Informed consent is one of the primary requirements of research involving human participants ... provided the conditions described on the waiver form are fulfilled.

a model consent form included in the protocol and listed in the Table of Contents of the protocol with the same wording, or in the contract or agreement. An explanation of whom to contact for answers ...

Obtaining informed consent is more than getting a signature on a form. Informed consent is one of the primary ethical considerations underlying research with human subjects. ALL human subject research ...