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 is a requirement for studies meeting the definition of a clinical ... the RIT PI bears the responsibility of ensuring the requirement for posting of the consent form is met. For multi-site ...

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

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 ...

Requesting a Waiver or Alteration of the Consent Process Significant alterations or complete waivers of the consent process may be granted if a study is determined ... in which signing forms is not ...

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 ...