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

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Version 7, 30 April 2026​

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Title: Congenital Heart Alliance of Australia and New Zealand (CHAANZ) Congenital Heart Disease Registry

Short Title: CHAANZ CHD Registry

Protocol Number: X17-0441

Project Funding: Medical Research Future Fund

Coordinating Principal Investigator: Professor David Celermajer

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Click here to download a copy of this form

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Part 1. What does participation involve?

 

1. Introduction

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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 gain a better understanding of the health-related experiences and needs of people with CHD from childhood to adulthood.

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Participation in this research is voluntary. If you decide you do not want the person in your care to take part, they do not have to and you can choose to “Opt out”. They will receive the best possible care whether or not they take part.

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The person in your care will be automatically included in the CHAANZ CHD Registry, unless you decide to opt out.

 

If you would like to receive a paper copy of this Participant Information Sheet to keep, please contact us at ChaanzAdmin@chaanz.org.au and we will send one to you. You can also find more information about the study at https://www.chaanz.org.au/.

 

2. What is the purpose of this research?

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Congenital heart disease is a heart condition people are born with, affecting children and an increasing number of adults due to advances in care and later-life diagnoses. The Registry collects health information from people diagnosed with CHD who are managed at Congenital Heart Units across Australia and New Zealand. The CHAANZ CHD Registry aims to analyse all information entered into the database about everyone’s CHD diagnosis, treatment and outcomes, and illustrate whether complications can be improved over time. This database will also enable researchers to assess the quality of CHD care and implement strategies to improve outcomes for people with CHD.

 

The Registry was established in 2016 with consumers (including patients, people caring for people with CHD, clinicians) helping to design the project from the outset, and they continue to play an active role in guiding its ongoing priorities and research agenda.

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3. What does participation in this research involve?

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If you are happy to have the person in your care’s health information included in the Registry, you do not have to do anything. Information relevant to their CHD care will be collected from their medical record and entered into a secure database. This will happen approximately four weeks after you have received this information. Additional information will be added each time they visit their doctor or at periodical intervals.

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The study doctor and research staff will review their 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, medications);

• 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 their medical record will also be linked with administrative health datasets and other approved databases. We may share their personal information with the Australian Institute of Health and Welfare (AIHW) to link their data with other databases routinely collected by the Government including the Medicare Consumer Directory, Medicare Benefits Schedule, Pharmaceutical Benefits Scheme, National Death Index, Australian Cancer Database, National Hospitals Data Collection, National Hospital Morbidity Database, National Non-Admitted Patient Emergency Department Care Database, National Non-Admitted Patient episode-level Database, National Disability Insurance Scheme, ANZ Intensive Care Society and the National Health Data Hub. Personal details will be stored separately from de-identified data, with all linkage activities strictly bound by privacy laws and rigorous security approvals.  Using these datasets helps us understand how people use health services and can improve care for people with CHD.

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

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There are no costs associated with participating in the Registry, nor will the person in your care be paid.

 

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

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Participation in any research project is voluntary. If you do not wish for the person in your care 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 them from the Registry at any stage.

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If you would prefer for them not to participate in the Registry, you will need to tell us by completing the “Opt-Out Form” at the end of this information sheet. If we do not hear from you within four weeks, we will assume that you are happy for us to collect their information. Please note that the four-week period is a minimum and you can choose to opt out at any time after the initial four-week period. While we cannot remove your information from research that has already been published or datasets that have already been anonymised and linked, your data will be removed from the Registry. This will ensure your data is not included in any future research, publications, or new data linkages.

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We make every effort to ensure that patients who have opted out of the study are not invited again to take part. Errors can occur, for example, if you have already opted out at one hospital, and then attend a second hospital, your wishes may not be known to the second hospital. We sincerely apologise for any inconvenience caused.

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Your decision to take part or not to take part, or withdraw, will not affect the person in your care’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?

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While we intend that this research study furthers medical knowledge and may improve CHD outcomes in the future, it will not be of direct benefit to the person in your care.

 

6. What are the possible risks of taking part?

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There are no risks to having health information stored in the Registry. Researchers directly involved with collection of data will have access to the person in your care’s medical record. To ensure that their private information is safeguarded, study staff must comply with very strict privacy principles. Researchers will not release your information to any person or organisation outside the Registry except for the purposes of linkage with administrative health datasets (see section 3) or training and utilising artificial intelligence tools for data collection. Even in these specific cases, your privacy remains strictly protected. Any work with artificial intelligence involves collaboration with approved academic researchers who will access data at the University of Sydney, we will not share their data with commercial organisations. No report will contain identifying information about the person in your care.

 

7. What if I withdraw the person in my care from this research project?

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If you decide to withdraw the person in your care 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 information sheet.

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If you decide to leave the research project at any time, the research team will not collect any additional health information about the person in your care. Any data already collected that have not been included in publications or in anonymised, linked datasets can be removed upon request. Information collected up to the time you withdraw may still form part of the research project results unless you request removal of eligible data at the time of withdrawal.. 

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8. What will happen to information about the person in my care?

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Any information collected for the Registry that can identify the person in your care will remain confidential. We will use this information only for research purposes. Health information and personal information which may identify them will be permanently stored in a secure, password protected, electronic database. Only the researchers involved with this project at the CHD service, the Registry management team and the Ethics Committee can have access to this information.

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Once the information is entered into the Registry, it will be given a unique identification number. Only the research team can re-identify their information if it is necessary to do so. The database platform managed by the data custodian is located on secure servers in Sydney, Australia and are accessible only by named researchers approved by the Ethics Committee.

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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.

 

9. Future use of Data 

 

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, however the use of the data will be subject to ethics approval.

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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).

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Reports may be presented at conferences or published in medical journals. The person in your care 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 at https://www.chaanz.org.au/.

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10. Further information and who can I contact?

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If you want any further information concerning this project or if you have any problems which may be related to the person in your care’s involvement in the project, you can contact a member of the research team with the contact information listed on your invitation letter, or you can email ChaanzAdmin@chaanz.org.au to get in touch with the coordinating team, and we will respond to your query within 14 days.

 

11. Ethics Approval and Complaints

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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.