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Well, this is a fine mess all us health care providers are all getting into isn't it? I mean, we have oil spills, the earthquakes, and volcanoes and various other sundries out there to make our lives more complicated and miserable.
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A woman came in for breast implants and went under anesthesia. The silicone implants she had selected were not available; only saline ones were there.
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[Editor's note: This is the second part of a two-part series on a new guideline from the Society for Healthcare Epidemiology of America (SHEA) regarding the management of providers who are infected with hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV). In last month's issue, we gave you an overview of the guideline, which procedures are at greatest risk of transmission, and the recommendations for infected staff. In this issue, we further explain the new guidelines and discuss how to decide which workers to test.]
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In the past 10 years, there have been about 100 settlements of self-referral and kickback between the Office of Inspector General (OIG) of the Department of Health and Human Services and health care facilities. Twenty of these cases occurred in the past two years.
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As concerns grow over the expense and slow progress of classic randomized clinical trials (RCTs), an intriguing alternative is gaining steam adaptive design, in which trials change at various decision points in response to accumulated data.
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Internet research has been an issue for IRBs since its roots in the 1990s, and the challenges ethics boards face in reviewing such studies are in pioneer territory.
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Internet technology and its impact on society have evolved so quickly in recent years that researchers and IRBs lag far behind in their efforts to understand and use this new forum.
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For researchers and IRBs there is an ethical paradox in behavioral studies involving populations that are hard to engage.
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As Americans become increasingly accustomed to learning more about their own health, it's becoming more common for research participants to expect to learn about their personal results during a study.
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Adaptive design clinical trials raise many of the same issues in IRB review as do unplanned modifications to existing trials, says Marjorie Speers, PhD, executive director of the Association for the Accreditation of Human Research Protection Programs (AAHRPP) in Washington DC.