Bhar, Sunil
Davison, Tanya E.
Schofield, Penelope
Quinn, Stephen
Ratcliffe, Julie
Waloszek, Joanna M.
Dunkerley, Sofie
Silver, Mark
Linossier, Jennifer
Koder, Deborah
Collins, Rebecca
Milte, Rachel
Funding for this research was provided by:
National Health and Medical Research Council (APP1150902, APP1150902, APP1150902, APP1150902, APP1150902, APP1150902, APP1150902, APP1150902, APP1150902, APP1150902, APP1150902, APP1150902)
Article History
Received: 22 January 2023
Accepted: 25 August 2023
First Online: 12 September 2023
Declarations
:
: This project has been approved by Swinburne University Human Research Ethics Committee (SUHREC) in line with the <i>National Statement on Ethical Conduct in Human Research</i> - (Ethics ID: SHR Project 2019/162). All study methods are performed in accordance with these national guidelines and committee regulations. Informed consent is obtained from all participants or their legal guardians. Verbal informed consent is provided by residents and recorded by the research assistant prior to the eligibility screen. The procedure to obtain verbal informed consent was endorsed by SUHREC. All participants provide their own verbal or written consent before participating in the project, except for when staff believe that the resident lacks capacity to provide informed consent or when the resident prefers proxy consent. In such cases, consent by proxy is obtained from the resident’s power of attorney or legal representative. Signed consent forms are stored separately to the data to ensure confidentiality and all consent forms are accessible only by members of the research team. Adverse events related to study procedures are recorded and reported to SUHREC. Trial conduct is monitored by the project operational committee every 2 weeks and reported to project investigators at least 3 times a year. The trial is subject to random audit by SUHREC. The project is audited on an annual basis by the project manager and such audits are reported to SUHREC. Protocol amendments are reviewed by SUHREC. Information about publicly available post-trial treatment options is disseminated to all participating RAC facilities to forward to residents. Information about further treatment options is also included in study consent documentation.
: Not applicable.
: The authors declare no competing interests.