Consent Form Attachment G - Two-Session Consent Form

VIRGINIA POLYTECHNIC INSTITUTE AND STATE UNIVERSITY

Consent to Take Part in a Research Study
Title of research study: Human Factors in ADS-Equipped CMVs (IRB #21-827)
Principal Investigator: Matthew Camden, M.A. Virginia Tech Transportation Institute
Telephone: (540) 231-1503 Email: [email protected]
Other Study Contacts: Susan Soccolich, 540-231-1032, [email protected]
Key Information: The following is a short summary of this study to help you decide whether to be

a part of this study. More detailed information is listed later in this form.

Why am I being invited to take part in a research study?
We invite you to take part in this research study because you are 21 years of age or older and have a
Class A or B CDL.

What should I know about being in a research study?
● Someone will explain this research study to you.
● Participation is optional.
● The video, other data, and additional information that could be used to identify you will be
held under a high level of security.
● If you decide to take part, you are always free to change your mind and exit the study at any
point without penalty.
● You are welcome to ask all the questions you want before you decide

Why is this research being done?
This simulator study seeks to understand driver distraction in Commercial Motor Vehicles and how
drivers take over control when driving automated vehicles. This research will also evaluate a driver
distraction training program for those who drive automated vehicles. Data from this study will be
used in a confidential way to understand automated driving systems in Commercial Motor Vehicles.

How long will the research last?
Participation in the study will last a total of 8 hours. You will come to VTTI for 2 separate sessions
that are 4 hours each. These 2 sessions are typically scheduled approximately 2 months apart but in
some cases it may be necessary to schedule them up to 18 months apart.

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What will I need to do if I choose to participate?
If you choose to participate, you will need to do the following:
1. Come to VTTI in Blacksburg, Virginia for two separate sessions.
2. Complete several questionnaires that will gather information about you, your driving history,
your thoughts on different in-vehicle technologies, and your feedback on a driver training
program.
3. “Drive” in a driving simulator and perform other secondary tasks while driving as instructed by
an experimenter.
4. Let the experimenter know if you begin to experience any nausea, dizziness, or other symptoms
that sometimes occur when driving in a simulator.

Is there any way being in this study could be bad for me?
You may experience symptoms of ‘simulator sickness’ including dizziness and nausea. More detailed
information about the risks of this study can be found under “Is there any way being in this study
could be bad for me? (Detailed Risks)”.

Will being in this study help me in any way?
There are no benefits to you from your taking part in this research.

What happens if I do not want to be in this research?
Taking part in research is completely up to you. You can decide to participate or not to participate.

Detailed Information: The following is more detailed information about this study in addition to

the information listed above.

Who can I talk to?
If you have questions, concerns, or complaints, or think the research has hurt you, talk to the
research team at Telephone: (540) 231-1503 or Email: [email protected]
This research has been reviewed and approved by the Virginia Tech Institutional Review Board
(IRB). You may communicate with them at 540-231-3732 or [email protected] if:
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You have questions about your rights as a research subject
Your questions, concerns, or complaints are not being answered by the research team
You cannot reach the research team
You want to talk to someone besides the research team to provide feedback about this research

How many people will be studied?
We plan to include about 100 people in this research study.

What happens if I say yes, I want to be in this research?
If you agree to participate in this study, you will be asked to do the following:

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Consent to Take Part in a Research Study
Session 1 (Approximately 4 hours)
1. Read and sign this Informed Consent Form
2. Fill out a W9 form for compensation purposes
3. Complete a Pre-Study Demographics questionnaire, Perceptions of Technology & Vehicle
ADS questionnaire, and Pre-Study Driver Behavior questionnaire
4. Complete a Psycho-motor vigilance test (PVT) that requires you to use a VTTI tablet and
tap the screen when you see a counter appear at random intervals during a 3-minute test.
This test measures your reaction time.
5. Complete a short training on the driving simulator. After which you will complete a motion
sickness questionnaire to understand how the simulator affects you.
6. Drive in the Commercial Training & Prototyping Simulator (CTAPS) (a truck-driving
simulator) at VTTI for approximately 3.5 hours. The simulator will capture data on your
driving as well as video of the screens and you as a driver. Similarly, eye tracking data will
be collected via a small camera in the simulator. The simulator is designed to mimic driving
a commercial motor vehicle equipped with autonomous driving technology. During some
parts of the simulated drive, the simulator will control the vehicle’s steering, acceleration,
and braking. During other part of the simulated drive, you will control the vehicle’s
steering, acceleration, and braking. The simulator will alert you when you need take control
of the vehicle (i.e., after you hear an alert, you will need to act as if you are driving
normally).
7. While you are ‘driving’ the researcher will ask you to complete tasks (e.g., reading or
writing paperwork, reading a roadside sign, programing a GPS unit, etc.) at set times.
There will also be portions of the driving session where the experimenter will let you know
that you are free to complete other tasks if you wish.
8. Answer researcher questions between simulator tasks.
9. The researcher will routinely ask you if you are experiencing any symptoms of Simulator
Sickness. You can also alert the researcher should you begin to be aware of symptoms.
10. Complete a post-study ADS experience & perceptions questionnaire
Session 2 (Approximately 4 hours)
1. Review, initial and date this Informed Consent Form
2. Complete a second 3-minute PVT reaction time test.
3. View training for drivers of Commercial Motor Vehicles on autonomous technology in
trucks.
4. “Drive” in the simulator for approximately 3 hours and perform different tasks as instructed
by the experimenter. The experimenter will also let you know when there are periods of
time where you are free to complete other tasks if you wish.
5. Answer researcher questions between simulator tasks.
6. The researcher will routinely ask you if you are experiencing any symptoms of Simulator
Sickness. You can also alert the researcher should you begin to be aware of symptoms.
7. Complete a post-training questionnaire about the training program.

What happens if I say yes, but I change my mind later?
You can leave the research at any time, for any reason, and it will not be held against you.

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If you decide to leave the research, let the researcher know so that they can compensate you for
your participation up to the time of withdrawal.
You are also free to not answer any questions that you choose without penalty.
If you are experiencing symptoms of simulator sickness, we will ask you to stay in a private room
at VTTI until you are symptom free for 20 minutes.

Is there any way being in this study could be bad for me? (Detailed Risks)
There are some minor risks and discomforts to which you may be exposed to in volunteering for
this research. These risks include:
1. Possible discomfort associated with Simulator Sickness. Symptoms may include fatigue,
headache, eye strain, difficulty focusing, increased salivation, dry mouth, sweating, nausea,
difficulty concentrating, fullness of head, blurred vision, dizziness, vertigo, nausea and
upset stomach. This is similar to what someone may experience after riding an amusement
park ride or when using virtual reality headsets.
2. The risk of completing the questionnaires is similar to completing office paperwork.
However, there is also risk associated with disclosing illegal behavior on two of the
questionnaires.
3. Due to the length of the sessions, you may become fatigued.
The following precautions will be taken to ensure minimal risk to the participants:
1. You will be driving in a simulator instead of live traffic situations to prevent harm from
crashes or other hazards while driving.
2. You will be given breaks from the driving simulator to ensure minimum discomfort. You
will be allowed to stop the simulator session at any time if you feel physical discomfort.
3. If you begin to experience symptoms of simulator sickness, you will be taken to a private
room where you will be monitored by an experimenter until you have been symptom free
for 20 minutes and can leave VTTI.
4. You may stop participating in the study at any time. You may also choose to skip questions
on the questionnaires.
5. If you are feeling unwell on the drive home due to simulator sickness, contact a research
team member whose information is listed above. A research team member will come pick
you up and allow you to rest at VTTI until you are able to drive home safely.

What Information and Data Will Be Collected?

INFORMATION
1. Contact information includes your name, address, email address, phone numbers, and similar
information used to contact you when needed. It will be stored securely in electronic form
during the study and destroyed one year after the study is complete. This information will not
be used in any research or analysis.
2. Auxiliary study information includes your Social Security Number and information that you
provide on the W9 form. Virginia Tech requires this to compensate you for your participation.
This information will not be linked to your study data and will not be used in any research or
analysis.

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Consent to Take Part in a Research Study
DATA (Used for Research)
1. Driver data includes your answers to the questionnaires and the PVT. These data will not
contain your name or any identifying information and will be used in analyses, both on their
own and in combination with the driving data. Audio recording will also take place in the
simulator. These data will be stored securely in electronic form indefinitely.
2. Driving and eye tracking data includes the data we collect from the simulator and eye
tracking device while you are ‘driving’, including video data, and sensor data. This information
will contain video of your face. These data will be stored securely in electronic form
indefinitely.
How Information and Data are Collected
The simulator will capture data on your driving as well as video of the screens and you as a driver.
Similarly, eye tracking data will be collected via a small camera in the simulator. Questionnaires and
PVT will be collected electronically using a VTTI tablet.

What happens to the information collected for the research?
We will make every effort to limit the use and disclosure of your personal information, including
research study records, only to people who have a need to review this information. We cannot
promise complete confidentiality. Organizations that may inspect and copy your information
include the IRB, Human Research Protection Program, and other authorized representatives of
Virginia Tech.
We will separate your private information from data that are collected during this research; deidentified data (which cannot be associated with your identity) could be used for future research
studies or distributed to another investigator for future research studies without your additional
informed consent.
We expect the driver data and driving data from this study to be useful for many years after the
study is over, therefore, we plan to keep and use it indefinitely. It is expected that other researchers
beyond the original study team identified in this form as well as industry partners may also find the
data and results of this study useful. We will allow these individuals to use the data under the
following conditions:
1. Data containing Personally Identifying Information (PII): These data contain information
that could be used to personally identify you. Examples of PII are images of your face and
audio recordings. PII will not be released outside the research team. However, other researchers
may be granted temporary access to the data in a secure environment.
a. VTTI researchers wishing to use data containing PII will be required to submit proof of
IRB approval. These researchers will only be allowed access to view these data in a
secure environment.
b. Researchers outside VTTI will be required to submit proof of IRB approval and sign a
data use license assuring that they will extend the same privacy protections to your PII
that are outlined in this form. These researchers will only be allowed to access these
data in a secure environment or in adherence with National Institutes of Health (NIH)
guidelines.

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2. Data not containing PII: These data do not contain any information that could be used to
personally identify you.
a. VTTI researchers will have access to this data.
b. Researchers outside VTTI may use data that does not contain PII after they sign a data
use license.
c. This data may also be posted online for public use in the future.
The results of this research study may be presented in summary form at conferences, in
presentations, reports to the sponsor, and academic papers. Additionally, video collected during
your study session may be included in presentations at conferences. Videos used in presentations
will not contain any information that can be used to identify you. A variety of technologies will be
used to blur your face, replace it with it with an avatar, remove or distort audio, etc.

Can I be removed from the research without my, OK?
The person in charge of the research study or the sponsor can remove you from the research study
without your approval. Possible reasons for removal include the research sponsor deciding to
suspend or cancel the study, uncooperative behavior, or you experience symptoms of simulator
sickness.

What else do I need to know?
This research is being funded by the Federal Motor Carrier and Safety Administration (FMCSA).
Any expenses accrued for seeking or receiving medical or mental health treatment will be your
responsibility and not that of the research project, research team, or Virginia Tech.
If you agree to take part in this research study, we will provide you with $200 at the end of each
session. A $100 bonus will be provided at the end of the second session for those that complete
both sessions of the study. Maximum compensation for full study participation in both sessions
will be $500. If you withdraw from the study in the middle of a session, you will be compensated
for the time you participated at the pro-rated rate of $50 per hour.
Compensation is provided via a prepaid MasterCard. Please allow one full business day for the
MasterCard to be activated. Once activated, this card cannot be used past its expiration date. As
stated in the ClinCard FAQ documentation you receive, the issuing bank will begin subtracting a
monthly service fee of $4.50 after three months of inactivity.

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Consent to Take Part in a Research Study
Signature Block for Capable Adult
Your signature documents your permission to take part in this research. We will provide you with a
signed copy of this form for your records.

Signature of subject

Date

Printed name of subject
Signature of person obtaining consent

Date

Printed name of person obtaining consent

If you are feeling unwell on the drive home due to simulator sickness, contact a research team
member whose information is listed below. A research team member will come pick you up and allow
you to rest at VTTI until you are able to drive home safely.
Matthew Camden
Telephone: (540) 231-1503

Virginia Tech Institutional Review Board Protocol No. 21-827
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Email: [email protected]

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