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PARTICIPANT INFORMATION SHEET AND CONSENT FORM
Study Title: The Australian Calciphylaxis Registry
Invitation
You are invited to participate in provision of data to The Australian Calciphylaxis Registry.
Collection of data is being coordinated by A/Professor Grahame Elder, Department of
Renal Medicine, Westmead Hospital.
Before you decide whether or not you wish to participate, it is important for you to
understand why the Registry has been established and what participation will involve.
Please take the time to read the following information carefully and discuss it with others if
you wish.
What is the purpose of the participation in the Registry?
You have been diagnosed with a condition called ‘calciphylaxis’. As your treating doctor
will have explained to you, this is an uncommon but serious condition that generally affects
people with kidney disease who are in most cases on dialysis. Calciphylaxis can cause
painful discolouration of the skin and ulceration leading to infection, and can sometimes
affect other organs. Although some of the predisposing factors to developing calciphylaxis
are known, there is little information on its specific causes. Knowing more about these
causes might lead to better management and treatments.
The function of The Australian Calciphylaxis Registry is to collect data in the form of a
questionnaire and to undertake laboratory tests on blood and tissue samples so that we
can gain a better understanding of the causes and potential treatments of calciphylaxis.
Because calciphylaxis is uncommon and any single centre will only have a few cases, the
Registry acts to accumulate data nationally and can collaborate with calciphylaxis
registries in other countries, so that progress can be made in understanding and managing
this condition.
Who will be invited to enter the study?
You are invited to participate in this study because you have been diagnosed with
Calciphylaxis.
Do you have a choice?
Participation is voluntary. It is completely up to you whether or not you participate. If you
decide not to participate, it will not affect the treatment you receive now or in the future.
Whatever your decision, it will not affect your relationship with the staff caring for you. New
information about the management of calciphylaxis may become available after your initial
contact with the Registry. You will be kept informed of any significant new findings that
may affect your willingness to continue to provide follow up information or other data to the
registry. If you wish to withdraw from providing follow up information or other data to the
Registry, you can do so at any time without having to give a reason. However, it may not
be possible to withdraw your data from the Registry if these have already had your
identifying details removed.
What will happen if I agree to participate in the Registry?
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PARTICIPANT INFORMATION SHEET AND CONSENT FORM
Study Title: The Australian Calciphylaxis Registry
If you agree to participate, you will be asked to sign the Participant Information and
Consent Form. The Registry has been initially set up to run over 3 years but the intention
is that it will collect data over a longer period.
If you agree to participate in the Registry, you will then be asked to undergo the following
procedures: Complete a questionnaire with the assistance of medical staff. The
questionnaire asks about factors that might have predisposed you to developing
calciphylaxis. In addition, the researchers would like to have access to some information
from your medical record to obtain information relevant to the study.
Next a 15 ml blood sample (around 7 teaspoons) will be required; however this can be
collected when you have a routine blood test or when you go onto dialysis, so it will not
require any additional blood collections. If you have already had a tissue biopsy collected
when the diagnosis of calciphylaxis was made, we will request the pathology department
send us some sample microscope slides from that tissue so that additional testing can be
performed. This will not have any impact on you.
Around 6 months after your 1st contact with the registry, staff at the Registry will ask the
medical staff at your institution to provide updated information on your progress. We may
also request an additional 10 ml blood sample be forwarded to the registry at that time.
Once again this would be taken at the time of routine blood sampling and will not require
an additional blood collection.
Participating in provision of data to Registry will not require any restrictions on your
lifestyle.
The initial questionnaire is expected to take up to 30 minutes for you to complete together
with one of the medical staff. Follow up questions will be able to be answered by the
medical staff and will not require your participation.
The questionnaire is attached to this patients information so that you can check what
questions will be asked.
What will happen to my tissue sample after it has been used?
The blood or tissue sample/s you provide during the study will be analyzed and then
stored for possible future analyses, which may be undertaken as additional information
becomes available on calciphylaxis . However if the registry closes, these samples will be
destroyed. You will be asked to sign an additional specific consent form regarding storage
of your samples. If you do agree to your tissue samples being stored, they will not be used
for other research projects, except with your written consent or, under some
circumstances, with the approval of a Human Research Ethics Committee at that time.
Are there any risks?
All medical procedures involve some risk of injury. However the only risk involved in
providing data to the Registry is the provision of a blood sample. Since no additional
venepuncture will be required, the risk is minimal.
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PARTICIPANT INFORMATION SHEET AND CONSENT FORM
Study Title: The Australian Calciphylaxis Registry
Are there any benefits?
This study aims to further medical knowledge and may improve future treatment of
calciphylaxis; however it may not directly benefit you.
Confidentiality / Privacy
Of the people treating you, only the medical and nursing staff involved in your care and
staff involved with data collection in the Registry will know whether or not you are
participating in the Registry. Any identifiable information that is collected about you in
connection with the Registry will remain confidential and will be disclosed only with your
permission, or as required by law. Only the staff or researchers indicated above will have
access to your details and results that will be held securely at Westmead Hospital,
Sydney.
Compensation
If you suffer any injuries or complications as a result of this study, you should contact the
study doctor as soon as possible, who will assist you in arranging appropriate medical
treatment. You may have a right to take legal action to obtain compensation for any
injuries or complications resulting from the study. Compensation may be available if your
injury or complication is sufficiently serious and is caused by unsafe drugs or equipment,
or by the negligence of one of the parties involved in the study (for example, the
researcher, the hospital, or the treating doctor). If you receive compensation that includes
an amount for medical expenses, you will be required to pay for your medical treatment
from those compensation monies. You do not give up any legal rights to compensation by
participating in this study.
If you are not eligible for compensation for your injury or complication under the law, but
are eligible for Medicare, then you can receive any medical treatment required for your
injury or complication free of charge as a public patient in any Australian public hospital.
Will taking part in the Registry cost me anything, and will I be paid?
Participation in this study will not cost you anything also, you will not be paid for
participation in the registry.
What will happen to information provided to the Registry?
If as a result of assessing your questionnaire responses or analysing your biological
samples, staff at the Registry feel that there is additional information that might assist in
your management, they will transmit that information to your treating doctor.
The Registry will also make general information on calciphylaxis and any advances in its
management available to you and to your treating doctors and other medical and nursing
staff, via its web site (calciphylaxis.org.au). General information on calciphylaxis and latest
data on calciphylaxis research will be available to patients and staff on that site, whether or
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Study Title: The Australian Calciphylaxis Registry
not they have contributed to the Registry. Of course, no data that could identify an
individual patient will be available on the web site.
What happens with the results?
If you give us your permission by signing the consent document, we plan to discuss these
Registry data with calciphylaxis registries that have been established in other countries
and to publish Registry results in peer-reviewed journals, and by presentation at
conferences or other professional forums.
In any publication, information will be provided in such a way that you cannot be identified.
Results of the study will be provided to you, if you wish.
Complaints
Establishment of the Australian Calciphylaxis Registry has been approved by Western
Sydney Local Health District Human Research Ethics Committee. If you have any
concerns about the conduct of the Registry, or your rights as a contributor, you may
contact:
XXXXXXX,XXXXXXX Hospital Patient Representative, (Contact details: Telephone No
XXXXXXX Email address: XXXXXXXXXX)
Contact details
When you have read this information, the researcher [name] will discuss it with you and
any queries you may have. If you would like to know more at any stage, please do not
hesitate to contact him/her on [number – or other if different]. If you have any problems
while on the study, please contact
Dr
XXXXXXXXXX
Working hours Telephone No -XXXXXXX
After hours Telephone No -
Thank you for taking the time to consider this study.
If you wish to take part in it, please sign the attached consent form.
This information sheet is for you to keep.
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PARTICIPANT INFORMATION SHEET AND CONSENT FORM
Study Title: The Australian Calciphylaxis Registry
CONSENT TO PARTICIPATE IN RESEARCH
Chief Investigator: XXXXXXXXX
1. I understand that the researcher will conduct this study in a manner conforming to ethical and scientific
principles set out by the National Health and Medical Research Council of Australia and the Good
Clinical Research Practice Guidelines of the Therapeutic Goods Administration.
2. I acknowledge that I have read, or have had read to me the Participant Information Sheet relating to this
study. I acknowledge that I understand the Participant Information Sheet. I acknowledge that the
general purposes, methods, demands and possible risks and inconveniences which may occur to me
during the study have been explained to me by ____________________________ (“the researcher”)
and I, being over the age of 16 acknowledge that I understand the general purposes, methods, demands
and possible risks and inconveniences which may occur during the study.
3. I acknowledge that I have been given time to consider the information and to seek other advice.
4. I acknowledge that refusal to take part in this study will not affect the usual treatment of my condition.
5. I acknowledge that I am volunteering to take part in this study and I may withdraw at any time.
6. I acknowledge that this research has been approved by the Western Sydney Local Health District
Human Research Ethics Committee.
7. I acknowledge that I have received a copy of this form and the Participant Information Sheet, which I
have signed.
8. I acknowledge that any regulatory authorities may have access to my medical records relevant to this
study to monitor the research in which I am agreeing to participate. However, I understand my identity
will not be disclosed to anyone else or in publications or presentations.
Before signing, please read ‘IMPORTANT NOTE’ following.
IMPORTANT NOTE:
This consent should only be signed as follows:
1. Where a participant is over the age of 16 years, then by the participant personally.
Name of participant _________________________________ Date of Birth __________________
Address of participant ____________________________________________________________
Signature of participant _______________________________ Date: ______________________
Signature of researcher ______________________________ Date: ____________________
Signature of witness ________________________________
Date: ____________________
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