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Four years ago, when the IRB at McGuire Veterans Affairs (VA) Medical Center in Richmond, VA, needed software to support the IRBs work, there appeared to be very little commercial software available. So the IRB decided to create its own software.
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Thanks to the rise in private equity ownership, the number of independent IRBs may be shrinking, but the number of services they offer is greatly expanding.
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As the use of central IRBs grows nationally, these models are increasing consistency in IRB review, but they also are causing some confusion for institutional IRBs.
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While consolidating the industry may not have been the goal of independent IRBs, the number of small and family owned IRBs continues to shrink.
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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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When research institutions and their IRBs work with centralized IRBs, questions arise about which board handles which responsibilities.
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Research institutions sometimes struggle with retaining experienced IRB members as the workload can be significant and there are so many competing duties and projects for these scientists, professors, bioethicists, and other professionals.