To find out more about your 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 my 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
you have been diagnosed with congenital heart disease. It explains what is involved. Knowing what
is involved will help you decide if you want to take part. Your 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 to 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 to take part, you do not
have to and you can choose to “Opt out”. You will receive the best possible care whether or not you
take part. You will be automatically included in the Registry, unless you decide to opt out.

You will be given a copy of this Participant Information Sheet to keep.

​

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 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, and 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 are happy to have your health information included in the Registry, you do not have to do
anything. Information will be collected from your hospital medical record and entered into a secure
database. This will happen approximately two weeks after you have received this information sheet.
Additional information will be added each time you visit your doctor or at periodical intervals.

The study doctor and research staff will review your medical records and collect the following
information about your 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,
medications);
• Investigations (e.g., echocardiogram reports, catheter tests, blood tests);
• Routine visits and monitoring (e.g., changes in your condition, medications, new heart
operations, complications, hospital admissions);
• Other factors influencing outcomes (e.g., pregnancy, substance use, transplant or death);
• Information about your general state of health.

Information collected from your 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
congenital heart disease.

Participating in the Registry will not require you to have any additional procedures or tests.

Personal information is required to link your information with any further follow-up visits. This
information allows us to collect information regarding your health care needs from other hospital
systems and administrative health datasets.

Most information will be obtained from your medical records, however one of the research staff may
call you to ask questions about the state of your 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 be paid.

​

4. Do I have to take part in this research project?​

​

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

​

If you would prefer 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 your information.

Your decision to take part or not to take part, or withdraw, will not affect your routine care or your
relationship with your heart doctor and staff who care for you 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 your health information stored in the Registry. Researchers directly
involved with collection of data will have access to their medical record. To ensure that your private
information is safeguarded, Registry staff must comply with very strict privacy principles. Except for
the purposes of linkage with administrative health datasets (see section 3), researchers will not
release your identifiable information to any person or organisation outside the Registry. No report
will contain identifying information about you.

 

7. What if I withdraw from this research project?​

​

If you decide to withdraw 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 to leave the research project, research team will not collect additional health information
about you, 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 will form part of the research project results. 

 

8. What will happen to information about me?​

​

Any information collected for the Registry that can identify you 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 you will be permanently stored in a
secure, password protected, electronic database. Only the researchers involved with this project at
your 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 your 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 you 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 at the end of this document if you
would like to access your 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 your 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
supervisor).

Reports may be presented at conferences or published in medical journals. You 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.