board review irb approved institutional consent informed signed form written 
authorized legally irb representative board applicable review document approved understand 
signed consent informed given study document patients approved registration prior 
board irb review approved sign document institutional informed consent understand 
irb board review approved sign understand able institutional document informed 
institutional regulatory dated accordance board review guidelines signed irb approved 
signed written informed consent provide provided irb subjects study approved 
conforms federal consent guidelines approved institutional form provide signed able