C.4.11 IRB Approval Letters LOI2-QUEX-14

OMB #: 0925-0593
EXPIRATION DATE: 07/31/2011

ATTACHMENT C.4.11 IRB APPROVAL LETTERS

Institutional Review Board (IRB)
Unit 1437
Phone 713-792-2933
Fax 713-794-4589

Office of Protocol Research
To:
From:
CC:

Michele Forman
05/26/2011
Veronica Roberts
Beverly J. Gor, Ladia M. Hernandez, Lorna H. McNeill
MDACC Protocol ID #:
2010-0916
Protocol Title:
Improving dietary assessment in pregnant women, infants, and children: The
National Children's Study
Version:
03
Subject:

Administrative IRB Approval -- Protocol 2010-0916

On Thursday, 05/26/2011, the Institutional Review Board (IRB) 4 chair or designee reviewed and
approved your revision dated 05/09/2011 for Protocol 2010-0916
These Pages Include:
·
·
·
·
·

Protocol Body -- Document header Date: 05/09/2011
Abstract Page -- Document header Date: 05/09/2011
Informed Consent(s) -- Document header Date: 05/09/2011
Appendices -- Document header Date: 05/09/2011
Collaborator(s) Page -- Document header Date: 05/09/2011

Revision included the following changes:
Revision response to contingencies from April 21, 2011 IRB4 meeting. Participants should be
reconsented if there is a desire to do anthropometric measures on the children already enrolled.
404 Pediatric Risk Assessment - Research not involving greater than minimal risk. – Only 1 parent
signature is required on Informed Consent Document. Consent updated to the new template.
The revision can now be implemented. Please inform the appropriate individuals in your department or
section and the collaborators of these changes.
Please inform the appropriate individuals in your department/section and your collaborators of these
revisions.
Please Note: This approval does not alter or otherwise change the continuing review date of this
protocol.
In the event of any questions or concerns, please contact the sender of this message at (713) 792-2933.
Veronica Roberts 05/26/2011 02:29:22 PM

This is a representation of an electronic record that was signed and dated
electronically and this page is the manifestation of the electronic signature and
date:

Veronica Roberts
05/26/2011 02:28:42 PM
IRB 4 Chair Designee
FWA #: 00000363
OHRP IRB Registration Number: IRB 4 IRB00005015

Colorado Multiple Instititutional Review Board, CB F490
University of Colorado, Anschutz Medical Campus
13001 E. 17th Place, Building 500, Room N3214
Aurora, Colorado 80045

303.724.1055
303.724.0990
uchsc.edu/comirb
[email protected]
FWA00005070

[Phone]
[Fax]
[Web]
[E-Mail]
[FWA]

University of Colorado Hospital
Denver Health Medical Center
Veteran's Administration Medical Center
The Children's Hospital
University of Colorado Denver
Colorado Prevention Center

Protocol Amendment Approval
18-Nov-2010
Investigator:

Dana Dabelea

Sponsor(s):

National Institute of Diabetes and Digestive and Kidney Diseases/NIH/DHHS~

Subject:

COMIRB Protocol 09-0563 Amendment

Effective Date:

16-Nov-2010

Title:

HEALTHY START

Amendment Description:
PAM007-1
Application Form: Protocol: Consent Form Revision: Documents Used with Subjects:
1. Extend the eligibility criteria for participation on Healthy Start to pregnant women < 23Weeks of gestation. This change is included in Protocol
application: Page # 7 H- Human Subjects, numeral 6: Inclusion Criteria and in page # 8, I- Procedures, numeral 2. And in the study protocol pages
#2.6 and 7.
2. Invite a random sample of participants (50% of those completing an IPV3) to bring their babies (4-6 months old) to The Children Hospital (TCH)
CTRC for an in person visit (IPV4) to assess anthropometric measures (weight, length, skinfolds, circumferences) and body fat (using the Pea Pod
measurement) . This addition is described in the Study Protocol pages # 8 and 9; in the protocol application page #8 I: Procedures numeral 2; and
in Attachment U pages: 4,5,11 and 12. Description of IPV4 methods for the selected sample is included in the consent form Pages #3, and
7.Copies of highlighted and clean application protocol, attachment U, protocol, and consents are attached.
3. Increase incentives for completion of IPV1 from $40 to $60 and IPV3 from $20 to $40, and compensate $60 to those participants completing
IPV4. This addition is reflected in the protocol application page #13 K Recruitment, numerals 4b and 4c; in the Healthy Start protocol Pages # 15
and 16. And in the consent pages #7. Copies of highlighted and clean protocol are attached.
4. When and if absolutely necessary, conduct visits I&2 in participant’s home. This procedure will be done on case by case basis and only if
participant can’t absolutely come to the clinic for the study visits. COMRIB and OSHA procedures will be followed with phlebotomy and blood
transportation, and interviewing. This is reflected in the protocol application G2 and J3; and in the protocol pg.15.
5. Conduct a pilot study on a convenience sample of N=50 Healthy Start participants to evaluate the feasibility, burden and data quality of collecting
dietary data on pregnant women using the 24-hour recall method (ASA24) rather than or in conjunction with a food frequency method. This pilot
work will inform the National Children’s Study on what dietary data collection approaches to use. We are already colleting ASA24 recalls in Healthy
Start participants, therefore, to accomplish this goal we would ask a sample of N=50 Healthy Start pregnant women who have completed an IPV1
to complete at home: 2 questionnaires on Acceptability of ASA24 recall (after the 2nd and third ASA24 recall) and a full food frequency questionnaire
(after the third ASA24 recall). They would return these questionnaires to the study team when they are seen for their Healthy Start IPV2. This
addition is reflected in the protocol application page #8 I: Procedures numeral 2, in the Healthy Start protocol Page s#7 and 8, and consent form
Pages #2 and 7. Copies of highlighted and clean application protocol, Attachment A, protocol and consents as well as questionnaire and survey
are attached. Participants completing this pilot study will be additionally compensated $ 25.
Documents Submitted and Approved:
1. Protocol application with attachments –Highlighted changes: application, Attachments A, D, E, F, G, H, I, J, M - Waiver of Consent, O - Waiver of
HIPAA, P, Q, R, S, and U dated 11-5-10
2. Consent forms- English and Spanish - Highlighted changes and clean copies dated 11-5-10
3. Protocol- Highlighted changes and clean copy dated 11-5-10
4. ASA24 Acceptability Questionnaire # 1 and #2
5. NCS Food Frequency Questionnaire

Sincerely,
UCD Panel C

https://webirb.research.ucla.edu/WEBIRB/Doc/0/167ON9TSSN8KN3...

11000 Kinross Avenue, Suite 102
Los Angeles, CA 90095-1694

webIRB

http://ohrpp.research.ucla.edu
GC-IRB: (310) 825-7122
M-IRB: (310) 825-5344

APPROVAL NOTICE
New Study
DATE:
TO:
FROM:
RE:

3/15/2011
LENORE ARAB
MEDICINE-GENERAL MEDICINE & HLTH SRVCS.
ALISON MOORE
Chair, SGIRB
IRB#10-001535
Improving Dietary Assessment in Pregnant Women and Children in the National
Children's Study
Version: LOI-2-14

The UCLA Institutional Review Board (UCLA IRB) has approved the above-referenced study. The UCLA IRB's
Federalwide Assurance (FWA) with Department of Health and Human Services is FWA00004642 (IRB00004474).
Submission and Review Information
Type of Review

Full Board Review

Approval Date

3/15/2011

Expiration Date of the Study 1/10/2012

Funding Source(s)

1) NIH/NATIONAL INST OF CHILD HEALTH AND
HUMAN DEVELOPMENT
Grant Title: Improving Dietary Assessment in
Pregnant Women and Children in the National
Children's Study
Grant Number: LOI-2-14

Regulatory Determinations

-- The UCLA IRB waived the requirement for signed informed consent for the
screening under 45 CFR 46.117(c)(2).
-- The UCLA IRB waived the requirement for obtaining the assent of the children
under 45 CFR 46.116(d) for the entire study.
-- The UCLA IRB determined that the research meets the requirements of 45 CFR

1 of 3

3/16/2011 2:15 PM

https://webirb.research.ucla.edu/WEBIRB/Doc/0/167ON9TSSN8KN3...

46.404 for research involving children as subjects.

Documents Reviewed included, but were not limited to:

Document Name
Craigslist Text.Child Chinese CLEAN.pdf
Craigslist Text.Pregnant Indian CLEAN.pdf
Eligibility Screener Script (preschooler) .pdf
Flyer Pregnant Chinese CLEAN 2.28.11.pdf.pdf
Craigslist Text.Child Indian CLEAN.pdf
Consent form Pregnant women.pdf
Flyer Children Chinese CLEAN 2.28.11.pdf.pdf
Consent form preschoolers.pdf
Flyer Pregnant SouthEastIndian CLEAN 2.28.11.pdf.pdf
Flyer Pregnant Filipino CLEAN 2.28.11.pdf.pdf
Craigslist Text.Child Filipino CLEAN.pdf
Recruitment Flyer (Children Filipino) CLEAN.pdf
Eligibility Screener Script (pregnant).pdf
Craigslist Text.Pregnant Filipino CLEAN.pdf
Flyer Children South East Indian CLEAN 2.28.11.pdf.pdf
Craigslist Text.Pregnant Chinese CLEAN.pdf

Document
Version #
0.01
0.01
0.01
0.01
0.01
0.01
0.01
0.01
0.01
0.01
0.01
0.01
0.01
0.01
0.01
0.01

Important Note: Approval by the Institutional Review Board does not, in and of itself, constitute approval for the
implementation of this research. Other UCLA clearances and approvals or other external agency or collaborating
institutional approvals may be required before study activities are initiated. Research undertaken in conjunction with
outside entities, such as drug or device companies, are typically contractual in nature and require an agreement between
the University and the entity.
General Conditions of Approval
As indicated in the PI Assurances as part of the IRB requirements for approval, the PI has ultimate responsibility for the
conduct of the study, the ethical performance of the project, the protection of the rights and welfare of human subjects,
and strict adherence to any stipulations imposed by the IRB.
The PI and study team will comply with all UCLA 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:
Ensuring that the personnel performing the project are qualified, appropriately trained, and will adhere to the
provisions of the approved protocol,
Implementing no changes in the approved protocol or consent process or documents without prior IRB approval
(except in an emergency, if necessary to safeguard the well-being of human subjects and then notifying the IRB
as soon as possible afterwards),
Obtaining the legally effective informed consent from human subjects of their legally responsible representative,
and using only the currently approved consent process and stamped consent documents, as appropriate, with
human subjects,
Reporting serious or unexpected adverse events as well as protocol violations or other incidents related to the

2 of 3

3/16/2011 2:15 PM

https://webirb.research.ucla.edu/WEBIRB/Doc/0/167ON9TSSN8KN3...

protocol to the IRB according to the OHRPP reporting requirements.
Assuring that adequate resources to protect research participants (i.e., personnel, funding, time, equipment and
space) are in place before implementing the research project, and that the research will stop if adequate
resources become unavailable.
Arranging for a co-investigator to assume direct responsibility of the study if the PI will be unavailable to direct this
research personally, for example, when on sabbatical leave or vacation or other absences. Either this person is
named as co-investigator in this application, or advising IRB via webIRB in advance of such arrangements.

3 of 3

3/16/2011 2:15 PM