C.2.6 IRB Approval Letters LOI3-PHYS-02

ATTACHMENT C.2.6 IRB APPROVAL LETTERS

OMB # 0925-0593
EXPIRATION DATE: 07/31/2013

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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:

4/6/2011
LENORE ARAB
MEDICINE-GENERAL MEDICINE & HLTH SRVCS.
ALISON MOORE
Chair, SGIRB
IRB#10-001815
An Evaluation of Ulnar Length Measurement for use in the National Children's Study
Version: PHYS-02-A

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

4/6/2011

Expiration Date of the Study

3/21/2012

Funding Source(s)

1) NIH/NATIONAL INST OF CHILD HEALTH AND
HUMAN DEVELOPMENT
Grant Title: An Evaluation of Ulnar Length
Measurement for use in the National Children's Study
Grant Number: PHYS-02-A

Specific Conditions for Approval

-- Until the UCLA IRB has received a copy of the approval notice from the lead site’s
Ethical Review Committee, no subjects may be contacted, recruited, or enrolled in this
research study. Therefore, no related recruitment, screening or consent document(s)
are stamped as approved and should not be used at this time. Once the approval notice
has been received, the UCLA IRB will stamp these documents and issue an Approval
Notice lifting this restriction. The approval notice from the lead site should be submitted
to the IRB as an amendment.
Regulatory Determinations

-- The UCLA IRB waived the requirement for signed informed consent for the screening
under 45 CFR 46.117(c)(2).

https://webirb.research.ucla.edu/WEBIRB/Doc/0/SLCIA7P4N654HBTCL7VQR8ALCA/fr...

4/6/2011

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-- Expedited Review Category(ies) - The UCLA IRB determined that the research
meets the requirements for expedited review per 45 CFR 46.110 category 4 and 7.
-- The UCLA IRB determined that the research meets the requirements of 45 CFR
46.404 for research involving children as subjects.
-- The UCLA IRB waived the requirement for obtaining the assent of the children under
45 CFR 46.116(d) for the entire study.

Documents Reviewed included, but were not limited to:

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 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.

https://webirb.research.ucla.edu/WEBIRB/Doc/0/SLCIA7P4N654HBTCL7VQR8ALCA/fr...

4/6/2011

Office of Research/Human Subjects Committee
SAD Room 124
Box 2201 SDSU
Brookings, SD 57007

November 15, 2010
To:

Lee Weidauer and Bonny Specker, E.A. Martin Program in Human Nutrition

Project title:

Anthropometry in Children: An investigation into different methods of length
and limb measurement in children from birth to 5 years.

Approval #:

IRB-1011011-CR

Thank you for bringing your protocol to the Human Subjects Committee. The Committee
approved the project at its duly convened meeting on November 9, 2010. The Committee
classified this activity as no greater than minimal risk, and your final protocol (11/15/10) was
approved using expedited review.
The one-year approval of your project will be dated starting 11/15/10. If you need to extend the
study beyond one year, please submit a request for continuing approval prior to the project end
date of 11/14/11. If you modify your study, changes must be proposed and approved prior to
implementation. Expedited review will be used for all protocol changes. At the end of the
project please inform the Committee that the study is complete.
If there are any unanticipated problems involving risks to subjects or others, please
immediately contact the SDSU Research Compliance Coordinator.
If I can be of any other assistance, don’t hesitate to let me know.
Sincerely,
Norm
Norman O. Braaten
Research Compliance Coordinator

IRB:

IRB_00045951

PI:

Laurie Moyer-Mileur

Title:

Anthropometry in Children: An investigation into different methods of length and limb
measurement in children from birth to 5 years

This New Study Application has been reviewed and approved by a University of Utah IRB convened board. 
The convened board approved your study as a Greater Than Minimal risk study on 2/9/2011.  Federal
regulations and University of Utah IRB policy require this research protocol to be re-reviewed and reapproved within 1 year from the approval date.
 Your study will expire on 2/8/2012. 
Any changes to this study must be submitted to the IRB prior to initiation via an amendment form.
APPROVED DOCUMENTS
Protocol Summary
Clean Protocol Summary 1.27.11
Parental Permission Forms
ParentalPermissionw/DXAClean2.14.11
ParentalPermissionClean2.14.11
Grant Application
LOI3-PHYS-02-B- Utah
Other Documents
Recruitment Flyer PDF Blck/Wht
SDSU Consent no DXA Form
SDSU Consent with DXA Form
Click IRB_00045951 to view the application and access the approved documents.
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https://erica.research.utah.edu/erica/Doc/0/9EGPN1P56JF4V785QBD8N9PV66/fromString.html[4/21/2011 12:54:29 PM]