... the extent stability permits, samples should be retained either until the analyses of the trial data are complete or as required by the applicable regulatory requirement(s), whichever represents ... are experimental. g) The reasonably foreseeable risks or inconveniences to the subject and, when applicable, to an embryo, fetus, or nursing infant. h) The reasonably expected benefits. When ... subject's legally acceptable representative and the impartial witness, where applicable. 4.8.7 Before informed consent may be obtained, the investigator, or a person designated by the investigator,...