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Cal U Irb Review Request Form

Cal U Irb Review Request Form

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So, before we climb the ladder of  IRB review we have to determine: one,   are our agents conducting some type of activity;   two, does the activity meet the definition of  regulated research or clinical investigation;   and three, does a regulated research or  clinical investigation involve a human subject.   If all three are yes, then we determine what level  of IRB review is required. IRB review is level is   largely determined by risk. Ok, so let's start  from the bottom. The first level of IRB review   is exempt review. If an activity that a  researcher is conducting is determined exempt,   this means that the activity is exempt from  the entirety of the federal regulations.   One must still follow basic ethical principles;  however, the intricacies of common rule - you know   I'm going to say it, 45 cfr 46 - do not apply.  Now, FDA has their own exempt categories which   differ significantly than HHS and we're not  going to go into that for this pres

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