IRB Advisor
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Inexact Science: The Complicated Quest To Replicate Research
A deeper look into the actual mechanics necessary to reproduce a trial reveals a process that is beset by variables that make clear conclusions difficult.
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Strategies to Better Manage Noncompliance
The IRB at the Biomedical Research Alliance of New York in Lake Success, NY, noticed a problematic trend of researchers amending their studies in the continuing review reports.
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Final Common Rule Is An Improvement, But Leaves Some Questions Unanswered
There were many changes between the Notice of Proposed Rulemaking and the final rule, and even more changes since the Advanced Notice of Proposed Rulemaking, which is a good thing, IRB experts say.
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Common Rule Change Took Six Years to Complete — And Could Be Upended in 30 Seconds
After six years of debate, criticism, and waiting, the 543-page Common Rule looks a lot better than the original proposal in 2011, but the biggest question now is whether the work will be upended with the stroke of a pen.
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‘Serious Noncompliance’ the Leading Incident Reported to OHRP
IRBs and research institutions may be concerned that reporting incidents of noncompliance to the HHS Office for Human Research Protections could be a red flag to prompt an investigation, but the reverse is actually true.
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The Ethical Question of Denying Children Antibiotics
As IRB members are no doubt aware, public health officials are warning that the overuse and misuse of antibiotics has selected out resistant strains of bacteria all over the globe. As a result, the short-lived miracle of the antibiotic era is at risk of coming to an end.
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‘Reimagining’ the IRB Model for the 21st Century
The IRB model created to protect human research subjects more than a half-century ago is in danger of being outstripped by technology-driven research and other forces. It must be “reimagined” for the 21st century to provide safe and ethical oversight of rapidly expanding research agenda, the authors of a recently published report argue.
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VCU IRB’s Member Handbook Covers What They Need to Know
The Virginia Commonwealth University IRB office created the IRB Member Handbook for training new members and to serve as a resource to all members.
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IRB’s New Member Handbook Improves IRB Training
Like many IRBs, the Virginia Commonwealth University IRB has been on a mission recently to streamline its processes, decrease approval time, and improve IRB member training.
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Here’s a List of Vulnerable Populations Historically Exploited in U.S. Research Studies
People who are part of vulnerable populations were exploited in the name of research over the years leading up to our current institutional review board and human research protections.