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April 1, 2021

View Archives Issues

  • Study of COVID-19 Vaccine in Pregnant People ‘Too Late’

    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.

  • United Kingdom Begins First COVID-19 Human Challenge Study

    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.

  • IRBs, Researchers Starting to Recognize Security Breaches of Online Survey Data

    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.

  • Take Steps to Prevent Damaging Security Breaches in Survey Studies

    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.