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As a research institution's human subjects research increases, so must an IRB's work. In some cases this means expanding to handling multicenter protocols, which bring may result in new challenges.
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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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When patients don't follow their discharge plan and end up back in the hospital or fail to keep their chronic disease under control, resulting in complications, it could be that they simply don't understand what they're expected to do.
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A program that provides face-to-face case management and hormone injection services for women at risk for pre-term birth has reduced the spontaneous pre-term birth rate by 8% among the Medicaid population served by the program.
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In a study reported online by the American Journal of Cardiology, Henry J. Michtalik, MD, MPH, and his colleagues tested heart failure patients on admission and discharge for levels of a protein that's considered a marker for heart stress.
