The government announced Monday that a healthy volunteer in Seattle is the first person in the U.S. to receive a dose of an experimental coronavirus vaccine as part of a new clinical trial. Let’s take a brief look at some of the bioethics issues this trial raises. #COVIDー19
Regulators require that a manufacturer show a product is safe and effective before it can be marketed and sold. While not strictly required, researchers almost always take the step of using lab animals before recruiting human volunteers.
This coronavirus vaccine trial is bypassing animal testing in order to speed the process. But by doing that researchers and the committees that oversee research won’t know as much about risks of harm or likelihood of efficacy before testing it to human research subjects.
This makes the informed consent process more challenging than usual. Potential subjects need to know that the vaccine hasn’t been proven safe in animals and the call for volunteers didn't seem to include that information, and so makes information about risks even more important.
Researchers also have to be sure that subjects aren't signing up for the trial because they think it will give them immunity before everyone else; volunteers in this first phase of research, which is focused on safety, are very unlikely to receive benefit.
In such trials on otherwise healthy subjects it's acceptable to compensate subjects for their time but unethical to pay them overly enticing amounts that might make them ignore the risks. Studies shouldn’t take advantage of people by offering large sums to accept research risks.
What does this accelerated trial mean for the future? If regulators allow changes to usual approaches in face of this public health threat, which may well make sense, how should we think about future trials and cutting down on time but also potentially reducing protections?
There is great pressure to be expedient in the midst of a crisis. But today’s ethical standards derive in large part from lessons learned from mistakes made during past crises, and so we must be careful and thoughtful as we navigate this crisis and try to learn for the future.
