Attach G_IRB Approval Letter

Date:

March 4, 2013

To:

Terisa Davis, Project Director

From:

Kerry Levin, Chair Westat IRB

Subject:

Amendment Approval of HINTS 4, Project 8861
FWA 00005551

As Chair of the Westat Institutional Review Board (IRB), I reviewed the materials submitted for the
following: HINTS 4, Project 8861. The Westat IRB reviews all studies involving research on
human subjects. This project was last reviewed in February 2013.




This request was to approve a new instrument and interview protocol.
Recruitment methods and procedures will be the same as the last round of cognitive testing.
Informed consent form and the incentive ($50) have not changed.

This round of testing will include 33 respondents: 22 in English and 11 in Spanish.
The regulations (45 CFR 46) permit expedited review of minor changes to previously approved
activities. I am therefore approving the modifications under expedited authority. This study can be
considered minimal risk and is approved under expedited authority.
As the Project Director you are responsible for the following:


cc:

You are required to submit this study for a continuing review on or before November 11,
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
Nancy Weinfield