Participants are given clear information that they do not have to give consent and that if they don’t it will not affect their care in any way, and that they are free to withdraw at any time, noting the consideration that if their samples and data have already been used then that cannot be rescinded.

Re-Consent

The consent for child participants recruited under the age of 14 is completed by their parents / guardians on the child’s behalf. If the child is listed on two Medicare cards, both parents / guardians must co-sign the consent form.

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

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

If a child participant is recruited between the ages of 14 and 18, they will co-consent, together with their parent or guardian. The parent/guardian is responsible for consenting to future contact, sample donation, questionnaires and data linkage except for Services Australia data which participants aged 14 and older must consent to on their own.

Refer to the following FAQ sections for more information:

Participant-led Withdrawal

A3BC participants can change their mind at any time about participating in the A3BC. They are not required to give a reason for their withdrawal, although any feedback is appreciated and used to improve the A3BC.

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

Like the consent, withdrawal is flexible, so they can withdraw from some or all participation. For example, they 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 they completely withdraw, they can still access news and updates via the A3BC website.

Participation remains current for the life of the project, even after death, unless the participant explicitly choose to withdraw participation as defined by their selection(s) in the A3BC Withdrawal of Participation Form.

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

For more information please refer to the following FAQ section:

Investigator-led Withdrawal
The investigator may withdraw a participant from the A3BC if the participant:
• Is in violation of the protocols.
• Requires early discontinuation for any reason.
• Experiences a serious or intolerable adverse event.
• Develops symptoms or conditions listed in the exclusion criteria.
• Has a change in diagnosis to a condition other than RA, JIA, PsA or AS.

Use of Samples/Data After Death
The National Statement (section 2.2) does not specifically require that research participants be asked what should happen to samples and data after their death. However, whilst concerning biospecimens obtained after death for research, section 3.4.5 states that “Any wish expressed by a person about the use of their biospecimens post-mortem should be respected.” As such, the A3BC clearly asks for permission to use the participant’s stored samples/data and linkage to re-identifiable health information following their death for use in future HREC-approved health and medical research.