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RB, FDA, IBC, RAC, DSMB just a few of the alphabet soup organizations and regulatory body steps a researcher must go through to get a protocol written, reviewed, and approved. This can lead researchers to burnout dubbed by some at the National Institutes of Health (NIH) as regulatory fatigue syndrome.
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Working with different central IRBs and using different models has created some confusion for local IRBs.
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The Association for the Accreditation of Human Research Protection Programs (AAHRPP) is moving in some new directions as Elyse I. Summers, JD, president and chief executive officer, celebrates her first anniversary with the organization.
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How investigators report serious adverse events (SAEs) can be subject to gray zones. Answers are not always a clear yes or no.
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Medical malpractice plaintiffs attorneys are increasingly confident about obtaining potentially game-changing documents that risk managers assumed would never be seen by the other side.
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News: The patient, a 30-year-old man, was admitted to a medical center in September 2010 for a laparoscopic gallbladder removal procedure. The procedure was performed by a surgeon with more than 20 years of experience.
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With plaintiffs getting their hands on more and more documents that previously were off limits, the best way to avoid that danger is to be strict about separating fact and opinion.