Researcher works at a lab bench

Human Subjects Research in Emergencies: An Ethical and Legal Guide (Part I)

By Jennifer S. Bard

This post is the first in a series about conducting human subjects research in emergencies. These posts are being written in response to a rapidly evolving situation and will reflect the state of knowledge at the time of writing.

The world is facing a medical emergency in the form of the rapid spread of a new virus, COVID-19, for which there is no known effective treatment and no preventive vaccine.

Without minimizing the need for haste or the significance of the threat, it is still important to remain aware of the risks inherent in rushing to treat patients with anything that might work and simultaneously conducting the research necessary to identify safety and effective interventions.

News of the global effort to find effective therapies and a much needed vaccine often takes the form of breathless press releases from the FDA or pharmaceutical companies proclaiming their “fast tracking” and “all-hands-on deck” approach that involves one new program after another to expedite the development of potentially safe and effective life-saving treatments by developing new products or repurposing those already approved for other purposes.

While information is scarce, we already hear about trials proceeding without the usual requirement of first testing for safety and efficacy in non-human animals as well as expedited IRB reviews. It is reasonable to be concerned that communities with under-served health needs that already suffer disproportionately poor health outcomes, such as Native Americans, African Americans, and people living with disabilities, will be asked to take on unwarranted risks or, conversely, be excluded from equal access to the possible benefits of being a research subject. In times when the only access to effective care is through enrollment in a clinical trial, we have longstanding reasons for concern about equal allocation of the opportunity to participate.

On a global level, the WHO has already called for the inclusion of more African nations in the drug trials it has initiated and at the same time expressed concern that vaccine tests treat “humans equally” wherever they live.

In the best of times, conducting clinical drug trials with very sick patients raises difficult ethical and legal challenges.  For example, the current legal standard, clinical equipoise, requires offering unproven treatment only when it is as least as good or better than existing treatments. But in a situation where many patients get better with only supportive care, it is difficult to know whether there is actual equipoise between an unapproved pharmaceutical and existing standards of supportive care.

The field of research ethics is by definition, a multi-disciplinary discipline looking both forwards and backwards. Often we learn of human subjects research protection concerns long after the research concludes.

These posts will consider issues of equipoise, of just subject selection, and of informed consent in the context of the challenging scenarios presented to researchers by COVID-19. In so doing, it will also highlight what we already know about conducting research in times of emergency like those at the time of  HIV, SARS, smallpox, polio, and Ebola, and highlight some of the extensive literature available to us in addressing today’s frightening times.

Coming next: What is an “emergency” and how should it affect the process of conducting human subjects research?

Jennifer S. Bard

Jennifer S. Bard

Jennifer S. Bard is a professor of law at the University of Cincinnati College of Law where she also holds an appointment as professor in the Department of Internal Medicine at the University of Cincinnati College of Medicine. Prior to joining the University of Cincinnati, Bard was associate vice provost for academic engagement at Texas Tech University and was the Alvin R. Allison Professor of Law and director of the Health Law and JD/MD program at Texas Tech University School of Law. From 2012 to 2013, she served as associate dean for faculty research and development at Texas Tech Law.

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