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.

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 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.

With millions more healthcare workers and the general public slated to be immunized for COVID-19, researchers report that the Pfizer SARS-CoV-2 mRNA vaccine is causing anaphylactic shock reactions at 10 times the rate of typical vaccines.

“In talking to infection preventionists around the country who are being vaccinated — it is like hope. It is a positive step forward. It is a step towards the solution," said Connie Steed, MSN, RN, CIC, FAPIC, president of the Association for Professionals in Infection Control and Epidemiology.

Adults of any age with “certain underlying medical conditions are at increased risk for severe illness from the virus that causes COVID-19” and can be immunized with the approved mRNA COVID-19 vaccine “provided they have not had a severe allergic reaction to any of the ingredients in the vaccine,” the Centers for Disease Control and Prevention reports.

Current COVID-19 vaccines have not undergone the process for full FDA approval, but have been authorized under a streamlined process known as an emergency use authorization. Because of this, the vaccines are technically considered experimental and are subject to regulations that may affect whether employers are permitted to mandate their use by employees.

Under certain circumstances, employers are permitted to mandate their employees to receive a COVID-19 vaccination as a condition of their employment. That position was outlined by the Equal Employment Opportunity Commission in guidance published in December 2020. However, this guidance is not without its limits.