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IRBs are no different from other boards in how their psychological structure could lead to personality clashes and conflicts. However, unlike many organizations, when IRBs ignore such conflicts, the outcome might be a less-effective human subjects protection program or regulatory problems.
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Improving consent form should be top priority: Think outside the box and go beyond regulations
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The consent form is the IRBs document, but the sponsor may say, If youre not willing to include this language, this disclaimer, then we wont open the trial at your institution, Joffe explains. Then the IRB can think of creative ways to put it in there without distracting from the message they want to convey in the consent form.
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IRB members and others in the research community sometimes have misconceptions about the use of the expedited review process, including the idea that an expedited review is different from a review by the full IRB.
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Drug and biotech companies that have paid government scientists for consulting services soon will receive a request from a House subcommittee to voluntarily release financial details of such agreements.
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A basic tenet of research involving human subjects is those who agree to be participate must give their informed consent after being informed about the known and unknown risks inherent in their participation. One category of risk is the possibility of injury.
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When health care costs for its employees soared by 60% and out-of-network claims increased by 20% in just a few years, Davis Memorial Hospital in Elkins, WV, took action. The 90-bed community hospital called on the expertise of Tod Thorpe, RN, CPC-H, its former case management director, to manage the health care of its 650 full-time equivalent employees.
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The Breakthrough Series Collaborative model effectively employed by the Institute for Healthcare Improvement (IHI) on a national level has been translated successfully to the regional level in the state of Washington, achieving significant improvement in the self-care efforts of diabetes patients and clinical improvements in areas such as blood sugar and cholesterol.
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Physicians aligned with Sutter Health in Sacramento, CA, are giving glowing reviews to a care coordination program they once failed to recognize, pleased that it is meeting myriad patients needs and saving office time in the bargain.
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After working 15 years as a discharge planner and earning masters degrees in nursing and clinical research, theres an incongruity that Diane Holland, RN, MS, MBS, who is now pursuing a PhD through the doctoral program at the University of Minnesota School of Nursing in Minneapolis, would like to resolve.