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Why Prisoners Were Left Out of COVID-19 Vaccine Trials

Strict federal rules on research with prisoners, written after decades of abuse, kept people in prison out of the 2020 COVID-19 vaccine trials.

Written by Brandon Sample · Updated October 9, 2026 · Filed under Federal sentencing legislation

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Update (October 2026): This post was written in September 2020, before any COVID-19 vaccine was authorized in the United States. It describes the debate at that time. The federal rules on research with prisoners it discusses are still in place at 45 C.F.R. Part 46, Subpart C.

Why people in prison were not in the trials

In 2020, large COVID-19 vaccine trials in the U.S. did not include people in prison. That was true even though prisons had some of the worst outbreaks in the country. Strict federal rules on prison research, written after decades of abuse, were a big reason why.

At the time this post was written, scientists around the world were racing to make a vaccine. The original article reported that only China, Britain, and the United States had candidates ready for human trials. In the U.S., phase-3 trials were expected to enroll more than 30,000 high-risk people. People in prison, a high-risk group, could not take part.

Why prison research is so restricted

Prisoners have been left out of most research studies since 1978. Before then, they were often used in medical experiments that failed to inform or protect them. Many were never warned about dangerous conditions during testing or about side effects. These experiments often happened with no federal oversight, which raised the risk of permanent injury or even death.

That changed when the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research stepped in, and unethical or exploitative studies ended. The commission also stopped research that posed more than a minimal risk to prisoners' health, and studies that did not improve the health and well-being of any prisoner. It concluded that prisoners should take part in trials only in the most compelling circumstances. Federal rules adopted in 1978 now allow research with prisoners only in narrow cases.

Under 45 C.F.R. § 46.306, federally funded research with prisoners is limited to four types:

Low-risk studies of the causes and effects of incarceration and criminal behavior.
Low-risk studies of prisons as institutions, or of prisoners as incarcerated people.
Research on conditions that affect prisoners as a group, after expert review and public notice.
Research on practices that are likely to improve the health or well-being of the people in the study.

The review board that approves the research must include a prisoner or a prisoner representative.

In the original article's view, these categories should allow prisoners to take part in COVID-19 vaccine trials, as long as they stay fully informed throughout the testing.

Calls to change the rules

In 2006, the Institute of Medicine (now the National Academy of Medicine) recommended updating these rules. It suggested allowing prisoners to take part in some low-risk, proven testing, with strong protections. Its list of allowed research included phase-3 clinical trials. Those changes were never adopted, and the original limits are unchanged.

Why it mattered during COVID-19

The categories above are not the only hurdle. Federal and state rules often keep researchers from doing their work well. For example, federal rules require a panel of experts to be assembled before research can begin in a prison or jail. The original article argued that these outdated policies are exactly why an overhaul is needed.

Respiratory viruses like the flu and COVID-19 spread fast in prisons, and most facilities cannot properly quarantine sick people. Prisoners also have higher rates of chronic illness, which can lead to serious complications from COVID-19.

The original article reported that 39 of the 50 largest COVID-19 outbreaks in the United States were in prisons and jails.

What experts proposed

In an August 2020 JAMA article, researchers argued that prisoners could be included in vaccine trials if there were strong safeguards:

Participation must be truly voluntary, coming from a real wish to help the research.
Each person must give informed consent, with a full explanation of the trial.
Most importantly, any testing should go through an independent review board, including a prisoner representative, that guards against pressure and exploitation. With a board like this, prisoners have a better chance at fair, ethical, and equal treatment.

Protection versus access

The 1978 rules dealt with the ethics of research in prisons, but they may also block more modern testing. The question in 2020 was whether those same rules were keeping a high-risk group from the protection of a new vaccine.

The original article argued that with COVID-19 spreading through so many prisons, it was imperative to include this high-risk group in vaccine trials. In its view, only in these settings could we truly see how well the vaccines work on a large scale.

Source: Wang EA, Zenilman J, Brinkley-Rubinstein L. Ethical Considerations for COVID-19 Vaccine Trials in Correctional Facilities. JAMA. Published online August 17, 2020. doi:10.1001/jama.2020.15589