Commercial Driver Individual Differences Study Informed Consent

PRA-2126NEW.CDIDS.APPENDIX K.Commercial Driver Study Informed Consent Ltr.doc

Commercial Driver Individual Differences Study

Commercial Driver Individual Differences Study Informed Consent

OMB: 2126-0052

Document [doc]
Download: doc | pdf

COMMERICAL DRIVER INDIVIDUAL DIFFERENCES STUDY INFORMED CONSENT


VIRGINIA POLYTECHNIC INSTITUTE AND STATE UNIVERSITY

Informed Consent for Participants of Investigative Projects



Title of Project: Case Control Commercial Driver Individual Differences Study


Investigators: Dr. Jeffrey Hickman, Dr. Rich Hanowski, Dr. Feng Guo, Erin Mabry, and Laurel Marburg


I. THE PURPOSE OF THIS RESEARCH PROJECT


The Case-Control Commercial Driver Individual Differences Study (CDIDS) will examine a wide array of driver and situational factors and determine the prevalence of these factors as well as their relationship to being involved in a crash and/or violation. The goal of the CDIDS is to identify and prioritize commercial driver individual differences with respect to risk factors. The proposed study will identify risk factors by linking the characteristics of individual drivers with their driving records during the duration of the study. Approximately 21,000 commercial drivers like yourself will participate in this study.


II. PROCEDURES


After reviewing and signing this Informed Consent Form, you will begin the study. You will fill out the questionnaires included in this Driver Survey. These questionnaires should take approximately 60 minutes to complete, but you may take as much time as needed. The questionnaires will ask you to record basic personal information, such as marital status and driving history, recent life experiences, your opinions of yourself, and your driving behavior. Once you complete the Driver Survey, you will seal it in the tamper-proof envelope provided and hand it to a staff member of your fleet, along with this signed ICF, who will send your study materials to VTTI. Note that your Driver Survey will remain sealed in the tamper-proof envelope and will not be opened or accessed by fleet staff. Note that your participation, or lack of participation, will have no influence on your job status.


If you agree to voluntarily participate in the CDIDS, your carrier will permit the research team to access your most recent Medical Examination Report for Commercial Driver Fitness Determination (Form 649-F). Researchers will also be contacted by your fleet if and when you are involved in a DOT reportable crash or violation.


You may be contacted in the future by the research team (within the next three years) to voluntarily participate in some additional data collection and analyses. You will not be obligated to participate in additional data collection if you are contacted. Note that your participation, or lack of participation, will have no influence on your job status.


III. RISKS


There is minimal risk involved in this study. Minimal risks include: possible minor discomfort due to disclosing personal information, feelings, and emotions. Potential risks may also include discomfort returning completed surveys to fleet personnel who may unlawfully open a driver’s sealed envelope to access the Driver Survey. You have been given a tamper-proof envelope in which to return completed surveys to fleet personnel to ensure confidentiality. You may withdraw from this study at any time if you feel uncomfortable for any reason. Your participation, or lack thereof, will have no impact on your job status.


The research team has taken effort to reduce potential risks to subjects. Participating fleet staff will undergo extensive training with the VTTI research team and will complete human subjects protection training to ensure they understand their obligation as a member of the research team to respect the study participants and collected data, avoid coercion to participate during recruitment, minimize risk to the participants and treat the collected data with confidentiality. Participating study sites will be audited monthly to ensure each site is complying with the research protocol and study procedures.


IV. BENEFITS


No promise or guarantee of benefits will be made to encourage your participation. This landmark study promises to provide a better understanding of CMV driver individual differences and crash/violation risk factors. The study results may improve truck driver health and safety, thereby making our Nation’s roadways safer for all drivers.


V. EXTENT OF ANONYMITY AND CONFIDENTIALITY


The data gathered in this experiment will be treated with confidentiality. Coding (i.e., Driver#0001) will be used so participant names will not be linked with any data collected. All data that is reported or shared with management will be in summary form so that your participation will remain anonymous. For example, data that is reported may indicate that 21,000 drivers participated in this study (19,000 males, 2,000 females; average age was 45 years old).


The data from this study will be stored at the Virginia Tech Transportation Institute within a secure, password protected, and limited access data folder on a VTTI secure server. Once collected data has been entered electronically into the secure, password protected database at the VTTI, all collected data will be stripped of identifying information. It is possible that the Institutional Review Board (IRB) may view this study’s collected data for auditing purposes. The IRB is responsible for the oversight of the protection of human subjects involved in research. Access to the data will be under the supervision of Dr. Jeffrey Hickman, Dr. Rich Hanowski, Dr. Feng Guo, Erin Mabry, and Laurel Marburg. All data collected in this study will be saved until the completion of the study and then will be destroyed or deleted.





VI. COMPENSATION


You will be compensated with a $20 cash/gift/debit card when you return the completed Driver Survey to fleet personnel. Should you decline to return the Driver Survey to fleet personnel or the VTTI research team, you will not be compensated.


VII. FREEDOM TO WITHDRAW


As a voluntary participant in this study, you are free to withdraw at any time for any reason. Further, if you withdraw it will not adversely impact your employment status with the company.

VIII. APPROVAL OF RESEARCH


This research project has been approved, as required, by the Institutional Review Board for Research Involving Human Subjects at Virginia Polytechnic Institute and State University. This approval is good for the period of time listed at the end of this document.


IX. PARTICIPANT’S RESPONSIBILITIES


If you voluntarily agree to participate in this study, you will have the following responsibilities:


  1. To be physically free of any substances (alcohol, drugs, etc.) that might impair your ability to complete the surveys accurately.

  2. Have a valid, Class-A CDL

  3. Be willing to express your honest opinions and responses requested on the surveys.


X. PARTICIPANT’S PERMISSION


I have read and understand the requirements, procedures, and conditions of this project. I have had all of my questions answered. I hereby acknowledge the above and give my voluntary consent for participation in this project. If I participate in this study, I understand that I may withdraw at any time without penalty. I agree to abide by the rules of this project.



_____________________________________________________________________

Participant’s name (Print) Signature Date



_____________________________________________________________________

Researcher’s name (Print) Signature Date


Should I have any questions about this research or its conduct, I may contact:


Jeff Hickman, Principal Investigator (540) 231-1555, [email protected]


If I should have any questions about the protection of human research participants regarding this study, I may contact:


Dr. David Moore

Chair of the Virginia Tech Institutional Review Board for the Protection of Human Subjects

(540) 231-4991

[email protected]

Research Compliance Office

1880 Pratt Drive, Suite 2006 (0497)

Blacksburg, VA 24061



NOTE: The participant must be given a copy of this consent form to keep.


File Typeapplication/msword
Authorherman.dogan
Last Modified Byherman.dogan
File Modified2012-05-09
File Created2012-05-09

© 2024 OMB.report | Privacy Policy