February 1, 2021
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The first month of the COVID-19 vaccine rollout among frontline healthcare workers was a reality check to the human research world after many people said no to the vaccine. There are several reasons for vaccine hesitancy, including distrust in the accelerated vaccine development process.
The COVID-19 vaccine rollout has raised issues about trust among many Americans who are hesitant or unwilling to take the vaccine. The issue of trust is especially problematic among minority communities that have been harmed in historic medical and research incidences. People also are skeptical of a vaccine that was developed in record time, considering most vaccines take 10-15 years to make it to market.
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.
Revisions to the Common Rule took effect in 2018, but questions remain about how these changes have affected the Federalwide Assurance (FWA) and institutional responsibilities under the FWA.