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Guidelines and regulations related to research ethics often are conflicting and difficult to follow, so IRBs are left with a multitude of ways to interpret human subjects research issues that arise during the protocol review process.
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The NIH has created a framework and benchmarks program for evaluating research ethics. Christine Grady, PhD, RN, head of the section on human subjects research in the department of clinical bioethics at NIH, provides these insights into the seven principles outlined in the framework:
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Add one more discipline to the list of those that have issues with IRB review: Oral historians, who maintain that they should not be required to seek review for their interviews with participants.
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As IRBs deal with the privacy provisions of HIPAA, they often must decide whether researchers are allowed to waive individual authorization for use of patients data.
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One of the drawbacks for research conducted in this age of checklists and strong regulatory oversight is that IRBs and research institutions do what theyre required to do and sometimes neglect to address the bigger picture, an ethics expert says.
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By now, hospitals should have fully developed and implemented a process to comply with 2005s National Patient Safety Goal (NPSG) 8 of the Joint Commission on Accreditation of Healthcare Organizations in Oakbrook Terrace, IL: Accurately and completely reconcile medications across the continuum of care.
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FDA issues public health advisory for aprotinin injection (Trasylol); FDA revises format of prescription drug information; Current influenza viruses resistant to amantadine, rimandatine; Report: Many CAD patients dont take drugs that could extend lives; ICAP approves uniform labeling guidelines; Serious liver toxicity reported with use of telithromycin (Ketek)
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Exenatide is an incretin mimetic that is similar to the glucagon-like peptide-1(GLP-1) in the body, and acts by binding to GLP-1 receptors. It improves glycemic control by increasing glucose-dependent insulin secretion, improving first-phase insulin response, decreasing glucagon secretion, slowing gastric emptying, and reducing food intake.
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