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There are a number of innovative practices IRBs can employ to improve their office's efficiency and work quality.
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The clinical trial industry continues to experience major delays, leading to higher costs and a slow pipeline of products making it to market, experts say.
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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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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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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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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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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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Every other week, those most directly involved in protecting human subjects in Vanderbilt Universitys research programs meet in an effort to ensure that the universitys policies and procedures are implemented consistently across its four institutional review boards.