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Nonaffiliated and nonscientist members of IRBs the so-called lay or community members say they need more introductory education and ongoing training to better meet the challenges of their roles.
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One of the challenges in clinical trial operations is to recruit patients to participate. The Food and Drug Administration notes that recruitment methods and material also should be reviewed as a part of the IRB oversight function.
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IRBs located in universities might find themselves inundated with low-risk protocols if they reviewed every single study proposed by college students working on their graduate papers. On the other hand, it would be poor policy and possibly provide risk to human subjects if these studies were routinely ignored.
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Recruiting students for research at universities and colleges is no longer as simple as having professors offer extra credit in exchange for participation. It has become an area that has created controversy within institutions and IRBs.
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The skyrocketing cost of medical malpractice insurance has affected physicians throughout the nation. Many emergency physicians (EPs) have seen the costs of insurance nearly double in the past three years. Some insurers have deemed EPs with three claims against them in a five-year period as uninsurable. This months ED Legal Letter will provide insight into the malpractice crisis by looking at the cause, effect, and potential solutions to the problem. Furthermore, it will review why past legislative attempts to remedy previous malpractice crises have failed.
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The Centers for Medicare & Medicaid Services (CMS) has released its proposed rule for inpatient Medicare payments for fiscal year 2004.
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The Joint Commission on Accreditation of Healthcare Organizations has released a proposed leadership standard on emergency department (ED) overcrowding.
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A process for making follow-up calls after new moms are discharged with their babies from Sacred Heart Medical Center in Spokane, WA, has helped to improve discharge instructions at the health care facility.