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No ROMP in the Park: The Complex Intersection Between QI and Clinical Research
Somewhere between typical human research and clinical practice, there is gray area assigned the acronym ROMP — “research on medical practices” — that includes activities such as continuous quality improvement, comparative effectiveness research, and electronic medical record review, the authors of a new study explain.
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A Fresh Method to Adverse Event Tracking in Behavioral Studies
Researchers in Texas studied a state-of-the-art adverse event monitoring program for behavioral health clinical trials.
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‘Very Serious Ethical Problem:’ Adverse Events Often Unpublished
Much information on adverse events in clinical trials remains unpublished — and the number of adverse events is higher in unpublished than published versions of the same study, according to a recent review.
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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.
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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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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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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.