Appendix C - IRB Approval

Appendix C

Westat IRB Approval Notice

Date:	January 30, 2015
To:	Doreen Deleonardis, Project Director
From:	Kerry Levin, Chair Westat IRB
Subject:	Expedited Approval of CHILD RESTRAINT SYSTEM, Project 6286.01 FWA 00005551

As Chair of the Westat Institutional Review Board (IRB), I reviewed the materials submitted for the following: CHILD RESTRAINT SYSTEM (CRS), Project 6286.01. The Westat IRB reviews all studies involving research on human subjects. This study is funded by the National Highway Traffic Safety Administration.

The purpose of this study is to improve child passenger safety by reducing errors in installation.

Westat’s role will include the following objectives:

1. Identify user errors related to: the selection of a CRS based on a child’s height/weight/age, installation of the selected CRS in the various vehicle types, and securing the child in the CRS.

2. Evaluate the causal roles of any factors that might contribute to the various types of errors, and the relationships between individual differences, confidence in installation, CRS familiarity and the observed errors.

3. Examine caregivers’ levels of perceived risk with inaccurate CRS installations. Ultimately, findings will transition to efforts in reducing/removing error-prone factors and educating the public.

Westat will collect data from 150 participants. Each participant will complete four installations, resulting in approximately 600 installations distributed across vehicle type, CRS type, and child’s age, weight, and height

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.

As the Project Director, you are responsible for the following:

• You are required to submit this study for a continuing review before January 30, 2016.

• 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.

cc: Institutional Review Board

James Jenness