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303 A p p e n d i x K ParticiPant consent Form For secondary driver, variable enrollment Period (4â7 months) in-vehicle driving behavior and crash risk study (âThe SHRP 2 Naturalistic Driving Studyâ) 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 sen- sors in peopleâs 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. WHAT DO I HAVE TO DO IF I CHOOSE TO PARTICIPATE? The owner, co-owner, or lessee of a vehicle you sometimes drive has allowed us to install a data collection system in their vehicle as part of a study. Data will be collected whenever the vehicle is driven, and some of this data may identify you as the driver. Data that could identify you includes face video and location information (such as your home, work, and school loca- tions). We are inviting you to participate in the study as well and to allow us to use your identifying information for research purposes. There are three options with regard to participation: 1. You may choose to participate fully by reading and signing this consent form and following the steps listed below. 2. You may decline to participate fully but continue to drive the vehicle. If you choose this option, data will be collected whenever you drive the vehicle, but the data will be deleted once it is determined that you were the driver and that you did not sign a consent form. Secondary Driver Consent Form
304 3. You may decline to participate and choose not to drive the vehicle while it is in the study. In this case, no data would be collected. The study involves a _______ month data collection effort in which a data collection system containing sensors and video cam- eras will be installed in the vehicle(s) you regularly drive to record a variety of driving measures. As a fully enrolled secondary par- ticipant, you would complete the following activities: 1. Complete the enrollment process, which should take no more than 20 minutes, and return the forms to CUBRC. These forms include: a. This informed consent form b. A brief questionnaire about you and your driving history c. A questionnaire about your driving behaviors 2. Provide us with a digital picture of your face so that we may automatically identify you as a secondary driver. We will pro- vide instructions on how to do this when we talk to you on the phone about your participation. 3. Drive as you normally would. 4. Let us or the primary participant know if you notice any unusual warning light activity, for example, warning lights that go on or off. 5. 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. 6. 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 inves- tigated in more detail. This interview would ideally take place soon after the crash, but only when you are comfort- able and able to do so. e. Allow us to have access to the police accident report, if any, which results from the crash. 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 should 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. 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 vehicleâs radio, keyless entry key fob, or other electronic components or sensors, such as the tire pressure monitoring system. If this happens in the study vehicle, CUBRC will use engineering countermeasures to attempt to minimize the interference to an unnoticeable level. If the study vehicle experiences persistent tire pressure monitoring system problems, the primary participant will be asked to leave the study, while for other problems, the primary participant will be given the option to continue participation with the problem unresolved or to leave the study. Five cameras are 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 Consent 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
305 provided a letter for the glove box which can be used to explain the vehicleâs 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 Cer- tificate 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 participantâs 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 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 questionnaires is no more than when you are doing activities in your daily life like filling in forms, and working at a computer. 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 locations. 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). 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. Driver data includes your answers to questionnaires. 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 electronic form throughout the lifetime of the data (defined below). 3. 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 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. We will also treat the digital picture
306 you send us as driving data. This data will be stored securely in electronic form throughout the lifetime of the data (defined below). 4. 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 studyâs 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 studyâs 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 confidential- ity 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 move- ments. 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 OnStarâ¢. It simply records your voice in an audio file that remains in the vehicle until the data is collected. 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 supervision of the Virginia Tech Transportation
307 Institute, the organization overseeing the data collection for the entire study. It is possible that, after data collection is com- plete, one copy of study data will be transferred to the U.S. Department of Transportation (or other secure facilities as deter- mined 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 Consent 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 consent. 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, driverâs 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 the secondary partici- pants, 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 consenting to this study, you are consenting 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 vehicle will likely capture the events leading up to the event. You are under NO LEGAL OBLIGATION to voluntarily mention the data collection equip- ment or your participation in this study at the time of a crash or traffic offense. We have placed a letter in the glove box for these cases. The letter describes the vehicleâs 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 col- lision should occur. 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, 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, crimi- nal, administrative, legislative, or other proceedings. Identifying information for the purposes of this study includes your con- tact information, your auxiliary study information, the digital picture of your face, your driving data (including video of your face and GPS coordinates 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). 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 consent to receive research information, then the researchers may not use the Certificate to withhold that information. The Certificate of Confidentiality also does not prevent the researchers from disclosing voluntarily matters such as child abuse, or subjectâs 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 removing you from the study or informing others of our observations. In the event of a crash, it may not be possible to prevent the equipment and the
308 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. 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. 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 driving data about you. If you consent to participate in the study, the digital picture, 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. If you do not agree to participate, all of the data collected while you are driving will be deleted. 2. 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. 3. 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 consent. 4. 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 participantâs 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. WILL I RECEIVE PAYMENT FOR PARTICIPATING IN THIS STUDY? Upon enrollment (completing this consent form, completing the questionnaires, and providing a digital picture of your face), you will receive $25 via check or direct deposit. You will need to provide a mailing address in order to receive this payment, and you may be asked to provide you Social Security Number. WHAT ABOUT INSURANCE? Please note that since you are not driving a vehicle owned by study personnel nor their respective organizations, neither study personnel 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.
309 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 agrees 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 Com- monwealth of Virginia shall be brought in a court of the Commonwealth 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. You are free to choose not to answer any questions or respond to any tests that you choose without penalty. If you decide to withdraw or are dismissed from the study, you need to notify one of the research team listed on the last page of this form so that any future data collected with you as a driver will be deleted. However, we will retain data collected before your withdrawal/dismissal. 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 CONSENT? I ___________________________ (participant) have read and understand this consent form and conditions of participa- tion. 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 I hold a valid United States driverâs license. I certify that I am 18 years old or older. I also understand that if I choose not to participate, the data collected while I am driving will be deleted once it is deter- mined that the driver of the vehicle for any trip did not sign a consent form. I also understand that if I choose not to partici- pate, that my data may not be protected by the Certificate of Confidentiality, but again, the data will be deleted as soon as it is determined that the driver for that trip did not sign a consent form. ______________________________ ______________________________ ______________ 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.
