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irb citi belmont report ich gcp guideline disapprove modify approve freezing experiment sea water experiment high altitude blood coaguation poisons clinical research respect of subject justice beneficience inform consent medical community ra dsmb investigator subjects sponsor bicon biologics clinical trials efficacy safety anesthesia terminal procedure posterior vena cava blood vessel cannulation tarsal vein tail snip tail vein cardiac puncture marginal ear jugular vein retro-orbital laboratory animals blood collection method