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CHAANZ CHD Registry Consent for Parents & Guardians

To find out more about your child’s participation in the CHAANZ CHD Registry, please read the
following information. If you choose to not participate in the research, please complete the Opt-Out
Form located here at the end of this form.

Version 4, 01 March 2023

Part 1. What does the child’s participation involve?


1. Introduction

The CHAANZ Congenital Heart Disease (CHD) Registry, is a database collecting health information
on children and adults living in Australia and New Zealand who have had a diagnosis of a CHD. The
registry has been designed to better understand the health-related experiences and needs of people
with CHD from childhood to adulthood.

This Participant Information Sheet has been given to you to tell you about the Registry and because
the child in your care has been diagnosed with congenital heart disease. It explains what is involved.
Knowing what is involved will help you decide if you the child want to take part. The child’s heart
doctor is best placed to convey and discuss this with you.

Please read this information carefully. Ask questions about anything that you don’t understand or
want to know more about. Before deciding whether or not the child can take part, you might want to
talk about it with a relative, friend or local health worker.

Participation in this research is voluntary. If you decide you do not want for the child in your care to
take part, they do not have to and you can choose to “Opt out”. The child will receive the best possible
care whether or not they take part. The child will be automatically included in the Registry,
unless you decide to opt out.


2. What is the purpose of this research?

Congenital heart disease (CHD) is a heart problem people are born with. It is the most common
congenital disorder in newborns and although it is often associated with babies and children,
congenital heart disease now affects more teenagers and adults who are either living longer due to
surgical and medical advancements, or are being diagnosed with the condition later in life.

The CHAANZ CHD Registry is a database collecting health information. The aim of the registry is to
gain a better understanding of the experiences and needs of people with CHD from childhood to
adulthood. Information from the registry will be used to monitor the clinical care that is provided,
including treatment, complications and both short- and longer-term outcomes. This information will
be used to help identify trends and whether gaps exist in service provision. It will be imperative to
people with CHD, the healthcare professionals responsible for managing them and health policy
makers, to ultimately deliver better, more sustainable models of care. The Registry will become a
unique tool to help researchers and doctors to improve the health and quality of care for people with
CHD through all phases of life.

The Registry will be collecting data on people who have been diagnosed with congenital heart
disease and those who are being managed at Congenital Heart Units at participating hospitals in
Australia and New Zealand.

This research project is being coordinated by the Congenital Heart Alliance of Australia and New
Zealand (CHAANZ) and funded by HeartKids Limited with support from The Kinghorn Foundation
and The Pinnacle Charitable Foundation, and a Medical Research Future Fund from the Australian
Government Department of Health.


3. What does participation in this research involve?

If you decided that the child may take part in the Registry, you do not have to do anything. Information
will be collected from the child’s hospital medical record and entered a secure database. This will
happen approximately two weeks after you have received this information sheet. Additional
information will be added each time the child visits their doctor or at periodical intervals.

The study doctor and research staff will review the child’s medical records and collect the following
information about their health and wellbeing, if available:

• Demographic information (e.g., name, date of birth, address, cardiologist, next of kin etc.);
• Medical history (e.g., diagnosis, heart operations, other health conditions, complications,
• Investigations (e.g., echocardiogram reports, catheter tests, blood tests);
• Routine visits and monitoring (e.g., changes in their condition, medications, new heart
operations, complications, hospital admissions);
• Other factors influencing outcomes (e.g., pregnancy, substance use, transplant or death);
• Information about their general state of health.

Information collected from the child’s medical records will also be linked with administrative health
dataset. Administrative datasets are data collected for the purposes of running and managing
Australia’s health systems at the state and federal level. Information in the federal datasets can
include claims from the Medicare Benefits Schedule (i.e. GP visits), the Pharmaceutical Benefits
Scheme (i.e. medications) or the National Death Index (mortality data). Information from the state
datasets can include hospital admissions, emergency department admissions or ambulance care.
The use of administrative datasets can provide a rich source of information about how people interact
with the health system and can provide insights that can improve health service delivery for people
with CHD.

Participating in the Registry will not require the child to have any additional procedures or tests.
Personal information is required to link the child’s information with any further follow-up visits. This
information allows us to collect information regarding the child’s health care needs from other
hospital systems and administrative health datasets.

Most information will be obtained from the child’s medical records, however one of the research staff
may call you to ask questions about the state of the child’s health each one to two years. This call
will usually take three to five minutes to complete.

There are no costs associated with participating in the Registry, nor will you or the child be paid.


4. Does the child have to take part in this research project?

Participation in any research project is voluntary. If you do not wish for the child to take part, they do
not have to. If you decide they can take part and later change your mind, you are free to withdraw
then from the Registry at any stage.

If you would prefer for the child to not to participate in the Registry, you will need to tell us by
completing the “Opt-Out Form” at the end of this form. If we do not hear from you within two weeks,
we will assume that you are happy for us to collect the child’s information.
Your decision to take part or not to take part, or withdraw, will not affect the child’s routine care or
their relationship with their heart doctor and staff who care for them in any way.


5. What are the possible benefits of taking part?

There are no immediate benefits for you participating in the Registry. However, it is possible that
information learned from the Registry will help doctors have a better understanding of CHD, be used
to further medical knowledge and improve patient care and will most likely benefit people diagnosed
with this condition in the future.

There will be no clear benefit to the participant from their participation in the research.


6. What are the possible risks of taking part?

There are no risks to having the child’s health information stored in the Registry. Researchers directly
involved with collection of data will have access to their medical record. To ensure that the child’s
private information is safeguarded, Registry staff must comply with very strict privacy principles.
Researchers will not release the child’s identifiable information to any person or organisation outside
the Registry. No report will contain identifying information about the child.


7. What if I withdraw from this research project?

If you decide to withdraw the child from this research project, you will need to notify a member of the
research team and you will need to complete the “Opt-Out Form” at the end of this form.

If you decide for the child to leave the research project, research team will not collect additional
health information about them, although information already collected will be retained to ensure that
the results of the research project can be measured properly and to comply with law. You should be
aware that data collected up to the time you withdraw the child will form part of the research project

Part 2. How is the research project being conducted?


8. What will happen to information about the child?

Any information collected for the Registry that can identify the participant will remain confidential.
We will use this information only for research purposes. We can disclose this information only with
your permission, except as required by law.

Health information and personal information which may identify the child will be permanently stored
in a secure, password protected, electronic database. Only the researchers involved with this project
at the child’s congenital heart disease service, the Registry management team and the Ethics
Committee can have access to this information. Once the information is entered into the Registry, it
will be given a unique identification number. Only the research team can re-identify the child’s
information if it is necessary to do so. In accordance with relevant Australian and/or state privacy
and other relevant laws, you have the right to request access to the information about the child that is collected and stored by the research team. You also have the right to request that any information
with which you disagree be corrected. Please inform the research team member named on the
business card if you would like to access to the child’s information.

As this is an ongoing Registry, data will be kept indefinitely in a secure environment as long as the
Registry exists. If the Registry ceases to exist, the information stored in the Registry will be destroyed
in a secure manner.

The data collected in this project may also be used in future research studies. The results of this
study and de-identified data may be shared in the future with national and international collaborators.
Any data that is used for related or future research will first be reviewed and approved by an
appropriately constituted Ethics Committee. If you do not wish for the child’s data to be used in future
research, please contact a member of the research team with the contact details provided on the
business card to notify them of your decision.

The data in the Registry may form part of an Honours, Masters by Research or a Doctor of
Philosophy thesis. Prospective students must be associated from a contributing centre and the site
Principal Investigator must be involved in the student’s supervision (either as lead or as auxiliary

Reports may be presented at conferences or published in medical journals. The child will not be
identified in any reports or publications. If you are interested in the research findings from the
Registry, summaries and the latest news will be available on the CHAANZ website.


9. Further information and who can I contact?

The person you may need to contact will depend on the nature of your query. If you want any further
information concerning this project or if you have any problems which may be related to your
involvement in the project, you can contact a member of the research team with the contact
information listed on your business card. For general queries related to the CHAANZ Registry, you
can complete the contact form on this website to get in touch with the coordinating team.


10. Ethics Approval and Complaints

This study has been approved by the Ethics Review Committee (RPAH Zone) of the Sydney Local
Health District. Any person with concerns or complaints about the conduct of this study should
contact the Executive Officer on 02 9515 6766 and quote protocol number X17-0441.

Please ONLY complete this form if you DO NOT want to participate in the Registry

This form is only to be completed if you do not want the child’s information to be collected for the Registry

Declaration by Parent/Guardian

  1. I do not wish for the child to participate in the Registry and I understand that my decision will not affect the child’s future health care.

  2. I have read the attached Participant Information Sheet. 

  3. I understand the purposes, procedures and risks of the research described in the project.

  4. I have had an opportunity to ask questions and I am satisfied with the answers I have received.

Please complete the following information so your preferences are successfully recorded:

Thanks for submitting!

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