The Distracted Driving Project HomePage

Distracted Driving Project

This page links you to the background pages and the letter of informed consent for the Distracted Driving Project on the University of PEI Health.AHS server.

Background Information & Letter of Informed Consent

Establishing the Test-Retest Reliability for the Driving Simulator

You have been invited to participate in a research study. Please read the consent form carefully and ask as many questions as you would like before you decide whether you want to participate in this study. You are free to ask questions at any time before, during or after you agree to participate in this study. You can contact Kenneth Murnaghan by telephone at (902) 314-0325, or by email at: kenneth.murnaghan@gmail.com. He will do his best to respond to each of your questions. Concussions and issues related to post concussion events have gained prominence in North American media, as they become a major focus of injury prevention in sports and recreational activities across all levels of participation. A concussion is a brain injury. Sometimes referred to as a mild traumatic brain injury - a concussion injury results from impact to the brain as a consequence of a blow to the head, or a severe collision to the body.

Concussion injuries were previously accepted as a common event in many sports and recreation activities, especially if the event had an element of physical contact between participants or the risk of physical contact between the athlete and the activity environment. However, we no longer accept that injuries of any kind, especially a concussion injury, is a natural happenstance of participation in physical activity. Similarly, we are most vigilant about monitoring participation and the events within an activity that can increase the risk of injury.

Over time things have changed in the way we look at concussions and the recovery aspect. When one receives a concussion they are removed from play or work and there is a protocol to follow, before one returns to play or work. But one area that is overlooked is driving. Should one not drive after receiving a concussion and if so for how long? These are some questions that we will be exploring as we move forward into researching this topic.

When one receives a concussion, functions such as attention, problem solving and reaction time are altered even after symptoms have disappeared. Driving is a task that requires precise coordination of cognitive, motor and visual abilities, all the while adapting to the surrounding environment. Driving restrictions impact on the mental and fiscal well-being of individuals, so therefore healthcare workers are reluctant to advise patients to stop driving. The Driving Simulator is a possible device for evaluating concussion. Driving simulation is one of the most widely utilized alternative measures of driving performance.

This is due to its ability to reliably measure driving performance. While also ensuring driver safety and eliminating difficult to control areas such as traffic density and weather conditions. However at this point we have no comparison database and we have not established the test retest reliability of the driving simulator.

Driving is one of the most dangerous activities that one may engage in. It involves motor coordination, visual perception and also cognitive skill ie: attention, planning & decision making. We will investigate the disturbance of cognitive skills and reaction time using a driving simulator. Understanding the effects concussions have on driving is the first step. The main goal of this study is to provide evidence to support the use of the driving simulator for the assessment and post injury evaluation of recovery from a concussion.

What is the purpose of the research study?

The purpose of this study is to establish the test retest reliability of the driving simulator in a cohort of healthy individuals. Why have I been asked to participate? You have been asked to participate because you are among the specific target population identified within the scope of the research project. That is, you are a male or female over 18 years of age, and you have not incurred a concussion.

Do I have to take part in this research process?

Your participation in any part of this research is voluntary. You may refuse to participate in this research without giving any reason. You have the option to withdraw from the testing process at any point without giving any reasons. If you choose to withdraw from this research, any data you have already provided may be retained and used for the purposes of this research. What will I do if I agree to participate?

If you choose to participate, you will be asked to read and sign this document.

THE TESTING PROCESS:

You will be asked to be seated in the STISIM Driver Model 100 driving simulator. You will be given a 5 minute orientation drive to familiarize yourself with the controls and feel of the driving simulator. Once you feel comfortable with the driving simulator, a 20 min simulation and data collection will begin. Reaction time will be measured through various scenarios and recorded. The drive will take about 20 min. You will be asked to return in two weeks and complete the same drive test again. Are there any possible disadvantages from participating?

The only known risks associated would be simulator sickness. If there is any unexpected discomfort, disadvantage or risk to you during the course of the simulated drive please bring it to the attention of Dr. William Montelpare [(902) 620-5186; or e-mail wmontelpare@upei.ca], to help you find support. What if something goes wrong?

There are no known risks or harm with this research process. If you are harmed by taking part in this research process, there are no special compensation arrangements. If you have any problems with the ethical conduct of this study please send an email to reb@upei.ca or call (902) 620-5104.

What are the possible benefits from taking part?

The suggested benefits for those participating in the research process is the contribution of data for research, and the opportunity to be assessed on the driving simulator. Will my participation be kept confidential? Yes, all information collected will be kept strictly confidential. You will be assigned a personal identification number (ID) or pseudonym to identify your responses. Personal identifiers will be removed from responses during the analysis of the data and replaced with a pseudonym. During the study Dr. William Montelpare and members of the research team will have access to data that you submit. Your ID and details that you submit will be stored on a password-protected computer. Your test responses will not be held together with your personal details. Data will be stored on the University of Prince Edward Island firewall protected secure server that is only accessible via password for security and safety. After finishing this study the data will be stored in a password protected computer of the supervisor (Dr William Montelpare) for a minimum of 5 years and then destroyed according to the University policy on data protection. What type of information will be sought and why the collection of this information? The information we will be collecting will include scores for how well an individual maintains consistent speed, demonstrates vehicle control and the participant’s response time to critical events. The information collected will be used to indicate the reliability of the driving simulator.

What will happen to the results of the research project?

A summary of the findings will be emailed to all interested participants. However, NEITHER YOU NOR YOUR SPECIFIC RESULTS WILL BE IDENTIFIABLE IN THESE FINDINGS. The results of the study will be submitted for publication in peer reviewed journals and presented at academic and professional conferences.

Who is organizing and funding the research?

The study is being led by Dr. William Montelpare and is supported by a research grant from the Canadian Institute for Health Research. Who can I contact for further information?

For questions about this research please contact:

Professor William J. Montelpare, Ph.D.,

Margaret and Wallace McCain Chair in Human Development and Health,

Department of Applied Sciences, Faculty of Science,

Health Sciences Building, University of Prince Edward Island,

550 Charlottetown, PE, Canada, C1A 4P3

(T) (902) 620-5186

Some basic guiding principles for the partnership between the researchers and the participants: I have read the information sheet for this study. I have also been provided a contact number of the Principal Investigator and an invitation to ask questions about the study or my participation in the study. I understand that my participation is voluntary and that I am free to withdraw at any time without giving any reason, without my legal rights being affected and I give consent for any data already given to be retained and used. I understand that I will not benefit financially if this study leads to the development of education and training or future research/education/technological developmental outcomes. I know how to contact the study team if necessary. I understand that I can contact the UPEI Research Ethics Board at (902) 620-5104, or by email at reb@upei.ca if I have any concerns about the ethical conduct of this study. I understand that by signing the letter of informed consent with this study I am agreeing to participate in this study.

AUTHORIZATION

I have read the information provided for the research conducted at UPEI related to Establishing the Test-Retest Reliability for the Driving Simulator -- Background Information & Letter of Informed Consent as described in this consent form. My questions have been answered to my satisfaction and I agree to participate in this study. I voluntarily choose to participate in this study, but understand that my consent does not take away my legal rights in the case of negligence or other legal fault of anyone who is involved in this study. I have been given a signed copy of this consent form.

Name of Participant: _____________________________________

Signature of Participant: _____________________________________

DATE: ____________________________

If participant wishes to receive a summary of finding Please leave your email and we will email you a copy.

Email________________________________________________________