Articles Tagged With: irbs
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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.
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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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Biometrics Expert Discusses Data Integrity for COVID-19 Clinical Trials
The first remdesivir double-blind, placebo-controlled clinical trial for treating COVID-19 was published recently in Lancet. A member of the trial’s data safety monitoring board is Weichung Shih, PhD. Shih discussed the role of biostatisticians in protecting data integrity for clinical trials and the challenges during the COVID-19 pandemic.
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Enhance Health Literacy Among Study Participants
IRBs can help improve health literacy among potential research participants using several tactics, including asking studies to use plain language in informed consent forms. IRBs can review informed consent and subject recruitment materials to ensure the study information is clear and adheres to regulatory requirements.
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IRB Highlights Standardized and Effective Metrics Model
As IRBs and research programs increasingly seek IRBs of record and form reliance agreements, they will need to know whom to trust. IRBs also need their own performance data to share with sponsors, researchers, and others. The challenge is developing metrics that work and can be used by other IRBs for benchmarking purposes.
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New FDA Guidance Explains COVID-19 Expanded Access Policy
The Food and Drug Administration published an eight-page guidance for IRBs handling expanded access to investigational products during the pandemic. The guidance, issued in June, explains how IRBs might review individual patient expanded access requests for investigational drugs and biological products during the COVID-19 public health emergency.
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Actions for IRBs Reviewing Vaccine Challenge Trials
As the world looks for a safe and effective vaccine against SARS-CoV-2, IRBs should review the bioethical implications of this type of study design, including assessing risks and benefits.
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IRB Pandemic Impact Report
In this question and answer special report, a dozen IRB administrators, directors, chairs, and other leaders from across the United States were asked about their facilities’ experiences during the COVID-19 pandemic’s early weeks.