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Researchers are finding the HIPAA to be a significant barrier to recruiting research participants, in part because of the inconsistent way in which IRBs deal with requests for HIPAA waivers.
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Reacting to allegations that clinical trials showing unfavorable results often go unpublished, two states are proposing legislation that would require clinical researchers to register their studies with the NIHs clinical trials database if they involve studies designed to evaluate a drugs safety or effectiveness.
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Should a terminally ill 10-year-old have a say in determining her end-of-life care? Can a teenager make an informed consent to treatment? Questions of this type will be the mainstay of the Center for Pediatric Bioethics, the nation first center for bioethics solely dedicated to pediatrics, which will be located at Childrens Hospital and Regional Medical Center in Seattle.
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Public opinion of FDA sliding in Vioxx wake; CAM therapies must meet standards.
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Patients with psychiatric illness pose a particular problem to researchers and to the IRBs that review studies involving them. They can have widely varying capacity to give informed consent and that capacity can wax and wane depending upon the progression of the illness and the patients current treatment. Issues such as the use of placebo and the role of surrogates can be thorny.
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A video created to dispel patient misconceptions about clinical trials benefited from a diverse array of viewpoints everyone from physicians and nurses to subjects and even those who decide not to take part in clinical trials, says the woman who spearheaded the effort.
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The 1999 research-related death of Jesse Gelsinger achieved one more step toward resolution with the announcement of a settlement between the federal government and researchers and research institutions involved in the case.
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The turnover of ED physician contracts at Methodist Hospital in St. Louis Park, MN, has brought into focus some of the major issues evolving in the competition between smaller, physician-owned ED groups and the larger corporate entities, such as EmCare, of Dallas; Team Health of Knoxville, TN; and Sterling Healthcare of Durham, NC. While some of those issues are philosophical, others are legal and may have significant implications for ED managers.
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When Ocala (FL) Regional Medical Center announced a new screening initiative that would involve counseling nonurgent patients to seek alternative care, a funny thing happened: Local competitors Monroe Regional and Timber Ridge became involved when they heard about our initiative, because they felt they would then be inundated by patients who were not having their treatment here, notes Susan Atkin, RN, ED director.
