IRB Advisor – May 1, 2011
May 1, 2011
View Issues
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Recent lawsuit suggests IRBs need a formal appeals process
A recent lawsuit against Brown University in Providence, RI, is an important sign that it's time for research institutions to create formal appeals processes in the event of contested IRB review decisions. -
VCU office simplifies IRB appeal process
The Vice President's Office for Research at Virginia Commonwealth University in Richmond, VA, has developed a formal process for investigators who wish to appeal an IRB determination. -
R&D center adapts for multicenter studies
As a research institution's human subjects research increases, so must an IRB's work. In some cases this means expanding to handling multicenter protocols, which bring may result in new challenges. -
Assuring IRB submissions are mistake-free
IRB application submissions often lack consistency, have omissions and errors, and other problems that IRBs should teach investigators to anticipate and correct before filing their application. Among these mistakes are policy errors, data security concerns, and other procedural problems. -
Protecting participants in first-in-human trials
First-in-human clinical trials raise difficult ethical issues for researchers and IRBs because of the uncertainty that accompanies them. Did the preclinical studies that preceded them provide enough information about effectiveness and risks and benefits to proceed with human volunteers? -
Survey shows DSMBs' structure, operations
A data and safety monitoring board (DSMB) can be crucial to protecting participants in higher-risk studies, by reviewing the accumulating study data for potential emerging risks and if necessary, by recommending that a study be changed or even halted as a result. -
TMI in informed consent?
Can the informed consent process actually provide too much information?