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The American Geriatrics Society has published guidelines on the use of vitamin D supplementation for the prevention of falls in the elderly, but some researchers are not on board with this.
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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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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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Working with different central IRBs and using different models has created some confusion for local IRBs.
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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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When research institutions and their IRBs work with centralized IRBs, questions arise about which board handles which responsibilities.
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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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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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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.
