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To find out more about your participation in the ACHD Database and 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 at the end of this form.

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Version 12, 30 April 2026            ​​

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Title: Adult Congenital Heart Disease (ACHD) Database and the Congenital Heart Alliance of Australia

and New Zealand (CHAANZ) Congenital Heart Disease Registry

Short Title: ACHD Database and CHAANZ CHD Registry

Protocol Number: X18-0189 and X17-0441

Project Sponsor: Not applicable

Principal Investigator: Professor David Celermajer

Associate Investigators: Associate Professor Rachael Cordina, Dr David Baker

Location: Royal Prince Alfred Hospital and associated clinics

 

Click here to download a copy of this form 

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Part 1. What does my participation involve?

 

1. Introduction
 

You are being invited to take part in two related studies. The first is the Adult Congenital Heart Disease Database, which is the local research database at Royal Prince Alfred Hospital and its associated clinics, collecting information from people receiving medical treatment for congenital heart disease. This database forms part of the larger CHAANZ Congenital Heart Disease (CHD) Registry. 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. By participating, your information will be included in both the local ACHD Database at Royal Prince Alfred Hospital and the CHAANZ CHD Registry.

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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 databases, 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/.

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2. What is the purpose of this research?
 

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 ACHD Database will be collecting information from people receiving medical treatment for congenital heart disease at the Royal Prince Alfred Hospital and its associated clinics. 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.

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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 your health information included in the databases, you do not have to do anything. Information relevant to your CHD care will be collected from your 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 you visit your doctor or at periodical intervals.

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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 record will also be linked with administrative health datasets and other approved databases. We may share your personal information with the Australian Institute of Health and Welfare (AIHW) to link your 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. Your 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 studies will not require you to have any additional procedures or tests.

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

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

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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 databases at any stage.

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If you would prefer not to participate, 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 your 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 databases. 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 your routine care or your relationship with your heart doctor and staff who care for you in any way.

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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 you.

 

6. What are the possible risks of taking part?​

There are no risks to having your health information stored in the databases. Researchers directly involved with collection of data will have access to your medical record. To ensure that your 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 studies 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 your data with commercial organisations. No report will contain identifying information about you.

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

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If you decide to withdraw from these research projects, 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 projects at any time, the research team will not collect any additional health information about you. 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 me?​

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Any information collected for the databases that can identify you will remain confidential. We will use this information only for research purposes. 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 CHD service, the database management team and the Ethics Committee can have access to this information.

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Once the information is entered into the databases, it will be given a unique identification number. Only the research team can re-identify your 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 these are ongoing databases, data will be kept indefinitely in a secure environment as long as they exist. If the databases cease to exist, the information stored in the databases will be destroyed in a secure manner.

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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. You will not be identified in any reports or publications. If you are interested in the research findings from the databases, 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 your 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.

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11. Ethics Approvals and Complaints 

 

These studies have 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 these studies should contact the Executive Officer on 02 9515 6766 and quote protocol number X18-0189 or X17-0441.

 

The conduct of this study at Royal Prince Alfred Hospital has been authorised by the Sydney Local Health District. Any person with concerns or complaints about the conduct of this study may also contact the Research Governance Officer on 02 9515 6766 and quote protocol number X18-0189 or X17-0441.​

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