Research is an important part of our healthcare system. In NSW and across Australia, our researchers contribute to discoveries that help us lead longer, healthier lives.
The researcher asking you to take part study might provide your care, or they might work for a hospital or practice that you visit.
You are being asked to participate in health and medical research by:
• donating a sample to the NSW Health Statewide Biobank, and
• giving permission for NSW Health to link your health and personal information to the sample.
You can read more about type of health and personal information linked to your sample in the health and personal information and health data section of the FAQs.
Your participation provides researchers with a valuable resource that helps them to understand and improve the way disease is detected, diagnosed and treated.
If you choose to take part, to you are encouraged to tell your family about your decision to support research in this way.
A biobank is a collection of human biological samples or ‘biospecimens’ (e.g. tissue removed during an operation, blood or bone) and/or their products (e.g. DNA). Like a bank, samples donated for health and medical research are kept under tight security and in carefully controlled conditions.
Health data is also linked your sample. Samples are stored securely, together with samples from many other people, for use in ethically approved health and medical research projects, now and into the future.
Storing samples together allows researchers from across NSW and Australia to work together to find new or better treatments for illness and disease.
The NSW Health Statewide Biobank is a secure NSW Government facility. It’s the largest facility of its kind in the Southern Hemisphere and uses robotic technology to store and process millions of biospecimens to support health and medical research.
The Biobank provides approved researchers with access to a range of human samples (such as blood or tissue) and linked health data to help them better understand, detect and treat illness. It could even help them discover new treatments for diseases such as cancer or diabetes.
You can find more information at www.biobank.health.nsw.gov.au.
It is not likely participants will benefit directly. Your choice to donate a sample and allow access to your health and personal information will support research that could result in discoveries that could change, improve and save the lives of others in the future.
Health information is regarded as one of the most sensitive types of personal information. For this reason, there are laws, policies and procedures in place to protect the safety and security of your sample and your health and personal information.
While we take the greatest possible care to protect you, there are some risks associated with participating in health and medical research. This could include:
• There is a rare risk that a serious incidental finding could be made. This happens when a researcher discovers something potentially serious about your health that they weren’t looking for. If a finding is confirmed after further tests, there is a chance your future income protection and private health insurance policies could be affected. It might also have health implications for you or your genetic relatives. Read more about this in the FAQ section on serious findings.
• There is a rare risk of breach of privacy. If this were to happen, it would be dealt with in line with strict NSW and Commonwealth Government privacy laws and guidelines. Read more about this in the FAQ section on protecting your privacy.
DONATING A SAMPLE
How and when your sample is collected will depend on the type of condition and/or procedure you have. It will also depend on the type of research intended for your sample and the type of sample collected.
For example, if you have surgery to remove tissue (e.g. from a cancer tumour), with your consent any remaining from your sample after diagnosis would be stored in the Biobank. You could also be asked to donate a separate blood sample.
The researcher can give you more information about how and when your sample is taken.
Your sample will be stored in the NSW Health Statewide Biobank under strict conditions to ensure it remains safe and in the highest quality condition.
Your sample could be held indefinitely and made available to researchers with ethically approved studies, now and into the future.
You can choose to withdraw your consent and donation at any time. If you decide to stop taking part, your sample would be removed from the Biobank and destroyed.
HEALTH AND PERSONAL INFORMATION AND HEALTH DATA
Health and personal information is information about you and your health. It includes information that could identify you.
Legal definitions can be found here:
The term ‘data linkage’ is now commonly used to describe how a sample is electronically matched to your health data, using your health and personal information.
Linking your sample to your health data, provides researchers with a valuable resource that helps them to investigate and improve the way disease is detected, diagnosed and treated.
For more information, see www.cherel.org.au/how-record-linkage-works.
The matching of your donated sample with your health data gives researchers a broader picture of your health over the course of your life.
Data linkage helps researchers better understand a person’s individual health and healthcare. It allows a person’s health to be followed over time, which can reveal more about how an individual’s lifestyle, medications, treatments, genes or other factors might affect future health.
Data linkage also helps researchers better understand the health and wellbeing of our communities. It can also help to improve the delivery of healthcare, develop future treatments and even cures.
The type and source of health data linked to your sample is detailed in the Participant Information Sheet.
This might include:
- your diagnosis, for example operation and test results
- the times you go to the emergency department or had to stay in hospital
- the times you go to the family doctor (based on Medicare Benefits Schedule claims)
- the prescription medicines you get from a pharmacy (based on Pharmaceutical Benefits Scheme claims)
- other information that affects health, such as your education, employment and lifestyle, and
- research that is done on your sample.
This will not include:
- information from the Police
- information from the Australian Taxation Office, or
- information from Centrelink
When health data is given to researchers it will not include your name and address.
NSW Health, including the NSW Health Statewide Biobank, could hold health and personal information forever. It is kept under strict security and privacy conditions in line with the law.
You can choose to stop taking part at any time.
RESEARCHER ACCESS TO SAMPLES AND HEALTH DATA
Committee. It must also be supported by the research institution or organisation they work for.
Only legitimate and approved health and medical researchers can apply for access to your sample and health data.
Before they can access samples and linked health data, researchers must apply to the Biobank. They must provide detailed information about their research project and credentials.
Research projects must also be approved by a Human Research Ethics Committee.
For more information, see www.cherel.org.au/how-record-linkage-works.
Researchers can hold your sample and health data in accordance with the Human Research Ethics Committee approval for their research project.
This can vary between research projects.
After your information is linked, researchers are provided with your health data. Your name and address has been removed and replaced with a random number. This helps to protects your privacy.
In rare cases, researchers might be able to identify you from your health data. If this happens, researchers are required by law to maintain your privacy.
It is common in health and medical research for interstate and international researchers to work together. Your sample and health data may be sent interstate or overseas for collaborative research purposes. It will not include your name or address.
Collaboration helps to speed up the time it takes to translate research lab discoveries into better patient care.
Your sample and data will only ever be shared with researchers after a Human Research Ethics Committee (or an equivalent committee that meets internationally accepted ethical standards) has approved the research.
PROTECTING YOUR PRIVACY
Your data will be held securely by NSW Health or by an approved institution, for example a Medical Research Institute or University.
All data will need to be held securely according to the ethics approval, privacy laws and the legal contract with NSW Health.
Your information is protected under the NSW Privacy and Personal Information Protection Act (1998) (https://www.ipc.nsw.gov.au/privacy/nsw-privacy-laws/ppip-act) and the Health Records Information Privacy Act (2002) (https://www.ipc.nsw.gov.au/privacy/nsw-privacy-laws/hrip-act) or international equivalent.
The NSW Health Statewide Biobank, and Australian and international researchers accessing the Biobank must adhere to these laws, their ethics approval and policy.
You will not always know what research projects your sample is being used for. This is because your sample is safely stored in the NSW Health Statewide Biobank and shared with approved researchers without your identifying details, such as your name, address or date of birth.
A list of research projects that store and access samples in the NSW Health Statewide Biobank and publications from this research are available our website.
You can also find some examples of the types of research projects your samples may be used for in the Participant Information Sheet.
No. By making a decision to donate your sample, you are consenting for your samples to be used for ethically approved health and medical research.
It could be used to help a number of researchers who are searching for new and better treatments for conditions such as cancer, rare diseases and strokes, now and into the future.
Serious findings are also known as 'incidental findings'. These findings happen when a researcher discovers something potentially serious about your health that they weren't specifically looking for.
Very rarely when tests are done on donated samples, a potentially serious and important piece of information can be discovered. For example, a change in your DNA could indicate a higher risk of a heart problem. This DNA might be something you share with your genetic relatives, such as your parents, siblings or children.
In the consent form, we ask you to agree to be contacted, by your doctor or healthcare professional, about a potentially serious finding.
You would only be contacted about potentially serious findings if they meet each of the following criteria
- Significant: The finding indicates a potentially life-threatening health condition or affects your reproductive health.
- Actionable: There are specific established treatments or other available actions that might help you.
- Confirmed: The finding has been checked and confirmed as accurate and/or valid, as far as reasonably possible within a research context.
General health information, such as evidence of increased risk of high cholesterol or diabetes, will not be returned. It is important to continue your regular health check-ups with your family doctor.
For more information on how we deal with potentially serious findings, see here.
In the rare event that a potential serious finding is discovered, the matter would be referred to clinical experts.
If the clinical experts determine that the potential serious finding is significant, actionable and confirmed, they would inform your doctor or healthcare professional.
The nominated clinician would contact you to tell you that a potential serious finding might exist and you would be referred to a medical expert or genetic counselor.
You are being told about a potential serious finding, as this knowledge could give you early access to information that helps you understand or protect your health and wellbeing, or the health and wellbeing of your family.
In rare cases, taking part in health and medical research might affect health or life insurance cover for you and your blood relatives. For example, if you have a serious and life threatening genetic condition that you share with your family, it could affect insurance you apply for in the future (for example life insurance or income protection). A fact sheet is available at https://www.fsc.org.au/resources/1785-moratorium-key-facts.
You are encouraged to seek specific advice from your doctor and/or your insurer.
If you are contacted about a potential serious finding, but you do not wish to see a medical expert or take further testing, you do not have to.
No. Your decision to take part in health and medical research is voluntary and you will not receive any payment for your donation.
WITHDRAWAL OF CONSENT OR CHANGE OF DETAILS
Click here to complete the withdrawal of consent form.
If you choose to stop taking part, the samples you donated will be removed from the NSW Health Statewide Biobank and destroyed. Your health and personal information, held in the Biobank, will be deleted. Your sample might have already been given to a researcher and used for a study. They will be asked to destroy this sample if it has not already been used up.
Not yet, but the NSW Health Statewide Biobank will work to make these available in other languages.
If you would like more information about the NSW Health Statewide Biobank or your participation, call 02 4920 4140 or email NSWPATH-Biobanking@health.nsw.gov.au.
Please keep a copy of your Participant Information Sheet with the copy of your signed Consent Form.
If you have any concerns or complaints, these should be directed to: Sydney Local Health District Human Research Ethics Committee Ph: 02 9767 5622 or firstname.lastname@example.org.