Informed consent is more than just a form; it is a process that actively involves the participant. It is an "ongoing exchange of information between the investigator and [participant]" per the OHRP.

This may include counseling with another provider, a consultation for medication or other medical treatment, career testing, academic skills development, etc . This informed consent explains the ...

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 ...