Bhardwaj, Anjali K.
,
Allsop, David J.
Copeland, Jan
McGregor, Iain S.
Dunlop, Adrian
Shanahan, Marian
Bruno, Raimondo
Phung, Nghi
Montebello, Mark
Sadler, Craig
Gugusheff, Jessica
Jackson, Melissa
Luksza, Jennifer
Lintzeris, Nicholas
Funding for this research was provided by:
National Health and Medical Research Council (1088902)
Article History
Received: 31 August 2017
Accepted: 28 March 2018
First Online: 18 May 2018
Ethics approval and consent to participate
: Ethics Approval and consent to participate: South Eastern Sydney Local Health District Human Research Ethics Committee. Ref: 14/289 (HREC/14/POWH/701). Hunter New England Local Health District and Western Sydney Local Health District received site-specific ethical approval. All participants signed a Participant Information Consent Form [PICF] before being enrolled in the study. Informed consent involved a 3-step process. 1. Verbal information about the trial was given to potential participant either face-to-face or over the telephone during an initial screen. 2. Participants eligible for a medical screen were asked to sign a ‘consent to participate in a medical screen’ form before seeing the trial medical officer. 3. If participant was deemed eligible by trial medical officer, the medical officer/trial researcher verbally discussed the trial to the participant and invited any queries or concerns to be addressed. The participant was given a copy of the main PICF to take home and review. The PICF was signed by the participant and a witness on day 1 of commencing the trial.
: The participant information consent form includes a section relating to consent for de-identified data to be published. This is however not applicable for this paper.
: The authors declare that they have no competing interests.
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