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last updated 4/17/08

AMENDMENT SUBMISSIONS

Any change to an approved research study requires the submission of an amendment to the IRB. This applies to changes in any or all of the following:

· the research plan, including number or type of subjects
· consent process and form
· co-investigators
· other research personnel
· method(s) of subject recruitment, including any change to an approved advertisement.

The revised protocol narrative, consent form, advertisement(s), and/or Investigator Brochure must be attached to the amendment submission form with the changes clearly marked (highlighted).

Submission are due by 5 PM on the deadline date, unless otherwise noted. Late submissions will be reviewed at the next scheduled meeting. Incomplete submissions will not be reviewed until all necessary materials have been received regardless of the date the initial submission was received.

Note that if this protocol involves a PI change, the IRB requires the signature of both the departing and the incoming PI on the amendment submission form.

Forms

Form	Purpose	Version date	Posted
Amendment Submission Form	required for all amendment submissions	April 2008	4/17/08
Supplemental Form A	Co-investigators	APRIL 2007	4/19/07
Supplemental Form B	Other research personnel	APRIL 2007	4/19/07
Supplemental Form C	Research involving children	March 2007	4/19/07
Supplemental Form D	Research involving drugs	October 2005	4/4/06
Supplemental Form F	Research involving devices	03/13/2006	4/4/06
Supplemental Form G	Genetic testing and/or sample banking	October 2007	11/29/07
Supplemental Form H	Radioactive drugs/devices	December 2007	1/10/08
Supplemental Form I	Advertising on U of C webpages	October 2005	4/4/06
Supplemental Form J	Research involving prisoners	March 2006	4/4/06
Supplemental Form K	Research involving pregnant women, fetuses, and/or fetal tissue	July 2006	7/12/06
Supplemental Form N	Research involving nonviable neonates	March 2006	4/4/06
Supplemental Form P	Proxy consent request		4/19/07
Waiver of Authorization	Use of PHI during screening	August 2006	4/19/07

Guidance

Submission

What to include/not to include in advertisements

What is PHI?

Consent

Written Consent Form Template revised 4/19/07 (to change IRB mailing address)

Written Consent Form Template (Spanish Translation) revised 4/19/07 (to change IRB mailing address)

Sponsor Statements Regarding Research Related Injury

HIPAA Elements to Include in Written Consent

Instructions to Obtaining Proxy Consent

Healthcare Surrogate Act Certification

Enrollment of Non-English speaking subjects

BSD/UCH Institutional Review Board · The University of Chicago · McGiffert Hall, 2nd Floor · 5751 S. Woodlawn Ave. · Chicago, IL 60637