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The University of California at Berkeleys Consent Builder application relies on the simplified language and template structure previously developed by the institutions IRB office.
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While monstrous hurricanes are not a frequent occurrence, it always pays to be prepared. Hurricane Sandy was something of an anomaly, but cities and hospitals in the Northeast braced for the monster hurricane, putting plans in place to evacuate patients when needed and ways to continue operations even if the worst happened.
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Years of improvements to the informed consent process and many hours of developing tools and templates to assist IRBs and investigators in fine tuning informed consent documents have helped pave the way for Consent Builder.
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The American Association of University Professors (AAUP) released a report taking IRBs to task over what they call inappropriate, indeed absurd, alterations in research protocols and overly stringent guidelines for study submission and approval.
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A new research ethics program seeks to repair problems when investigators misbehave or are in noncompliance.
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The newly accredited MaGil IRB in Rockville, MD, has review process timelines that might seem impossible to other organizations, including a self-imposed deadline of four hours from the time an IRB review submission is made to the time it is seen by IRB members.
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For IRBs at mid-sized institutions, monthly meetings can go for hours and involve many protocols. This can be very time-consuming and cumbersome for IRB members and investigators alike. Protocol discussions may not get the time they need, and members simply may not have enough time to review all the agenda items.
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Human research protection offices have found that adopting policies and procedures regarding the reporting of unanticipated problems (UPs) has helped to reduce IRB busywork and improve the research communitys understanding of when to report problems, experts say.
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The IRB office at the University of Utah in Salt Lake City takes its standard operating procedures (SOPs) very seriously. The IRB even dedicates one highly experienced, part-time professional to make frequent revisions and improvements to the SOPs and guidance.
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The University of California Los Angeles (UCLA) recently updated its guidance on reporting unanticipated problems (UPs), adverse events (AEs), and other incidents in human subject research, providing a model for IRBs.
