IRB Review & Approval of the
Informed Consent Document
The
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 #).
- The
final, approved version of the consent document should be copied for
enrollment purposes.
- A
master copy of every version of every approved consent document should be
maintained in a study specific Regulatory Binder.
- Every
copy of the consent document presented to a potential subject must be have the currently approved IRB stamp
on the signature page.