Clinical trials are being performed across the globe on COVID-19 vaccines. When a person agrees to participate in a clinical trial, he or she shouldn’t have to be concerned about the possibility of becoming a fatality statistic, That raises the issue of when a person agrees to participate in a drug trial, what are they agreeing to?

Risk of Harm vs. Value

As per the National Institute of Health, there are many different types of clinical trials. In the context of COVID-19, trials are conducted for either treating the virus or developing a vaccine for it. Researchers want to determine whether a particular treatment or possible vaccine is safe and effective. Clinical trials can’t haphazardly expose participants to unreasonable risks though. Informed consent must be obtained from the participants, and the trials must be approved and followed by an institutional review board for purposes of ensuring minimal risk of harm to participants in relation to the value of any COVID-19 treatment or vaccine.

What is a Wrongful Death Action?

Every state has its own wrongful death statute. They involve claims or lawsuits by a family or estate against a person or entity that can be held liable for the negligent, reckless or intentional death of a person. Each state also specifies the types of damages that might be awarded in a wrongful death case. For example, damages can include medical and burial expenses, loss of income, loss of companionship, and other financial losses that a family might face as a result of the death.

Informed Consent

Every clinical trial has risks. Anybody who participates in a clinical trial must be informed of the risks that they might be taking in the trial, especially if those risks are mathematically and physically significant, like one in 10,000 chance of death. The person or entity performing the trial must obtain the informed consent of every participant.

What can come to issue with informed consent is that required disclosures might be incomprehensible to the participants. Some informed consent forms might even be misleading to the point of being deceptive. A few lawyers have picked up on clinical trial disclosures, and wrongful death lawsuits have been filed that raise issues on a participant’s informed consent rights.

Benefits vs. Risks of Clinical Trials

In the context of COVID-19, some clinical trials have only started, and others will begin in the immediate future. Indeed, there is a risk of death for participants. As per the U.S. Department of Health and Human Services, there are many benefits to participating in a clinical study. Those might include the following:

  • Obtaining COVID-19 treatment or a vaccine before it’s available to the general public.
  • Being provided with more frequent care and check-ups.
  • Helping others get treatment in the future.

There are also potential risks of being in a clinical trial. Some of those also follow:

  • Adverse reactions could be severe, permanent or even fatal.
  • It’s entirely possible that the new treatment just doesn’t work.
  • You might be part of a control group that receives standard treatment or no treatment at all.

Dropping Out

Informed consent is invaluable in protecting clinical trial participants. Before participating in a clinical trial, you should be fully and clearly informed in understandable language as to what you’ll be participating in, what you should expect as a participant and everything that might happen, including death. By signing off on an informed consent form, you’re not entering into a binding contract. You can leave a clinical at any time if you so desire.

Cite this article as:
Editorial Staff, "Covid-19 Death During Clinical Trial: Can the Family Successfully Pursue a Wrongful Death," in Medicalopedia, September 12, 2020, [Permalink: https://www.medicalopedia.org/9239/covid-19-death-during-clinical-trial-can-the-family-successfully-pursue-a-wrongful-death/].