Collins, Michael G. https://orcid.org/0000-0003-2169-9087
Fahim, Magid A.
Pascoe, Elaine M.
Dansie, Kathryn B.
Hawley, Carmel M.
Clayton, Philip A.
Howard, Kirsten
Johnson, David W.
McArthur, Colin J.
McConnochie, Rachael C.
Mount, Peter F.
Reidlinger, Donna
Robison, Laura
Varghese, Julie
Vergara, Liza A.
Weinberg, Laurence
Chadban, Steven J.
,
Funding for this research was provided by:
Health Research Council of New Zealand (17/414)
Department of Health, Australian Government (APP1152390)
Baxter Healthcare Corporation (Baxter Medication Delivery Grant 2017)
Royal Australasian College of Physicians (Jacquot Research Establishment Award 2017)
National Health and Medical Research Council (APP1092957)
Article History
Received: 3 April 2020
Accepted: 28 April 2020
First Online: 25 May 2020
Ethics approval and consent to participate {24}
: This study is being performed in accordance with the 2000 Edinburgh, Scotland Revision of the Declaration of Helsinki, the National Health and Medical Research Council of Australia (NHMRC) Statement on Human Experimentation, Joint NHMRC/AVCC Statement and Guidelines on Research Practice, applicable ICH guidelines and the Therapeutic Goods Administration - Note for guidance on GCP (CPMP/ICH/135/95) annotated with TGA. All transplant procedures are being carried out in accordance and compliance with the Declaration of Istanbul on Organ Trafficking and Transplant Tourism.Ethics approval for the BEST-Fluids trial was obtained from the Northern A Health and Disability Ethics Committee (approval number 17/NTA/62) for New Zealand, and from the Sydney Local Health District Human Research Ethics Committee, Royal Prince Alfred Hospital (approval numbers X17–0201 and HREC/17/RPAH/308), for Australia. The study has received local governance approvals at each of the participating sites. Protocol amendments are submitted to and approved by the ethics committees prior to implementation. Written informed consent has been obtained from all participants in the study. For children, consent has been obtained from parents or guardians, with assent sought from adolescents and children where appropriate.
: Consent for publication is not applicable since there are no identifying images or other personal or clinical details of participants presented. A model participant information sheet and consent form are provided in Additional file .
: MC has received research support from Baxter Healthcare Pty Ltd., the manufacturer of Plasmalyte, through a Baxter Investigator Initiated Research grant that provided fluids for this trial (commercial value of US $36,270). DJ has received consultancy fees, research grants, speaker’s honoraria, and travel sponsorships from Baxter Healthcare and Fresenius Medical Care, consultancy fees from Astra Zeneca and AWAK, speaker’s honoraria and travel sponsorships from ONO, and travel sponsorships from Amgen. DR, LR, LV, EP, and JV are employees of the Sponsor, The University of Queensland. KD’s salary is funded by a BEAT-CKD grant and she is an employee of the ANZDATA Registry. PC is the Deputy Executive Officer at the ANZDATA Registry. CH has received fees for research committee activities from Janssen and GlaxoSmithKline paid to her institution, personal fees from Otsuka, research grants from Fresenius, Shire and PKD Australia outside the submitted work, and research grants from Baxter and NHMRC related to the current project. LW works at the Department of Anaesthesia at Austin Health, which has received funding from Baxter Healthcare for investigator-initiated clinical research. LW has received honoraria from Baxter Healthcare for consulting activities. All LW’s fluid-related research, including study design, execution, data collection, analysis, and reporting have been conducted independently of Baxter Healthcare and other commercial entities. The other authors declare that they have no competing interests.