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Hospitals are scrambling to develop a policy regarding organ donation after cardiac death (DCD) in order to be in compliance with a revised standard from the Joint Commission on Accreditation of Healthcare Organizations that goes into effect Jan. 1, 2007.
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As IRBs seek to improve efficiency in their own operations, they often suffer from a lack of the most basic data about the costs of reviewing protocols.
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IRBs sometimes reject an investigator's request to use the short informed consent form, even when it would meet regulatory and ethical standards.
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A small but notable percentage of veterans in a long-term drug study were unable to retain some of the simplest information about it including the purpose of the study, the name of the drug and its main side effect for the entire course of the trial.
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The rapid growth in international research is providing challenges for human subjects protection in other countries, many of which lack the resources that American IRBs have.
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The IRB office at Memorial Medical Center in Johnstown, PA, began as many small IRB offices do, with one part-time employee. As the workload increased to about 80 protocols per year, the office turned the part-time position into a full-time administrator position, and organizational procedures were put in place.
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Surgical masks provide virtually no protection against inhalation of airborne particles. Influenza involves airborne transmission as well as other forms of transmission.
