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A data and safety monitoring board (DSMB) can be crucial to protecting participants in higher-risk studies, by reviewing the accumulating study data for potential emerging risks and if necessary, by recommending that a study be changed or even halted as a result.
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Can the informed consent process actually provide too much information?
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IRB professionals might not have gotten into the business of protecting human subjects because of their love for mathematics and statistics. But many now are finding that tracking data and analyzing numbers helps them do their job better.
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When internal job mobility is stagnated, it can result in high staff turnover rates a problem no IRB wants to experience.
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IRB offices routinely handle protocol submissions that are incomplete or flawed in other fundamental ways. These problems cause roadblocks that slow down the IRB approval process and frustrate investigators and IRB staff alike.
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A recent analysis of clinical trials showed that researchers routinely ignored previously published and relevant clinical trials when conducting their own studies.
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Investigators, particularly when they are new to human subjects research, often fail to include all necessary information in their IRB applications because they are unaware of what's required.
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The state of Michigan has moved forward with its plan to store blood samples left over from screening newborns for medical conditions in a biorepository that will make the deidentified samples available for research.
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IRBs sometimes balk at studies that ask sensitive questions about topics such as sex and violence, based on concerns that participants may find them distressing.
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A major obstacle to implementing process or quality improvement measures is finding out what the people impacted by the change think.
