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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
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  1. COVID-19 Vaccines


CME Disclosure Statement: Unless noted, all individuals in control of content reported no relevant financial relationships. If applicable, all relevant financial relationships have been mitigated.

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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