document willingness understand sign ability written informed consent subject subjects 
understand ability informed consent provide willingness written nature signed study 
participate study consent willing patients informed patient refuse willingness ability 
ability consent informed willingness donor patients lack demonstrate precludes likely 
voluntarily understand ability informed consent sign form document willingness fanca 
sign willingness understand ability written informed consent subjects registration patients 
consent informed patients capacity willingness documented refuses assent subjects understand 
competent mentally consent informed sign understand form willingness ability irb 
sign willingness form understand ability consent informed written study initiation