NHTSA Form 1169 Participant Consent

STUDY: Driver Distraction Study
STERLING IRB ID: 4066-001
DATE OF IRB REVIEW:

PARTICIPANT INFORMED CONSENT FORM
STUDY TITLE:

Driver Distraction Study

STUDY
INVESTIGATOR:

Elizabeth N. Mazzae

STUDY SITE:

NHTSA Vehicle Research and Test Center
10820 State Route 347, Bldg. 60
East Liberty, OH, 43319

TELEPHONE:

1-800-262-8309

SPONSOR:

U.S. Department of Transportation
National Highway Traffic Safety Administration (NHTSA)

You are being asked to participate in a research study. Your participation is strictly voluntary,
meaning that you may or may not choose to take part. To decide whether or not you want to be
part of this research, you should understand the study risks and benefits in order to make an
informed decision. This process is known as informed consent. This consent form describes
the purpose, procedures, possible benefits, and risks of the study. This form also explains how
your information will be used and who may see it. After reading the consent form, if you would
like to participate, you will be asked to sign this form.
The study investigator or research staff will answer any questions you may have about this form
or the study. Please read this document carefully and do not hesitate to ask anything about this
information. Please ask for explanation of any words or information that you do not understand.
You may have a copy of this form to review at your leisure and keep for your records.
PURPOSE
The purpose of this study is to gather information on driver distraction. The study involves a
driving experiment that will gather information regarding the impact of performing distracting
tasks (such as radio tuning, dialing a cell phone) on driving performance. For this study you will
be asked to drive a test vehicle equipped with data recording equipment while performing nondriving tasks.
STUDY REQUIREMENTS
You are being asked to participate in this research study because you:
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Are 18 years of age or older
Have a valid U.S. driver’s license with no restrictions (excluding corrective eyewear)
Have a minimum of 2 years driving experience
Have a minimum of 6 months driving experience with one of the vehicle models involved in
this study and drive that vehicle on a regular basis
Drive at least 7,000 miles per year

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Version Date: 07 June 2012

Participant's Initials ____________

STUDY: Driver Distraction Study
STERLING IRB ID: 4066-001
DATE OF IRB REVIEW:

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Are in general good health

NUMBER OF STUDY SITES AND PARTICIPANTS
This study will take place at one research site, the NHTSA’s Vehicle Research and Test Center
(VRTC) which is located on the grounds of the Transportation Research Center (TRC) and will
include approximately 150 men and women.
STUDY PROCEDURES
Before participating in this research study, you will be asked to read this consent form. After
your questions have been answered, you will be asked to sign this form to show that you
voluntarily consent to participate in this study.
During all driving taking place on the grounds of the Transportation Research Center (TRC), you
will be required to wear the vehicle’s seat belt. In addition, a member of the research staff will
give you detailed instructions regarding where to drive and guide you as you drive a test vehicle
through the study procedure. However, it is important to remember that you, as the driver, are
in control of the vehicle at all times and you must be the final judge as to when to complete the
tasks during this study.
By signing this form, you agree to participate in one study participation appointment lasting
about 60 minutes and consisting of a drive to become familiar with the vehicle and the “study
drive.” Procedure steps include:
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You will be asked to review and sign this consent form.
o Prior to the study drive, you will perform a familiarization drive so that you become
familiar with the test vehicle and with how to move between driving courses where the
study drive will take place. You will perform various basic driving maneuvers.
Following the familiarization drive, you will receive instruction on how to perform a nondriving task, such as radio tuning, and then perform a study drive in the test vehicle. This
test vehicle will be equipped with video cameras and sensors to record information on your
steering, braking and gas pedal use. This allows the study team to collect data that
describes how you are driving as you perform the study tasks.
Following the study drive, your participation in the study will end.

RISKS
During the familiarization drive and study drive, you will be exposed to all risks and uncertainties
normally associated with driving on the TRC roads (two-lane rural roads) and in parking lots.
The study will be conducted only in daylight and favorable driving conditions. In the event of
bad weather, the driving tasks may be delayed until conditions for driving improve. For these
reasons, the risks are considered to be less than might be expected when performing
comparable driving tasks while traveling on public two-lane roads under light to moderate traffic
conditions.

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Version Date: 07 June 2012

Participant's Initials ____________

STUDY: Driver Distraction Study
STERLING IRB ID: 4066-001
DATE OF IRB REVIEW:

You will not be asked to perform any unsafe acts. There may be risks that are unknown.
NEW INFORMATION
No changes to procedures are anticipated to occur during this study. However, any new
information that may affect your willingness to participate will be provided to you.
BENEFITS
There is no personal benefit to you from participating in this study. You are not expected to
receive direct benefit from your participation in this research study. However, your participation
in the study will provide information on driver behavior and performance that may be used by
researchers to develop recommendations or standards for increasing vehicle and driving safety.
ALTERNATIVES
This study is for research purposes only. Your alternative is to not participate.
COSTS TO YOU
Other than the time you contribute, there will be no costs to you.
COMPENSATION
You will receive compensation based upon a rate of $54.00 per hour upon completion of the
study for your time and travel. If you do not complete the entire study, you will receive a prorated portion of this amount. In addition, you will be compensated 51 cents ($0.51) per mile (up
to a maximum of $200.00) for driving from your residence or workplace to TRC to attend the
single required laboratory visit.
In rare instances, severe weather may cause a delay in your completion of required driving. If
severe weather occurs, you will be given the opportunity to return at another time to complete
the study drive. If you are able to wait for the severe weather to pass, you will receive $54.00
per hour for up to a total of 3 hours spent at the research facility. The study investigator or
research staff will make the decision whether your study drive must be called off or rescheduled
due to weather or other unexpected complications.
COMPENSATION FOR RESEARCH-RELATED INJURY
The contractor assisting with the conduct of this study, TRC Inc., will maintain insurance that will
provide coverage for you in the event of a crash occurring on TRC facilities while driving a test
vehicle. This insurance will provide coverage for injuries to you up to a limit of $10,000.00. You
should contact your insurance company to check on additional coverage. Coverage will also be
provided for injuries to others, including the driver and any passengers of other vehicles
involved in the crash, as well as damages resulting from any crashes occurring during your
participation in this study, up to a $1,000,000 limit. Except to the extent covered by such
insurance policy, TRC, TRC Inc. and NHTSA will not be responsible for your actions during this
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Participant's Initials ____________

STUDY: Driver Distraction Study
STERLING IRB ID: 4066-001
DATE OF IRB REVIEW:

study, and they will not compensate you for any problems arising out of your actions or the
normal risks associated with driving. However, you will not be liable for loss or damage to the
vehicle instrumentation, the test vehicle, or other equipment during your participation unless
there is gross negligence on your part.
If you are injured in a crash while on TRC facilities, emergency personnel will be dispatched to
treat you. The nearest hospital is about 15 miles away. If you are injured while driving off-site
after your participation in the study, either you or your insurance company will be responsible for
the costs associated with your medical treatment and your vehicle repairs.
CONDITIONS OF PARTICIPATION, WITHDRAWAL, AND TERMINATION
Participation in this research is voluntary. By consenting to your participation, you agree that
while driving the research vehicle you will operate it in accordance with all instructions provided
by the research staff. If you fail to follow instructions or behave in a dangerous manner, you
may be terminated from the study and forfeit your compensation. You may withdraw your
consent and discontinue your participation without penalty at any time. If you decide to
withdraw from the research study, you should notify the study investigator.
USE OF INFORMATION COLLECTED
In the course of this study, the following data will be collected:
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Video/audio data (such as the information recorded by video cameras)
Engineering data (such as speed, steering, and braking information)

Information NHTSA may release:
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The video data recorded in this study includes your video-recorded likeness. Video data will
be used to assess your driving performance. NHTSA may publicly release video image data
(in continuous video or still formats), either separately or in association with the engineering
data for scientific, educational, research, or outreach purposes.

Information NHTSA may not release:
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Any release of video data will not include release of your name. However, in the event of
court action, NHTSA may not be able to prevent release of your name or other personal
identifying information. NHTSA will not release any information collected regarding your
health and driving record.

PRIVACY NOTICE
AUTHORITY: 49 U.S.C. Chapter 301 authorizes the U.S. Department of Transportation (DOT),
National Highway Traffic Safety Administration (NHTSA) to prescribe motor vehicle safety
standards and to carry out needed safety research and development. In furtherance of these
authorized activities, NHTSA is conducting this study involving human subjects which requires
the collection of personally identifiable information. PURPOSE(S): DOT will use the information
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Participant's Initials ____________

STUDY: Driver Distraction Study
STERLING IRB ID: 4066-001
DATE OF IRB REVIEW:

provided to solely to administer the research. ROUTINE USE(S): Data that personally
identifies you will not be disclosed to individuals or entities outside of government or its
contractors. DISCLOSURE: Provision of the requested information is voluntary; however
failure to furnish the requested information may result in your disqualification from participating
in this study.
QUESTIONS
Any questions you have about the study can be answered by Elizabeth Mazzae or the research
staff by calling 1-800-262-8309.
If you have questions regarding your rights as a research participant, or if you have questions,
concerns, complaints about the research, would like information, or would like to offer input, you
may contact the Sterling Institutional Review Board Regulatory Department, 6300 Powers Ferry
Road, Suite 600-351, Atlanta, Georgia 30339 (mailing address) at telephone number 1-888636-1062 (toll free).

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Version Date: 07 June 2012

Participant's Initials ____________

STUDY: Driver Distraction Study
STERLING IRB ID: 4066-001
DATE OF IRB REVIEW:

INFORMED CONSENT
By signing the informed consent statement contained in this document, you agree that
participation is voluntary and you accept all terms of this agreement. Also by signing the
informed consent statement, you agree to operate the study vehicle in accordance with all
instructions provided by the study staff. You may withdraw your consent and discontinue your
participation in the study at any time without penalty.
NHTSA will retain a signed copy of this Participant Informed Form. A copy of this signed form
will also be provided to you.
Informed Consent Statement:
I certify that:
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I have a valid, U.S. driver’s license with no restrictions (excluding corrective lenses).
I am the primary driver of the following vehicle: ________________________________.
All personal and vehicle information as well as information regarding my normal daily driving
habits provided by me to NHTSA and/or the Transportation Research Center (TRC) Inc.
employees associated with this study during the pre-participation screening process was
true and accurate to the best of my knowledge.
I have been informed about the study in which I am about to participate.
I have been told how much time and compensation is involved.
I have been told the purpose of this study and the nature of the study procedures.

I have been told that:
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The study involves a period of observation while I am driving a study-related vehicle on the
TRC facilities. The risk of injury due to a motor vehicle collision is less than in real world
driving due to the closed environment and safety precautions which include study staff ready
to intervene if necessary.
For scientific, educational, research or outreach purposes, video images of my driving which
will contain views of my face may be used or disclosed by NHTSA, but my name and any
health data or driving record information will not be used or disclosed by NHTSA.
My participation is voluntary, and I may refuse to participate or withdraw my consent and
stop taking part at any time without penalty or loss of benefits to which I may be entitled.
I have the right to ask questions at any time and I may contact the study investigator,
Elizabeth Mazzae, at 800-262-8309 for information about the study and my rights.

Page 6 of 7 – NHTSA Form 1169
Version Date: 07 June 2012

Participant's Initials ____________

STUDY: Driver Distraction Study
STERLING IRB ID: 4066-001
DATE OF IRB REVIEW:

I have been given adequate time to read this informed consent form. I do not give up any of my
legal rights by signing this form. I hereby consent to take part in this research study.
I,

, voluntarily consent to participate.
(Printed Name of Participant)

Signature of Participant

_________________
Date

Signature of Person Obtaining Consent

_________________
Date

INFORMATION DISCLOSURE
By signing the information disclosure statement below, you agree that NHTSA and its
authorized contractors and agents will have the right to use the video data collected during your
participation for scientific, educational, research or outreach purposes. This includes wide
distribution or publication of your likeness in video or still photo format. Neither NHTSA nor its
authorized contractors or agents shall release your name. You have been told that, in the event
of court action, NHTSA may not be able to prevent release of names or other personal
identifying information. NHTSA will not release any information collected regarding your health
and driving record, either by questionnaire or medical examination. Your permission to disclose
this information will not expire on a specific date.
Information Disclosure Statement:
I,
, grant permission to the National Highway
Traffic Safety Administration (NHTSA) to use, publish or otherwise distribute NHTSA video
image data of my likeness (including continuous video and still photo formats) collected in this
study, either separately or in association with the appropriate engineering data for scientific,
educational, research or outreach purposes. I have been informed that such use may involve
widespread distribution to the public and may involve distribution of my likeness in video or still
photo formats, but will not result in release of my name or other identifying personal information
by NHTSA or its authorized contractors or agents. I have been told that my permission to
disclose this information will not expire on a specific date.

Signature of Participant

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Date

Participant's Initials ____________