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A recent lawsuit against Brown University in Providence, RI, is an important sign that it's time for research institutions to create formal appeals processes in the event of contested IRB review decisions.
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The Vice President's Office for Research at Virginia Commonwealth University in Richmond, VA, has developed a formal process for investigators who wish to appeal an IRB determination.
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IRB application submissions often lack consistency, have omissions and errors, and other problems that IRBs should teach investigators to anticipate and correct before filing their application. Among these mistakes are policy errors, data security concerns, and other procedural problems.
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First-in-human clinical trials raise difficult ethical issues for researchers and IRBs because of the uncertainty that accompanies them. Did the preclinical studies that preceded them provide enough information about effectiveness and risks and benefits to proceed with human volunteers?
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A data and safety monitoring board (DSMB) can be crucial to protecting participants in higher-risk studies, by reviewing the accumulating study data for potential emerging risks and if necessary, by recommending that a study be changed or even halted as a result.
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Can the informed consent process actually provide too much information?
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If anyone knows how difficult it is to measure something as ephemeral as "good communication," it is David Maxfield.
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Perhaps one of the most startling sentences in a recent Health Affairs article by Joint Commission president Mark Chassin, MD, FACP, MPP, MPH, is one in which he and his co-author, commission executive vice president Jerod Loeb, state that "...we know of no health care organization that has been able to achieve a consistent state of high reliability."
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The Joint Commission has announced that it and its Center for Transforming Healthcare will participate in the Partnership for Patients, a public/private initiative designed to make hospitals safer by reducing harm and readmissions.
