

    The prison vaccine research supported by the authors is obviously different from the Willowbrook experiments. There is no proposal to intentionally infect prisoners. But the justification for using prisoners embraces the justification in Willowbrook. It is the overcrowding and other prison conditions that puts prisoners at increased risk for covid. Perhaps we should consider improving those conditions instead of using them as an excuse for turning inmates into research subjects.

    Finally, the authors say that prisoner consent must be "voluntary." The author's might wish to consider the voluntariness of consent in a condition where prisoners are at high risk of infectivity due to prison conditions, and their only hope would be to volunteer for a vaccine study with some chance of protecting them.
    CONFLICT OF INTEREST: None Reported
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    Ask the prisoners.
    Mark Hauswald, MS, MD | University of New Mexico
    Discussions about experiments in prison all seem to be by people who will never face a day in a cell. By definition this makes the opinions theoretical and historical. Those of us who have been incarcerated have views grounded in a more “concrete reality”. Prison is mostly stupefyingly boring. Almost anything interesting is better than the daily reality. And prisons make it almost impossible to do good - to do anything positive. This is soul stealing. The working assumption is functionally that prisoners are irredeemably evil and incapably of agency. My experience is that if there is no external pressure at all many prisoners would gladly volunteer, particularly if there was a chance for direct benefit. Research on prisoners obviously requires rigorous protections but these are not impossible to implement. Prison is inherently dehumanizing and prisoners are very vulnerable but this is the reality they face. Denying them the right to make decisions about their own bodies just makes this worse.
    CONFLICT OF INTEREST: None Reported
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