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 stamp with an expiration date 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
The IRB prefers
that a consent addendum be used instead of requesting that the subject sign
a fully revised consent, as this may cause potential confusion for the subject.
Some study sponsors
require that subjects be fully re-consented. Check with sponsor if an addendum
is sufficient.