Walsh, Robyn http://orcid.org/0000-0003-0879-387X
Reath, Jennifer
Gunasekera, Hasantha
Leach, Amanda
Kong, Kelvin
Askew, Deborah
Girosi, Federico
Hu, Wendy
Usherwood, Timothy
Lujic, Sanja
Spurling, Geoffrey
Morris, Peter
Watego, Chelsea
Harkus, Samantha
Woodall, Cheryl
Tyson, Claudette
Campbell, Letitia
Hussey, Sylvia
Abbott, Penelope
Funding for this research was provided by:
National Health and Medical Research Council (GNT1120317)
Article History
Received: 3 May 2021
Accepted: 4 March 2022
First Online: 14 April 2022
Declarations
:
: The CIs and Aboriginal Health Service research teams are conducting this trial in accordance with the NHMRC National Statement on Ethical Conduct in Human Research 2007 (updated 2018) [CitationRef removed], ICH Harmonised Guideline Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2) Current <i>Step 4</i> version dated 9 November 2016 [CitationRef removed], and Ethical conduct in research with Aboriginal and Torres Strait Islander Peoples and communities: Guidelines for researchers and stakeholders 2018 [CitationRef removed]. The INFLATE trial is overseen by the following Human Research Ethics Committees (HRECs): Western Sydney University Human Research Ethics Committee (H12368); Aboriginal Health & Medical Research Council Ethics Committee (AHMRC) (1286/17); Metro South Health Service District Human Research Ethics Committee (HREC/17/QPAH/461), University of Queensland Medical Research Ethics Committee (HREC-2017-2895) and Human Research Ethics Committee of the Northern Territory Department of Health & Menzies School of Health Research (HREC-2017-2895). The protocol, participant information sheet and consent forms, and recruitment and participant materials were submitted to the five HRECs for review and approval prior to enrolling the first patient. Approval for subsequent amendments is obtained before implementing any changes to the trial.
: Not applicable
: JR, DA, GS, CW, CT, LC, and SH work at participating trial sites, in dual roles as researchers and clinicians or managers.