Our participants’ privacy and confidentiality is of the utmost importance to the A3BC team. By signing the consent form you consent to the study doctor and relevant research staff collecting and using personal and health information about you for A3BC purposes. Any information obtained in connection with this project that can identify you will remain confidential.
Information about your participation in this project may be recorded in your health records. Your health information will be kept secure and confidential in accordance with legal requirements and guidelines of The National Statement on Ethical Conduct in Human Research (2007) – made in accordance with the National Health and Medical Research Council Act 1992.
Generally, researchers are only provided information without identifying marks (e.g. name and address). However, should a breach of privacy occur, the A3BC will ensure the situation is dealt with in accordance with existing privacy principles and guidelines.
Occasionally genetic information derived from donated tissue may allow for the identification of participants, however the A3BC requires this information to be kept confidential and follows legal requirements for researchers to maintain your privacy.
All paper information will be stored securely in a locked filing cabinet in a swipe-card accessed, monitored office within your receiving local A3BC biobank node (see location on first page of this document). Your paperwork will also be scanned and stored on an encrypted, password-protected computer database with controlled and tracked access.
For electronic consent and survey forms, a number of sophisticated technologies will be used to protect your information, including two-factor authentication (e.g. where a code is sent to your phone to allow you to complete a transaction) and personally identifiable information unique to you (e.g. driver’s license number, DOB).
In the future, access to your samples or genetic information may be given to researchers as part of the search for a genetic cause of RA, JIA, PsA, AS or other research purposes. Your sample will have identifiers (e.g. name and personal details) removed (before researchers can use them for research) and replaced with a unique A3BC code. It will be possible to reidentify the sample as yours using the code.
Unless you withdraw consent, the A3BC will store your sample and information indefinitely, in such a way that, ordinarily, only authorised biobank investigators can identify you, thus protecting your confidentiality. Your samples and data will be used for the purposes of the A3BC and related projects and not be released for other use without your prior consent, unless required by law.
Your health records and any information collected and stored by the study doctor during the project may be reviewed for the purpose of verifying the procedures and the data. This review may be done by the ethics committee that approved this project, regulatory authorities and authorised representatives of the Sponsor (University of Sydney), this organisation (the relevant responsible health district/network), or as required by law. In these circumstances, the Sponsor will not collect (i.e. record) your personal information. By signing the consent form, you authorise release of, or access to, this confidential information as noted above.
In accordance with relevant Australian and/or State/Territory privacy and other relevant laws, you have the right to request access to your information collected and stored by the study team. You also have the right to request that any information with which you disagree be corrected.
What will happen to my biological samples?
In this study we will collect and use body fluid samples and personal and health information about you for use in any future research studies related to arthritis and autoimmune disease. Blood giving is a mandatory component of the A3BC (except where saliva is taken as an alternative option), however tissue and fluid collection is optional based on participant treatment circumstances and collection specific to certain national sites of the A3BC.
The information will be re-identifiable. This means that we will remove your name and give the information and samples a special code number. Only authorised members within the biobank team can match your name to their special code number, if we need to. Your samples will be kept in a freezer in a locked laboratory at your local biobank node.
All samples and data collected from you and stored in the A3BC Biobank will be kept indefinitely in secure storage for future research, unless you tell us you don’t want us to anymore. If the biobank were to close down or the research was to stop, we will contact you via email, mail and the A3BC website. Your samples and data will not be destroyed but will stay stored, be looked after and used in ethically approved research by the A3BC Biobank’s researchers.
Your biospecimens will not be used for research involving reproductive technology, human embryos or cloning.
When we write or talk about the results of the A3BC, we will report information about the whole group of participants. This means that no one will be able to identify you. Every effort will be made to protect your confidentiality and privacy when sharing samples and data with other researchers.
In the future other researchers working in the areas of arthritis and autoimmune diseases may request access your samples and data. These researchers will need to apply to the A3BC Biobank committee for permission to use your samples and data. The biobank will only release your samples and data to other researchers once their application has been approved by the A3BC Biobank committee and by an authorised ethics committee. No identifiable data will be shared with other researchers/companies.
Australian laws and regulations may not protect samples and data sent overseas. However, we will use our own legal contracts to ensure that your sample and data are protected. It is possible that we may release your blood/tissue/fluids to a company for use in commercial development related to the treatment of arthritis or autoimmune disease. It is important to understand that you will not receive any personal reward for this and you will not be entitled to or be able to claim any potential commercial value of any discovery or development that results from the use of your samples.
Banking of Health Information
In order for researchers to better conduct research it is important that they are able to link your samples to health information about you. This type of information might include details collected during your treatment, such as your operation, diagnosis history, pathology results, emergency department records and genetic or family history details.
Any information we collect from you will remain confidential. We will use this information only for the purposes for which you have given consent for it to be used. Only the researchers granted access to your information by the relevant Human Research Ethics Committee can have access to this information.
The A3BC requires this information to be kept strictly confidential, and there are legal requirements for researchers to maintain your privacy. Generally, third parties cannot access your health information. However, there may be circumstances where a legal requirement to provide your health information to third parties arises, such as law enforcement agencies. While these situations are rare, the biobank will be required to comply with its legal requirements and make available your information. You have the right to look at, and ask for correction of, your
information in accordance with the Freedom of Information Act 1982.