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For years, the debate has continued about returning the results of research to the study participants who made it possible. Would such a process be expensive and unwieldy? Could it cause more harm than good, when participants receive bad news?
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When is the dual role of physician/investigator a conflict of interest? This is the question IRBs might consider in the aftermath of clinical trial participant Dan Markingson's suicide.
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When the answer to the question of "Could there be incidental findings from this study?" is "Yes," experts agree that the protocol should include an incidental findings management plan.
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Researchers using magnetic resonance imaging (MRI) in a cognitive psychology study note a suspicious mass in the brain of a supposedly healthy volunteer.
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Sometimes IRB members will need to view a particular human subject research issue with more of an eye on what is the most ethical decision to make, as opposed to what is the best way to comply with rules and regulations.
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A recent legal case involving a clinical trial participant who committed suicide raises a variety of questions for IRBs.
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Medication errors harm roughly one out of 15 hospitalized children, according to a new study. Researchers reported an 11.1% rate of adverse drug events in pediatric patients. Of those, 22% were deemed preventable, 17.8% could have been identified earlier, and 16.8% could have been mitigated more effectively.
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If a patient noticed a health care provider didn't wash his hands, or suspected she was being given an incorrect dosage of medication, would she hesitate to speak up about her concern?
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In an effort to clarify the requirements of its Universal Protocol, The Joint Commission has made several revisions and additions, effective Jan. 1, 2009.
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Health care-associated infections due to multiple drug-resistant organisms, central line-associated bloodstream infections, and surgical site infections. The Joint Commission's new National Patient Safety Goals (NPSGs) for 2009 require you to implement evidence-based practices to prevent all three of these.