340 FR 1 (2013-1)
This template language should be inserted into the consent form or compound authorization form
for those studies that will enroll subjects who may become decisionally impaired during the
course of their participation in the study to allow the subject to name an individual that he/she
would like to act as his/her surrogate to provide permission for the subject’s continuation in the
study.
Advance Research Directive
If at any time during this study my ability to give informed consent becomes impaired, then I
would like _____________________________ to make decisions on my behalf regarding my
continued participation in this study. In the event that he/she is unable or unwilling to perform
this function, then I would like ______________________________ to make decisions on my
behalf regarding my continued participation in this study.