Phyland, Ruby K http://orcid.org/0000-0001-5465-3451
McKay, Adam
Olver, John
Walterfang, Mark
Hopwood, Malcolm
Hicks, Amelia J
Mortimer, Duncan
Ponsford, Jennie L
Funding for this research was provided by:
National Health and Medical Research Council (APP1174473)
Epworth Healthcare (Not Applicable)
Monash University (Not Applicable)
Article History
Received: 3 May 2020
Accepted: 23 June 2020
First Online: 20 July 2020
Ethics approval and consent to participate
: This protocol and other study-relevant material were approved by the Alfred Hospital Ethics Committee on 03 January 2019 (project number 663/18). Ethics approval has also been secondarily attained from Monash University (reference number 18372) and Epworth HealthCare (reference number EH2018-323). Any modifications to the protocol will require a formal protocol amendment. The decision to amend the protocol will be made by the Coordinating Principal Investigator. Changes to the protocol will be communicated to ethics committees, DSMC, study staff, investigators and ward staff, as appropriate. If necessary, trial registration will also be updated. Version control using protocol identifiers and dates, as well as a list of amendments, will be employed. All PIs will hold an up-to-date Good Clinical Practice training certificate.Informed telephone and/or written consent will be provided by MTDMs prior to the patient’s enrolment into the trial. If no MTDM is available to consent, this will be provided by the Office of the Public Advocate. Written consent will consequently be obtained from participants upon confirmation of emergence from PTA and cognitive capacity for consent.
: Not applicable
: The authors declare that they have no competing interests.