A signed informed consent form notifies potential research participants of their ... witness to the consent process and signature of the person conducting the consent interview. Investigators should ...

The IRB determines, for each protocol it reviews, which of the following elements and disclosures must be included in the informed ... in the form of a letter signed by the sponsor(s) with the same ...

Investigators may request a waiver or alteration of the informed consent process or waiver of consent documentation, provided the conditions described on the waiver form are fulfilled.