Form 1794 UMD CIREN Consent form patient occupant

RESEARCH CONSENT FORM /INFORMATION SHEET
Protocol Title: Core Protocol for Biomechanics Studies
Study No.: HP-40290
Principal Investigator: Margaret Lauerman, MD
R Adams Cowley Shock Trauma Center
National Study Center for Trauma and EMS
University of Maryland, Baltimore
22 South Greene Street
Baltimore, MD 21201
410-328-3587
Sponsor: National Highway Traffic Safety Administration (NHTSA)
This is a research study to determine the types and severity of injuries that may be sustained as
the result of a motor vehicle crash. Participation is voluntary and you may ask questions at any
time. If you are reading this consent form as a legally authorized representative for someone
who is unable to read for themselves, the word "you" in this document will refer to the person
you are reading for (family member, etc).
PURPOSE OF STUDY
The purpose of this study is to gather information on injuries received by pedestrian (on foot) or
occupants of motor vehicle crashes. Since you were involved in a crash, we would like to
include you in this study. A total of 11,500 people at five trauma centers across the country will
be included in this study. You will be one of approximately 1,600 people participating at this
location. Other trauma centers participating in this project include Fairfax Inova Hospital,
University of Alabama Birmingham, Wake Forest University, and Grady Memorial Hospital.
PROCEDURES
You will be one of approximately 1,600 subjects included in the study at the R Adams Cowley
Shock Trauma Center at the University of Maryland. If you agree to participate in this study, we
will ask you some questions relating to the circumstances surrounding your crash and some
additional questions relating to your injuries, your health and activities, your use of alcohol and
drugs, and other general information. Your cooperation in answering these questions will be of
great help in providing services to families of other trauma patients and will hopefully aid in
reducing the effects of vehicular trauma in the future. The interview should only require about 10
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to 20 minutes of your time. If your injuries and crash circumstance meet the inclusion criteria we
will document the nature and extent of your injuries and photographs of your injuries will be
taken, if possible. Information on your hospital, professional and rehabilitation charges will also
be recorded, as will detailed information about the crash and vehicle damage. We ask your
permission to look at your medical records to get vital signs (pulse, blood pressure, etc), to
document your injuries, and to describe any procedures (surgeries, x-rays and CT scans) that
were performed as part of your care while at Shock Trauma. If you do not meet the inclusion
criteria you will be withdrawn from the study and no further data will be collected. This study is
an ongoing effort by the National Highway Traffic Safety Administration.
POTENTIAL RISKS/DISCOMFORTS:
Participation in this study is voluntary and does not involve any change in your medical care.
The interview contains questions about alcohol and drug use. You may refuse to answer any
question that makes you uncomfortable. This study requires the use of confidential information
(name, medical record number) in order to obtain all the data required for analysis. To avoid any
breach of confidentiality, this information will only be available to the researchers involved
directly with the project and will be maintained in a locked offices and filing cabinets. This is an
observational study and, in the event that you may be pregnant, there is no risk to the fetus.
POTENTIAL BENEFITS
You will receive no direct benefit from participation in this study. However, your participation
may help the investigators better understand how injuries occur in a motor vehicle crash and will
provide information to the National Highway Traffic Safety Administration and to automobile
manufacturers that will assist them in developing rules and safety systems that may help prevent
serious injuries from occurring. Research findings from this study may be published by NHTSA
and in relevant medical journals.
ALTERNATIVES TO PARTICIPATION
This is not a treatment study. Your alternative is to not take part. If you choose not to take part,
your healthcare at University of Maryland, Baltimore will not be affected.
COSTS TO PARTICIPANTS
There are no costs to you as a consequence of your participation in this research study.
CONFIDENTIALITY AND ACCESS TO RECORDS
This study involves the collection of confidential information. Information collected will only be
available to the researchers involved directly with the project and will be maintained in a locked
offices and filing cabinets. Prior to disclosure to any entity outside of the research team at the
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University of Maryland, all data is sanitized and any identifying names/numbers are removed
from the information collected. The researchers have obtained a Certificate of Confidentiality
from the Department of Health and Human Services and the National Institutes of Health which
will help them protect your privacy, unless you consent in writing to the release of research
information. However, if the researchers learn that you or someone else is in serious danger of
harm (such as in cases of child abuse) they may make disclosures to protect you and/or the other
person. The Certificate of Confidentiality does not indicate an endorsement of the CIREN
research by the Department of Health and Human Services or the National Institutes of Health.
The data from the study may be published. However, you will not be identified by name. People
designated from the institutions where the study is being conducted and people from the sponsor
will be allowed to inspect sections of your medical and research records related to the study.
Everyone using study information will work to keep your personal information confidential.
Your personal information will not be given out unless required by law.
RIGHT TO WITHDRAW
Your participation in this study is voluntary. You do not have to take part in this research. You
are free to withdraw at any time. Refusal to take part or to stop taking part in the study will
involve no penalty or loss of benefits to which you are otherwise entitled. If you decide to stop
taking part, if you have questions, concerns, or complaints, or if you need to report a medical
injury related to the research, please contact the investigator Margaret Lauerman, MD at 410328-3587. There are no adverse consequences (physical, social, economic, legal, or
psychological) of your decision to withdraw from the research.
UNIVERSITY STATEMENT CONCERNING RESEARCH RISKS
The University is committed to providing participants in its research all rights due them under State and
federal law. You give up none of your legal rights by signing this consent form or by participating in the
research project. This research has been reviewed and approved by the Institutional Review Board (IRB).
Please call the Institutional Review Board (IRB) if you have questions about your rights as a research
participant.
The research described in this consent form has been classified as minimal risk by the IRB of the
University of Maryland, Baltimore (UMB). The IRB is a group of scientists, physicians, experts, and
other persons. The IRB’s membership includes persons who are not affiliated with UMB and persons who
do not conduct research projects. The IRB’s decision that the research is minimal risk does not mean that
the research is risk-free. You are assuming risks of injury as a result of research participation, as
discussed in the consent form.
If you are harmed as a result of the negligence of a researcher, you can make a claim for compensation. If
you have questions, concerns, complaints, or believe you have been harmed through participation in this
research study as a result of researcher negligence, you can contact members of the IRB or the staff of the
Human Research Protections Office (HRPO) to ask questions, discuss problems or concerns, obtain

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information, or offer input about your rights as a research participant. The contact information for the IRB
and the HRPO is:
University of Maryland Baltimore
Human Research Protections Office
620 W. Lexington Street, Second Floor
Baltimore, MD 21201
410-706-5037

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Health Insurance Portability and Accountability Act (HIPAA)
AUTHORIZATION TO OBTAIN, USE AND DISCLOSE
PROTECTED HEALTH INFORMATION FOR RESEARCH

Name of Study Volunteer:

________________________________________________

Date of Birth: ________________ Medical Record Number: ___________________________

NAME OF THIS RESEARCH STUDY:

Patterns and Consequences of Injuries Occurring in
Collisions of Vehicles with Modern Occupant
Restraint Systems

UMB IRB APPROVAL NUMBER:

40290

RESEARCHER’S NAME:

DR. MARGARET LAUERMAN

RESEARCHER’S CONTACT INFORMATION:
National Study Center for Trauma and EMS
University of Maryland School of Medicine (UMSOM)
110 South Paca Street – 4th Floor
410-328-5085

This research study will use health information that identifies you/your child. If you/your child
agree to participate, this researcher will use just the health information listed below.
THE SPECIFIC HEALTH INFORMATION TO BE USED OR SHARED:
 Health-related information you/your child have been asked to provide for the study during
interviews and questionnaires.
 Information collected from you/your child’s medical records from the University of Maryland
Medical Center (UMMC) relating to eligibility for the study and participation in the study
including: doctors’ notes or summaries, treatments, laboratory results, reports of x-rays and
other diagnostic tests.
 Health information about you/your child obtained from your clinical care providers.
 Information related to the damage sustained by your vehicle in the crash.
Federal laws require this researcher to protect the privacy of this health information. He/she will
share it only with the people and groups described here.
PEOPLE AND ORGANIZATIONS WHO WILL USE OR SHARE THIS INFORMATION:
 UMMC Medical Records staff
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
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Dr. Lauerman and her research team.
The National Highway Traffic Safety Administration (NHTSA)
Investigators conducting similar research at the following institutions: Inova Fairfax
Hospital and the University of Virginia, Wake Forest University and Medical Center, Emory
University and Grady Memorial Hospital, Medical College of Wisconsin, and the University
of Alabama Birmingham.
Prior to disclosure to any entity outside of the research team at the University of Maryland,
all data is sanitized and any identifying names/numbers are removed from the information
collected. A Federal Certificate of Confidentiality has been obtained to protect the privacy of
research subjects from the involuntary release of their identities to any persons not connected
with this research.

THIS AUTHORIZATION WILL NOT EXPIRE. BUT YOU CAN REVOKE IT AT ANY TIME.
To revoke this Authorization, send a letter to this researcher stating your decision. He/she will stop collecting health
information about you/your child. This researcher might not allow you/your child to continue in this study. He/she
can use or share health information already gathered. The data will be destroyed at the time indicated below:



There is no scheduled date at which this information will be destroyed or no longer used.
This is because information that is collected for research purposes may be analyzed for many
more years and it’s not possible to determine when analysis will be complete.

ADDITIONAL INFORMATION:
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You can refuse to be in this study. If you refuse, you cannot participate in this study. This will not affect the
care you/your child receive at:
o University Physicians, Inc. (UPI)
o University of Maryland Medical System (UMMS)
It will not cause any loss of benefits to which you/your child are otherwise entitled.
Sometimes, government agencies such as the Food and Drug Administration or the Department of Social
Services request copies of health information. The law may require this researcher, the UMSOM, UPI, or
UMMS to give it to them.
This researcher will take reasonable steps to protect your/your child’s health information. However, federal
protection laws may not apply to people or groups outside the UMSOM, UMB, UPI or UMMS.
Except for certain special cases, you/your child have the right to a copy of your/your child’s health
information created during this research study. You may have to wait until the study ends. Ask this research
how to get a copy of this information from him/her.

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