The Chair opened the meeting at 1pm and welcomed Committee members, noting that apologies had been received from Dr Catherin Jackson. The noted that Ms Toni Millar was attending in an observational capacity and was not reviewing applications. The Chair noted that the meeting was quorate. The Committee noted and agreed the agenda for the meeting. Confirmation of previous minutes The minutes of the meeting of 11 October were confirmed. New applications 1 Ethics ref: 16/NTA/188 A study of RO7062931 in healthy subjects and patients chronically infected with hepatitis B virus infection Principal Investigator: Professor Ed Gane Sponsor: Covance NZ Ltd Clock Start Date: 03 November 2016 Dr Paul Hamilton and Ms Mary Ellis-Peglar were present by teleconference for discussion of this application. Potential conflicts of interest The Chair asked members to declare any potential conflicts of interest related to this application. No potential conflicts of interest related to this application were declared by any member. Summary of Study The study is a phase I clinical trial of the study drug, RO7062931, to test its’ safety and tolerability in human subjects. The Committee noted that that the study protocol is an umbrella protocol. The drug is administered subcutaneously and the researchers aim to recruit 80 participants in this trial. Summary of ethical issues (resolved) The main ethical issues considered by the Committee and addressed by the Researcher are as follows. The Committee queried how long the first phase of the study takes. The researchers explained that the first phase takes 29 days. The first three days are in-house and there are 6 follow up visits up to the 29th day endpoint.
Please note the future unspecified research appears to be requiring additional blood samples (taken at the time of other samples) not just leftover blood, please note this. Please add an area code for the Māori contact person. Please remove the statement about an HDEC-approved auditor from the consent form. Decision This application was provisionally approved by consensus, subject to the following information being received. Please amend the information sheet and consent form, taking into account the suggestions made by the Committee (Ethical Guidelines for Intervention Studies para 6.22). Please explain what procedures are in place to manage the potential coercion in the recruitment process. Please confirm that the study will not be terminated purely for commercial reasons. This following information will be reviewed, and a decision made on the application, by Ms Rosemary Abbott and Dr Christine Crooks. 3 Ethics ref: 16/NTA/177 Title: ICU-ROX Principal Investigator: Ms Diane Mackle Sponsor: Medical Research Institute of NZ Clock Start Date: 28 October 2016 Dr Paul Young and Ms Diane Mackle were present by teleconference for discussion of this application. Potential conflicts of interest The asked members to declare any potential conflicts of interest related to this application. No potential conflicts of interest related to this application were declared by any member. Summary of Study This seeks to determine if healthcare professionals participating in the ICU ROX study will change their practice and attitudes to oxygen management in an observable way, regardless of the ICU ROX study outcomes. The second aim is to detect if a significant difference in favour of a more conservative oxygen therapy model then it will occur in participating units, rather than in non-participating units, or those outside Australia and New Zealand. The Committee sought clarification on what part of the they should be reviewing as the documents provided were not clear. The researchers explained that they would like the Committee to examine the retrospective review of data and the prospective observational (Inception Cohort) study. The health professional survey had been reviewed and approved by an Institutional Committee. The prospective observational study involves the recording of oxygen levels and other routinely collected data from ICU patients in order to determine current practice before and after the ICU ROX study (one sites will not be involved in ICU ROX). Consent will not be sought prospectively or retrospectively.