As we rush to develop better and more effective treatments and vaccines to combat the COVID-19 pandemic, we cannot forget about the concerns and risks in conducting research, especially in vulnerable populations like children. This month’s Ethics Rounds in Pediatrics (2020-010728) reviews the ethics behind testing a COVID-19 treatment on a particularly vulnerable child who has no parents to consent for care or research.
As with any clinical trial, researchers need to weigh the risks and possible benefits for each patient. However, clinical trials should be conducted from a starting point of equipoise: where both arms of the trial are designed to have potentially the same outcome and thus offer the same risk/benefit ratio to any study subject. Thus the real question is whether or not to participate in the study at all.
Therefore, it is easy to argue that vulnerable patients should not participate in research. To that point, in Nebraska, there is a state policy which prevents any state ward from participating in research. This policy was put into place to protect state wards from the risk of research. However, it is also true that by preventing a population from participating in research, they may be excluded from the benefits of research. For example, we know that children in foster care are at higher risk for post-traumatic stress disorder (PTSD) as a result of adverse childhood experiences. If we were studying a drug which mitigated the effects of PTSD, but excluded those children in foster care, we may find an overall effect that is smaller or may even miss an adverse event that occurs because of the high burden of trauma in this population.
It is true that there are vulnerable populations which are identified at high risk during clinical research trials. Rather than completely excluding these vulnerable populations from clinical trials, there needs to be an ethical discussion weighing the risks and benefits of participation for each study and possibly (as in this case) for each patient.
