Univ of Minnesota IRB Change in Protocol Approval 06062014

Route this form to:
See instructions below

Revised
October 2013

Change In Protocol Request
Instructions:
Use this form when submitting change requests to approved 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 or deferral 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

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

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

1101S94592
Ann S Masten
Assessment of Executive Function for the National Children's Study
5/27/14
Drug(s) / Biologic(s)
Device(s)

Indicate the type of change(s)
Change(s) to Study
Procedures/Protocol Amendment
Protocol Version
Dated

,

Additional information/requirements
Does the change affect study design, change the study endpoint(s) or change
the statistical method?
No

Yes

Is this protocol under Masonic Cancer Center’s Cancer Protocol Review
Committee (CPRC) review?
No
Yes, CPRC #
If “Yes” is checked for both questions above, this submission (Change in
Protocol form and any supporting documentation) must be reviewed by CPRC
([email protected]) prior to review by the IRB. CPRC will forward this
submission to the IRB after CPRC approval. Submission to CPRC must meet the
IRB signature requirement (signed by the PI or sent from the PI’s x.500 UMN
email account).
Notice of Closure to Accrual
Recruitment
changes/Advertisements
Revised Investigator Brochure
Updated consent form
Other

Attach a copy of the revised material (flyer, script, etc.) with the submission
Version
, Dated
Include both an updated form with changes highlighted and a “clean” version
Briefly Describe:

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.
We propose changing the wording in the consent form about "confidentiality." This section will now refer to "privacy" instead.
OMB language required for this project also has been added.

2. Describe the rationale for the change(s):
NICHD has requested that we change the language of our consent forms for this project to align with new decisions
for the overaching National Childen's Study IRB requirements. For the new consent wording, the word
"confidentiality" is changed to "privacy." They want us to make these changes in all of our consent forms. The
proposed wording is as follows (changes are also noted in the tracked changed/ highlighted versions of the consent
form):
[New Version]
Privacy:
Within the limits permitted by law, the records of this study will be kept private to the extent permitted by law. In
any sort of report about the study, there will be no information to identify you or your child. Research records will
be stored securely and only researchers will have access to the records.
You should be aware that there are legal limits to our ability to keep certain information about you private. If we
were to learn that a child is being harmed or that a parent or child seriously intended to harm themselves or
someone else, we would be required to report this situation.
[Currently Approved Version ]
Confidentiality:
Within the limits permitted by law, the records of this study will be kept strictly private and confidential. In any sort
of report about the study, there will be no information to identify you or your child. Research records will be stored
securely and only researchers will have access to the records.
You should be aware that there are legal limits to confidentiality. If we were to learn that a child is being harmed or
that a parent or child seriously intended to harm themselves or someone else, we would be required to report this
situation.
In regard to OMB language, the required language for headings and footnotes have been added as required.

3.

How will these changes affect the overall risk to subjects in this study?
No change.

4.

Do the changes to the study prompt changes to the consent form(s)?
No.
Yes. If yes:
x Attach a copy of the revised consent form(s) with changes tracked or highlighted as well as a clean copy.
4.1 Will currently enrolled subjects will be notified of the changes?
No
Yes, explain below 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.).

5.

List and attach all documents included with this request, including version dates:
Consent Form Delve with 2nd revised HIGHLIGHTED 5.27.14
Consent Form Delve with 2nd session revised 5.27.14
Consent Form Delve with no 2nd revised HIGHLIGHTED 5.27.14
Consent Form Delve with no 2nd session_REVISED 5.27.14
Consent Form UofM with 2nd session revised HIGHLIGHTED 5.27.14
Consent Form UofM with 2nd session_REVISED 5.27.14
Consent Form UofM with no 2nd session revised HIGHLIGHTED 5.27.14
Consent Form UofM with no 2nd session_REVISED 5.27.14

______________________________
Principal Investigator’s Signature

_____________________
Date

Cancer Protocol Review Committee (CPRC) Use Only: