Att 20_IRB approval

Route this form to:
See instructions below.

Change In Protocol Request

Rev: Nov 2012

Instructions:
Use this form when submitting change requests on IRB protocols. This form is for use
when the changes are initiated by the PI. Do not use this form to respond when changes
are requested by the IRB. Please do not use this form when responding to changes
requested in a stipulation letter.
Submit this form to the Human Research Protection Program:
U.S. Mail Address:
or
Human Research Protection Program
MMC 820
420 Delaware St. SE
Minneapolis, MN 55455-0392

Electronic Submission:
Submit to: [email protected]
PI must submit request using
University of Minnesota e-mail
Account.

FOR IRB USE ONLY:
The UMN IRB reviewed and APPROVED this 
The University of Minnesota IRB Human Sub‐
submission including all a
achments listed 
jects Commi
ee has reviewed and APPROVED 
on this form by expedited review. 
this submission including all a achments listed 
By
Christina Dobrovolny on
on this form. 

Feb 26, 2013

IRB Protocol Information
IRB Study Number:
Principal Investigator:
Primary StudyTitle:
Date of this Submission
Study Includes

1209M21047
Lyn M. Steffen, PhD
Salt Sources Study
February 18, 2013
Drug(s) / Biologic(s)

Device(s)

Indicate the type of change: :
Protocol Amendment:
Version
, Dated
Revised Investigator Brochure: Version
, Dated
Recruitment Changes/Advertisements
Notice of Closure to Accrual
Change(s) to Study Procedures
Other:Change grade level of language in Consent form to 8 th grade level
1. Briefly summarize the change(s). For protocol amendments, do not say “See summary of changes provided with
amendment.” Rather, summarize the nature of the significant revisions.
The CDC requested that we lower the grade level of the Consent Form from 11 th grade to 8th grade level.

2. Describe the rationale for the change(s):
CDC would not approve the 11th grade level of the Consent form - requested that the language level change to 8th
grade.

3. In your opinion as principal investigator, how will these changes affect the overall risk to subjects in this study?
The subjects will better understand the information imparted to them.

4. Do the changes to the study prompt changes to the consent form(s)?
No.


Yes.
If yes:
Attach a copy of the revised consent form(s) with changes tracked or highlighted as well as a clean copy.

The University of Minnesota is an equal opportunity educator & employer.
 2008 by the Regents of the University of Minnesota.

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

Confirm whether currently enrolled subjects will notified of the changes and how they will be notified (i.e. subjects
will be re-consented with the updated form once approved, subjects will be provided with an information sheet,
subjects will be told of changes at next study visit, etc.).
Recruitment has not started yet.

5. List and attach all documents included with this request, including version dates:
Consent form attached (version date 1/14/2013).

Lyn M. Steffen (steff025)

2/18/2013

Principal Investigator’s Signature (x500)

Date

The University of Minnesota is an equal opportunity educator & employer.
 2008 by the Regents of the University of Minnesota.

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