PARTICIPANT INFORMATION AND CONSENT DOCUMENT
TITLE:
Novel Approaches to Studying Liver Fibrosis - Transient elastography
(FibroScan)
PRINCIPAL
INVESTIGATOR: Dr. Marina Klein
STUDY SITE:
Royal Victoria Hospital, Montreal, Quebec
SPONSOR:
Canadian Institute Health Research (CIHR)
INTRODUCTION
You are being asked to participate in this research study because you are part of the Canadian
Co- infection Cohort, CTN 222.
Before you decide to participate, it is important that you understand the content of this consent
form, the risks and benefits to make an informed decision, and ask any questions if there is
anything that you do not understand. Please read this entire consent form and take your time to
make a decision. If you decide to participate in this study, you will be asked to sign this informed
consent form, and a copy will be given to you.
PURPOSE OF THE STUDY
Currently, liver biopsies are the gold standard to diagnosis liver fibrosis (scarring). They are the
main way of deciding who should receive HCV treatment and when. However, liver biopsies can
be painful, costly and carry some risk. Non-invasive methods to measure liver health could
provide a safe alternative to monitor liver disease.
Transient elastography (FibroScan) is a rapid, non-invasive, method to evaluate liver fibrosis by
measuring liver stiffness. A pulse is generated at the skin surface, which is propagated through
the liver.
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The purpose of this study is to determine if Transient elastography can help measure liver
fibrosis resulting from all pathologies that cause damage to the liver.
STUDY PROCEDURES
The FibroScan® technique will be used to quantify liver fibrosis in a non-invasive and painless
manner. Performed at the bedside in the clinic, a mechanical pulse will be generated at the skin
surface, which will spread through the liver. The speed of the wave will be measured by
ultrasound. The speed of this wave correlates with the stiffness of the liver, which in turn reflects
the degree of fibrosis – the stiffer the liver is the greater the degree of fibrosis and damage to the
liver.The measurement is represented in pressure (kPa) and the results appear on a screen. In
general, the whole examination process can be completed within 15 minutes.
You will be asked to undergo the fibroScan every six months for a maximum of five years and
you will be asked few questions regarding your past and current activities associated with your
HCV diagnosis. You may refuse to answer any of the questions with no explanation.
This Fibroscan will be performed by technical personnel and/or hepatologist at the Royal
Victoria Hospital and the results will be reported to the investigators.
POTENTIAL DISCOMFORTS & RISKS
There are no potential discomforts or risks involved with the Fibroscan procedure. However,
according to the recommendations of use and based on safety and efficacy matters; pregnant
women, patients with ascites, persons with active implementable medical devices and persons
with a waist size more than 100cm will be exclude from this study.
POTENTIAL BENEFITS
You should not expect any direct benefit from participating in this study. However, your
participation on this study may help further our knowledge of this procedure, and potentially
help improve future patient care.
REIMBURSEMENT
You will not be paid for participating in this study. However, you will be compensated for your
travel and childcare up to a maximum of $15.00 per visit.
CONFIDENTIALITY
Your identity will be kept confidential at all times, except where disclosure is required by law.
As a participant in this study, you will be identified by a study number and not by your name. As
part of this research, the study staff will have access your personal medical records for health
information, such as your medical history and past test results.
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Your medical records and personal health information may be inspected by:

government regulatory authorities (e.g., Health Canada)

the Ethics Committee of this hospital (this is an independent committee that reviews clinical
studies to protect the rights and welfare of study participants)
The results of this study may be presented at meetings or in publications, but your identity will
not appear in any reports or presentations.
You may cancel or withdraw permission allowing the use and disclosure of your personal health
information at any time. If you withdraw your permission, you will not be able to continue being
in this study. No new health information about you will be gathered after that date. However,
information that has already been collected may still be used if it is needed to make sure the
study is done properly or for reasons required by the law.
VOLUNTARY PARTICIPATION AND/OR WITHDRAWAL
Your participation in this study is strictly voluntary. You may refuse to participate or discontinue
your participation at any time without explanation, and without penalty or loss of benefits to
which you are otherwise entitled. If you decide not to participate or if you discontinue your
participation, you will suffer no prejudice regarding your medical care or your participation in
any other research studies.
IN CASE OF AN INJURY RELATED TO THIS RESEARCH STUDY
You are not giving up any of your legal rights by signing this consent and agreeing to participate
to this study.
SIGNIFICANTS FINDINGS
You will be told by the study doctor or his/her staff of any significant new findings that develop
during the course of this study that may affect your willingness to continue participating in this
study. You may then use this information to make a decision about remaining in the study. Also,
at the end of the study your physician will inform you of the research findings.
STUDY RECORDS AND RETENTION POLICY
For security purposes, especially to be able to communicate with you rapidly, your family name,
first name, coordinates and the start and end date of participation in the project would be stored
for one year after the completion of the project in a separate registry maintained by the
researcher in charge of the project or by the institution.
This register is among some of the measures established, by the Ministry of Health and Social
Services, for your protection. This will allow the hospital, should the need be, to contact you.
None of the information collected from this register will serve research and all information will
be destroyed at the latest 12 months following the end of your participation in this research
study.
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CONTROL OF THE ETHICAL RESEARCH ASPECTS OF THE RESEARCH
PROJECT
The Research Ethics Board of the McGill University Health Centre approved this study and is
responsible for following the study and making sure that you are protected. Before any change is
made to the Information and Consent Form or to the study, it must first be approved by the
Research Ethics Board.
QUALITY ASSURANCE PROGRAM
The MUHC implemented a Quality Assurance Program that includes active continuing review of
projects (on site visits) conducted within our establishment. Therefore, it must be noted that all
human subject research conducted at the MUHC or elsewhere by its staff, is subject to MUHC
Routine and Directed Quality Improvement Visits.
CONTACT INFORMATION
If you have any questions regarding this research study, contact Dr. Klein at 514 843-2090.
In case of emergency during clinic hours (8:00-16:00), contact Dr. Klein at 514 843-2090. After
working hours, call 514 934-1934, ext. 33333 and ask for the physician-on-call for the
immunodeficiency service.
If you have any questions about your rights as a research participant, contact the McGill
University Health Center Ombudsman at (514) 934-1934, ext 35655, who will provide you with
independent advice.
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Study title: Novel Approaches to Studying Liver Fibrosis - Transient elastography (FibroScan)
DECLARATION OF CONSENT
I have read the contents of this consent document, and I voluntarily agree to participate in this
research study, understanding that I may withdraw my participation at any time. I have had the
opportunity to ask questions and all of my questions have been answered to my satisfaction. I
have been given sufficient time to consider the above information and to seek advice. I grant
direct access to my study and medical records. I will inform the study doctor if I wish that my
primary physician be informed of my study participation. I will be given a copy of this signed
and dated Informed Consent Form. By signing this consent form, I am not waiving any of my
legal rights nor am I freeing the investigators, sponsors, or the health establishment where the
study takes place from their legal and professional responsibilities.
Printed Name of Participant
Signature of Participant
Date
Printed Name of Investigator/
Delegate Obtaining Consent
Signature of Investigator/
Delegate Obtaining Consent
Date
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