Articles Tagged With: participants
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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.
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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.
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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.
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OHRP Looks Back at its First 20 Years
IRB Advisor asked OHRP to look back since its launch in June 2000 to see how human research protections has evolved.
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COVID-19 Trial Protocol/Consent Issues Discussed on National Stage
Placebo vs. access to the available vaccine
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High Efficacy of COVID-19 Vaccines Buoys Hopes
Although questions and caveats remain, preliminary reports of two new COVID-19 vaccines in the 90% to 95% effectiveness range have bolstered hopes that healthcare workers may soon be protected and potentially large portions of the public immunized in 2021.
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IRB Websites Can Offer a Wealth of Useful Tools
An important and useful function of an IRB’s website is its ability to give researchers — as well as the public — access to a wide variety of forms, guidance, and tools. When created well, an IRB’s website can be easy to navigate. It also should be updated with new and revised information regularly. Like crowdsourcing websites and with permission, an IRB’s website also can adopt and adapt tools that researchers and other IRBs have found useful.
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Diversity and Inclusion Go Beyond Race and Ethnicity
Researchers assessing the demographic statistics of All of Us Research Program participants prioritized enrolling racial, ethnic, and other minorities that, historically, have been underrepresented in clinical trials. The researchers concluded studies need to incorporate more diverse factors as key variables to ensure inclusion and identify barriers that limit research participation.
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Research Organizations Face Challenges New and Old
As current studies resume and new studies are approved, IRBs and researchers should keep basic safety and regulatory practices in mind, according to experts on the front lines of human research protection and clinical trials.
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IRB Experts Offer Advice for Changing Research Landscape
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.