Covid-19 Vaccine Trials and Incarcerated People — The Ethics of Inclusion

Strassle, Camila; Jardas, Emma; Ochoa, Jorge Flores; Berkman, Benjamin E.; Danis, Marion; Rid, Annette; Taylor, Holly A.

doi:10.1056/nejmp2025955

Cited by 14 publications

(29 citation statements)

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“…Moreover, given the overrepresentation of racial and ethnic minorities in correctional settings, the inclusion of incarcerated populations may improve the generalizability of COVID-19 vaccine results. Despite this, conducting COVID-19 vaccine trials in correctional settings is ethically, legally and logistically complex, and warrants further reflection [6] .…”

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confidence: 99%

Prioritizing incarcerated populations for COVID-19 vaccination and vaccine trials

Kronfli¹,

Akiyama²

2021

EClinicalMedicine

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Correctional settings have become the epicenter of COVID-19 outbreaks across the globe. Decarceration of thousands of individuals and increased infection and prevention control measures have helped to mitigate SARS-CoV-2 in correctional facilities; however, case-and mortality rates remain several-fold higher than most surrounding communities [1]. Explosive transmission rates in correctional settings highlight the need for additional mitigation strategies including vaccination. Despite this, incarcerated individuals have largely been absent from the discourse on priority populations for vaccination and COVID-19 vaccine trials [2].People in correctional facilities should be considered high priority for COVID-19 vaccination for several reasons. First, correctional settings are at high risk for SARS-CoV-2 outbreaks due to overcrowding, poor ventilation, and unsanitary conditions. Such conditions jeopardize the effectiveness of basic preventative measures. Mass screening of 16 US prisons and jails found a SARS-CoV-2 prevalence of up to 87% [3] À a prevalence that rivals the hardest hit long-term care facilities [4,5]. Second, people in correctional settings are disproportionately affected by poor social determinants of health leading to a higher prevalence of chronic diseases such as hypertension and diabetes, resulting in increased risk for severe COVID-19-associated disease and mortality. Third, the borders between correctional settings and surrounding communities are porous; inter-institutional transfers, staff cross-deployment, and the constant daily movement in and out by both staff and visitors risk propagating the virus both within and outside correctional facilities.

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confidence: 99%

Prioritizing incarcerated populations for COVID-19 vaccination and vaccine trials

Kronfli¹,

Akiyama²

2021

EClinicalMedicine

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“…Three months later, Camila Strassle and colleagues, writing in the New England Journal of Medicine , more clearly delineated three reasons prisoners might justifiably be enrolled in Covid‐19 vaccine trials: to get early access to treatment, to have the same choices about and access to treatment as nonincarcerated people, and to speed up the process of establishing vaccine efficacy. Unlike the JAMA authors, however, the NEJM authors conclude that a proliferation of “currently unmet ethical conditions” should continue to preclude the participation of incarcerated people in vaccine trials, at least during the Covid‐19 pandemic 7 . In fact, the current public health crisis has only exacerbated the very conditions that have made U.S. prisoner participation in vaccine trials untenable—since (and since before) the 1970s implementation of federal regulations limiting the participation of vulnerable human subjects in research.…”

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confidence: 95%

Does a Public Health Crisis Justify More Research with Incarcerated People?

Reiter¹

2021

Hastings Center Report

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Covid‐19 has infected thousands and killed hundreds in prisons, jails, and immigration detention facilities across the United States. Responding to this crisis, leading medical researchers have called for expanding opportunities for people in prison to participate in vaccine trials. These calls, like current regulations, focus on individualized risk assessments around consent, coercion, and harm, while ignoring the unnaturalness of deprivation conditions in U.S. prisons. We need new frameworks of analysis that refocus on structural, rather than individual, risk assessments. Integrating structural perspectives—including skepticism of claims of scarcity, avoidance of representational distortions, and attention to institutional agency—into our existing, overly individualistic frameworks might permit the design of more ethical research projects involving people who are incarcerated. Still, the unnatural deprivations of incarceration might be so great that research subjects might need to be removed from prison entirely in order to ethically participate in research.

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“…Pessoas encarceradas tem maior probabilidade que a população em geral de desenvolver complicações associadas ao COVID-19, devido a fatores como superlotação, Research, Society and Development, v. 9, n. 12, e9791210570, 2020 (CC BY 4.0) | ISSN 2525-3409 | DOI: http://dx.doi.org/10.33448/rsd-v9i12.10570 espaço confinado, saneamento precário e acesso precário a cuidados de saúde, associado a elevadas taxas de problemas de saúde subjacentes (Strassle et al 2020). Strassle et al, 2020 relatam que as consequências do surto de COVID-19 em penitenciárias são maiores em pessoas negras devido a injustiça estrutural, ou seja, elas têm maior probabilidade de serem encarceradas do que os indivíduos brancos e, consequentemente, morrerem por esta doença.…”

Section: Estudos Envolvendo Populações Específicasunclassified

“…Diante disso, esses autores consideram que as pessoas privadas de liberdade devem ser incluídas em ensaios de eficácia em locais que estão testando vacinas contra a COVID-19 depois que houver evidência da segurança de tais vacinas. Os argumentos para inscrever as pessoas encarceradas em testes de imunobiológicos são: acesso precoce a uma vacina eficaz, proporcionar a opção a esta população de participar de uma pesquisa médica e encurtar o tempo necessário para estudar a eficácia da vacina, se as taxas de transmissão continuarem altos nesses locais (Strassle et al 2020).…”

Section: Estudos Envolvendo Populações Específicasunclassified

“…Recentemente, tem havido um apelo para inclusão de presidiários em pesquisas com intuito de expandir o acesso aos benefícios potenciais da participação. Todavia, Strassle et al, (2020) relata que expandir o acesso aos testes de vacina para os indivíduos encarcerados não garante benefícios, pois as vacinas experimentais têm mais chance de falhar do que de ter êxito. Além disso, o ambiente não possui recursos clínicos mínimos para os participantes da COVID-19 que apresentarem complicações ou efeitos adversos graves.…”

Section: Estudos Envolvendo Populações Específicasunclassified

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Aspectos bioéticos envolvidos nos testes de vacinas contra o vírus SARS-COV-2

Cairo

Antonio

Silva

et al. 2020

RSD

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Objetivo: analisar as produções científicas que discorrem sobre a relação entre a bioética e a realização de testes de vacinas contra o vírus SARS-CoV-2. Metodologia: trata-se de uma revisão integrativa, onde o levantamento bibliográfico foi realizado nas bases de dados MEDLINE, SCIELO e BVS, através dos descritores “bioethics”, “COVID” e “vacinne” associados por meio do operador booleano “AND”. A análise dos dados foi realizada de forma descritiva com base na leitura integral dos artigos, categorização, síntese, extração e interpretação dos dados. Resultado: a pesquisa mostrou que a população utilizada nos estudos foram: 68,2% estudos de desafio com seres humanos (HCS), 9,1% tratavam-se de pesquisa com a população em geral e 22,7% de pesquisas com populações específicas (gestantes, negros, população encarcerada e crianças). Conclusão: nesse ponto é notório a falta de consenso entre os estudos analisados, embora a maior parte dos estudos argumentem em favor da realização dos estudos de desafio, outros são taxativos em afirmar que os testes não têm amparo bioético.

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Covid-19 Vaccine Trials and Incarcerated People — The Ethics of Inclusion

Cited by 14 publications

References 2 publications

Prioritizing incarcerated populations for COVID-19 vaccination and vaccine trials

Prioritizing incarcerated populations for COVID-19 vaccination and vaccine trials

Does a Public Health Crisis Justify More Research with Incarcerated People?

Aspectos bioéticos envolvidos nos testes de vacinas contra o vírus SARS-COV-2

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