April 1, 2021
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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.
Lawmakers, academics, and the research community have hotly debated the ethics of a human challenge study since the first months of the COVID-19 pandemic. Now that the United Kingdom has started dosing patients in its human challenge study, some bioethicists say this trial can show vaccine efficacy in ways the larger vaccine trials cannot.
Researchers at the University of Houston discovered a survey study had been breached. Large number of surveys poured in, with batches arriving in two-minute intervals. Other signs of a breach included suspicious responses, unusual email addresses and patterns, responses from outside the United States, and missing contact information.
IRBs can help investigators create a plan to prevent survey security breaches that can lead to false data and study slowdowns and shutdowns. IRBs should ensure researchers know that if they detect a breach that changes/corrupts data, leads to someone outside the research team accessing data, causes potential harm to participants, or requires a change in procedures or informed consent, it should be reported to the IRB.