The next point of the recruitment process will be for the treating rheumatologist to obtain consent for the participant to enter the A3BC. This can be achieved through a one- or two-step process, depending on the individual rheumatologist:
1. ONE-STEP:
The rheumatologist completes the A3BC PTC and then discusses the A3BC Participant Information Sheet and Consent Form (PICF) with the patient and/or parent/guardian, and the patient and/or parent/guardian completes the consent form (either on paper or electronically) then and there to enter the A3BC.
2. TWO-STEP:
The rheumatologist briefly discusses the A3BC with the patient and/or parent/guardian and completes the A3BC Permission to Contact Form (PTC) – either on paper or electronically. This form provides baseline clinical information, the patient’s contact details, and permission for the A3BC to contact for full consent (via the A3BC PICF) to enter the A3BC.

 

 

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

1. Enrol to ANZ CLARITY
2. Enrol to A3BC Longitudinal

JIA 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 of the ANZ CLARITY study. If the participant agrees to enter the ANZ CLARITY, they will then immediately be asked if they would agree to extend their participation to longitudinal collection within the A3BC (and ARAD). 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.