Form NHTSA Form 1718 NHTSA Form 1718 Online Eligibility Questionnaire

OMB Control Number: xxxx-xxxx

Expiration Date: xx/xx/xxxx

Study Introduction + Consent for Eligibility Questionnaire

This questionnaire is administered online and contains branching and display logic not shown in this Word version. This version was created via PDF converted to Word, so formatting and font do not display correctly.

Under the Paperwork Reduction Act, a federal agency may not conduct or sponsor, and a person is not required to respond to a collection of information subject to the requirements of the Paperwork Reduction Act unless that collection of information displays a current valid OMB Control number. The OMB Control Number for this information collection is XXXX-XXXX (expiration date: MM/DD/YYYY). Responding to this collection of information is estimated to be approximately 15 minutes per response, including the time for reviewing instructions, completing and reviewing the collection of information. All responses to this collection of information are voluntary. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: Information Collection Clearance Officer, National Highway Traffic Safety Administration, 1200 New Jersey Ave, S.E., Washington, DC, 20590

Thank you for your interest in our study!

The purpose of this research is to identify how various inputs for driver monitoring systems impact the ability of the system to assess driver states (such as distracted or drowsy) accurately and reliably. You will be driving on the NADS-1 simulator with motion. There are two studies, referred to as Track A and Track B. Track A will evaluate distraction only and Track B will evaluate both drowsiness alone and distraction while drowsy. A subset of people will be asked to complete both tracks. Track A will be completed first. Information for both tracks is provided below.

To create a more diverse data set in both studies, we request that you bring a few clothing items to layer. For example, you could bring a sweater, jacket, hat, scarf, shawl, sweatshirt, etc. You may bring any layering items you wish. We also encourage reading glasses, if needed.

You will be required to come to our facility, the University of Iowa Driving Safety Research Institute (DSRI), home of the National Advanced Driving Simulator (NADS), located on Oakdale Blvd. to participate. You are responsible for arranging your own transportation to and from study visits; DSRI will not be arranging any transportation. For the drowsiness study (Track B), you will not be allowed to drive, bike, or walk yourself after the visit ends and DSRI will be offering reimbursement of $35 per trip ($70 total) to cover transportation expenses for this visit. We ask that you refrain from recreational drugs and alcoholic beverages within 24 hours of any study visit.

Track A (Distraction Study):

This track involves one study visit lasting approximately 2 hours. At this visit, we will review and sign the informed consent document, have you complete a payment form, verify your driver's license validity, and take a breath alcohol (BrAC) measurement (must be 0.000% to be eligible to continue). We will take a picture of your face to obtain skin tone data, take facial shape and height (both standing and seated) measurements, and then you will watch a training presentation. You will be escorted into our NADS-1 simulator and complete a familiarization drive of about 20 minutes. After this we will ensure you are feeling well enough to continue in the study. You will then complete a study drive of approximately 60 minutes. You will complete a rating of your current sleepiness level before and after your study drive. After your drive, you will again be asked how you are feeling and your visit will be complete.

If you complete the study visit and all study procedures, you can earn up to $60 for your time and effort. If you withdraw from the study or your participation ends (e.g., due to simulator issues or protocol non-compliance), your compensation will be pro-rated at a rate of $30/hour. You will receive a minimum of $10 if you meet eligibility criteria at the visit. If you fail to meet study eligibility criteria at the visit, you will receive only $5 and be sent home.

Track B (Drowsiness and Distraction while Drowsy Study):

This track involves one study visit lasting approximately 9 hours. The visit will start at either 5:15 p.m. or 6:45 p.m. The time of your visit will be given to you in advance so that you know when to arrive at the facility. At this visit, we will review and sign the informed consent document, have you complete a payment form, and verify your driver’s license validity. We will also take a picture of your face to obtain skin tone data and take facial shape and height (both standing and seated) measurements.

Your eligibility to complete the study visit will be determined at the visit. You will need to be sure you are awake by 7:00 a.m. the day of your study visit. You must refrain from sleep, including naps, until you arrive for your study visit. You must also avoid stimulation such as aerobic exercise or caffeine after 1:00 p.m. the day of your study visit. We will collect a breath alcohol measurement at the start of the visit and ask you to complete a questionnaire about your sleep and food intake for the past 24 hours to ensure your continued eligibility.

You will receive instructions regarding driving the NADS-1 simulator and the study drives at your visit. You will be asked to complete one familiarization drive of approximately 20 minutes and three study drives each of approximately 60 minutes. The first drive will occur while you are still alert and not experiencing signs of drowsiness. The next two drives will begin once you are showing signs of drowsiness and have been awake for at least 14 hours. We will have you wait a number of hours to ensure you are showing signs of drowsiness. You will complete several sleepiness ratings before and after your study drives, as well as during the waiting period (approximately every 30 minutes for 3-4 hours). We will also be asking you how you are feeling to ensure you are well enough to continue driving between each drive. You will again be asked how you are feeling after your final drive. After this, your visit will be complete. You will not be permitted to walk, bike, or drive yourself home after this visit and will need to arrange your own transportation to and from the visit.

You may also bring things to do for use during the waiting period. During this time, you will not be able to do stimulating activity such as consume caffeine or exercise, but you could bring a book, knitting, an electronic device for movies or music, etc.

If you complete the study visit and all study procedures, you can earn up to $340 for your time and effort. You will receive up to $270 for completing the study visit with an additional $35 per trip ($70 total) to reimburse for transportation expenses to and from the overnight study visit. If you withdraw from the study or your participation ends, your compensation will be pro-rated at a rate of $30/hour. You will receive a minimum of $10 if you meet study eligibility criteria at the visit. If you fail to meet study eligibility criteria at the visit, you will receive only $5 and be sent home.

General Information:

As part of this eligibility questionnaire, we are asking you some demographic and driving questions. In order to ask these only once (and not ask again at your study visit(s)), we will be keeping your responses to these questions if you enroll into Track A, Track B, or both. This means that if you sign an informed consent document at a study visit, we will be keeping your demographic and driving responses as data. No other responses to this eligibility questionnaire will be kept, and we will only be keeping the demographic and driving responses as data if you sign a consent document. If you do not sign a consent document, we will not keep your data. This block of questions is specifically highlighted in the questionnaire so that you know which responses will be kept.

If you are not interested in this research, exit this questionnaire early, or are determined not eligible, we will not ask for your name or any other information that would identify you. If you are determined potentially eligible, you will be asked to provide your contact information so that a researcher may contact you to set up a study appointment. There is no compensation for completing this eligibility questionnaire. Compensation for the study visits is as described above.

We will keep your information secure and confidential. However, federal regulatory agencies and the University of Iowa Institutional Review Board (a committee that reviews and approves research studies) may inspect and copy records pertaining to this research.

We encourage you to ask questions. If you have any questions about the research study itself, please contact Rose Schmitt (319-335-4666, [email protected]). If you have questions, concerns, or complaints about your rights as a research subject or about research related injury, please contact the Human Subjects Office, 105 Hardin Library for the Health Sciences, 600 Newton Rd, The University of Iowa, Iowa City, IA 52242-1098, (319) 335-6564, or e-mail [email protected]. General information about being a research subject can be found by clicking "Info for Public" on the Human Subjects Office web site, http://hso.research.uiowa.edu/. To offer input about your experiences as a research subject or to speak to someone other than the research staff, call the Human Subjects Office at the number above.

Are you interested in participating in this research study? Yes No

If Yes:

Thank you. Several criteria must be met for participation in this study. You will be asked several questions to determine your eligibility. We ask that you respond honestly to all questions. You will not be allowed to skip any questions because we need these answers to be able to determine your initial eligibility for the study. If at any time you do not wish to continue, simply close your browser window. If you do not meet criteria at certain points while taking this questionnaire, you will receive a message stating you do not meet criteria and you will not be able to continue the questionnaire.

We will be collecting personal and health information as part of this eligibility screening. This information will only be kept until this study is complete. Researchers have access to this data until it is deleted.

We will also be collecting demographic and driving information that will be kept as data if you enroll into the study, as described in the study information on the previous page. This information will only be kept if you enroll into the study, otherwise it will only be kept until this study is complete. Researchers have access to this data until it is deleted.

No personal identifiable information will be released to the public.

Do you still wish to continue? By selecting "yes", you are consenting to provide us information for screening purposes and to keep your demographic and driving data if you enroll into the study. (If selecting "yes", you may need to click "Next Page" on the next page to continue to the questions.)

Yes No

If No:

We appreciate the time you took to read about our research and to consider participating. There are no additional questions. Press "Next Page" to exit the questionnaire.

If you have any questions about the research that may affect your interest, please email [email protected] (refer to study "WDD") and a researcher will gladly speak with you. A phone call can be set up via this email address if that is preferred.

If you would like to be added to our registry for future research, or if you are in the registry and would like to update your information, you can visit drivingstudies.com to fill out a submission form.

Thank you!

Eligibility Questions

Yes No

^{Can you attend one visit to DSRI} that lasts approximately 2

hours? (Track A specific)

^{Are you comfortable with and} willing to engage in distracting

tasks such as reaching into the backseat, interacting with a screen over your shoulder, interacting with the touchscreen in the center console of a vehicle, interacting with a cell phone (for calls or emails), or other similar tasks?

^{Do you agree to abstain from} alcohol use and recreational

drug use in the 24 hours prior to your appointment(s)?

^{Do you go to sleep and wake at} approximately the same time

every day?

^{Do you possess a valid U.S.} Driver's License?

^{Have you been a licensed driver} for at least 2 years?

^{In a typical year, do you drive at} least once weekly or at least

2000 miles per year?

Do you have any of the following restrictions listed on your driver's license? Check all that apply.

Intermediate License (Restriction Y in Iowa) or similar

No interstate or freeway driving (Restriction Q in Iowa) or similar Maximum speed of 35 mph (Restriction R in Iowa) or similar

No driving when headlights required (Restriction G in Iowa) or similar None of the above

Yes No

^{Can you attend one visit to DSRI} beginning at 5:15 p.m. or 6:45

p.m. and lasting approximately 9 hours overnight?

^{Do you agree to abstain from} sleep beginning as early as 7:00

a.m. the day of your study visit (this includes no napping)?

^{Do you agree to abstain from} stimulation such as aerobic

exercise or caffeine after 1:00

p.m. the day of your study visit?

^{Do you agree to abstain from} driving for the day following your

overnight study visit?

^{Do you agree to arrange for
transportation} home from the overnight study visit? You will not be
allowed to drive, bike, or walk yourself
home.

Considering your own "feeling beat" rhythm, at what 5:00 AM - 6:30 AM time would you get up if you were entirely free to 6:30 AM - 7:45 AM

plan your day? 7:45 AM - 9:45 AM

9:45 AM - 11:00 AM

11:00 AM - 12:00 PM

During the first half-hour after you've woken in the Very tired

morning, how tired do you feel? Fairly tired Fairly refreshed Very refreshed

At what time in the evening do you feel tired and as a 8:00 PM - 9:00 PM result in need of sleep? 9:00 PM - 10:15 PM

10:15 PM - 12:45 AM

12:45 AM- 2:00 AM

2:00 AM - 3:00 AM

At what time of the day do you think you reach your 5:00 AM - 8:00 AM "feeling best" peak? 8:00 AM - 10:00 AM

10:00 AM - 5:00 PM

5:00 PM - 10:00 PM

10:00 PM - 5:00 AM

One hears about "morning" and "evening" types of Definitely a "morning" type

people. Which ONE of these types do you consider Rather more a "morning" than an evening type yourself to be? Rather more an "evening" than a "morning" type

Definitely an "evening" type"

What is your age?

What is the sex listed on your driver's license? Male Female X

How do you identify with respect to your gender identity?

What is your race and/or ethnicity?

Select all that apply and enter additional details in the spaces below.

• American Indian or Alaska Native – Enter, for example, Navajo Nation, Blackfeet Tribe of the Blackfeet Indian Reservation of Montana, Native Village of Barrow Inupiat Traditional Government, Nome Eskimo Community, Aztec, Maya, etc.

_______________________________________________

• Asian – Provide details below.

  • Chinese

  • Vietnemese

  • Asian Indian

  • Korean

  • Filipino

  • Japanese

Enter, for example, Pakistani, Hmong, Afghan, etc.

_______________________________________________

• Black or African American – Provide details below.

  • African American

  • Nigerian

  • Jamaican

  • Ethiopian

  • Haitian

  • Somali

Enter, for example, Trinidadian and Tobagonian, Ghanaian, Congolese, etc.

_______________________________________________

• Hispanic or Latino – Provide details below.

  • Mexican

  • Cuban

  • Puerto Rican

  • Dominican

  • Salvadoran

  • Guatemalan

Enter, for example, Colombian, Honduran, Spaniard, etc.

________________________________________________

• Middle Eastern or North African – Provide details below.

  • Lebanese

  • Syrian

  • Iranian

  • Iraqi

  • Egyptian

  • Israeli

Enter, for example, Moroccan, Yemeni, Kurdish, etc.

__________________________________________________

• Native Hawaiian or Pacific Islander – Provide details below.

  • Native Hawaiian

  • Tongan

  • Samoan

  • Fijian

  • Chamorro

  • Marshallese

Enter, for example, Chuukese, Palauan, Tahitian, etc.

__________________________________________________

• White – Provide details below.

  • English

  • Italian

  • German

  • Polish

  • Irish

  • Scottish

Enter, for example, French, Swedish, Norwegian, etc.

__________________________________________________

It is important that we enroll individuals with a variety of skin types to test the ability of the driver monitoring system sensors to detect everyone.

Please select which Type most closely matches your face, specifically your cheeks.

Type 1 Type 2 Type 3 Type 4 Type 5 Type 6

How often do you drive? Less than once weekly

Please select the most appropriate category. At least once weekly At least once daily

How many years of driving experience do you have?

Do you have an active tumor, or have you had a stroke in the past 6 months?

OR

Do you have any of the following lingering symptoms from a stroke, tumor, head injury, or infection?

• Vision impairment (blurring, loss, or double vision)

• Weakness or numbness in arms, legs, or face

• Trouble swallowing or slurred speech

• Coordination issues or loss of control

• Trouble walking, thinking, remembering, talking, or understanding

OR

Are you currently receiving any radiation and/or chemotherapy treatment, or have you received any radiation and/or chemotherapy in the last six months?

OR

Have you been diagnosed with a serious illness where the condition is still active or has lingering effects?

Examples include (but not limited to) cancer, Crohn's disease, Hodgkin's disease, Parkinson's disease, Huntington's disease, Lou Gehrig's disease (ALS), Alzheimer's, multiple sclerosis, or any condition requiring radiation or chemotherapy treatments.

Yes No

(If you can answer "yes" to any of these questions, please mark "yes")

Do you have normal or corrected-to-normal (via surgery, glasses, contacts, hearing aids, or similar) vision and hearing?	Yes	No
Do you experience any daytime drowsiness? This can be the result of sleep apnea, narcolepsy, sleep habits, mental health, etc.	Yes	No
Have you recently (past 72 hours) had any inpatient or outpatient procedures done that required the use of anesthesia?	Yes	No

Are you, or is there any possibility that you are pregnant?	Yes	No Not Applicable
Have you ever been diagnosed with seizures or epilepsy?	Yes	No
Have you had a seizure in the past 12 months?	Yes	No
Have you experienced any pain from neck or back injuries within the last year?	Yes	No
Is it a current or chronic neck or back injury?	Yes	No
Do you have any mobility issues that would make climbing down a short ladder or walking on a narrow walkway without assistance difficult for you to perform safely?	Yes	No
*In the event normal exiting of the simulator is not possible (e.g., rare instances such as power outage or fire), you would need to climb down a short ladder and walk on a narrow, grated walkway to the nearest exit location.*
Do you require the use of any special equipment to help you drive, such as pedal extensions, hand brake or throttle, spinner wheel knobs, seat cushion, booster seat, or other non-standard equipment?	Yes	No

Medications, Supplements, or Herbal Remedies
Are you currently taking any prescription or	Yes	No
over-the-counter medications, supplements, or herbal
remedies?
Have you been taking any of the medications,	Yes	No
supplements, or herbal remedies for less than 6 months
or do any of them cause daytime drowsiness or make you
drowsy?
Please tell us which medications, supplements, or
herbal remedies you have been taking for less than 6

months, cause daytime drowsiness, or make you drowsy.

Please use this space for any comments you would like to add about your responses to any of the health questions.

Do you have Ménière's Disease or any inner ear, dizziness, vertigo, or balance problems?

Note:

Ménière's Disease is a problem in the inner ear that affects hearing and balance. Symptoms can be low- pitched roaring in the ear (tinnitus), hearing loss that may be permanent or temporary, and vertigo.

Vertigo is a feeling that you or your surroundings are moving when there is no actual movement, described as a feeling of spinning or whirling and can include sensations of falling or tilting. It may be difficult

to walk or stand and you may lose your balance and fall.

Yes No

Do you experience discomfort or motion sickness when using an electronic device (such as a cell phone) as a passenger in a moving vehicle?

A moving vehicle can include, but is not limited to, a passenger vehicle (such a sedan, truck, SUV, van) or a transit vehicle (such as a bus).

Yes No Unsure

Please describe your discomfort or motion sickness while trying to use an electronic device as a

passenger. Please include how or when this occurs and the severity.

Never Rarely Sometimes Often

^{Nausea Headache Dizziness Fatigue Eye-Strain}

Have any of these symptoms stopped you using any of these devices or made you avoid viewing such displays? Never Rarely Sometimes Often

If you have answered stopped or avoided, please list the devices or displays that you avoid:

Please use this space for any comments you would like to add about your responses to any of the questions

(e.g., situations that may cause motion sickness, more information about a diagnosis, mobility concerns,

etc.).

Eligibility Questionnaire

If deemed ineligible by background scoring logic, prospective subject will see this message.

Thank you for your interest in our study. Unfortunately, it appears you are not eligible at this time. You may still qualify for future research with the Driving Safety Research Institute. If you would like to be added to our registry for future research, or if you are in the registry and would like to update your contact information, you can visit drivingstudies.com to fill out a submission form.

If you have any questions about your eligibility, please email [email protected] (refer to study "WDD") and a researcher will gladly speak with you. A phone call can be set up via this email if that is preferred over email contact. Thanks again!

Eligibility Questionnaire

If deemed potentially eligible for the study by background logic, prospective subject will see the following.

Thank you for your responses! A research team member will contact you if you are eligible to continue or if there is a need to follow up on a response. If you wish to contact a researcher directly, please email [email protected] and reference "WDD" and a researcher will get in touch as soon as possible.

Be sure to add [email protected] to your contact list or safe senders group so you don't miss any emails from us.

If you'd like us to contact you to participate, please enter your contact information below.

*Please note that by providing contact information, you are linking your name and contact information to your questionnaire responses. This is required to verify eligibility for our study. If you do not provide a name or contact information, your responses will not be associated with you in any way, but we will be unable to verify eligibility to participate or contact you to participate.*

Preferred or Chosen First Name

You will be addressed by this name in communications from us.

Legal First Name

Legal Last Name

Email Address

This is the primary contact method.

Primary Phone Number When might we call you?

You will be called at this number if your email address bounces back as undeliverable, if we have a

last-minute appointment available that might work for you, if we need to cancel your appointment on short notice, or if you are running late to your

appointment.

If you have any comments regarding your contact information, please note those in the space provided.

Have you ever gone by another name?

For example, if your name is Kathryn, have you ever preferred to go by Katie? Have you ever had a different last name?

This allows us to look you up in our registry and check your participation history to confirm you haven't done a related study that might exclude you from participation. Please note potential other names in the space provided, if you are comfortable doing so.

*prior study participation does not necessarily exclude you*

Monday Tuesday Wednesday Thursday Friday

8 a.m. to 11 a.m. 3:30 p.m. to 8:30 p.m.

Monday Tuesday Wednesday Thursday Friday Saturday Sunday

5:15 p.m. 6:45 p.m.

Please indicate any dates that you know will NOT work for a study visit through (date to be entered once

data collection window confirmed)

NHTSA Form 1718