IRB Letter

Date:

July 6, 2015

To:

Scott Crosse, Project Director

From:

Kerry Levin, Chair Westat IRB

Subject:

Amendment Approval of PATH, Project Number 8954
FWA 00005551

As Chair of the Westat Institutional Review Board (IRB), I reviewed the materials submitted for the
following: PATH, Project 8954. The Westat IRB reviews all studies involving research on human
subjects. This project was last reviewed in May 2015.
This request was to approve Wave 4 Questionnaire development including cognitive testing and focus
groups.
The regulations (45 CFR 46) permits expedited review of minor changes in previously approved activities.
I am therefore approving the modifications under expedited authority. In addition, per [45 CFR 46 404
and 408], adequate provisions will be made for obtaining assent from youth and permission from parents.
Since obtaining consent from only one parent does not adversely affect the rights and welfare of the
subjects, and that the research may not practicably be carried out without the waiver, the request to waive
permission of one parent or guardian [45 CFR 46.116 of Subpart A and 46.408 (b)] is also approved.
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You are required to submit this study for a continuing review before April 18, 2016.
In the interim, you are responsible for notifying the IRB Office as soon as possible if there are any
injuries to the subjects as well as problems or changes with the study that relate to human subjects.

cc: Institutional Review Board
Katie Gasque