Financial and public relations risks are obstacles to their inclusion
March 24, 2021
On Feb. 18, Pfizer and BioNTech announced they would dose about 4,000 healthy pregnant women with the COVID-19 vaccine to evaluate its safety, tolerability, and immunogenicity. Although pregnant people were excluded initially from the COVD-19 trials, research has shown they are at higher risk for more severe disease.
Minority populations are more likely to participate in clinical research activities when they are encouraged by trusted authority figures, such as family physicians or pastors. One such pastor and author, Bishop T.D. Jakes of The Potter’s House in Dallas, decided to use his popular YouTube channel to broadcast information about the COVID-19 vaccine to dispel myths and to encourage his followers to take the shots.
The COVID-19 pandemic has created more uncertainty in human research protections in 2021. One issue IRBs will face is whether the benefits continue to outweigh the risks for people who enroll in COVID-19 vaccine studies.
Many patients may be surprised to find out the treatment they are taking is not any better than a placebo. Clinicians may think this is no big deal, as long as the person is feeling better and is grateful.
It is clear that clinical trials now exist in a different world from what researchers, IRBs, and sponsors experienced in 2019. The key challenges are how to restart clinical trials, how to return to in-person visits, and how to manage the growing number of studies related to COVID-19.
Innovative neuroscience research is vital, but individuals with mental illness pose some unique ethical concerns in terms of their participation. The results of a recent study provided some reassurance on the decision-making processes of individuals.
All clinical trials raise certain ethical issues. But trials conducted during epidemics are especially difficult, both ethically and practically. Poorly designed studies subject patients to the risks of adverse events without learning if the intervention works.
While some researchers try to learn useful information from COVID-19 case data, other scientists are working on the early stages of various clinical trials, seeking a pharmaceutical remedy to the virus.