Form 1332 Older Drivers’ Self-Regulation and Exposure Consent Form

Title of Study: Older Drivers’ Self-regulation and Exposure

Older Drivers’ Self-Regulation and Exposure

Appendix F

Informed Consent to Participate in Research Information to consider before taking part in research that has no more than minimal risk.

Title of Research Study: Older Drivers’ Self-regulation and Exposure

Principal Investigator (PI): Dr. Dennis Thomas

Institution/Department or Division: Dunlap and Associates, Inc.

Address: 110 Lenox Avenue, Stamford, CT 06906

Telephone #: 203-967-1374

Study Sponsor/Funding Source: U.S. Department of Transportation, National Highway Traffic Safety Administration

Paperwork Reduction Act Burden Statement: 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. The average amount of time to complete this consent form is 15 minutes. All responses to this collection of information are voluntary. If you have comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, send them to: Information Collection Clearance Officer, National Highway Traffic Safety Administration, 1200 New Jersey Ave, S.E., Washington, DC, 20590.

Researchers at Dunlap and Associates, Inc. and TransAnalytics, LLC study safety in society and transportation. Our goal is to try to find ways to improve the lives of you and others, such as by assisting older drivers to remain safely on the road as long as they are able. To do this, we need the help of volunteers who are willing to take part in research.

Why is this research being done?
The purpose of this research is to examine the conditions under which drivers in various age groups choose to drive and how general driving habits vary by age group.

Why am I being invited to take part in this research?

You are being invited to take part in this research because you are an older adult, aged 60-89 years, who drives and who expressed an interest in volunteering. If you volunteer to take part in this research and you are selected, you will be one of about 60 people in the study. The decision to take part in this research is yours alone to make.

Are there reasons I should not take part in this research?

You should not volunteer for this study if you are under 60 years of age or over 90 years of age, do not have a valid drivers license, do not regularly drive at least 3 times per week, if you require special controls in your car, or if you have a medical condition that impacts your driving.

What other choices do I have if I do not take part in this research?

You can choose not to participate. It is totally your choice.

Where is the research going to take place and how long will it last?

Step 1 is a brief, 5 minutes or less, phone or face-to-face survey to see if you quality for the study. Step 2 is the installation of a video camera and tracking device in your car that will allow researchers to observe your driving habits and the conditions under which you drive. Installation will take about 5-20 minutes depending on your vehicle and will not damage your vehicle in any way or impede your ability to drive normally. In Step 3, you will be driving normally in your own vehicle for a period of approximately 30 days. You should drive just as you would normally if you were not participating in this study. Researchers may visit you once or twice by appointment during this 30-day period to gather information from the data collection device and to make sure it is operating correctly. This will take no more than 15 minutes each time. Step 4 includes the completion of a short, computer-based standard cognitive assessment battery that will take about 10-30 minutes at a nearby location and will be scheduled at your convenience. Step 5 involves an hour-long drive with a certified driving rehabilitation specialist on a predetermined route as part of the same session in which you take the computer-based battery. The total amount of time you will be asked to devote to this study above and beyond your normal driving time during the 30-day driving period is approximately 2-3 hours.

What are the details of the steps I will be asked to do?

You are being asked to complete the following 5 steps:

1. Answer the screening survey. These are questions about you and your driving to determine your eligibility to take part as a research participant. Based on your answers, you may be invited to volunteer to continue through Steps 2-5.

2. Have the data collection device installed in your vehicle. The data collection device uses a dual-camera system that records the view inside and outside your vehicle. The video recordings will be used to verify that it is indeed you driving on a given trip and to gather other information such as the number of passengers travelling with you. Trips for which you are not the driver will be excluded from the study. The external camera will allow researchers to determine such conditions as the traffic, road type, and weather during each of your trips. The device also measures speed, accelerations, and provides tracking capabilities that will allow us to determine the length of your trips. The device is designed to be unobtrusive and should not interfere with your driving.

3. Drive for 30 days: You will drive for approximately 30 days in your home area following your normal routine. You are free to drive anywhere you like during this 30 day period. If you plan to take any atypical trips lasting more than 3 days during the study period, such as a vacation drive, you should notify the research team when you return this form as this study is most interested in your normal daily driving habits. Researchers will visit you by appointment up to twice throughout the 30-day period in order to offload the data from the data collection device and to verify that it is working.

4. Complete standard research battery: At a study field office by appointment, you will complete a computer-based cognitive assessment research battery that measures:

• Visual acuity and Contrast sensitivity

• Brake response time

• Working memory

• Visualizing missing information

• Visual attention

• Visual search

• Route planning.

5. Drive with a certified driving rehabilitation specialist (CDRS). A driving performance evaluation will be carried out by a CDRS using dual-control vehicle provided by the CDRS. The CDRS will take you on a standardized test route that begins and ends at a central point near where you take the research battery. The route will take approximately one hour to complete in order to provide a comprehensive examination of your driving skill. This assessment is for research purposes only, will remain totally confidential, and can have no impact on your driver’s license status.

What possible harms or discomforts might I experience if I take part in the research?

The risks associated with this research are no more than what you would experience in everyday life when doing any of the tasks, including normal driving. You are not being asked to do anything unusual or dangerous while on the road.

What are the possible benefits I may experience from taking part in this research?

We do not know if you will get any personal benefit by taking part in this study. This research will help us learn more about how driving habits may or may not change as a person ages. There may be no personal benefit from your participation, but the information gained by doing this research may help others in the future. At your verbal request, the CDRS will give you a verbal assessment of your driving skills, which could help you improve your driving.

Will I be paid for taking part in this research?

We will pay you for the time you volunteer if you are accepted into this study. There is no payment for the brief eligibility screening (Step 1). You will receive $50 at the time the data collection device is installed in your vehicle (Step 2). If you complete the 30-day driving period, computer-based assessment, and on-road assessment, you will receive an additional $150 for your participation in the study (Steps 3, 4, and 5). You will also receive the on-road evaluation by a CDRS, which would normally cost $350, at no charge.

What will it cost me to take part in this research?

The only out-of-pocket cost you will be expected to pay above and beyond what your normal driving will cost is for fuel for your vehicle to and from the device installation and post-drive assessment locations, which will be nearby to your home.

Who will know that I took part in this research and learn personal information about me?

As part of this research effort, the people and organizations listed below may know that you took part in this research. They may also see information about you that you provided that is normally kept private. With your permission, these people may use but not divulge your private information only in order to do this research:

• The Principal Investigator and other research staff at Dunlap and Associates, Inc.

• Researchers at TransAnalytics, LLC

• The staff at the National Highway Traffic Safety Administration.

What information about me will you collect?

The study will collect the following personally identifiable information (PII) for each participant: name, date of birth, address, email address, and a telephone number (home, cell, or work). The name, address, phone number, and email PII will only be utilized for scheduling and payment purposes and will never be associated with any other information/data collected as part of the study. Date of birth will be utilized to calculate age for classification purposes. Research information collected will include responses to the screening survey, video and data of actual driving, computer-based assessment results, and on-road evaluation results. All study data including video files will only be identified by participant number.

How will you keep the information you collect about me secure? How long will you keep it?

All data will be coded with a number and kept in the locked facilities at the Dunlap and Associates, Inc. offices. The data will be separated from your name and identified by a code number. Only the PI will be able to associate the code number with your PII. Your contact information will be deleted upon your completion of the study. Your name will be retained only on this consent form as well as on the receipt form that indicates you were paid for the study. The video recordings will only be used to analyze your driving trips and will be deleted after the analysis is complete. This consent form and the receipt will be retained for 3 years after the completion of the study, and the study data identified only by code number (no identifying information) will be kept by NHTSA and may be analyzed further in the future in accordance with this consent form.

Who will have access to data about me and for what purposes? Researchers at Dunlap and Associates, Inc., TransAnalytics, LLC, and NHTSA will have access to your video recordings and other data during the study. At the conclusion of the study, after the videos have been analyzed and destroyed, these same researchers and NHTSA will have access to your de-identified study data, which may be shared publicly at research conferences, for research purposes (for example, in reports), or in connection with other efforts to improve highway and road safety, and as otherwise required by law, but in so doing, your name will never be disclosed or associated with your study data.

What if I decide I do not want to continue in this research after I start?

If you decide you no longer want to be in this research for any reason after it has already started, you may stop at any time. You will not be penalized or criticized for stopping. You will be paid for those parts of the study that you have started even if you did not finish them.

Who should I contact if I have questions?

The people conducting this study will be available to answer any questions concerning this research now or in the future. You may contact Dr. Dennis Thomas, the PI at 203-967-1374 at any time (24/7).

I have decided I want to take part in this research. What should I do now?

The person obtaining informed consent will ask you to read the following and, if you agree, you should sign this form and initial each of its pages:

• I have read (or had read to me) all of the above information.

• I have had an opportunity to ask questions about things in this research I did not understand and have received satisfactory answers.

• I know that I can stop taking part in this study at any time.

• By signing this informed consent form, I am not giving up any of my rights.

• I have been given a copy of this consent document, and it is mine to keep.

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Participant's Name (PRINT) Signature Date

Person Obtaining Informed Consent: I have conducted the initial informed consent process. I have orally reviewed the contents of the consent document with the person who has signed above and answered all of the person’s questions about the research.

Person Obtaining Consent (PRINT) Signature Date

Page 5 of 4

NHTSA Form 1332

Consent Version # or Date: Version 1 ________________

Participant’s Initials