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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

JAMA

Published Online: August 17, 2020

Viewpoint

Article Information and Disclosures

Emily A. Wang, MD, MAS^1,2;

Jonathan Zenilman, MD, PhD³;

Lauren Brinkley-Rubinstein, PhD^4,5

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

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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

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

The COVID Prison Project. Accessed July 12, 2020. http://www.covidprisonproject.com

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 PubMed Google Scholar

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.

Lerner BH . Subjects or objects? prisoners and human experimentation. N Engl J Med. 2007;356(18):1806-1807. doi:10.1056/NEJMp068280 PubMed Google Scholar Crossref

Gostin LO , Blair P , Cambra S , et al Ethical Considerations for Research Involving Prisoners. Washington, DC: National Academies Press; 2006.

Protection of Human Subjects. 45 CFR §46.303 (2020).

Christopher PP , Stein MD , Johnson JE , et al. Exploitation of prisoners in clinical research. IRB. 2016;38(1):7-12.PubMed Google Scholar

Nellis A , The Color of Justice: Racial and Ethnic Disparity in State Prisons. Washington, DC: The Sentencing Project; 2016.

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 PubMed Google Scholar Crossref

AMA CME Accreditation Information

Credit Designation Statement: The American Medical Association designates this Journal-based CME activity activity for a maximum of 1.00  AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to:

1.00 Medical Knowledge MOC points in the American Board of Internal Medicine's (ABIM) Maintenance of Certification (MOC) program;;
1.00 Self-Assessment points in the American Board of Otolaryngology – Head and Neck Surgery’s (ABOHNS) Continuing Certification program;
1.00 MOC points in the American Board of Pediatrics’ (ABP) Maintenance of Certification (MOC) program;
1.00 Lifelong Learning points in the American Board of Pathology’s (ABPath) Continuing Certification program; and
1.00 CME points in the American Board of Surgery’s (ABS) Continuing Certification program

It is the CME activity provider's responsibility to submit participant completion information to ACCME for the purpose of granting MOC credit.