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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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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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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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IRBs have to adhere to regulations on diversifying their board memberships, but specifically finding the appropriate expertise for any particular meeting and finding dedicated non-scientist members are major challenges IRBs face.
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Patricia MacCubbin, MS, executive director of research conduct and special advisor to the vice chancellor for research at the City University of New York (CUNY) in New York City offers some suggestions for educating researchers and IRB members in a large, diverse organization.
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Large research institutions can improve IRB consistency, education, and networking by establishing an oversight board that will bring IRB chairs together at committee meetings.
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[Editor's note: This is the second part of a two-part series on how IRBs can cut costs during these lean budget times. States are forcing higher education payroll and departmental budget cuts across the nation, and IRBs likely will be impacted. IRB Advisor asked a number of IRB efficiency experts to discuss how IRBs can make do with fewer resources. In this month's issue we present a case study of how one university approached IRB cost-cutting. In the April, 2009, issue, there were stories on collecting outcome data and making your IRB more cost-efficient.]
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Any facility subject to water intrusions from flooding, faulty HVAC systems, or any source of water into the building envelope should have a written mold management plan, says Suzanne M. Avena, JD, an attorney with Garfunkel Wild in Great Neck, NY, specializing in environmental law.
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A child presents at a hospital emergency department (ED) complaining of a fever and rash. A physician's assistant employed by the hospital examined the child and described the rash in the child's chart. The child was discharged with instruction to see a pediatrician but with no guidance as to how to manage the fever. The child's symptoms became worse, and the child was eventually diagnosed with staph sepsis.
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When defense attorney James J. Nosich, JD, of McGrane Nosich in Coral Gables, FL, was faced with a seemingly unwinnable case of a quadruple amputee alleging failure to diagnose, he didn't hold out much hope of his client being found not liable. But he vowed to fight, and the defense strategy began with the jury selection, trying to select jurors who could put sympathy aside and concentrate on the facts of the case.
