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In this issue of IRB Advisor, we are starting a new column designed to answer reader questions. If you have questions regarding IRB responsibilities, federal regulations, adverse event reporting, day- to-day functions, anything related to clarifying the duties and responsibilities of your IRB, wed like to know.
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As the scrutiny and duties of IRBs steadily increase, demanding ever more time from IRB members, it has become clear to some research universities and hospitals that there should be a change in whether and how IRB members are compensated for their time.
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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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Schulman Associates Institutional Review Board Inc., the University of Cincinnati, and the University of Kentucky will host a one-day conference, IRBs: The Times They Are A Changing, Sept. 19, 2003, at the Northern Kentucky Convention Center in Covington.
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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.