The Institutional Review Board, Division of Biological Sciences, University of Chicago

Amendment Submission

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/or consent 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). In addition, the specific change(s) must be clearly described on the amendment submission form.

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. Amendments that may be expedited will not be processed until administrator and/or reviewer comments have been addressed and will not be reviewed at a convened meeting unless they are found to be non-expeditable.

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.

Amendment Submission Forms

Form

Purpose

Version date

Amendment Submission Form

Required for all amendment submissions

April 2008

Supplemental Form A

Co-investigators

April 2007

Supplemental Form B

Other research personnel