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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.
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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.
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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.
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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.
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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.
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Patients may arrive for outpatient surgery, only to find out the bill is estimated to be more than $10,000.
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After a 31-year-old student and part-time clerk underwent an excisional biopsy on her left breast, the physician diagnosed the woman with cancer and recommended commencement of chemotherapy. About six months later, the woman came under the care of a hospital breast clinic and was evaluated by a general surgeon employed by the hospital who recommended a mastectomy.
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Your surgeon says she wants to use a medical device in a different manner than it was approved by the Food and Drug Administration (FDA). She says he has the data to ensure it will be used safely, and the patient already has given informed consent.
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Everything seems to be about health care these days. Everyone has an agenda on what is best, for whom, and how much it will cost whom.
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This spring during the H1N1 epidemic, registrations through EDs increased dramatically nationwide. The processes of virtually every patient access department were put to the test.