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When a 57-year-old man walked into the emergency department (ED) at North Broward Medical Center in Fort Lauderdale, FL, with slurred speech and left facial drooping, his wife told nurses that the symptoms had started about 30 minutes earlier. We immediately assumed the worst case scenario: that it was a stroke, says Sharon S. Cohen, RN, MSN, CEN, CCRN, trauma clinical nurse specialist.
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Final security standards under the Health Insurance Portability and Accountability Act (HIPAA) for protecting patient health information when it is maintained or transmitted electronically have been adopted by the Department of Health and Human Services (HHS).
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The emergency physician (EP) and nurse often may encounter patients with the chief complaint of eye pain or visual problems. Generally, the diagnosis easily is obtained and quickly treated. Unfortunately, a subset of patients will present with an illness that threatens permanent vision loss or impairment. EPs must have a broad differential diagnosis and structured approach in evaluating these patients to ensure appropriate diagnosis and treatment.
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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.
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The Baylor College of Medicine in Houston has a prescribed inquiry process for complaints generated by human subject research at the institution, says Kathleen Motil, PhD, MD, associate professor of pediatrics and chair of two of the colleges IRBs.
