IRB Advisor – November 1, 2009
November 1, 2009
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A fine mess: IRBs overloaded with unnecessary adverse event reports
It's a constant refrain: IRBs are overburdened by adverse event reports (AERs) â many of which are unnecessarily reported to them and which they often lack the information to properly analyze. -
Study finds adverse reports inaccurate in cancer trials
A study of serious adverse event reports (AERs) sent to an IRB from clinical trials of a breakthrough cancer drug revealed they were too often incomplete and inaccurate when compared to the original medical records from which they were taken. -
Pregnant pause: Psych research and moms-to-be
Handling mental illness during pregnancy can be a double-edged sword. Because of the scarcity of clinical research with pregnant women, there are no FDA-approved medications for treating such illnesses. On the other hand, untreated mental illness in pregnancy carries its own risks. -
New IRB requirements rankle researchers
Requirements that IRBs see as minor or routine may have serious consequences for a practice-based research network (PBRN), says Barbara P. Yawn, MD, MSc, FAAFP, director of research at Olmstead Medical Center, Rochester, MN. -
IRB cuts 35 days from protocol turnaround
When a Yale University research facilitation office first looked at improving protocol review turnaround time in late 2007, the time from intake, through development, to IRB submission and approval averaged 80 days. -
AHRQ provides free tool to help with informed consent
IRBs and researchers now have a new toolkit that will make it easier to ensure proper informed consent has been obtained from subjects with limited literacy and proficiency in English. -
AHRQ toolkit provides examples of 'teach-back'
"The AHRQ Informed Consent and Authorization Toolkit for Minimal Risk Research," published in September, 2009, provides very concrete examples of ways investigators and IRBs can improve the informed consent process.