IRB Approval Letter

Date:

July 7, 2020

To:

Janice Machado, Project Director

From:

Sharon Zack, Westat IRB Administrator

Subject:

Initial Approval of Infant Feeding Practices Study III (IFPS-III), Project
Number 6717
FWA 00005551

As Administrator of the Westat Institutional Review Board (IRB), I reviewed the materials
submitted for the following: IFPS-III, Project Number 6717. The Westat IRB reviews all studies
involving research on human subjects. Centers for Disease Control and Prevention funds this study.
The purpose of this study is to understand the current state of mothers’ intentions, behaviors,
feeding decisions, and practices from pregnancy through their child’s first two years of life and
how these change. It will also assess the impact of these practices on the child’s feeding and
health outcomes during the first two years, and explore emerging issues related to infant and
toddler feeding practices.
Westat will be responsible for all project activities from the design of materials, programming
instruments, recruiting mothers, implementing data collection, delivering data and reports.
IRB regulations permit expedited review of certain activities involving minimal risk [45 CFR pt. 46.110].
This study can be considered minimal risk and is approved under expedited authority. Per [45 CFR
46.117], a waiver of documentation of informed consent is also approved as the research involves no
more than minimal risk and involves no procedures for which written consent is normally required
outside of the research context.
Please note the following:
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

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You are required to submit this study for a continuing review before July 7, 2021.
IRB approval is required before any new or modified research activities are conducted
or when there is a problem involving risks to human subjects.
Upon learning of an incident, you must contact the IRB Office within 24 hours via
telephone (301-610-8828) or email (IRB@westat.com).

For questions regarding this memo, contact Sharon Zack at 301-620-8828 or
sharonzack@westat.com.
cc: Institutional Review Board
Frank Bennici