Data Privacy
GenI-AIRSPACE is a research study coordinated and sponsored by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP) and funded by the Victorian State Government. The study adheres to guidance from the organisations involved in the research to ensure the data you provide in the study is secure and your privacy is protected.
Overview
Data Collection
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When you undergo genetic (also referred to as genomic) testing, samples from your previous cancer biopsies are tested. These samples are used to analyse your DNA for specific markers that might provide important health information and impact your care.
In the study, these samples will only be labelled with a unique laboratory identification code linked to your study identification number, preventing researchers from linking your samples to personal information.
Only the necessary data is collected, and you will be asked to provide written consent for the use of your genomic data for the study.
The results of the analysis would then be provided to you and your doctor to refer for shared decision-making of your best personalised treatment option.
Data Storage
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Once your genetic data is analysed, it is stored securely in a digital format by ANZUP using a database called REDCap. Think of this as placing your genetic information in a highly secure, digital vault that strictly adheres to data protection and privacy laws.
Data used for the study does not contain your name, only a unique study-specific identification (study ID) number.
The link between your study ID number and any personally identifiable information will remain confidential and securely stored separately from data used for research.
We must keep this data for at least 15 years from the end of the study, after which it will be destroyed securely.
Data Use
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Your genetic data is used to study how genetic information can guide the management of localised prostate cancer and whether we can safely use these results to make a stronger recommendation for active surveillance for people who have lower genetic risk scores.
This study hopes to provide a better prediction of the risk of prostate cancer progression to alleviate the anxiety that pushes people with favourable risk prostate cancer to opt for radical treatments that may not improve their quality of life (despite limited oncological benefits).
In some cases, with your consent (optional), it may also contribute to important medical research. For example, researchers might use anonymous data for secondary research to better understand the nature of prostate cancer.
Importantly, your data is only used in ways you have explicitly agreed to.
Further information
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Encryption: Protecting Your Data
Whenever your data is stored or shared, it is encrypted—similar to how banks protect your financial information. This means that even if someone were to intercept your data, they wouldn’t be able to read or use it without the proper authorisation.
Anonymity and De-identification: Safeguarding Your Identity
During this project, your personal identifiers (such as your name) are removed from your genetic data before it is used for research purposes. This process, known as de-identification, ensures that the data used for the purposes of the study cannot be traced back to you.
Ethical Standards: Responsible Data Use
The institutions that handle your genetic data adhere to strict ethical standards. These standards ensure that your data is used only for legitimate purposes and that privacy, confidentiality, and ethical principles are always respected.
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Only authorised healthcare professionals and researchers, who have undergone the appropriate training, can access your genetic information. Access is controlled and monitored to ensure your data is handled responsibly and securely.
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Before your genetic data is collected or used, you will be fully informed about how it will be handled, stored, and shared and asked to give your written consent. This will indicate that you have understood the information and freely agree to take part in the study as described.
In accordance with relevant Australian and State privacy and other relevant laws, you have the right to:
Access information about you that is collected and held by the project team.
Request that any information with which you disagree be corrected.
Please contact the study team on (phone) or email (krupa.mistry@unimelb.edu.au) if needed.
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The results of this trial will be published and presented by the researchers in scientific/medical journals and conferences. In any publication and presentation, they will not include information that can identify you personally.
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You are free to withdraw from the research project at any stage, without giving a reason, by contacting the research team on (phone) or email (krupa.mistry@unimelb.edu.au).
This will not affect your routine treatment or care, nor your relationship with those treating you.
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What Happens if There’s a Data Breach?
While data breaches are rare, we take them very seriously. If a breach were to occur, we have protocols in place to respond quickly, including notifying you and taking steps to secure your data. Our goal is to prevent breaches from happening and to minimise any potential impact if they do. If you suspect that your data has been breached, contact us immediately on (phone) and our study staff will guide you through planned procedures.
Will My Data Be Shared with Third Parties?
Your samples will not be shared or sold by the study sponsor (ANZUP) nor the study staff at any time and your data will never be shared with third parties without your explicit consent. If you consent (optional) to share your data for secondary research, it will be anonymised to protect your privacy and used only for studies that are approved by ANZUP and a Human Research Ethics Committee.
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If you join this clinical trial as a participant, you will be provided with a full participant information and consent form that will outline who to contact if you have concerns or complaints.
E: krupa.mistry@unimelb.edu.au