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Knowing that an investigator has a financial interest in a clinical trial doesn't substantially affect people's willingness to participate, according to a study that surveyed 470 people about their reaction to informed consent documents that detailed such interests.
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A recent study of an instrument for assessing decisional capacity in patients with Alzheimer's disease shows that it's a reliable tool for determining whether those patients are competent to give their own consent for research.
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The new IRB Advisor pilot program at Rutgers, The State University of New Jersey in New Brunswick, NJ, resulted in a reduction in protocol submissions that had to be returned to investigators, according to the IRB director.
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It's just about a given that informed consent documents making their way to the IRB for approval will need to be revised for comprehension and readability. Investigators and sponsors tend to include long sentences and paragraphs and technical jargon that leads the MEGO syndrome "my eyes glaze over," says Stewart A. Laidlaw, PhD, an associate vice president for compliance at the Los Angeles Biomedical Research Institute at the Harbor-UCLA Medical Center (LA BioMed) in Torrance, CA.
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Quality assurance programs for clinical trials do more than improve the data coming out of studies and the validity of the results.
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Is it the end of an era for The Joint Commission? Following on the heels of Congress' move to require the organization to reapply for deeming authority for the first time, DNV Healthcare on Sept. 26 was granted deeming authority from the Centers for Medicare & Medicaid Services (CMS).
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Anticoagulants, or blood thinners, have taken the mainstream media by storm with salacious tales of medical errors and tragic stories of babies' deaths.
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While The Joint Commission is asking health care facilities to use computerized physician order entry and bar coding technology as an adjunct to arm themselves in managing high-risk medications including anticoagulants, a recent study highlights the errors implicit in this kind of information technology support.
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In September, the American Hospital Association issued a quality advisory on implementing standardized colors for patient alert wristbands, citing a near miss when a nurse mistakenly placed a wrong-colored bracelet on a patient, confusing the color codes of the two hospitals for which she worked.
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A story that ran in the Sept. 12 issue of the Philadelphia Inquirer "Hospitals' mistakes are going unreported" might have shocked readers with its description of unreported errors in New Jersey and Pennsylvania despite the states' mandatory reporting requirements.
