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~Updated Model Consent Forms - Effective September 1, 2014~
Model consent forms have been updated effective September 1, 2014 to reflect changes in the University of Washington compensation for injury plan, new draft guidance from FDA on informed consent, and several other important updates. New research projects submitted after September 1, 2014 must have the new compensation language, all other changes should be implemented in new research projects as soon as practical but no later than the end of 2014. Model consent forms can be found on the Consent page.
~Institutional Review Office publishes minimum accepted standards for IRB submissions - September 1, 2014~
As noted in our Summer Newsletter - effective August 1, 2014 the Institutional Review Office will be returning incomplete submissions to the research team. A list of minimum accepted standards for all IRB submissions can be found here - IRB Submissions - Minimum Accepted Standards.
~IRB Committee D Starts August 1, 2014~
The Center's Human Research Protection Program continues to grow. To keep up with an increasing number of human research projects a 4th IRB has been added. Committee D will be meeting on the 1st Wednesday of each month. Our IRB system now includes 4 IRBs with a convened meeting each week. An updated meeting schedule with agenda deadlines is on the IRB Meeting Schedule page.
~Updated Review Requirements for Multi-Center projects!~
In response to new regulatory guidance the FHCRC IRB has updated its requirements for review multi-center research projects. Some current processes have been eliminated and a few new requirements added. New Application, Modification, Continuation Review, and Multi-Center Supplement forms have been updated effective May 15, 2014. to reflect the new requirements. Older versions of these forms will be accepted in the Institutional Review Office until end of day June 30, 2014. All IRB forms are available on the Forms Page. More information about the new requirements can be found on the Multi-Center Studies Page.
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