IRB Consent form discussion:

Our institution creates and revises all IRB consent forms.  At the bottom
of our consent form we have the Research Office project number identified
and a creation and expiration date.  The reason for having this type of
control is one of uniformity and completeness as to DHHS policies for
consent forms.

An investigator could create or submit a sponsor's consent form to the IRB
for review and approval.  Our IRB administrator will then create a consent
form, from our office, on our letterhead, for that particular investigator
and project.  We have a certain format for which the consent form must
adhere to or it will not receive approval from the IRB.  Our office also
requires that all signed original consent forms be sent to our office for
record keeping.  This is to insure that the study participant did not
receive an incomplete consent form or that they had all the necessary
information available to make an informed decision.

To what extent does your institution control the consent form?  Where is
the original consent form kept?  Is your institution's IRB covered by your
indemnification agreement/contract clause?

Looking forward to the discussion!

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Thane J. Peterson
Associate Director, Research Office
Evanston Hospital Corporation
2650 Ridge Avenue
Evanston, Illinois  60201
708.570.2533
708.570.2933 FAX
xxxxxx@nwu.edu
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