Frequently Asked Questions

Australian Arthritis & Autoimmune Biobank Collaborative (A3BC)

Taking part

The Australian Arthritis and Autoimmune Biobank Collaborative (A3BC) was formed as an expansion of the national Australian Rheumatology Association Database (ARAD). The A3BC vision is to find cures for musculoskeletal and autoimmune diseases.

Musculoskeletal conditions affect your bones, joints and/or muscles due to several reasons and have names like Gout, Lower Back Pain and Osteoarthritis (OA). Autoimmune conditions happen when your body is attacked by its own immune system and have names like: Vasculitis, Sjogren’s Syndrome and Scleroderma. While a number of conditions are both musculoskeletal and autoimmune, including: Rheumatoid Arthritis (RA), Juvenile Idiopathic Arthritis (JIA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS) and Myositis.

Research is an important part of our healthcare system and the A3BC’s aim is to give researchers and doctors the best chance of discovering why some people are more likely to develop these conditions. The A3BC will also research why some develop a worse type of these conditions, and why some people respond or don’t respond to different treatments.

The A3BC is a valuable resource to help researchers and doctors better understand and improve the way these conditions are detected, diagnosed and treated.

The project is led by a national scientific committee, led by Professor Lyn March at Royal North Shore Hospital (Sydney, NSW).

You are being invited to take part in the A3BC project because you have a musculoskeletal and/or autoimmune condition affecting your bones, joints, muscles, immune system or other parts of your body. Or, you may participate in the A3BC as an important healthy or at-risk control participant.
NOTE: THIS IS NOT A DRUG / CLINICAL TRIAL. You and your rheumatologist / GP will continue to decide which treatment is best for you.

Full participation in the A3BC project would involve you:
1.     Completing online surveys every 6 – 12 months
2.     Permitting access to your medical/health data
3.     Donating small samples of your blood, tissue or fluids (biospecimens) over a 2-year period (or later if disease flare, treatment change or surgery occurs).

If you prefer, you could also partially participate, for example, only donate biospecimens and/or permit health data access.

You can read more about the types of health and personal information linked to your sample in the Health and Personal Information and Health Data section of this FAQ.

If you choose to take part, you are encouraged to tell your family about your decision to support musculoskeletal and autoimmune research through participating in the A3BC project.

A biobank is a collection of human biological samples or ‘biospecimens’ (e.g. blood, tissue removed during an operation, joint or other body fluid or bone) and/or their products (e.g. DNA, serum, cells). Like a bank, samples donated for health and medical research are kept under tight security and in carefully controlled conditions.

Health and personal data are also linked to your samples. 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 Australia to work together to better understand illness and disease. This includes the causes, risk factors, diagnosis and treatment of disease, genetics or multi-omic research and clinical trials.

The A3BC is a biobank-registry that was formed as an expansion of the national Australian Rheumatology Association Database (ARAD), with the aim of giving researchers and doctors the best chance of discovering why some people are more likely to develop these diseases, why some develop a worse type of these diseases, and why some people respond or don’t respond to different treatments. Our vision is to find a cure for these diseases.

The Australian Rheumatology Association (ARA) is a Partner Organisation of A3BC. The project is led by a national scientific committee, led by Professor Lyn March based at Royal North Shore Hospital in Sydney, NSW. The project has unrestricted funding from Government, charity, medical research and pharmaceutical organisations, which are managed through the University of Sydney.

If you have a child with JIA, you may also be contacted by our paediatric research partner studies, the Australian Juvenile Arthritis Registry (AJAR), and the Australia and New Zealand ChiLdhood Arthritis Risk factor Identification sTudY (ANZ CLARITY) led by Professor Jane Munro at the Murdoch Children’s Research Institute in Melbourne. The A3BC and ANZ-CLARITY are working together to gather information and biological samples from children with JIA.

The NSW Health Statewide Biobank (NSWHSB) is a secure NSW Government facility which the A3BC uses (as a service) for part of its blood collections in NSW. 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.

As a service, the NSWHSB 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.

If researchers apply for A3BC samples/data stored by the NSWHSB and funded by the NSW Biospecimen Collection Grant (NSW BCG), the access process will follow the NSW Statewide Biobank’s Access Policy for NSW Health Supported Strategic Collections (v2 or later). If researchers apply for access to a mixture of A3BC funded and NSW BCG funded samples, both A3BC and NSWHSB access policies will apply. If researchers apply for A3BC samples/data stored entirely by the A3BC, only the A3BC Access Policy is used.

You can find more information at biobank.health.nsw.gov.au

It is not likely that A3BC participants will directly benefit. Your choice to donate a sample and allow access to your health and personal data will support research for the public good that may result in discoveries that could change, improve or save your life or 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 the A3BC 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, it might have health implications for you or your relatives. Read more about this in the FAQ section on Serious Findings. There is also a chance your future income protection and private health insurance policies could be affected.
  • There is a rare risk of breach of privacy. If this were to happen, it would be dealt with in line with strict State and Commonwealth Government privacy laws and guidelines. Read more about this in the FAQ section on Protecting your Privacy.

Yes, A3BC participation options have been designed to be as flexible as possible. On the Consent Form you have the option to participate in all (Option A) or some (Option B) parts of the project. For example, in Option B you may opt-in to completing online questionnaires and providing samples, but not data-linkage, if you wish.

For brief surveys, questionnaires and biological specimens you can also choose to participate in an ongoing or one-off manner. Ongoing collections (vs one-off) give researchers far more information to allow them to make ground-breaking discoveries for better disease understanding and improved health care.

We strongly encourage full participation as much as possible to maximise to the research possibilities of your contributions.

Yes, full participation is still possible, however A3BC consent, questionnaires, notifications and reminders are delivered by email to make life easy for participants and the A3BC. If you do not have an email, we advise that you get one – we can guide you if needed. Participation can still occur using paper forms, however this will make certain actions difficult, particularly sending questionnaires and scheduling times with you for data and/or blood collection.

Thank you for your valuable contributions to the Australian Rheumatology Association Database (ARAD), the arthritis surveys you’ve completed and the data linkage you consented to have helped advance scientific knowledge of the impact of arthritis and its treatments. The ARAD has now joined forces with the A3BC. The A3BC was formed in 2016 by the same group of rheumatologists that started ARAD, along with Australian rheumatologists and scientists passionate to improve arthritis healthcare.

As part of this merger, your ongoing ARAD surveys will now be sent to you by the joint A3BC-ARAD team. Your existing ARAD survey and linkage information will be moved from Monash University to a new, highly secure database still governed by the whole A3BC-ARAD team but housed at the University of Sydney (Sydney, New South Wales). This presents no added risk to you or your information and the privacy of your information remains the highest priority for the A3BC-ARAD.

The A3BC expands on the benefits of ARAD by giving you the option to also donate samples (such as blood, saliva and synovial fluid) at a hospital, pathology centre or or clinic near you. If you haven’t already completed A3BC consent and are interested in learning about the A3BC-ARAD and/or would like to express your interest in donating, please contact us via our website:  a3bc.org.au/contact-us/, call 02 9463 1891, email info@a3bc.org.au or speak to your rheumatologist. The A3BC-ARAD will then contact you to discuss your consent for participation.

Yes, your family members can participate, even if they haven’t been diagnosed with arthritis or an autoimmune disease. This is called being a ‘control’ participant.

First degree blood relatives of A3BC participants with inflammatory arthritis or autoimmune disease are particularly important to help researchers understand why some people develop certain illnesses and others don’t.

Yes, the A3BC recruits both healthy and at-risk controls.

Healthy control participants are people who typically have no history of inflammatory arthritis or autoimmune disease and who otherwise meet all the eligibility criteria for study enrolment.

At-risk control participants are people either with a first- or second-degree relative with inflammatory arthritis or autoimmune disease or who have a disease-related positive antibody test.

Healthy and at-risk control participants are very important in research for comparison with patients who have diseases. They can help researchers understand why some people develop certain illnesses and others don’t. Depending on the specific project you may be a first-degree relative, friend accompanying an A3BC participant to the clinic, someone with a positive antibody test, or a member of the community.

While the A3BC is not a clinical trial itself, it occasionally partners with clinical trials to provide support for participant recruitment and collection of data and biospecimens via A3BC approved sites and personnel, using a dual consent model (biobank consent and clinical trial consent). This process helps maximise the research impact of the trial by facilitating short-term trial-specific research questions, while also allowing for future unspecified research questions to be answered that weren’t conceived at the outset of the trial. Participation in the A3BC biobank-registry cohort also allows for longer term follow-up information to be gathered after the trial has finished, ensuring that researchers can better understand long-term implications of clinical trial interventions.

Donating samples

Sample collections are scheduled by local A3BC staff or Pathology staff at the hospital or clinic where you see your doctor. They will contact you via email and/or phone to remind you of upcoming collections. Collections can be rescheduled if required. Depending on consent choice, all or some of the following will be collected at 0, 6, 12 and 24 months from the time of consent for ongoing collection (or ideally at 0 months only if one-off collection):

  1. A blood sample (up to 80mls or 5 tablespoons for adults; up to 50mls or 2.5 tablespoons for children [weight-based]) will be collected when you enrol in the A3BC (time 0), then at 6, 12 and 24 months after enrolment (a total of 4 blood collections over 2 years). This is generally collected during a routine blood collection before your scheduled visit. Collection times will vary (under or over 24 months), to account for disease flares, treatment changes or surgeries.
  2. In some instances, a small sample of tissue and/or fluid may be collected as part of your routine medical care, or as part of HREC-approved research you have also consented to. Any extra tissue not needed for pathology purposes will be stored. Examples are synovial tissue/ fluid, bone, cartilage, muscle, rheumatoid skin nodules or artery biopsies.
  3. In some instances, your Newborn Screening Card (NBSC) is stored in State genetic services. All newborn Australian babies have a NBSC taken in the first few days of life. Some blood is tested for serious diseases, while the remainder is stored as an NBSC. Our access depends on how long each State keeps them: VIC, SA, TA, NT – indefinitely; QLD – 25 years, NSW – 18 years, and WA – 2 years.
  4. In some instances, you will be asked if you would be willing to collect a sample of your saliva and/or faeces in a mailed collection kit and return it to the biobank. These samples contain the microbiome (i.e. bacteria and viruses) that live inside our bodies, which may play a role in the causes of musculoskeletal disease and response to treatment. These collections allow people to participate from remote regions where collecting research blood samples is not possible.
  5. Depending upon the treatment for your condition, the A3BC may also seek approval from pathology services to access samples previously collected from you, and/or collect further samples over your treatment course.

Your samples will be stored in an A3BC biobank node under strict conditions to ensure they remain safe and in the highest quality condition. The A3BC will be the custodian of your samples, responsible for processing and storing the samples, and releasing samples and/or data to researchers.

Your samples will be stored for the life of the project and made available for future unspecified musculoskeletal and autoimmune research as approved by a Human Research Ethics Committee (an independent committee that has ethical oversight of research involving humans) and the A3BC Access Committee(s). The research may be published, however you will not be identified in any way (the data is de-identified).

You can choose to withdraw some or all of your sample consent at any time. Refer section “Withdrawal of consent or change of details”.

Your samples can be used for many different types of ethically approved health and medical research. The A3BC Access Committee(s) discusses each proposed research project and only gives access based on strong scientific merit and potential benefits of the project to people with musculoskeletal and autoimmune conditions.

If you have an upcoming operation or procedure, the A3BC may be interested in collecting your excess tissue, which would otherwise be discarded as medical waste. Examples of operations include joint replacement (e.g. hip or knee), tendon repair, joint cleaning or biopsies related to your musculoskeletal or autoimmune disease.
There are two ways that the A3BC can be notified of your wish to donate your tissue/fluid samples for research:

  1. Your treating rheumatologist/specialist and/or orthopaedic surgeon will ask if you would like to donate your tissue/fluid to the A3BC. This is completely voluntary and only done with your permission. The A3BC will contact your doctors to co-ordinate the tissue /fluid collection, with no inconvenience to you.
  2. You can contact the A3BC via email or phone to discuss your upcoming operation or medical procedure and determine if collection of your tissue/fluid will be feasible. The A3BC will contact your doctors to co-ordinate the tissue/fluid collection, with no inconvenience to you.

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:

https://www.ipc.nsw.gov.au/privacy/nsw-privacy-laws/hrip-act
https://www.ipc.nsw.gov.au/privacy/nsw-privacy-laws/ppip-act

The term ‘data linkage’ is a method of bringing together information from different sources about the same person. An example is the linking of tissue or other biological samples with health data such as pathology results.

Linking your samples to your health data provides researchers a valuable resource to help 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, more holistic 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 helps researchers better understand the health and wellbeing of our communities, and can help to improve the delivery of healthcare, develop future treatments and even cures.

In addition to the information provided in your patient-reported surveys/questionnaires, the A3BC will ask for consent to collect your health data through data linkage processes. We collect your Medicare number or Department of Veterans’ Affairs (DVA) number to do this. Depending on consent choice, all or some of the following will be collected at 0, 6, 12, 18 and 24 months then 12-monthly from the time of consent for ongoing collection. The one-off survey/ questionnaire is ideally collected in the 6 months after consent.

Source Type of information
Hospital electronic medical record (EMR) data from public and private hospitals/clinics/pathology Blood test results, clinical / discharge notes, treatment outcomes and medical imaging (e.g. x-ray)
State health datasets and registries from your State Department / Ministry of Health or Australian Institute of Health and Welfare (AIHW) Details of care received during past & future hospital visits (inpatient, outpatient and emergency departments), any conditions the State has been notified of (e.g. cancer and death registries, serious infections)
National data from your My Health Record (Australian Digital Health Agency, ADHA) Data on diagnoses, medications, allergies, prescribing and medical imaging reporting
Longitudinal/Lifecourse research study data Data from the ARAD, ANZ-CLARITY, North West Adelaide Health Study (NWAHS) and 45 & Up Study, Australian Longitudinal Study on Women’s Health (ALSWH)
National health data from Services Australia and/or Australian Institute of Health and Welfare (AIHW) Data on Medicare Benefits Schedule (MBS) and Pharmaceutical Benefits (PBS) claims (examples below), Australian Immunisation Register (AIR), National Cancer and Death Index data

These links will not allow the A3BC to access:

  • information from the Police
  • information from the Australian Taxation Office, or
  • information from Centrelink

Unless you choose to withdraw from the project, the A3BC will, compliant with State requirements, store your data for a minimum of 15 years after the conclusion of the project, or after research subjects have reached or would have reached the age of 25 years, whichever is longer. Health and personal information is kept under strict security and privacy conditions in line with the law.

We will securely maintain your data (without need to contact you) so it can continue to contribute to future research. However, you can choose to stop participating (partially or completely) at any time. Please refer to the Withdrawal of Consent section.

In the instance you request your data to be removed from the system, in accordance with Australian regulations, A3BC will ensure the complete destruction of all identifiable copies. This includes SQL delete command and purging of copies contained in system/network backups and cloud data. Where information is stored in the cloud, we ensure the service contract stipulates, under retention and disposal requirements, that all copies should be destroyed. The following records are kept to demonstrate disposal: date of the destruction, method of destruction, person authorising the destruction, description of the files, date range of the files, and quantity of files (gigabytes). A statutory declaration form indicating safe destruction will be completed and returned to Services Australia. Paper-based documents will be disposed of in secure waste bins or B Class shredders.

You will be asked to sign a consent form authorising the study to access your complete Medicare Benefits Schedule (MBS), Pharmaceutical Benefits Scheme (PBS) and/or Australian Immunisation Register (AIR) data as outlined in the consent form.

Medicare collects information on your doctor visits and the associated costs, while the PBS collects information on the prescription medications you have filled at pharmacies. The Australian Immunisation Register is a national register that records vaccines given to people of all ages in Australia.

The consent form is sent securely to Services Australia who holds MBS, PBS and AIR data confidentially.

The A3BC would like to link your data with data from any of your housemates or first* or second** degree relatives already in the A3BC database, in order to characterise environmental, genetic, microbial and immune factor relationships within families and communities. Importantly, the A3BC will never share any of your data with your housemates or relative(s).

Relatives Only (not housemates): Any link within the A3BC database can only occur with the consent of both you and your relative. The link within the database will be made using information you provide here. If an exact or partial match to a participant already in the A3BC database is found, and both you and your suspected relative have consented, we will contact you to confirm the participant is your relative.

*First degree includes parents, siblings or children (i.e. share ~ 50% of their genes); **Second degree includes uncles, aunts, nephews, nieces, grandparents, grandchildren, half-siblings (share ~ 25% of their genes.)

Researcher access to samples and health data

Before they can apply to use your samples, researchers must have their project reviewed and approved by a Human Research Ethics Committee. Only legitimate and approved health and medical researchers can apply for access to your A3BC samples and data. Researchers are only provided information without identifying personal information (your name and contact details will not be released).

MBS/PBS/AIR data will not be used in future/unspecified research outside of the scope of the approved A3BC project.

The participant-reported survey information will be shared with your treating rheumatologist (if applicable) to help improve the understanding of your condition and your care. If you move to a new rheumatologist, they will not have access to your previous survey information unless you consent to that.

There may be very rare circumstances where we have a legal requirement to provide some of your information to parties who are not approved access researchers. Likely examples are the discovery of a highly infectious agent that could affect other people, or a court order requiring release for use for forensic purposes related to illegal activity.

Before they can access samples and data, researchers must apply to the A3BC and provide detailed information about their research project and credentials.

Research projects must also be approved by an accredited Human Research Ethics Committee.

Researchers can hold your sample and health data in accordance with the Human Research Ethics Committee (HREC) approval and A3BC Data and/or Material Transfer Agreement (MTA3; where required) for their project. This can vary between projects but can be a few years. The researchers are not allowed to use your samples or data for any additional projects that have not been approved by an HREC and the A3BC Access Committee. Unused samples of verified quality will be returned to the biobank for further use.

After your data is collected and linked, researchers can be provided with your health data. However, your name and address has been removed and replaced with a random number (code). This helps to protects your privacy. The researchers will not be able to identify you or contact you personally.

Your personal information will only be accessible to authorised members of the A3BC project team and data support contractors, all of whom will have received training in handling private information and who will be required to sign a confidentiality agreement.

In any publication discussing the project, information will be reported in such a way that you cannot be identified. Aside from requirements in reporting incidental health findings (see Serious Findings section), there is almost no possibility of unsolicited re-identification of your data at any stage, including within publications.

Aside from requirements in reporting incidental health findings, there is almost no possibility of unsolicited re-identification of participant data at any stage. 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.

An exception here is your MBS, PBS and AIR data from Services Australia – this will NOT be sent overseas in any circumstance.

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.

All possible precautions will be taken but it is important to note that Australian laws may not apply to samples and data sent overseas. Researchers will only have access to your samples and/or deidentified data.

In the future, if your treating doctor is a member of the A3BC study team, they will be able to access your research data for discussion at your clinic visits.

For security reasons, your data cannot easily be made available to you at present, however we hope to develop these capabilities in the future by creating a Participant Web Portal.

Protecting your privacy

Your electronic information will be stored in a highly secure, encrypted database managed by the University of Sydney under strict security protocols (restricted use local servers) which conform to Australian data standards.

Your biospecimens will be stored in special laboratory freezers at the A3BC site listed on the Participant Information Sheet and Consent Form. Biospecimens are occasionally relocated to another A3BC biobank node site for analysis or operational logistics (e.g. for managing space in freezers). Some of your de-identified biospecimen data may also stored in highly secure, encrypted databases managed by biobanking service providers (e.g. NSW Health Statewide Biobank, St Vincent’s Institute Biobank, Victorian Cancer Biobank, Murdoch Children’s Research Institute) who support the biospecimen handling at some recruitment sites.

If your information was recorded on a paper form it will be stored in swipe-card secured room, inside a locked filing cabinet at the location listed on the Participant Information Sheet and Consent Form.

Your data and samples will be handled securely according to the relevant ethics approvals, privacy laws and contracts.

Your identifying information is only visible to your doctor (A3BC study investigator) and essential A3BC staff, all of whom will have received training in handling private information and who are required to sign a confidentiality agreement. Authorised access is password-protected and restricted by the A3BC Data Manager so that data-entry staff can only use parts (e.g. view, create, edit, delete, export, logging, lock/unlock) of the database relevant to their role. The database records an extensive field-level audit log of all users (incl. ID, date, time, change made) who access and modify the database. Login detail sharing is prohibited and the system has two-factor authentication capability.
External researchers wishing to access the A3BC are only provided information without identifying information (e.g. name, address), and need approval from a Human Research Ethics Committee (HREC).

Should any breach of privacy occur, the A3BC will ensure the situation is dealt with in accordance with jurisdictional privacy laws and guidelines. Any publication discussing the project will be reported in such a way that you cannot be identified

Your information is protected under the national Privacy Act (1988) and state health record privacy acts. The A3BC, as well as Australian and international researchers accessing the A3BC resource, must adhere to these laws.

Consenting children

If you are a child participant recruited under the age of 14, your parent or guardian will sign consent on your behalf. If you are listed on two Medicare cards (with different Medicare card numbers), both parents / guardians must co-sign the consent form.

At 14 years of age you will be contacted by the A3BC to re-consent to Services Australia MBS/PBS/AIR data release.

At 18 years of age you will be contacted by the A3BC to re-consent to continue your full A3BC participation as an adult.

If you are a child participant recruited between the ages of 14 and 18, you will co-consent, together with your parent or guardian. You parent/guardian is responsible for consenting to future contact, sample donation, questionnaires and data linkage except for Services Australia data which you consent to on your own.

Research projects

Your samples and associated data are securely stored and are only used for ethically approved health and medical related research. This includes research on causes, risk factors, diagnosis, treatments, as well as genetics research and clinical trials.

You will not always know what research projects your sample is being used for. This is because your sample is safely stored in the A3BC biobank and shared with approved researchers without your identifying details, such as your name, address or date of birth.

However, we will provide important discoveries (always de-identified group data) from researcher use via our website and/or newsletters. A list of research publications which required data and samples from the A3BC Biobank will also be available on the A3BC website (a3bc.org.au).

The A3BC is working with patient partners and plans to seek input for patient priorities to guide our research priorities. But at this stage you cannot individually direct your samples to specific research projects. By making a decision to donate your samples, you are consenting for your samples to be used for unspecified ethically approved health and medical research.

The A3BC Access Committee discusses each proposed research project and only gives access based on strong scientific merit and potential benefits of the project to people with musculoskeletal and autoimmune conditions.

Serious findings

In this document, 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 another medical problem. This DNA might be something you share with your genetic relatives, such as your parents, siblings or children.

In the A3BC Consent Form, we specifically ask you understand you may be contacted in the future if an incidental finding is discovered that has serious and significant health implications for you (and possibly your genetic relatives).

You would only be contacted about serious incidental 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, like evidence of increased risk of high cholesterol, will not be returned. It is important to continue regular health check-ups with your family GP.

In the rare event that a potential serious incidental finding is discovered, the matter will be referred to clinical experts, who will evaluate the result to determine whether it is a serious finding and whether it should be returned to you. This may involve further tests, genetic or otherwise, to ensure the validity of the finding.

If the clinical expert(s) determine that the 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 counsellor.

As the findings may impact on your genetic relatives, we encourage you to inform them of your participation in the biobank. After further testing, this information may become part of your health record as health information.

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, participating 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 (e.g. 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 incidental finding, but you do not wish to be told details, see a medical expert or take further testing, you do not have to.

Even if you don’t agree to be told details about your serious incidental finding, in rare cases your doctor may contact your family members if there is a serious and imminent threat to their health.

Payment

No. Your decision to participate in the A3BC for health and medical research is voluntary and for the public good. You will not receive any payment for your donation.

Withdrawal of consent or change of details

You can change your mind at any time about participating in the A3BC. You are not required to give a reason for your withdrawal, although any feedback would be appreciated and used to improve the A3BC.

There are two major options for withdrawal. Option 1 is to stop actively participating but allow for your valuable samples and data already in the biobank to continue to be used in research. Option 2 is to stop actively participating and do not allow continued use of your samples and data and request your samples and data are destroyed.

Your withdrawal is flexible, so you can withdraw from some or all participation. For example, you may only want to withdraw from providing further blood samples but continue receiving questionnaires; or withdraw questionnaire participation but still receive contact about future A3BC developments or research opportunities. Even if you completely withdraw, you can still access news and updates via our website.

Your participation will remain current for the life of the project, even after your death, unless you explicitly choose to withdraw participation as defined by your selection(s) in the A3BC Withdrawal of Participation Form.

You can complete the form by phoning or emailing the A3BC team for assistance, or you can download it from our website, complete it and email it to the A3BC team.

Phone 02 9463 1891, email info@a3bc.org.au or visit our website a3bc.org.au

You will be given the following two options for A3BC Withdrawal of Participation Form:

OPTION 1: I withdraw from further participation, BUT allow researchers to keep using my previously collected data and biospecimens (TICK either A, B or C below):

A.    I would like to withdraw ONLY from further contact for project clarifications and/or additional participation

OR

B.    I would like to withdraw SOME of my further participation (tick which apply):

  • Contact about project clarifications and/or additional participation
  • Linking me in the A3BC database to my relatives using information I provided
  • Providing me with brief surveys (~10 mins)
  • Providing me with patient-reported questionnaires (~60 mins)
  • Collection of blood samples
  • Collection of tissue/fluid samples
  • Collection of stool/saliva samples
  • Collection of screening card samples
  • Linkage to my data in other cohort studies (e.g. ANZ CLARITY)
  • Linkage to my local hospital medical record data (e.g. blood tests, Dr’s notes)
  • Linkage to my State Health Department data (e.g. emergency, cancer, death)
  • Linkage to my Australian Agency for Digital Health data (My Health Record)
  • Linkage to my Australian Institute of Health & Welfare data (e.g national death)
  • Linkage to my Services Australia data (i.e. MBS, PBS claims, vaccine  data)

OR

C.    I would like to withdraw ALL of my further participation

OR

OPTION 2: I withdraw from ALL further participation, AND do not allow researchers to keep using my previously collected data and biospecimens, AND ask that my data and biospecimens are destroyed

I understand my data that has already been analysed or published may not be able to be destroyed.

For children under the age of 18, the consenting parent/ guardian must complete the withdrawal form. Children aged between 14 and 18 are required to complete a separate form for withdrawal of Services Australia data release only.

Should you consent to be recontacted, the A3BC may contact you regarding the following four scenarios (although we will keep contact to a minimum);

  1. To ask you for clarification, additional participation, or invite you to take part in other studies (may need separate consent, but not affect your A3BC participation).
  2. You may be contacted by a clinician to notify you of any serious incidental findings that are discovered, which have health implications for you or your relatives.
  3. Re-consent of children at 14 years of age to comply with Services Australia requirements where a child must provide consent for their own health information to be released.
  4. Re-consent of children at 18 years of age as the participant is now legally an adult and therefore their previous parent/guardian consent is no longer legally valid for ongoing medical research.

Because the A3BC involves long-term follow-up, it is important that we have up-to-date contact details for all participants. To assist us in maintaining contact with you we will ask you to notify us if you change your name, address, or doctor. In case you move house and forget to tell us, we will ask you to nominate one person who will be able to tell us your new contact details if we lose contact.

If you have consented to receive emailed questionnaires you can easily update your personal and contact details within your questionnaire.

You can also email us at info@a3bc.org.au or call 02 9463 1891 if you prefer. It is important that we have your current email on file as this is our main method of communication with participants.

More information

Not yet, but in time the A3BC will make these available in other languages.

If you would like more information about the A3BC or your participation, please call 02 9463 1891, email info@a3bc.org.au or visit our website at a3bc.org.au.

Please keep a copy of your Participant Information Sheet with the copy of your signed Consent Form.

Queries, concerns and complaints

1. If you have any queries, concerns or complaints about the conduct of the A3BC (HREC reference 2019/ETH10386), these should be directed to:

Northern Sydney Local Health District Human Research Ethics Committee – Phone: 02 9926 4590

2. For more information on the NSW Health Statewide Biobank:

Phone: 02 4920 4140, or Email: NSWPATH-Biobanking@health.nsw.gov.au

3. If you have a privacy complaint in relation to the use of your MBS/PBS/AIR data you should contact the Office of the Australia Information Commissioner. You will be able to lodge a complaint with them.

Website: www.oaic.gov.au

Telephone: 1300 363 992

Email: enquiries@oaic.gov.au

Mail: GPO Box 5218, Sydney NSW 2001

FAQs last updated: 7th March 2024 (A3BC FAQs v1.6)