Attach 13. IRB Approval Letters

Attachment 13 IRB APPROVAL LETTERS

OMB#: 0925-XXXX
EXPIRATION DATE: XX/XX/XXXX
Route this form to:
Rev: Jan 2010

Change In Protocol Request

See instructions below.

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.
1.

Submit this form to the Human Research Protection Program:
U.S. Mail Address:
Human Research Protection Program
MMC 820
420 Delaware St. SE
Minneapolis, MN 55455-0392

Campus Mail:
Human Research Protection Program
MMC 820
Minneapolis Campus

Deliver to:
D-528 Mayo Memorial Building
Minneapolis Campus
8-4:30, M-F

IRB Protocol Information
IRB Study Number:
Current Principal Investigator:
Primary Title:
Submission Date

1101M94612
Patricia M. McGovern
Self Reported Stress and Cortisol Measurement: Development of an Optimized
Measure of Chronic Stress in Pregnancy
06/13/2011

Indicate the type of change/addition and attach all applicable documents:
Protocol Amendment:
Version
, Dated
Revised Investigator Brochure: Version
, Dated
Recruitment Changes/Advertisements
Notice of Closure to Accrual
Change(s) to Study Procedures
Other: Revised versions of IRB approved study documents, including consent form
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 following protocol changes are being submitted for local IRB review by each of the nine
Study Centers collaborating in this formative research that is part of the National Children’s
Study. The significant changes to our currently approved protocol are:
1. We will ask participants to allow audio taping of their Stressful Life Events Schedule
(SLES) interview, so that an accurate narration of their responses can be written by
the interviewer after the study visit. No names will be used on the recordings. Each
taped interview will be identified by a study number only and the recording will be
destroyed once the written narration has been completed.
2. Participants will now be asked to complete the SLES only once, at their second study
visit.
3. The amount of blood to be collected at each study visit has been reduced.
4. The method for collecting the hair sample has been improved to eliminate use of
string.
A number of revisions have been made to existing study documents. Some items have been
moved from previous documents to more appropriate documents, while other items that were
not needed or not appropriate to pregnant women have been eliminated. “Don’t Know/
Refused” response options have been added for each question of the Demographic and Stress
Surveys.
A separate Participant Contact Information Sheet has been created to allow us to remove all
personal identifiable information (PII) from the Enrollment Survey. This information will
exist only on paper in the locally held participant file folder, and no PII will be included in the
Study’s central database.
The University of Minnesota is an equal opportunity educator & employer.
 2008 by the Regents of the University of Minnesota.

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All changes to the study documents are laid out by document in the attached Study Revisions
List and we have attached each document. The collection and processing documents for blood,
hair and salvia were not finalized at the time of our initial submission in January 2011 and we
are including them now.
2.

Describe the rationale for the change(s):

These changes are being made in order to minimize the inconvenience to participants while
still guaranteeing the high quality of the data collected, sufficient to answer our research
questions. By reducing the amount of blood drawn, asking the SLES only once, and audio
taping to assure complete and accurate capture of the participant’s SLES responses, we expect
to preserve the quality of study information collected while reducing the burden on our
participants. Separating the participant’s PII from other study data allows better protection of
each participant’s identity and the privacy of their study information. The improved method
for collecting the hair sample should make the procedure easier for both participant and
researcher. Finally, changes to the items included in each instrument are intended to improve
the cogency and ease of completion of study questionnaires.
3.

In your opinion as principal investigator, how will these changes affect the overall risk to subjects in this study?

The overall low risk to participants in this study will not be increased by the proposed protocol
changes. Because less blood will be collected, this risk may be reduced.
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. Use this space to
further describe consent form changes if necessary:

Our consent form has been edited to reflect the audio taping and one-time administration of the SLES and the
reduced amounts of blood to be drawn at each visit.

______________________________
Principal Investigator’s Signature

__06/13/2011_______
Date

By Christina Dobrovolny at 12:52 pm, Jun 16, 2011

IRB Expedited Review includes approval of
consent form dated 6/14/2011 and study
materials received 6/13/2011

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

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The link ed image cannot be display ed. The file may hav e been mov ed,
renamed, or deleted. Verify that the link points to the correct file and location.

University of Pittsburgh
Institutional Review Board

3500 Fifth Avenue
Pittsburgh, PA 15213
(412) 383-1480
(412) 383-1508 (fax)
http://www.irb.pitt.edu/

Memorandum
To:

Hyagriv Simhan MD

From:

Margaret Hsieh MD, Vice Chair

Date:

2/1/2011

IRB#:

PRO11010057

Subject: Self Reported Stress and Cortisol Measurement: Development of an Optimized Measure of
Chronic Stress in Pregnancy

At its full board meeting on 1/18/2011, the University of Pittsburgh Institutional Review Board,
Committee B, reviewed the above referenced research study and approved it pending minor
modifications. Your responses to these comments have been reviewed and the research
submission, in its currently modified form, adequately addresses the concerns of the IRB and is
therefore approved.
Please note the following information:

The risk level designation is Minimal Risk.
Approval Date: 2/1/2011
Expiration Date: 1/17/2012
For studies being conducted in UPMC facilities, no clinical activities can be undertaken by
investigators until they have received approval from the UPMC Fiscal Review Office.
Please note that it is the investigator’s responsibility to report to the IRB any unanticipated
problems involving risks to subjects or others [see 45 CFR 46.103(b)(5) and 21 CFR 56.108(b)].
The IRB Reference Manual (Chapter 3, Section 3.3) describes the reporting requirements for
unanticipated problems which include, but are not limited to, adverse events. If you have any
questions about this process, please contact the Adverse Events Coordinator at 412-383-1480.
The protocol and consent forms, along with a brief progress report must be resubmitted at least
one month prior to the renewal date noted above as required by FWA00006790 (University of
Pittsburgh), FWA00006735 (University of Pittsburgh Medical Center), FWA00000600
(Children’s Hospital of Pittsburgh), FWA00003567 (Magee-Womens Health Corporation),
FWA00003338 (University of Pittsburgh Medical Center Cancer Institute).

Please be advised that your research study may be audited periodically by the University of
Pittsburgh Research Conduct and Compliance Office.

Kaitlin A. Wolfe
From:
Sent:
To:
Subject:

Office for the Protection
of Research Subjects

[email protected]
Tuesday, March 22, 2011 2:15 PM
[email protected]
IRB Approval Letter Ready

Northwestern University
750 North Lake Shore Drive
Suite 700
Chicago, Illinois 60611
[email protected]
Phone 312-503-9338
Fax 312-503-0555

3/22/2011
Dr. Ann Borders
Assistant Professor
Obstetrics and Gynecology
250 E. Superior, 5th floor Suite 02-2175
Chicago IL 60611
[email protected]
IRB Project Number: STU00039484
Project Title: QUEX 01: Self Reported Stress and Cortisol Measurement: Development of an Optimized
Measure of Chronic Stress in Pregnancy
Project Sites:

Northwestern Medical Faculty Foundation (NMFF)
Clinical Research Unit (CRU) formerly GCRC
Northwestern University (NU)
Northwestern Memorial Hospital (NMH)
Other: Lead sites involved in specimen processing: Northwestern University, University of Irvine, California,
University of Texas, San Antonio, and University of Washington
Additional sites recruiting subjects: Brown University, Children's Hospital of Philadelphia, Tulane University
School of Public Health and Tropical Medicine, University of Minnesota, and University of Pittsburgh

Sponsor Information (Grant #, if applicable):

1

View National Institutes of Health

HHSN275200800016C

Submission Considered: New Submission Submission Number: STU00039484
Review Type: Expedited
Review Date: 3/21/2011
Status: APPROVED Approval Period: (3/21/2011 - 3/20/2012)
Dear Dr. Borders,
The IRB considered and approved your submission referenced above through 3/20/2012 . As Principal
Investigator (P.I.), you have ultimate responsibility for the conduct of this study, the ethical performance of the
project, and the protection of the rights and welfare of human subjects. You are required to comply with all NU
policies and procedures, as well as with all applicable Federal, State and local laws regarding the protection of
human subjects in research including, but not limited to the following:





Not changing the approved protocol or consent form without prior IRB approval (except in an
emergency, if necessary, to safeguard the well-being of human subjects).
Obtaining proper informed consent from human subjects or their legally responsible representative,
using only the currently approved, stamped consent form.
Promptly reporting unanticipated problems involving risks to subjects or others, or promptly reportable
non-compliance in accordance with IRB guidelines.
Submit a continuing review application 45 days prior to the expiration of IRB approval. If IRB reapproval is not obtained by the end of the approval period indicated above, all research related activities
must stop and no new subjects may be enrolled.

IRB approval includes the following:
Written Consent Form/Consent Form and Authorization for Research:

Name
NCS Stress Collaboration Consent Form 3.21.11.final.doc
Protocol Document:

Name
NCS Stress Collaboration IRB Protocol 2.17.11

Recruitment Materials:

Name
NCS Stress Collaboration Flier
Survey/Questionnaires:

2

Name
NCS_Stress_Collaboration_Stress_Surveys Revised 12 06 10 final.doc
For more information regarding OPRS submissions and guidelines, please consult
http://www.northwestern.edu/research/OPRS/irb.
This Institution has an approved Federalwide Assurance with the Department of Health and Human
Services: FWA00001549.

3

November 22, 2010
To:

Douglas E. Williamson, PhD
c/o Deanne Hargita, MC 7792, MED 772E Psychiatry, UTHSCSA

From:

Institutional Review Board

Subject:

Expedited Approval of a New Human Research Protocol (Initial Review)
Protocol Number: HSC20110100H
Title: Self Reported Stress and Cortisol Measurement: Development of an Optimized Measure of Chronic Stress in
Pregnancy

Dear Principal Investigator,
Your request to conduct this minimal risk research was approved by Expedited Review on November 19, 2010, under the
following regulation(s):
45 CFR 46.110(b)(1) Category 2: Collection of blood samples by finger stick, ear stick, or venipuncture as
follows: from other adults and children, considering the age, weight, and health of the subjects, the
collection procedure, the amount of blood to be collected, and the frequency with which it will be collected.
The amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection
may not occur more frequently than 2 times per week.
45 CFR 46.110(b)(1) Category 3: Prospective collection of biological specimens for research purposes by
noninvasive means.
45 CFR 46.110(b)(1) Category 5: Research involving materials (data, documents, records or specimens)
that have been collected, or will be collected solely for non-research purposes (such as medical treatment
or diagnosis).
45 CFR 46.110(b)(1) Category 6: Collection of data from voice, video, digital, or image recordings made
for research purposes.
45 CFR 46.110(b)(1) Category 7: Research on individual or group characteristics or behavior; or
research employing survey, interview, oral history, focus group, program evaluation, human factors
evaluation, or quality assurance methodologies.
The inclusion of children (not to include neonates) under 45 CFR 46.404 was also approved. The inclusion of pregnant
women or fetuses, in this study, under 45 CFR 46.204 was also approved. Individuals engaged in the research may not
have any part in any decisions as to the timing, method or procedures used to terminate a pregnancy or determining the
viability of a neonate.
The IRB expiration date: November 19, 2011. Your progress report must be submitted to the IRB Office 34 days before
the IRB meeting that will occur before the study’s expiration date.
The following documents were reviewed: Signature Assurance Sheet; Form B - General Information; Form B-2 - Personnel
List; Form C - Research Description; Form D - HSC Consent; Form K - Intent to Conduct Research at Another Institution;
Form M - Data Collection Instrument(s); Other: Form B-1 Expedited Certification Form.
The attached informed consent document(s) digitally stamped with IRB APPROVED November 19, 2010 must be used.
Approval of the following affiliated institutions: UTHSCSA University Health System
Sincerely,

Research Compliance Specialist
Please retain this document in your IRB correspondence file

Institutional Review Board Office │ Mail Code 7830 │ 7703 Floyd Curl Drive │ San Antonio, Texas 78229-3900
210.567.2351 │ Fax 210.567.2360 │ http://research.uthscsa.edu/irb │ FWA00005928 │ IORG0000312
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