IRB Review & Approval of the
Informed Consent Document
IRB places an approval stamp on the signature page of every consent
document that is approved for use at our institution.
The approval stamp contains an approval date and a unique IRB
assigned identification number (CHRMS/BSS #).
final, approved version of the consent document should be copied for
master copy of every version of every approved consent document should be
maintained in a study specific Regulatory Binder.
copy of the consent document presented to a potential subject must be have the currently approved IRB stamp
on the signature page.