CHAANZ CHD Registry Consent for Participants
To find out more about your participation in the Adult Congenital Heart Disease (ACHD) Database and the CHAANZ Congenital Heart Disease (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.
Royal Prince Alfred Hospital ACHD (X18-0189) & CHAANZ (X17-0441)
Version 10.1, 26 February 2025
Part 1. What does my participation involve?
1. Introduction
Database and the CHAANZ Congenital Heart Disease (CHD) Registry. The ACHD Database collects information from people receiving medical treatment for congenital heart disease at the Royal Prince Alfred Hospital and its clinics. The CHAANZ 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. Both projects have been designed to gain a better understanding of the health-related experiences and needs of people with CHD from childhood to adulthood.
These projects are being overseen within this institution by Professor David Celermajer.
The database and registry aim to record information on every person who has been diagnosed with this condition. The success of the database depends on the amount of data we collect. We are asking you to participate by allowing us to document health information relevant to your condition.
This Participant Information Sheet has been given to you to tell you about these research projects 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 database and 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 ACHD Database and CHAANZ CHD Registry are databases that collect health information 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. These research projects will become unique tools to help researchers and doctors to improve the health and quality of care for people with CHD through all phases of life.
The ACHD Database will be collecting information from people receiving medical treatment for congenital heart disease at the Royal Prince Alfred Hospital and its clinics. The Registry will be collecting data on people with Congenital heart disease who are being managed at Congenital Heart Units at participating hospitals in Australia and New Zealand.
The ACHD Database is funded by the Adult Congenital Heart Disease Service at Royal Prince Alfred Hospital. The CHAANZ CHD Registry is coordinated by the Congenital Heart Alliance of Australia and New Zealand (CHAANZ). The Registry is funded by HeartKids Limited with support from the Kinghorn Foundation and the Pinnacle Charitable Foundation, and the Australian Government Department of Health’s Medical Research Future Fund.
3. What does participation in this research involve?
If you decide to take part in these research projects, you do not have to do anything. Information will be collected from your medical records at Royal Prince Alfred Hospital, the Children’s Hospital at Westmead and other institutions/practices where you may have received care for your congenital heart disease and stored in a secure database. This will happen approximately four 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
datasets and other approved databases. 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.
Researchers will continue to review your medical records in order to track the long-term patterns in your health. In the event that you are no longer being seen at Royal Prince Alfred Hospital or any other of the participating institutions/practices, researchers will continue to monitor information about your health status from Commonwealth health agencies under strict confidentiality conditions.
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 these projects, 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 these research projects, you will need to tell us by completing the “Opt-Out Form” on Page 6. 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 withdraw at any time after this period, and any data not already included in analysis will be removed.
Your decision to take part or not to take part, or withdraw, will not affect your routine care, your relationship with your heart doctor or your care at Royal Prince Alfred Hospital in any way.
5. What are the possible benefits of taking part?
There are no immediate benefits for you participating in these research projects. However, it is possible that information learned from these projects 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 databases. Researchers directly involved with collection of data will have access to your medical record. To ensure that your private information is safeguarded, all staff must comply with very strict privacy principles. Except for the purposes of linkage with administrative health datasets (see section 3) or utilising advanced computational tools for data extraction, 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 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 form.
If you decide to leave the research projects, 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 projects can be measured properly. 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 these research projects 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 the Royal Prince Alfred Hospital, the Database and Registry management team and the Ethics Committee can have access to this information. Once the information is entered into these 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.
In accordance with relevant Australian and/or NSW 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 these are ongoing research projects, data will be kept indefinitely in a secure environment as long as these databases exist. The ACHD Database is stored on a research database securely stored on RPAH cardiology department servers. If the database or Registry ceases to exist, the information stored 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 below 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 with 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. Who has reviewed the research project?
This project will be carried out according to the National Statement on Ethical Conduct in Human Research (2007). This statement has been developed to protect the interests of people who agree to participate in human research studies.
10. Further information and who can I contact?
Ethics Approval and Complaints
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 the participant has any problems which may be related involvement in the project, you can contact Danielle Osborn, ACHD Nurse Care Manager, Cardiology Department on 02 9515 7604 or email danielle.osborn@health.nsw.gov.au.
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 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.