IRB Advisor – October 1, 2014
October 1, 2014
View Issues
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Central IRBs: Consistency increases, but so does confusion
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. -
Dividing central and local IRB responsibilities
When research institutions and their IRBs work with centralized IRBs, questions arise about which board handles which responsibilities. -
One-page form aids in serious event reporting
How investigators report serious adverse events (SAEs) can be subject to gray zones. Answers are not always a clear yes or no. -
New president and CEO: "We’re AAHRPP ‘2.0’"
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. -
Examples of central IRB models
Working with different central IRBs and using different models has created some confusion for local IRBs. -
The changing world of independent IRBs
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. -
Finding new capital partners
While consolidating the industry may not have been the goal of independent IRBs, the number of small and family owned IRBs continues to shrink. -
A prescription for regulatory fatigue
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.