Internal Review Boards
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Mobile Technology, Wearables Are Changing Research, Challenging IRBs
Mobile technology and wearable sensors are broadening the limits of research and changing how IRBs view privacy. The voluminous data can point to health strategies previously unimaginable.
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Big Data Are Changing How IRBs Think About Research
Researchers and sponsors are adapting quickly to virtual technologies and using big data in studies, forcing IRBs and research protection programs to adapt — particularly when it comes to privacy. When IRBs review studies that use big data, they need to be reviewed through the lens of ethical review.
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Guidance Document Includes Tips for Making Clinical Research More Inclusive
The COVID-19 pandemic has put the spotlight on many problems, including the lack of diverse trial participant populations.
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FDA Releases Q&A for COVID-19 and Clinical Trials
The Food and Drug Administration recently released updated guidance on conducting clinical trials of medical products during the COVID-19 pandemic. The new version of the guidelines includes a question-and-answer section that clarifies some emergency changes affecting human research protection policies and procedures.
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SBER Programs Face Challenges with Revised Common Rule
Social-behavioral-educational research programs have always faced challenges fitting their work into the parameters of human research protection rules and regulations devised with biomedical research in mind. But the revised Common Rule has produced new issues with informed consent.
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IRB Members Can Build Good Relationships in Virtual Space
One long-time virtual IRB has learned how to develop camaraderie and rapport among IRB members without ever meeting in person — or seeing each other’s faces.
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Keeping Open Dialogue Part of Virtual IRB Meeting Plan
A full-time virtual IRB gives advice on bringing IRB meetings online during the COVID-19 pandemic.
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Research Group Increased Minority Participation by 533%
One barrier to enrolling minorities in research involves resources. For some studies, such as pediatric oncology clinical trials, there might not be enough resources to enroll one or two patients at a single site.
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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.