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Publication Number: FHWA-HRT-04-145
Date: December 2005

Enhanced Night Visibility Series, Volume XIV: Phase III—Study 2: Comparison of Near Infrared, Far Infrared, and Halogen Headlamps on Object Detection in Nighttime Rain

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APPENDIX B—INFORMED CONSENT FORM

[NAME OF UNIVERSITY]

Informed Consent for Participants of Investigative Projects

Title of Project: Nighttime Driving Evaluation of the Effects of Disability and Discomfort Glare from Various Headlamp Designs under Low and High Light Adaptation Levels

Investigators: (List names of investigators here)

The Purpose of the Research

The purpose of this study is to objectively identify the levels of discomfort and disability glare produced by various oncoming headlamps under two levels of light adaptation.

Procedures

During the course of this experiment you will be asked to perform the following tasks:

  1. Read and sign an Informed Consent Form.
  2. Show a current driver’s license.
  3. Complete four vision tests.
  4. Drive a vehicle on the Smart Road at 20 miles per hour, and notify the experimenter when you can detect and identify different objects along the roadway.
  5. Complete questionnaires
  6. Listen to the instructions regarding any tasks you may perform.

It is important for you to understand that we are evaluating the technology, not you. Any tasks you perform, mistakes you make, or opinions you have will only help us do a better job of designing these systems. Therefore, we ask that you perform to the best of your abilities. The information and feedback that you provide is very important to this project.

Risks

There are risks or discomforts to which you are exposed in volunteering for this research. They include the following:

  1. The risk of an accident normally associated with driving an unfamiliar automobile at 20 miles per hour or less, on straight and slightly curved roadways in clear conditions.
  2. Possible fatigue due to the length of the experiment. However, you will be given the option to take breaks when you choose.
  3. Possible discomfort associated with driving at night in the presence of normal glare similar to that of an approaching vehicle.

The following precautions will be taken to ensure minimal risk to you.

  1. The in-vehicle experimenter will monitor your driving and will ask you to stop if he/she feels the risks are too great to continue. However, as long as you are driving the research vehicle, it remains your responsibility to drive in a safe, legal manner.
  2. You will be required to wear the lap and shoulder belt restraint system while in the car. The vehicle is also equipped with a driver’s side and passenger’s side airbag supplemental restraint system.
  3. The Smart Road test track is equipped with guardrails to prevent vehicles from slipping off the road.
  4. The vehicle is equipped with a fire extinguisher and first-aid kit, which may be used in an emergency.
  5. If an accident does occur, the experimenters will arrange medical transportation to a nearby hospital emergency room. You will be required to undergo examination by medical personnel in the emergency room.
  6. All data collection equipment is mounted such that, to the greatest extent possible, it does not pose a hazard to you in any foreseeable situation.
  7. None of the data collection equipment or the display technology interferes with any part of your normal field of view in the automobile.
  8. The in-vehicle experimenters are aware of the location of other work vehicles on the road, and maintain radio contact with each other.
  9. If you are pregnant, you have reviewed this consent form with your obstetrician and discussed the risks of participating in this study with him/her. You are willing to accept all possible risks of participation.
  10. You do not have any medical condition that would put you at a greater risk, including but not restricted to epilepsy, balance disorders, and lingering effects of head injuries or stroke.

In the event of an accident or injury in an automobile, the automobile liability coverage for property damage and personal injury is provided. The total policy amount per occurrence is 2,000,000 dollars. This coverage (unless the other party was at fault, which would mean all expense would go to the insurer of the other party’s vehicle) would apply in case of an accident for all volunteers and would cover medical expenses up to the policy limit.

Participants in a study are considered volunteers, regardless of whether they receive payment for their participation; under Commonwealth of Virginia law, worker’s compensation does not apply to volunteers; therefore, if not in an automobile, the participants are responsible for their own medical insurance for bodily injury. Appropriate health insurance is strongly recommended to cover these types of expenses.

Benefits

There are no direct benefits to you from this research other than payment for participation. No promise or guarantee of benefits will be made to encourage you to participate. Subject participation may have a significant impact on future night vision systems.

Extent of Anonymity and Confidentiality

The data gathered in this experiment will be treated with confidentiality. Shortly after participation, your name will be separated from your data. A coding scheme will be employed to identify the data by participant number only (e.g., Participant No. 1). You will be allowed to see your data and withdraw the data from the study if you so desire, but you must inform the experimenters immediately of this decision so that the data may be promptly removed. At no time will the researchers release the results of this study to anyone other than the client and individuals working on the project without your written consent. The client has requested that the video, including your eye movement data and image, be given to them when the study is completed. They would only use the video for research purposes. Researchers will not turn over the video of your image to the client without your permission

Compensation

You will receive 20 dollars per hour for your participation in this study. This payment will be made to you at the end of your voluntary participation in this study. If you choose to withdraw before completing all scheduled experimental conditions, you will be compensated for the portion of time of the study for which you participated.

Freedom to Withdraw

As a participant in this research, you are free to withdraw at any time for any reason. If you choose to withdraw, you will be compensated for the portion of time of the study for which you participated. Furthermore, you are free not to answer any questions or respond to any research situations without penalty.

Approval of Research

This research has been approved, as required, by the Institutional Review Board for Research Involving Human Subjects at (Name of University) and by the (Name of Research Institute).

Participant’s Responsibilities

If you voluntarily agree to participate in the study, you will have the following responsibilities: To be physically free from any substances (alcohol, drugs, etc.) that might impair your ability to drive for 24 hours prior to the experiment, and to conform to the laws and regulations of driving.

Participant’s Permission

Check one of the following:

  • (Name of Research Institute) has my permission to give the videotape including my image to the client who has sponsored this research. I understand that the client will only use the videotape for research purposes.
  • (Name of Research Institute) does not have my permission to give the videotape including my image to the client who has sponsored this research. I understand that (name of research institute) will maintain possession of the videotape, and that it will only be used for research purposes.

I have read and understand the Informed Consent and conditions of this project. I have had all my questions answered. I hereby acknowledge the above and give my voluntary consent for participation in this project.

If I participate, I understand that I may withdraw at any time without penalty. I agree to abide by the rules of this project.

___________________________________________________        ____________________________
Participant’s Signature                                                                 Date

Should I have any questions about this research or its conduct, I may contact: (List name and contact information of PI, IRB Chair, and Experimenter)

 

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