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at any time, noting the consideration that if their samples and data have already been used then that cannot be rescinded.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-consenting at 18 years is also legally necessary if performed earlier by the parent/guardian as the young person is now legally an adult, therefore parent/guardian consent is no longer legally valid. As such, the A3BC will consent JIA participants via the adult version of the A3BC PICF once they reach 18 years of age
1. No further contact or sample/data collection with/from the participant, but researchers have permission to retain and use the participant’s previously obtained samples (blood and tissue/fluids) and data, and can continue to access/link participant health record data. Within this option, participants will also be given the sub-options to opt out of: (a) sample and data collection, (b) only sample collection, (c) only ARAD data collection, (d) only blood sample collection, or (e) only tissue/fluid sample collection.
2. No further contact, sample/data collection or data access/linkage with/from the participant, their samples/data or their health record data (respectively), but researchers have permission to retain and use previously obtained participant samples, ARAD data and health record data.
3. No further contact, sample/data collection, data access/linkage or use with/from the participant, their samples/data or their health record data (respectively). The A3BC will destroy the participant’s samples, Consent status but will hold information relating to the participant (including consent form and withdrawal) only for archival and auditing purposes. Information will be removed from current analyses, however it will be impossible to remove from completed analyses.
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.