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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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Get ready, IRBs data collection for financial conflicts of interest (FCOIs) is about to get more complicated.
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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.
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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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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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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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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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IRB staff professionals need a greater breadth of knowledge and training now than they might have a decade ago, which is why one HRPP recently created a more comprehensive educational program that also offers greater autonomy to staff.
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Just as companies are offering whole genome sequencing to individuals, companies are offering to sequence their microbiomes and determine how they compare to others.
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The Office of Human Research Protections (OHRP) and the Food and Drug Administration (FDA) encourage the use of the central IRB model to increase the efficiency and quality of multisite trials.