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Ethical Considerations for COVID-19 Vaccine Trials in Correctional Facilities

Educational Objective
To understand the ethical considerations of not including prisoners from correctional facilities in COVID-19 Vaccine trials
1 Credit CME

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.

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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
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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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