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An Institute of Medicine committee has proposed a bold solution to the vexing problem of trying to conduct healthcare research under the Health Insurance Portability and Accountability Act's Privacy Rule.
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Doubtless, few IRBs are holding their collective breaths waiting for a massive overhaul of privacy provisions in health research. And even the IOM Committee on Health Research and the Privacy of Health Information's less ambitious recommendations for HHS guidance on use of HIPAA may take a little while.
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Is reluctance to permit exceptions from informed consent in emergency research (EICER) preventing important studies from moving forward?
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When looking at a study that would involve the use of the exception from informed consent for emergency research (EICER), IRBs first should consider whether the exception is necessary and appropriate, says Graham Nichol, MD, MPH, medical director of the University of Washington Clinical Trials Center in Seattle.
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The deaths of three young cancer patients within a month of each other at St. Joseph's Hospital in Tampa, FL, were caused by toxic mold released during a hospital construction project, according to a lawsuit brought by the parents.
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High-powered Tampa, FL, attorney Steve Yerrid, JD, says the three children at the center of the lawsuit against St. Joseph's Hospital did not have to die from toxic mold. If only the hospital had taken the right steps to control the risks associated with a construction project, the children might have survived, he says.
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Most health care providers are more at risk for mold toxicity than the Florida hospital now facing lawsuits related to pediatric deaths, says one mold suppression expert.
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Don't assume that your insurer will cover mold-related liability, cautions David Dekker, JD, an attorney specializing in construction for Howrey LLP in Washington, DC.
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David V. Kramer, JD, an attorney with DBL Law in Crestview Hills, KY, points out that a disclaimer on the consent form must be worded carefully to ward off claims of "apparent authority."
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Every risk manager eventually faces that malpractice lawsuit that seems too big, too tragic, too difficult to fight. When the circumstances are terrible and you can't imagine trying to explain your actions to a lay jury, the temptation can be strong to just settle it and make it go away - even if that means paying a large sum beyond your insurance limits.
