B5.10 LOI2-QUEX-13 IRB Approval Letter

https://webirb.research.ucla.edu/WEBIRB/Doc/0/08R0OI4AP9KKF5O...
ATTACHMENT B.5.10 LOI2-QUEX-13
IRB APPROVAL LETTER

OMB #: 0925-0593
EXPIRATION DATE: 07/31/2013
11000 Kinross Avenue, Suite 102
Los Angeles, CA 90095-1694
http://ohrpp.research.ucla.edu
GC-IRB: (310) 825-7122
M-IRB: (310) 825-5344

APPROVAL NOTICE
New Study
DATE:

5/31/2011

TO:

MOIRA INKELAS
HEALTH SERVICES
ALISON MOORE
Chair, SGIRB

FROM:
RE:

IRB#11-000279
Measuring Child Health Disparities (Healthy Beginnings Study)
Version: 11-17-10

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

5/24/2011

Expiration Date of the Study

5/23/2012

Funding Source(s)

1) NIH/NATIONAL INST OF CHILD HEALTH AND HUMAN DEVELOPMENT
Grant Number: hhsn267200700017c

Regulatory Determinations

-- Pregnant Women or Fetuses - The UCLA IRB determined that the research meets the requirements of 45 CFR 46.204(b) for research involving
pregnant women or fetuses.
-- Waiver of Signed Informed Consent - The UCLA IRB waived the requirement for signed informed consent for the screening under 45 CFR
46.117(c)(2).

Documents Reviewed included, but were not limited to:

Study Consent - Cognitive Interview.pdf
T1 Phone Screener Script (English).pdf
Study Consent - Pregnant First-time Mothers.pdf
Recruitment Flyer - English.pdf

Document
Version #
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Cognitive Interview In-Person Screener Script (English).pdf
Recruitment Flyer - Spanish.pdf
Cognitive Interview Phone Screener Script (English).pdf
T1 In-Person Screener Script (English).pdf
Study Consent - Mothers of Children 0-5.pdf

0.01
0.01
0.01
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Document Name

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.

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