CU-p IRB Modification Request Form, submit if any change is needed on any previously CU IRB Approved protocol

Principal Investigator (PI) NAME

Date submitting form to the IRB

PI email Department

IRN # IRBNet #

CO-PI CO-PI email

If PI is student, Faculty Advisor:

Faculty Advisor email:

Study Title

IRB-approved protocol Start date

IRB approval Expiration date

Complete the three (3) parts of your Modification Request as described below, and upload this and any modified document (such as the modified consent form) in to your IRBNet project. You do this by clicking on your IRBNet project. When you do this, your project should be locked (since it had been reviewed and approved previously). When you click on this project, it will ask if you want to open a new package. Click “YES” to this. This new package will be your Modification. When you are done, please click SUBMIT so that the IRB will get notice that you have submitted this package for review.

1. Type your initials on each line below to give your assurance that you understand the definition of a minor modification in an approved and ongoing protocol. If you cannot initial both of these lines, then this indicates you are proposing a more substantial (not minor) modification, and this would require you to submit a modified Research Proposal Narrative for IRB Review in addition to this form.

____ I give my assurance that the modification fits reasonably with the original purpose of my IRB-approved protocol.

____ I give my assurance that the proposed modifications will not add a new procedure/interaction and does not extend the time period for the study procedures.

2. Briefly describe the modification specifically by writing why are you modifying, what are you modifying, what will this affect?

3. Describe how you will communicate this change to your participants and/or research team by completing these sentences.

The modification(s) is(are) to be presented (made into the procedure so you can be certain the change is consistently made and recorded/controlled) to the investigator team by:

The modification(s) is(are) to be presented to the existing participants by:

The modification(s) is(are) to be presented to the NEW participants by:

4. The investigator anticipates that A NEW CONSENT FORM: [write an “X” to answer]____ IS required____ IS NOT required.

If you checked a new/modified consent form (parental letter or assent form) is required, please describe the changes to the consent form you are making. You can copy and paste the relevant sections of your consent form and show with the “REVIEW” tab in Word called “track changes.” Use as much space as you need to adequately the way the consent form was worded before and the changes that you want to make.

If you checked a new/modified consent form (parental letter or assent form), you will need to provide a final version as you would like it approved to the IRB as a Word Document. If approved, the CU IRB will provide a new stamp, and you must use that consent form starting on that date.

Below are brief instructions for loading this in the IRBNet package:You will be on the “designer page.”

Click on “Add New Document” at the bottom of the designer page, and load this Modification Request Form.

Load other new documents (documents not submitted as a prior version before) in the same manner.

If you have modified documents (for example a new version of a consent form that was submitted before), then you upload a new version in place of the old version.

Click on the pencil icon next to your old document (for example, originally submitted consent form). When you click on the pencil, it will prompt you to load up a new version of the document (for example your new version of the Word consent form you want approved).

For individuals in a pressing hurry for modification, you can contact the IRB by email to remind them of the submission. Email irb@cu-portland.edu. If it is an emergency such that this needs to be reported as a significant event (complaint, unanticipated problem, or adverse outcome), please also contact the IRB Director, Dr. OraLee Branch, at obranch@cu-portland.edu. She might be able to assist you in finding interim solutions if this is an emergency.