The next point of the recruitment process will be for the participating research team to obtain consent for the participant to enter the A3BC. This can be achieved through an in-person or remote process depending on the rheumatologist/specialist and/or patient circumstances:

1. IN-PERSON:
The rheumatologist/specialist and research team complete the A3BC Permission to Contact (PTC) form (electronic or paper) and Case Report Form (CRF) with the patient and/or their parent/guardian and discusses the A3BC Participant Information Sheet and Consent Form (PISCF) with them and/or their parent/guardian. The patient and/or parent/guardian completes the consent form on paper or electronically to enter the A3BC and the participant’s first blood collection is scheduled.

2. REMOTE:
The rheumatologist/specialist and research team complete the A3BC PTC and CRF with the patient and/or their parent/guardian and the patient goes home. The patient and/or parent/guardian receives an email link containing the A3BC Participant Information Sheet and Consent Form (PISCF) and completes it to enter the A3BC. The patient and/or parent/guardian is soon thereafter advised when/where their first blood will be taken (usually part of routine care).

3. CONTROLS: Similar to 1 or 2 above, controls will complete the A3BC PTC and PISCF (Control) forms in all scenarios. Project-specific control participant recruitment process to be defined within an accessing project’s protocol through an A3BC-linked Low or Negligible Risk HREC application within the A3BC Access Process.

4. TISSUE-ONLY: Similar to 1 or 2 above, tissue-only cases will complete the A3BC PTC and PISCF (Tissue only) forms in all scenarios. These participants may be undergoing a procedure related to an undiagnosed inflammatory arthritis or autoimmune disease where collecting their excess tissue/fluid could be valuable in early disease and biomarker studies. In these instances, an A3BC investigator will discuss the A3BC with the patient at a pre-operative clinic and complete the PTC form if they wish to receive further information. The ‘A3BC Adult (Tissue Only) Participant Information Sheet and Consent Form’ will be completed on paper or electronically to enable collection of their tissue/fluid, contact details, medical history and procedure details. These details will be collected at the time of the procedure in the ‘A3BC Tissue Collection and Transportation Form’.

 

Once completed, both the PTC and PISCF form will be emailed to the participant and/or their parent/guardian (if applicable) and uploaded/emailed to the A3BC database. The referring rheumatologist/specialist and Principal Investigator will also be automatically notified of the enrolment status of each participant via regular recruitment up-dates. After consent is confirmed, participants will be contacted by the A3BC to schedule biospecimen collection.

All rheumatologists/specialists referring patients and all staff responsible for obtaining consent will be appropriately qualified and trained to ensure that they are aware of their responsibilities, are capable of answering all questions and are sensitive to the needs of varying patients and any possible issues that may arise, including the avoidance of decision arising from a dependent relationship. An ability to speak English (or access to an interpreter) is required to understand the content effectively/efficiently to make a free and valid decision.

Paediatric Recruitment

Two defined recruitment/consent processes will occur for paediatric versus adult A3BC cases. While adult cases will be recruited and consented directly into longitudinal sample and data collection with the A3BC, paediatric cases will be sequentially offered consent to 2 levels of participation to avoid over-burdening patients and their families. The 2 paediatric case participation levels are as follows:

  1. Enrol to ANZ CLARITY (Australian and New Zealand ChiLdhood Arthritis Risk factor Identification sTudY – HREC/17/RCHM/334, RCH HREC 37278A)
  2. Enrol to A3BC Longitudinal

Paediatric participants will first be explained the purpose of both studies, and what their involvement would be, in similar detail. Following these explanations and allowance for questioning, the participant will first be asked if they consent to enter the once-off collection for the ANZ CLARITY study. If the participant agrees to enter the ANZ CLARITY, they will then be asked if they would agree to extend their participation to longitudinal collection within the A3BC. If the participant agrees to enter the A3BC, they will follow the associated biospecimen and data protocol (described here, developed in consultation between the A3BC and ANZ CLARITY), and the baseline biospecimens and data will become a shared resource between the two groups. Of note, while the baseline biospecimens and data will become a shared resource, longitudinal biospecimens and data collection beyond baseline will be the responsibility and custodianship of the A3BC Consortium. The ANZ CLARITY is a national extension to the original Victorian-based CLARITY study and is ethically approved by a separate HREA application.