IRB Approval

Date:

October 19, 2012

To:

Erica Reed-Gross, Project Director

From:

Kerry Levin, Chair Westat IRB

Subject:

Expedited Approval of AMAZING ME STUDY, Project 8417.10
FWA 00005551

As Chair of the Westat Institutional Review Board (IRB), I reviewed the materials submitted for the
following: AMAZING ME STUDY, Project 8417.10. The Westat IRB reviews all studies
involving research on human subjects. This study is funded by Centers for Disease Control and
Prevention.
Westat will help evaluate the effectiveness of a campaign conducted to detect early signs of
developmental disabilities in young children.
Westat’s responsibilities include:
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Confirming participation and receipt of materials by 250 pediatric practices.
Gathering feedback (e.g., opinions, suggestions) from practices regarding the materials.
Gathering information about facilitators and barriers to distributing the book to parents.

Per 45 CFR 46, IRB regulations permit expedited review of certain activities involving minimal risk
[45 CFR pt. 46.110 (b) 1]. This study can be considered minimal risk and is approved under
expedited authority.
As the Project Director you are responsible for the following:
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cc:

You are required to submit this study for a continuing review on or before October 19,
2013.
In the interim, notify the IRB Office as soon as possible if there are any injuries to subjects
as well as problems or changes with the study that relate to human subjects.
Institutional Review Board
Karen Della Torre