Typically used when there
is a substantive change to the risk/benefit profile.
Only includes information
that is new/different from the originally signed document, reducing the potential
for participant confusion.
Requires IRB review/approval
and IRB approval stamp prior to use. Reviewed,
signed and dated by the subject and the researcher in the same manner as the
original consent document.
The subject’s signature
indicates their willingness to continue participation in the study.
4. Full Consent
IRB policy
is that a consent addendum be used instead of requesting the
subject sign a fully revised consent, as this may cause potential confusion
for the subject.
Changes to this policy will be reviewed on a case-by-case basis.