Consent: Example of
Expiration Label Use
See how to document in the label click here.
Research did Change in Study has been approved
not affect the Research did not for continuation.
consent form. affect the consent Certificate of Approval
Change in Research did not The consent form. The arrives without a consent
affect the consent from. form retains the consent form document. Consent
Consent original date still approval date retains the retains the approval date
valid. No change to the from CIR#2. approval date from CIR#2.
master consent copy. from CIR#2.
Initial Approval CIR #1 CIR #2 CIR #3 Annual Review #1 CIR#4 Annual Review #2 Annual Review #3
Consent master copy
receives label with Study has been approved
Change in Research affected Study has been approved for continuation.
original approval date.
There will not be an consent language. Original for continuation. Certificate of Approval
expiration date assigned. consent document has Certificate of Approval arrives without a consent
expiration placed on label; arrives without a consent document. Consent
unused copies of document are document. Consent retains the approval date
destroyed, original master retains the approval date from CIR#2.
stored with study. Modified from CIR#2.
consent master prepared with
label exhibiting the new
approval date for the consent.