National Academies Press: OpenBook

Naturalistic Driving Study: Technical Coordination and Quality Control (2014)

Chapter: Appendix N - Minor Assent Form

« Previous: Appendix M - Minor (Teen) Participant Information Sheet
Page 313
Suggested Citation:"Appendix N - Minor Assent Form." Transportation Research Board. 2014. Naturalistic Driving Study: Technical Coordination and Quality Control. Washington, DC: The National Academies Press. doi: 10.17226/22362.
×
Page 313
Page 314
Suggested Citation:"Appendix N - Minor Assent Form." Transportation Research Board. 2014. Naturalistic Driving Study: Technical Coordination and Quality Control. Washington, DC: The National Academies Press. doi: 10.17226/22362.
×
Page 314
Page 315
Suggested Citation:"Appendix N - Minor Assent Form." Transportation Research Board. 2014. Naturalistic Driving Study: Technical Coordination and Quality Control. Washington, DC: The National Academies Press. doi: 10.17226/22362.
×
Page 315
Page 316
Suggested Citation:"Appendix N - Minor Assent Form." Transportation Research Board. 2014. Naturalistic Driving Study: Technical Coordination and Quality Control. Washington, DC: The National Academies Press. doi: 10.17226/22362.
×
Page 316
Page 317
Suggested Citation:"Appendix N - Minor Assent Form." Transportation Research Board. 2014. Naturalistic Driving Study: Technical Coordination and Quality Control. Washington, DC: The National Academies Press. doi: 10.17226/22362.
×
Page 317
Page 318
Suggested Citation:"Appendix N - Minor Assent Form." Transportation Research Board. 2014. Naturalistic Driving Study: Technical Coordination and Quality Control. Washington, DC: The National Academies Press. doi: 10.17226/22362.
×
Page 318
Page 319
Suggested Citation:"Appendix N - Minor Assent Form." Transportation Research Board. 2014. Naturalistic Driving Study: Technical Coordination and Quality Control. Washington, DC: The National Academies Press. doi: 10.17226/22362.
×
Page 319
Page 320
Suggested Citation:"Appendix N - Minor Assent Form." Transportation Research Board. 2014. Naturalistic Driving Study: Technical Coordination and Quality Control. Washington, DC: The National Academies Press. doi: 10.17226/22362.
×
Page 320
Page 321
Suggested Citation:"Appendix N - Minor Assent Form." Transportation Research Board. 2014. Naturalistic Driving Study: Technical Coordination and Quality Control. Washington, DC: The National Academies Press. doi: 10.17226/22362.
×
Page 321
Page 322
Suggested Citation:"Appendix N - Minor Assent Form." Transportation Research Board. 2014. Naturalistic Driving Study: Technical Coordination and Quality Control. Washington, DC: The National Academies Press. doi: 10.17226/22362.
×
Page 322

Below is the uncorrected machine-read text of this chapter, intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text of each book. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

313 A p p e n d i x n PARTICIPANT ASSENT FORM FOR MINORS—VARIABLE ENROLLMENT PERIOD (4–7 MONTHS) IN-VEHICLE DRIVING BEHAVIOR AND CRASH RISK STUDY (“The SHRP 2 Naturalistic Driving Study”) SPONSORS: National Academies of Science, Transportation Research Board, SHRP 2 Program The United States Department of Transportation INVESTIGATORS: Tom Dingus, Jon Hankey, Jon Antin, Suzie Lee, and Lisa Eichelberger: Virginia Tech Transportation Institute John Pierowicz, Alan Blatt, and Marie Flanigan: Calspan University of Buffalo Research Center (CUBRC) Ann Brach and Ken Campbell: National Academies, Transportation Research Board, SHRP 2 Program WHAT IS THE PURPOSE OF THIS RESEARCH? The Naturalistic Driving Study is a large research effort directed at improving Highway Safety in the United States where more than 30,000 people are killed and 2 million are injured every year in highway-related accidents. The study will help researchers gain a deeper understanding of the interaction between the driver, vehicle and roadway and lead to safer roadways, vehicles, and driver training programs. The SHRP 2 Naturalistic Driving Study will look at how people normally drive by installing cameras and sensors in people’s own vehicles. The study is being conducted at six locations across the United States with up to 3,300 participants. Length of enrollment varies from four months to two years. Your enrollment is scheduled to last _____ months. About 370 participants will be minors. WHAT SHOULD I KNOW BEFORE DECIDING TO PARTICIPATE? 1. Because you are a minor, a parent or legal guardian will need to be with you when you enroll in the study and they will have to sign a consent form allowing you to participate. If neither you nor the signing parent owns or leases the study vehicle, you will have to obtain the owner’s written permission to use the vehicle before you enroll in the study. 2. You are providing permission for us to collect data (including video) whenever the study vehicle is used or whenever you happen to drive another vehicle that is part of the study (for example, a vehicle owned by a friend who also happens to be in the study). If there are drivers of the study vehicle who have not signed consent forms, we will delete their data from every trip in which they drove the vehicle. 3. There will be video of your face and portions of your body and the roadway. Audio will not be recorded unless you press a red incident button. The video, audio, and other data that personally identifies you, or could be used to personally identify you, Minor Assent Form

314 will be held under a high level of security at one or more data repositories. Your data will be identified with a code rather than your name. Finally, only qualified researchers will be authorized to have access to data that personally identifies you, or can be used to personally identify you, and the level to which they have access will be based on their level of authorization. 4. No identifying information will be collected on passengers. 5. For the duration of the project you or the owner of the vehicle used in the study will be responsible for your insurance coverage. If you are in a crash, please contact emergency services as you normally would. We will then ask for more information, as detailed below. 6. You may withdraw from the study at any time. If you do withdraw from the study before your scheduled end date, or if the vehicle’s owner decides to withdraw the vehicle, you must agree to allow us to retrieve the data collection system from the vehicle as soon as is feasible. WHAT DO I HAVE TO DO IF I CHOOSE TO PARTICIPATE? The study involves a _____ month data collection effort in which a data collection system containing sensors and cameras will be installed in the vehicle to record a variety of driving measures. As a participant, you will complete the following activities: 1. Have the vehicle equipped (see the section below: “What will I have to do to get the vehicle equipped for the study?”). 2. Drive as you normally would. 3. Provide us with contact information for all other adult drivers (over the age of 18) who drive the vehicle at least once a week. We would like to contact them to get permission to use data collected any time they happen to be driving the vehicle. We will also ask them to fill out two brief questionnaires and provide a reference picture to allow us to identify when they are driving. 4. If requested, make an appointment to allow us to maintain the equipment or collect the driving data from the vehicle. Only one appointment is anticipated during your enrollment period. Appointments will typically take 15 minutes but could take up to one hour. They will be scheduled to take place at a location that is convenient for you such as your home, work, school, or at a local shopping mall. You will not need to do anything at an appointment apart from providing access to the trunk or interior of the vehicle; a trained technician will handle everything else. 5. If you are enrolled in the study at the time of your 18th birthday, we will contact you to change from an informed assent form to an informed consent form. 6. While you are in the study, we ask that you not drive the vehicle into any areas where cameras are not allowed, including any international border crossings, military bases, or similar facilities. 7. Advise other drivers of the video and audio equipment installed in the vehicle and ask them not to drive into areas where cameras are not allowed. Let these other drivers know that data will be collected when they drive the vehicle but will only be retained and analyzed if they sign a consent form. If they do not sign a consent form, then the data will be deleted for every trip in which they drove the vehicle. WHAT WILL I HAVE TO DO TO GET THE VEHICLE EQUIPPED FOR THE STUDY? 1. If you do not own or lease the study vehicle, you must first obtain the written permission of the vehicle owner. This can be provided on the day you enroll in the study by one of two methods: 1) the owner attends and signs the form in person, or 2) via a telephone call in which a third person at the study site will witness and sign the owner’s permission form on behalf of the owner. We cannot accept pre-signed owner permission forms in which we have not had personal or telephone contact with the vehicle owner. 2. Bring the vehicle to CUBRC at the scheduled day and time to have the data collection system installed. The technicians will strive to complete each vehicle in less than four (4) hours, but it may take longer in rare cases. The system will require a connection to the vehicle power and the vehicle network box. These connections will provide additional data as well as power for the system; by agreeing to participate, you are providing us permission to get information from the vehicle network as well as to install new sensors. Before we begin installation, we will show you where we will place the system and also show you pictures of what the completed installation will look like. The vehicle will be returned to its original state when your participation is concluded. 3. While the system is being installed on the vehicle, you will be provided a comfortable area in which to complete the consent process and testing at CUBRC, which should take about 2–3 hours. Specifically, you will be asked to: a. Provide us with proof of a valid U.S. driver’s license, proof of vehicle insurance, and proof of ownership (vehicle registra- tion showing the name of the owner or lessee of the vehicle so that we may confirm that we have correctly obtained the permission of the vehicle’s owner).

315 b. Review and sign this informed assent form. c. Undergo about 20 minutes of non-invasive vision tests, performed on a computer monitor and a machine that you will look into but that will not touch or blow air into your eyes. d. Take about 30 minutes of computer tests that will assess your memory, decision making, and attention skills, none of which require previous computer skill or knowledge. e. Take a 2 minute memory and attention test using pencil and paper and the following two tests of your body movements and strength. i. You will be asked to walk as fast as you can without falling or tripping to a point 10 feet away, and then to return to the starting point. This should take about one minute. ii. You will be asked to sit down and squeeze a device that measures grip strength. This should also take about two minutes. f. Fill out nine (9) questionnaires on a computer (some may be completed online from home later, if you prefer). The questionnaires vary in length and take between 5 and 15 minutes each to complete. They contain questions about: your health history and health status; driving behavior, history and knowledge. You will be asked to fill out one or more final questionnaires after completing your participation in the study. g. Take home and give copies of an Informed Consent form and questionnaires to any other adult drivers who drive the vehicle at least once a week. 4. Allow our technicians to drive the vehicle as needed during the installation and testing process. 5. When the vehicle is ready, we will show you the data collection system and provide you with information about who to contact if you have any vehicle problems that could be related to your data collection system, or if you notice any mainte- nance issues with the system (for example, a camera or device that comes loose). 6. We will take some reference pictures of you in the vehicle so that software can be used to identify you as the driver. WHAT DO I DO AFTER THE VEHICLE IS EQUIPPED FOR THE STUDY? 1. After you return home, you will be asked to complete any questionnaires you did not have time to complete during installa- tion of the data collection system into the vehicle. Once you have completed all of the online questionnaires, you will receive your first payment of $100 via check or direct deposit. 2. Drive as you normally would for the duration of your enrollment. 3. If you are in a crash while in the study, we ask that you do five things (in the following order): a. Seek emergency help the way that you normally would. b. If possible, press an incident button that is located near the rear view mirror to describe the incident. The system will then record your brief description. You will know the button is working if the red light comes on when you press it. c. Call us at (716) 204-5138 or (716) 204-5177 to notify us as soon as it is safe to do so. d. Allow a member of the research team to interview you about the crash if we decide that your crash should be investi- gated in more detail. This interview would ideally take place soon after the crash, but only when you are comfortable and able to do so. e. Allow us to have access to the police accident report, if any, which results from the crash. 4. We anticipate making an appointment with you to collect the driving data from the vehicle or to maintain the equipment. An appointment will typically take about 15 minutes, but could take up to one hour depending on what needs to be done. It will be scheduled to take place at a location that is convenient for you such as your home, work, school, or at a local shop- ping mall. You will not need to be in the vehicle when the data are collected, but you will need to provide us with access to the trunk or interior of the vehicle. As mentioned above, we also will collect data from the vehicle after a crash, either at a place of your choosing or where the vehicle was towed. 5. If you are enrolled in the study at the time of your 18th birthday, we will contact you to change from an informed assent form to an informed consent form. 6. Let us know if you notice any unusual warning light activity, for example, warning lights that go on or off. 7. While you are in the study, do not drive the vehicle into any areas where cameras are not allowed, including any interna- tional border crossings. 8. If we notice a new person driving the vehicle, we may contact you to find out if you have already asked them about participat- ing in the study.

316 WHAT HAPPENS WHEN THE STUDY IS OVER? 1. After _______ months, you will be asked to return to CUBRC so that we may remove the system from the vehicle. While the vehicle is being worked on, we will ask you to fill out some final questionnaires. This process is expected to take about two hours. After this session is complete, you will receive your final payment via check or direct deposit. 2. When you leave the study, we may ask you whether we can keep your contact information to contact you for participation in future follow-on studies. This will be optional, and if you do not agree, we will delete your contact information one year after data collection is complete at CUBRC. 3. Once we have all the data, we will begin data analysis and reporting. It is likely that you will see references to the results of the study in the news or elsewhere. However, these reports will not identify participants by name, nor will personally identifying video be shown. WHAT ARE THE RISKS OF PARTICIPATING IN THIS STUDY? The operation or drivability of the vehicle should not be affected by the instrumentation, and thus carries a similar risk as when you operate the vehicle normally. However, if you violate state or local driving laws (such as driving under the influence, exceeding posted speed limits, or driving while distracted), the instrumentation could record evidence of these violations. This has the potential to pose greater than minimal risk of legal harm. A variety of strategies and procedures have been developed to reduce the potential for legal or economic harms. These strategies include encrypting the data obtained by sensors and cameras, using a code number to identify you with the code key maintained in a secure location, and obtaining a Certificate of Confidentiality. More details on these strategies are provided below. All data collection equipment is mounted such that, to the greatest extent possible, it does not pose a hazard or problem for you when you drive. None of the data collection equipment should get in the way of your normal field of view. You are not being asked to change the way you drive or where you drive, except for your visits to CUBRC at the beginning and end of the study. In the vast majority of cases, placing the data collection system in the vehicle will not affect the operating or handling char- acteristics of the vehicle. In some rare cases, the electromagnetic signals generated by the data collection system may cause interference with the vehicle’s radio, keyless entry key fob, or other electronic components or sensors, such as the tire pressure monitoring system. If this happens in your vehicle, CUBRC will use engineering countermeasures to attempt to minimize the interference to an unnoticeable level. If you experience persistent tire pressure monitoring system problems, you will be asked to leave the study, while for other problems, you will be given the option to continue participation with the problem unresolved or to leave the study. If you like, CUBRC personnel can provide information on our latest experience (a rough likelihood) of this problem occurring with your vehicle’s particular make, model, year, and equipment package. There are non-driving risks resulting from participation. Five cameras will be placed in the vehicle. If you drive into an area where cameras are not allowed, including international border crossings, certain military and intelligence locations, and certain manufacturing plants, there is a risk that you may be detained or arrested or that the vehicle may be impounded. For this reason, by signing this Informed Assent and thereby agreeing to participate in the study, you also are agreeing not to drive into any such areas while you are in this study. We have provided a letter for the glove box which can be used to explain the vehicle’s role in the study while still maintaining your privacy and keeping confidential your role in the study. Throughout the study, we will take all possible steps to protect your privacy and keep confidential your role in the study and the confidentiality of your personally identifying information. To help us protect your privacy, we have obtained a Certificate of Confidentiality from the U.S. Department of Health and Human Services National Institutes of Health. With this Certificate, the researchers and study sponsors cannot be forced to disclose information that may identify you, even by a court subpoena, in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings. However, the Certificate of Confidentiality does not prevent the researchers from disclosing voluntarily matters such as child abuse, or a participant’s threatened or actual harm to self or others. In terms of a vehicle, this could also include items such as driving under the influence of drugs or alcohol, allowing an unlicensed minor to drive the vehicle, or habitually running red lights at high speed. Such behaviors may result in your removal from the study and reporting of the behavior to the appropriate authorities. In the event of a crash, it may not be possible to prevent the equipment and the data from falling into the hands of the police or an insurance company; if this happens, however, the data are still encrypted and inaccessible and unreadable to these individuals. However, you too, are responsible for taking steps to protect your privacy. Do not post or disclose your participation on any public forum including websites, Facebook, newspapers, radio and television. Protect your role in the study the same way that you protect other personal and private information. If you do not keep confidential your role in the study, there is a risk that

317 some of the data collected during the study, including your personally identifying information, may be used against you in a court case or other legal proceeding. The risk to you of completing the pre-collection questionnaires and tests while the data collection equipment is being installed in the vehicle is no more than when you are doing activities in your daily life like filling in forms, walking, squeezing your hand, and working at a computer. The assessment component involves filling in forms, standard vision tests, and stan- dard computer-based tests. It is believed that there are no more than minimal risks involved with such activities. In addition, you will be asked to squeeze a grip strength tester and to rapidly walk 10 feet back and forth as fast as you can without running or falling. The risk with using the grip strength tester is brief hand soreness. The main risk with the Rapid Pace Walk is falling if you try to go too fast. Because the assessment process may take 2 or 3 hours, you may get tired, but you can also take breaks as needed. If you are not the owner, co-owner, or lessee of the vehicle, there is a risk that the owner may decide to withdraw the vehicle from the study earlier than your planned term of enrollment. If this occurs, you will only be compensated for the portion of time you were enrolled in the study. WHAT ARE THE BENEFITS OF PARTICIPATING IN THIS STUDY? While there are no direct benefits to you from this research, you may find this study interesting. No promise or guarantee of benefits is being made to encourage your participation. Participation will help to improve the body of knowledge regarding driving behavior and safety. Participation may also help us design safer vehicles and roadways in future years. HOW WILL MY DATA BE KEPT CONFIDENTIAL AND SECURE AND WHO WILL HAVE ACCESS TO MY DATA? Any data collected during this study that personally identifies you or that could be used to personally identify you will be treated with confidentiality. As soon as you begin participating in this study, your name and other identifying information will be separated from the raw data collected while you drive the vehicle and replaced with a number. That is, your raw data will not be attached to your name, but rather to a number (for example, Driver 0011). The raw data collected while you drive the vehicle will be encrypted (made unreadable) from the moment it is collected until it is transferred to one or more secure central storage loca- tions. Your name also will be separated from any data about you, either provided by you in response to questionnaires or gathered by researchers during the study, including crash investigation data, and will be replaced by the same driver number (for example, Driver 0011). YOUR PARENTS WILL NOT HAVE ACCESS TO YOUR DATA RESULTING FROM THIS STUDY. However, if we have reason to believe that you pose an imminent or ongoing danger to yourself or others, we may notify your parents of our findings. Several types of information and data about you and the vehicle will be collected during the study: 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 course of the study and destroyed after the study is complete (unless you grant permission for us to keep your contact information when the study is over). This information will not be linked to or mingled with your study data, and will not be used in any research or analysis. 2. Auxiliary study information includes your Social Security Number, license plate number, bank account information (for those using direct deposit) and similar information. This information is used to verify your identity and to make payments for your participation. This information will be stored at the site in electronic form (securely encrypted) and destroyed after the study is complete. This information will not be linked to or mingled with your study data, and will not be used in any research or analysis. 3. Driver data includes your answers to questionnaires, vision test results, and the results of the brief physical tests described above. This data will not contain your name or any identifying information and will be used in analyses, both on its own and in combination with the driving data, vehicle data, and additional crash data. This data will be stored securely in elec- tronic form throughout the lifetime of the data (defined below). 4. Vehicle data includes the vehicle make and model, its condition, and how it is equipped. This data will not contain your name or any identifying information and will be used in analyses, both on its own and in combination with the driver data, driving data, and additional crash data. This data will be stored securely in electronic form throughout the lifetime of the data (defined below). 5. Driving data includes the data we collect from the vehicle while you are driving, including video data and sensor data. This information will contain video of your face and GPS coordinates of your trips, both of which could be used to personally

318 identify you. These data will be encrypted (stored in an unreadable format) from the moment of their creation until they are downloaded from the vehicle, transferred to a secure data storage facility, and verified. From this point on they will be decrypted (made readable) on as as-needed basis for each analysis. These data will be used for analysis, both on their own and in combination with the driver data, the vehicle data, and the additional crash data. This data will be stored securely in electronic form throughout the lifetime of the data (defined below). 6. Additional crash data includes items we may collect after a crash, including answers to an interview with one of our researchers and the police accident report resulting from the crash. This data will not contain your name or any identifying information and will be used in analyses, both on its own and in combination with the driver data, vehicle data, and driving data. This data will be stored securely in electronic form throughout the lifetime of the data (defined below). It is possible that an authorized Institutional Review Board (IRB) may view this study’s collected data for auditing purposes. An IRB is responsible for the oversight of the protection of human subjects involved in research. It is also possible that the study sponsors or investigators may view this study’s driver data and driving data for quality control or administrative purposes; in this case, the study sponsors or investigators will be required to maintain the security and confidentiality of any data that personally identifies study participants or that could be used to personally identify study participants. While driving the vehicle, a camera will videotape your face with some added space around the head to handle any head movements. An example is shown below. Also, video cameras will capture views of the forward view, the rear view, an external view to the right, as well as a dashboard/lap-belt view. A camera will also periodically take a permanently blurred snapshot of the vehicle interior which will allow researchers to count the number of passengers and make rough estimates of age, gender, and seatbelt use. Passenger identification will not be possible from these blurred snapshots. All video will be captured and stored in digital format (no tape copies will exist). There will also be an ambient atmospheric analyzer that is capable of detecting the presence of alcohol in the passenger compartment under certain conditions. It may not be able to distinguish whether the alcohol was imbibed or applied (as in hand sanitizer), and it will be unable to determine whether it is emanating from the driver or a passenger. However, this sensor will flag the data for possible indications of impaired driving. If a safety-related incident or crash occurs, you are asked to press a button on the unit mounted near the rearview mirror. You will know this button is working if a red light appears when you press it. This will allow researchers to find the incident in the database after the data have been collected. Also, pressing the button starts a microphone for 30 seconds. During these 30-seconds, you can tell us what happened. No audio will be captured except when you press this incident button. Please note that pressing this button does NOT make a phone call, unlike OnStar™. It simply records your voice in an audio file that remains in the vehicle until the data is collected.

319 During the data collection phase of this study, all data collected from the vehicle will be encrypted (made unreadable) from the time of its creation and then stored in a specific password-protected project folder on a secure server; the driving data will only be decrypted (made readable) once it has been stored in this folder. At the conclusion of the collection phase of this study, the driver data, driving data, and additional crash data will be permanently housed at one or more highly secure data storage facilities. One set of data will be permanently housed at Virginia Tech under the super vision of the Virginia Tech Transporta- tion Institute, the organization overseeing the data collection for the entire study. It is possible that, after data collection is complete, one copy of study data will be transferred to the U.S. Department of Transportation (or other secure facilities as determined by the Transportation Research Board) for permanent storage and oversight. Only authorized project personnel and authorized employees of the research sponsors will have access to study data that personally identifies you or that could be used to personally identify you. As explained below, other qualified research part- ners may be given limited access to your driver data, vehicle data, driving data, and additional crash data, solely for authorized research purposes and with the consent of an IRB. This limited access will be under the terms of a data sharing agreement or contract that, at a minimum, provides you with the same level of confidentiality and protection provided by this Assent Form. However, even these qualified researchers will not be permitted to copy raw study data that identifies you, or that could be used to identify you, or to remove it from the secure facilities in which it is stored without your assent. Project personnel, the project sponsors and qualified, authorized research partners may show specific clips of video at research conferences. The project sponsors also may show specific clips of video to the media, driver’s education teachers and students, and others involved in efforts to improve highway and road safety. The face portion of the video will be blurred, blacked out, or replaced with an animation for these purposes. Your name and other personally identifying information will never be associated with the showing of these video clips. Identifying location information will not be shown in association with these video clips. It is expected that the data we capture throughout the course of the entire study, including that from all the approximately 3,300 primary participants, will be a valuable source of data on how drivers respond to certain situations and how the roadway and vehicle might be enhanced to improve driver safety. Researchers who study traffic congestion and traffic patterns may also find the data useful. Therefore, it is expected that there will be follow-on data analyses using all or part of the data for up to 30 years into the future. These follow-on analyses will be conducted by qualified researchers with IRB approval, as required by law, who may or may not be part of the original project team. In assenting to this study, you are assenting to future research uses of the information and videos we gather from you, consistent with the protections described above and elsewhere in this document. If you are involved in a crash while participating in this study, the data collection equipment in the study vehicle will likely capture the events leading up to the event. You are under NO LEGAL OBLIGATION to voluntarily mention the data collection equipment or your participation in this study at the time of a crash or traffic offense. We have provided a letter which you should keep in the glove box for these cases. The letter describes the vehicle’s role in the study without identifying you as a participant in the study. Because the vehicle camera system is storing continuous video, it may capture some incriminating evidence if an at-fault collision should occur. To help us protect your privacy, we have obtained a Certificate of Confidentiality from the U.S. Depart- ment of Health and Human Services National Institutes of Health. With this Certificate, neither the researchers nor study sponsors can be forced to disclose information that may identify you, even by a court subpoena, in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings. Identifying information for the purposes of this study includes your contact information, your auxiliary study information, your driving data (including video of your face and GPS coor- dinates which may identify your home, work, or school locations), or any information in your driver data, vehicle data, or additional crash data that could be used to personally identify you. While your confidentiality is protected in most cases by the Certificate, you should know that in some rare instances involving alleged improper conduct by you or others, you may be prevented by a court from raising certain claims or defenses unless you agree to waive the confidentiality protection. The researchers and study sponsors will use the Certificate to resist any demands for information that would identify you, except as explained below. The Certificate cannot be used to resist a demand for information from personnel of the United States Government that is used for auditing or evaluation of federally funded projects or for information that must be disclosed in order to meet the requirements of the federal Food and Drug Administration (FDA).

320 This Certificate of Confidentiality does not mean that the Federal government endorses this study. You should understand that a Certificate of Confidentiality does not prevent you or a member of your family from voluntarily releasing information about yourself or your involvement in this research. If an insurer, employer, or other person obtains your written assent to receive research information, then the researchers may not use the Certificate to withhold that information. If you are not the vehicle owner, you should know that the vehicle owner will not have access to your data. The Certificate of Confidentiality also does not prevent the researchers from disclosing voluntarily matters such as child abuse, or subject’s threatened or actual harm to self or others. This could also include behaviors such as habitually driving under the influence of drugs or alcohol, allowing an unlicensed minor to drive the vehicle, or habitually running red lights at high speed. If this type of behavior is observed, we reserve the right to remove you from the study and inform the appropriate authorities of what we have observed. In most cases, we will notify you first of the behaviors we have observed prior to remov- ing you from the study or informing others of our observations. If you are removed from the study, your compensation will be prorated based on the time you have already spent as a participant in the study. The protections of the Certificate of Confidentiality described herein may not apply to passengers or drivers of the vehicle who have not consented to being in this study. For this reason, Informed Consent will be sought from all other adults who drive the vehicle, and these individuals will be protected by the Certificate of Confidentiality to the same degree as you are. To summarize, your level of confidentiality in this study is as follows: 1. There will be video of your face and portions of your body. There will be audio recorded, but only for 30 seconds if you press the red incident button. The study also will collect health and driving data about you. The video, audio, and other data that personally identifies you, or could be used to personally identify you, will be held under a high level of security at one or more data storage facilities. Your data will be identified with a code rather than your name. 2. All data collected from other drivers who have not signed a consent form, will be deleted. No identifying information will be collected on passengers. 3. For the purposes of this project, only authorized project personnel, authorized employees of the project sponsors, and qualified research partners will have access to study data containing personally identifying information, or that could be used to personally identify you. The data, including face video which has been blurred, blacked out, or replaced by anima- tion, may be shown at research conferences and by the research sponsors for the highway and road safety purposes identi- fied above. Under no circumstances will your name and other personally identifying information be associated with the video clips. 4. The personally identifying data collected in this study may be analyzed in the future for other research purposes by this project team or by other qualified researchers in a secure environment. Such efforts will require those researchers to sign a data sharing agreement which will continue to protect your confidentiality, and will also require additional IRB approval. The confidentiality protection provided to you by these data sharing agreements will be as great as or greater than the level provided and described in this document. Research partners will not be permitted to copy raw data that identifies you, or that could be used to identify you, or to remove it from the secure facility in which it is stored except with your assent. 5. A Certificate of Confidentiality has been obtained from the National Institutes of Health. With this Certificate, the research- ers and study sponsors cannot be forced to disclose information that may identify you, even by a court subpoena, in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings. However, the Certificate of Confiden- tiality does not prevent the researchers from disclosing voluntarily matters such as child abuse, or a participant’s threatened or actual harm to self or others. In terms of a vehicle, this could also include items such as driving under the influence of drugs or alcohol, allowing an unlicensed minor to drive the vehicle, or habitually running red lights at high speed. Such behaviors may result in your removal from the study and reporting of the behavior to the appropriate authorities. While your confidentiality is protected in most cases by the Certificate, you should know that in some rare instances involving alleged improper conduct by you or others, you may be prevented by a court from raising certain claims or defenses unless you agree to waive the confidentiality protection.

321 WILL I RECEIVE PAYMENT FOR PARTICIPATING IN THIS STUDY? Total payment for your participation in this research will be as follows, depending on the length of enrollment. You are sched- uled to be enrolled for ______ months. You are required to provide a valid social security number in order to receive your first payment. 1. After you have been enrolled in the study (the vehicle has been prepared for our study and you have completed the enroll- ment process, including the online questionnaires), you will receive $100 via check or direct deposit. 2. After your enrollment is complete, and after you return to CUBRC to have the system removed from the vehicle and com- plete a few final questionnaires, you will receive any final payment due via check or direct deposit. The amount of this final payment will depend on your length of enrollment, as follows: a. Four months: $100 (study total of $200). b. Five months: $110 (study total of $210). c. Six months: $152 (study total of $252). d. Seven months: $194 (study total of $294). If you discontinue your participation before the four month minimum enrollment, by your own choice, because the vehicle owner decides to withdraw their vehicle, or because you are asked to leave by someone on the study team, you will not receive any additional payment beyond your initial $100. If you are asked to leave due to persistent tire pressure monitoring system problems, you will be paid $42 for each month or partial month of participation. In addition, you will also be entered into a drawing for $1,000 paid in the same way as your other compensation. One $1,000 prize will be awarded every six months for every 150 drivers currently enrolled at your site, and you are guaranteed entry into the next scheduled drawing (next drawing date: _________________, ________) even if your scheduled enrollment is less than six months. WHAT ABOUT INSURANCE? Please note that since you are driving your own vehicle or another vehicle with the owner’s permission, neither study person- nel nor their respective organizations are responsible for the expenses that are caused by a crash you may experience. In the event of a crash, you are not responsible for any damage to the data collection system that is installed into the vehicle. Participants in a study are considered volunteers, regardless of whether they receive payment for their participation. Under New York state law, workers compensation does not apply to volunteers; therefore, the participants are responsible for their own medical insurance for bodily injury. Appropriate health insurance is strongly recommended to cover these types of expenses. If you get hurt in a crash, whether in or out of an automobile, the medical treatment available to you would be that pro- vided to any person by emergency medical services in the vicinity where the accident occurs. The participant and their parents, guardians, or other party with standing agree that this agreement shall be construed in accordance with the laws of the Commonwealth of Virginia, notwithstanding any conflicts of law provisions. Further, any and all claims and/or actions against Virginia Tech or the Commonwealth of Virginia shall be brought in a court of the Common- wealth of Virginia. AM I FREE TO WITHDRAW FROM THIS STUDY AT ANY TIME? As a participant in this research, you are free to withdraw at any time without penalty. If you choose to withdraw, you will receive partial payment as described in the Payment for Participation section of this form. You are free to choose not to answer any questions or respond to any tests that you choose without penalty. If you withdraw or are dismissed from the study, or if the vehicle owner withdraws the vehicle from the study, we will retain data collected before the withdrawal/ dismissal, but delete any data collected in the interval between when we become aware of the withdrawal/dismissal and before we are able to remove the data collection equipment. If you choose to end your participation in the study earlier than origi- nally planned, we will need to schedule a time to remove the data collection system from the vehicle. You will not receive any final payment due until we have removed the instrumentation from the vehicle.

322 HAS THIS RESEARCH BEEN APPROVED? Before this experiment begins, the research must be approved by the Institutional Review Board for research involving human subjects at Virginia Tech. The research has also been approved by the IRB for the National Academies of Science. You should know that this approval has been obtained and is valid through the date listed at the bottom of this form. HOW DO I PROVIDE MY ASSENT? I ____________________________ (participant) have read and understand this assent form and conditions of participation. I understand what is being asked of me. My questions have been answered. I freely agree to participate and have not been coerced into participation. I understand that participation is voluntary and that I may withdraw at any time without penalty. I certify that the owner, co-owner, or lessee of the vehicle has granted permission for the instruments and sensors to be installed in the vehicle. I certify that I hold a valid United States driver’s license, and that the vehicle that will be used in the study has at least the minimum amount of liability insurance required by the state in which it is registered. ______________________________ ______________________________ ______________ Participant (Print Name) Signature Date ______________________________ ______________________________ ______________ Experimenter (Print Name) Signature Date _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Should I have any questions about this research or its conduct, I may contact: Alan Blatt CUBRC Site Principal Investigator (716) ***-****-*****@cubrc.org Jon Antin Project Manager (540) ***-****-*****@vtti.vt.edu David Moore Chair, Virginia Tech Institutional Review (540) ***-****-*****@vt.edu Board for the Protection of Human Subjects Office of Research Compliance 2000 Kraft Drive, Suite 2000 (0497) Blacksburg, VA 24060 The Participant Must Be Provided With a Copy of This Consent Form.

Next: Appendix O - Parental Consent Form »
Naturalistic Driving Study: Technical Coordination and Quality Control Get This Book
×
MyNAP members save 10% online.
Login or Register to save!
Download Free PDF

TRB’s second Strategic Highway Research Program (SHRP 2)Report S2-S06-RW-1: Naturalistic Driving Study: Technical Coordination and Quality Control documents the coordination and oversight of participant- and vehicle-based operations for an in-vehicle driving behavior field study collected from naturalistic driving data and associated participant, vehicle, and crash-related data.

This report documents the methods used by six site contractors located at geographically distributed data collection sites throughout the United States to securely store data in a manner that protects the rights and privacy of the more than 3,000 participants enrolled in the study.

  1. ×

    Welcome to OpenBook!

    You're looking at OpenBook, NAP.edu's online reading room since 1999. Based on feedback from you, our users, we've made some improvements that make it easier than ever to read thousands of publications on our website.

    Do you want to take a quick tour of the OpenBook's features?

    No Thanks Take a Tour »
  2. ×

    Show this book's table of contents, where you can jump to any chapter by name.

    « Back Next »
  3. ×

    ...or use these buttons to go back to the previous chapter or skip to the next one.

    « Back Next »
  4. ×

    Jump up to the previous page or down to the next one. Also, you can type in a page number and press Enter to go directly to that page in the book.

    « Back Next »
  5. ×

    To search the entire text of this book, type in your search term here and press Enter.

    « Back Next »
  6. ×

    Share a link to this book page on your preferred social network or via email.

    « Back Next »
  7. ×

    View our suggested citation for this chapter.

    « Back Next »
  8. ×

    Ready to take your reading offline? Click here to buy this book in print or download it as a free PDF, if available.

    « Back Next »
Stay Connected!