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.

The goal of the informed consent process is to ensure that the research subject is treated ... Upper-case text placed in brackets within this form gives contextual information about developing ...

Note: The IRB must be provided with “sponsor verification” in the form of a letter signed by the sponsor(s) with the same wording given in the consent ... research use of their biological specimens ...

and agree or decline their child’s participation in the research study. Investigators should follow the required elements of informed consent when preparing a Parental Consent Form, except that the ...