Attachment J - Expedited IRB

Date:

April 20, 2010

To:

Doreen De Leonardis, Project Director

From:

Kerry Levin, Chair Westat IRB

Subject:

Expedited Approval of Speed Warning System, Project 8427.03
FWA 0551
As Chair of the Westat Institutional Review Board (IRB), I reviewed the materials submitted for the
following: Speed Warning System, Project 8427.03. The Westat IRB reviews all studies involving
research on human subjects. The Department of Transportation is funding this project.
This project will investigate the feasibility of an in vehicle speed monitoring device as a voluntary
program, with particular emphasis on at-risk drivers who are chronic speeders.
Westat will conduct one focus group to develop a set of strong candidate incentives that may be
used in the voluntary program. Participants will provide documented informed consent. Following
the focus group, Westat will train drivers on the use of the vehicle monitoring technology,
coordinate installation and removal of the monitoring devices, monitor the device performance
during the data collection period, and help trouble-shoot problems if they arise.
Approximately 80 chronic speeders will be recruited in the suburban Washington, DC area.
Participants must be licensed and insured who drive at least 100 miles per average week and has
accumulated at least 3 or more speeding citations during the past three years. Participants will be
required to provide written informed consent and will be provided with $150 for their time in the
study.
The first 2 weeks with the device participants will not receive in-car feedback. Upon completion of
the baseline period, the device will be initialized to begin the experimental phase for 4 weeks.
Following will be another two weeks where the feedback and notification features of the device will
be turned off.
Additionally, several participants will be provided with an extended treatment period in order to gain
insight into the effects of the device.
At the end of the study, participants will be debriefed in order to collect the following:
1.
2.

Perceived effectiveness of the device in changing driving behavior
Effects on relationship with other passengers in the vehicle

-23.
4.
5.
6.

Acceptability of the device (including any undesirable effects)
Usefulness of the device.
Satisfaction of drivers with unit performance, ease of use
Incidence and type of device tampering

Drivers will be told that it is their responsibility to monitor their own driving behavior as they see fit
and that neither Westat nor NHTSA will be responsible for daily monitoring of their driving
behavior. If in the course of data quality control checks Westat staff notice a driver who exhibits
extremely dangerous behavior that falls outside the range of behaviors exhibited by other drivers in
the study, the driver will be notified and the driver may be terminated from further participation in
the study.
Researchers will obtain a Certificate of Confidentiality in order to protect participants’ privacy and to
protect against being forced by subpoena to release personal data to anyone without the participant’s
permission.
The 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 by expedited authority.
If activities change, please contact the IRB Office to ensure that the status is accurately reflected in
our records. You are required to submit the study for a continuing review on or before April 20,
2011. In the interim, you are responsible for notifying the IRB Office as soon as possible if there are
any injuries to the subjects, problems with the study, or changes to the study design that relate to
human subjects.
cc:

Institutional Review Board
Mark Freedman