IRB Advisor – August 1, 2020
August 1, 2020
View Issues
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Research Community Seeks to Enroll More Minorities in Clinical Trials
Several months of data from the COVID-19 pandemic showed that African Americans and other people of color were disproportionately dying from the disease. Disparities in how COVID-19 affects minority communities highlight long-standing difficulties in achieving health equity in U.S. society, including clinical trials.
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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 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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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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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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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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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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