Form 1780 WFU CIREN Informed consent vehicle WFUHS

Department of Biomedical Engineering
INFORMED CONSENT FORM TO PARTICIPATE IN RESEARCH:
Vehicle access and event data recorder authorization for:

Crash Injury Research and Engineering Network (CIREN):
A Study to Correlate Crash Data by Matching Human Injuries with Vehicular Damage
R. Shayn Martin, MD, Co-Principal Investigator
Joel D. Stitzel, PhD, Co-Principal Investigator

INTRODUCTION
CIREN is the Crash Injury Research and Engineering Network center at Wake Forest
University School of Medicine, under the policies and regulations of the National Highway
Traffic Safety Administration (NHTSA), US Department of Transportation (DOT). Seven
CIREN centers across the country form a network of Level One trauma centers to conduct
motor vehicle crash investigations in order to conduct research that will improve the prevention,
treatment, and rehabilitation of crash injuries, and to reduce the deaths, disabilities, and
economic costs of these crashes. The data from the affected motor vehicle crashes and medical
records will be collected and stored at NHTSA’s secure location. All personally identifiable
information will be removed from the data before storage.
WHAT IS INVOLVED IN THE STUDY?
You are being asked to participate in the CIREN research study because your vehicle was
involved in a collision. The purpose of the study is to collect information about vehicles and
individuals who have been injured in crashes in order to help researchers find ways to improve
vehicle safety. The study includes the following procedures to investigate the vehicle:



Your vehicle will be accessed to measure and photograph evidence and impacts to
help investigators determine what happened in the crash.
The crash investigator might disassemble damaged interior trim, panels, covers, and
seats so that damage to concealed structural members, compressed shear capsules,
seat-back frames, and seat pans can be photographed and documented.

1

WFU School of Medicine
Institutional Review Board
IRB Number:BG05-483
Meeting Date Approved 7/11/2023
Version Valid Until: 7/10/2024



Data will be electronically downloaded from the event data recorder (EDR), if the
vehicle is so equipped. The EDR is an electronic device located on the vehicle
whose purpose is to determine which safety systems should be activated in a
crash. The EDR monitors sensors in the vehicle relevant to a crash, such as belt
use, travel speed, and brake activation, and then makes decisions as to which
safety systems are deployed. This information aids the crash investigator in
creating an accurate reconstruction while learning essential information regarding
the vehicle’s safety performance. Accessing the EDR may require removing
small pieces of interior trim from the vehicle, which will be reinstalled by the
crash investigator. The EDR device will not be physically removed in most
circumstances. On rare occasions, excessive damage to the vehicle’s electrical
system will require EDR module removal to access the data. In this event, the
module will be returned after downloading if requested.

Note: No personal identification information is associated with the EDR data. Any personal
identifying information is removed automatically when downloading the data.
WHAT ABOUT THE USE, DISCLOSURE, AND CONFIDENTIALITY OF PRIVATE
HEALTH INFORMATION?
When you sign this consent and authorization form you authorize or give permission for the
use of your vehicle information as described in the consent form. Note: no personal health
information is collected during the of vehicle inspection processes described within this
document. This authorization is valid for six years, or five years after the completion of the
study, whichever is longer. You can revoke or take away your authorization to use and
disclose your vehicle information at any time. You do this by sending a written notice to the
investigators in charge of the study at the following address:
R. Shayn Martin, MD, Co-Principal Investigator
Joel D. Stitzel, PhD, Co-Principal Investigator
Wake Forest University Health Sciences
Medical Center Blvd. Winston-Salem, NC 27157

2

WFU School of Medicine
Institutional Review Board
IRB Number:BG05-483
Meeting Date Approved 7/11/2023
Version Valid Until: 7/10/2024

SIGNATURES


I agree to take part in this study and authorize the crash investigator to access my vehicle to take
measurements and photographs.



I authorize the CIREN study team to download data from the event data recorder located on my
vehicle, and if necessary, to remove and send the recorder to a laboratory to download the data.



I authorize the study team to temporarily remove and reinstall parts of my vehicle to access the
event data recorder and to inspect other structural components of my vehicle.

By signing this consent and authorization form, I am not releasing or agreeing to release the
investigator, the sponsor, the institution, or its agents from liability for negligence.
Vehicle year, make, and model:
Vehicle owner name (printed):
Vehicle owner signature:

date

time

am pm

Person obtaining consent (printed):

date

time

am pm

Person Obtaining Consent:_________________________ date:_________ time:________ am pm

******************************************************************************

3

WFU School of Medicine
Institutional Review Board
IRB Number:BG05-483
Meeting Date Approved 7/11/2023
Version Valid Until: 7/10/2024

Legally authorized representative name (printed)
The above named legally authorized representative has legal authority to act for the vehicle owner
based upon (specify health care power of attorney, spouse, parent, etc.):
Legally authorized representative
Signature
pm

date

time

am

August 2018.1

4

WFU School of Medicine
Institutional Review Board
IRB Number:BG05-483
Meeting Date Approved 7/11/2023
Version Valid Until: 7/10/2024