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In recent years, efforts to address substance abuse among pregnant women have moved from being barely visible public health initiatives to controversial political battlegrounds.
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Paramedics in the Denver area will be administering an experimental blood substitute to patients who meet certain criteria under an unusual research protocol that allows patients to be recruited without giving informed consent.
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An experimental blood oxygenation device has the potential to help thousands of patients with severe emphysema or other lung conditions. The device has been thoroughly tested in laboratory animals, but human trials would involve major invasive procedures for research participants and place them at very high risk of death or serious complications.
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Knowledge is power, and knowing how an audit works can help you sail through, says Erich K. Jensen. Jensen has developed a course designed specifically to highlight what happens during an FDA audit and what can be done to make the process as easy as possible.
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Just about a year ago, the Privacy Rule, which is a part of the Health Insurance Portability and Accountability Act (HIPAA) regulations, became enforceable. Already, complaints are coming in and investigations are being launched some against mighty organizations such as Kaiser Permanente.
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Federal laws aimed at encouraging drug companies to study how well their products work in children have had the unintended consequence of weakening already vague protections that prevent child research subjects from being exploited, a leading human subjects research advocate claims.
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On-line university offers controversial course.
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When Christiana Hospital in Newark, DE, first instituted its hospitalist program in 1994, the hospital experienced a big drop in length of stay, especially with the uninsured patients who had no particular physician watching over them, recalls Thomas Mannis, MD, senior medical advisor for case management and head of the division of hospitalists.
