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 expiration date and a unique IRB assigned identification number (CHRMS/BS
#).
- The final, approved version
of the consent document should be copied for enrollment purposes.
- A master copy of every
version of every consent document should be maintained in a study specific
Regulatory Binder.
- Every copy of the consent
document presented to a potental participant must be the current IRB-approved
version and have a non-expired approval stamp on the signature page.