nontherapeutic $($no anticipated direct clinical benefit to the subject$)$ clinical trials $-$ may be conducted in subjects with consent of a LAR if the following conditions are metobjectives of trial cannot be met by means of a trial in subjects who can give informed consent personallyThe foreseeable risks to subjects are lowNegative impact on subjec'ts well$-$being is minimized and lowTrial is not prohibited by lawApprovable opinion of IRB is sought on inclusion of subjects and written approval covers this aspectTrials to be conducted in patients having a disease$/$condition for which the investigational product is intended.