Furthermore, unless the consent process has been specifically waived by the IRB, no subjects may be included ... The information and sample documents in the compliance form section are provided to ...

The consent form is one part of the dialogue that investigators have with each subject. It is recommended that forms for adult subjects be written at a 6 th-grade reading level or lower, information ...

Waivers of documentation allow for verbal consent procedures. The IRB will typically expect that subjects are ... A waiver of the need for subjects to sign a consent form can be granted if any one of ...