IRB Advisor – March 1, 2017
March 1, 2017
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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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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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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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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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Clinical Trials: More is Not Necessarily Better
While one may reasonably assume that more clinical research could increase the likelihood of medical breakthroughs, a contrarian’s view is that the effect could be quite the opposite — and it falls to IRBs to intervene and reduce the risks of the current glut of trials.
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Military IRBs May Err on the Side of Bureaucracy
Military IRBs may “err on the side of bureaucracy,” but the delays can place unnecessary burdens and risks on human research subjects.
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Teleconsent Boosts Recruitment of Rural Research Participants
One barrier to recruitment of qualified research participants for clinical trials is the cumbersome, time-consuming consent process. Another is the lack of access to participants in remote locations.