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Health care workers who are currently rolling up their sleeves for smallpox vaccine should skip the local blood drives for a while, the Food and Drug Administration (FDA) advises.
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OK. Time for a pop quiz. Heres the scenario: While obtaining a peripheral venous blood sample from a patient with the AIDS virus, a 35-year-old phlebotomist is injured by a bloody 18-gauge needle attached to a syringe.
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Admittedly distracted by bioterrorism, public health officials are marshalling their forces to do battle with an old foe before it gets completely out of its cage. Methicillin-resistant Staphylococcus aureus (MRSA) is in the news too much for anyones good, spreading through communities and mutating into full-blown vancomycin-resistant S. aureus (VRSA).
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Health care workers who are currently rolling up their sleeves for smallpox vaccine should skip the local blood drives for a while, the Food and Drug Administration (FDA) advises.
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Its a call an IRB office dreads getting a patient with a complaint about a study or a researcher, or an anonymous caller alleging problems with a clinical trial.
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As genetics research yields more and more information about individuals predispositions to disease and illness, researchers are beginning to question whether study participants should have access to the genetic information obtained about them.
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While the Health Insurance Portability and Accountability Act of 1996 (HIPAA) is clearly getting all the headlines and a great deal of attention in the research community, the recent Food and Drug Administration (FDA) Guidance for Industry on Electronic Records indicates it is not the only game in town.
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Two years ago, Baylor College of Medicine had a dilemma: double its staff to accommodate the increase in study protocols being submitted to its IRB or find an electronic solution to its problem. They chose the latter.
