Hi guys a question...
Wen a subject is illiterate at that time the LAR(legally acceptable representative) can explain the subject abt the study & sign on his behalf.
But wen the subject and his LAR both are illiterate at that time an Impartial Witness is called...This is what the Industry follows...
But i would like to say that when the subject is illiterate 1st the Impartial witness should be consider and he should explain and sign the ICF and then the LAR if required.
Coz at time the LAR sign the ICF coz he might be benefited in terms of Money or some thing else...Example, Bioequivalence studies the subject are compensated so for that interest the LAR can influence the subject and as the LAR family members the subject could also get influenced, or the LAR will not give the full details of the study to the subject.
So my take on this topic is if the subject is illiterate then firstly the impartial witness should be called and he will explain the entire details of the study to the subject and then if required the LARs consent to be taken..
Guys please give your Suggestion & Feedback