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For more than 30 years, the National Surgical Adjuvant Breast and Bowel Project has collected copies of every consent form signed by the more than 130,000 patients enrolled in its clinical cooperative group trials.
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When an institution conducts IRB reviews of hundreds of protocols, it can be hard to maintain consistency on such details as language used in informed consent to describe potential risks and adverse events.
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Some of the thorniest questions that IRBs face are those for which there are no clear-cut answers opinions may vary, arguments on both sides may be compelling, regulatory guidance may be scanty.
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The current system of regulating community-based participatory research (CBPR) doesn't truly engage or protect communities as it should and fails to follow up on promises made by researchers to IRBs and to those whom they study, says one community researcher.
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Three institutions recently were honored by the Health Improvement Institute for their contributions to enhancing the protection of research subjects.
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Tufts University researchers studying immigrant workers in a nearby community engaged local leaders and teens to help them create a survey and recruit and translate for the immigrant population. It was an example of community-based participatory research (CBPR), involving the community from start to finish.
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While federal regulations require that subjects be informed of the possible alternatives to their participation in a clinical trial, often subjects don't learn enough about those alternatives to make an informed decision, says a bioethicist who has studied the issue.
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A new process for managing radiological discrepancies in the ED at Catawba Valley Medical Center in Hickory, NC, has significantly improved the efficiency with which notifications are received and acted upon.
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Although the Centers for Medicare & Medicaid Services (CMS) made several minor modifications to the Outpatient Prospective Payment System (OPPS) for 2010 with impact on the emergency department, none result in a significant change in ED facility coding. However, there are references to several planned projects required to provide data to be used in future reporting and/or rate changes.
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As of January 2010, The Joint Commission has incorporated into its Quality Check web site (www.qualitycheck.org/consumer/searchQCR.aspx) the Centers for Medicare & Medicaid Services' (CMS') 30-day readmission rates for heart attack, heart failure, and pneumonia Medicare patients.
