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USDE human subjects review -Reply Gerald McCulloh 09 Nov 1998 10:01 EST

Beth,

Often the human subject applications occur in a medical school, teaching hospital and clinical trial setting.  At Loyola University Chicago a multiple assurance  approval was set up  at the Medical Center which meant the govt agency was considering the IRB process to covered for managing  many projects and the information requested was the code number of the assurance, at the Lake Shore Campus most human subject work is related to psychology , education, and is often course related so that some departments have separate IRBs that review informed consent forms, survey procedures etc.  with the larger IRB set retaled to external grant applications or programs providiing a separate assurance certification for each project with the signal that a current date indicates review within the required time to cover the start of research, maintain current supervision and indicate the end of approval  which is either the signal of removal of approval or the need for review to continue.  Sometimes the PI and sometimes the govy agency are experienced with one or the other procedures and not familiar with both and the language on the form does not distinguish them clearly.  The clue for saving time is to understand the significance of the blank for the reviewing committee procedure at the agency, not common sense or plain English, alas.  NCURA and SRA colleagues can help with this as well as the list.  Good luck. Jerry McCulloh aka xxxxxx@LUC.EDU