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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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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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Clinical trial professionals and investigators should reconsider the inclusion/exclusion criteria and other factors to meet the needs of their study participants, an expert suggests.
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Put any group of IRB administrators into the same room and soon you'll hear a discussion about how they have to deal with so many poorly-written protocols.
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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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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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When a judge recently ordered a pharmaceutical company to provide an investigational drug to a teenage boy who had not met the enrollment criteria for a phase II trial, the IRB world took note.
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Decision making in health care ethics consultation cases often involves difficult, complex issues and mediating differences of opinion.
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Bridges to Excellence (BTE) CEO Francois de Brantes doesn't mince words when asked if he thinks there is an ethical conflict between the payment model of pay-for-performance essentially giving physicians additional payments for good performance based on certain quality measures and ethical decision-making by physicians.
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More and more questionable ties between physicians and drug companies are being uncovered in an investigation into such financial relationships conducted by Sen. Charles Grassley (R-IA).