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). Steps should be taken to ensure Māori are equally able to participate in the study and cultural concerns are mitigated (Ethical Guidelines for Intervention Studies paragraph 4.7). Consent for Future Unspecified Use of Tissue should also be distinct from consent to collect the sample and distinct from consent to use the sample in specified research (Guidelines for the Use of Human Tissue for Future Unspecified Research Purposes paragraph 2). This following information will be reviewed, and a final decision made on the application, by Dr Nicola Swain and Mrs Kate O'Connor. 8 Ethics ref: 17/STH/154 Title: Understanding human muscle cellular function Principal Investigator: Dr. Troy Sponsor: The University of Auckland Clock Start Date: 31 August 2017 Dr. Troy and a co-investigator 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 ethical issues (resolved) The main ethical issues considered by the Committee and addressed by the Researcher are as follows. The Committee questioned the pain associated with muscle biopsies and whether this caused any issues with recruitment. The Researcher stated their view is that they are not very painful and it won’t cause issues for recruitment. The Committee questioned how long participants would have to consider participation after first receiving the Participant Information Sheet. The Researcher explained that the Participant Information Sheet would be sent to the potential participants after they discussed the research with a member of the research team, then they would also go through it again in person before obtaining informed consent. The Committee discussed the ethical issues associated with growing cell lines for this study, noting that as this is the primary purpose of the study and participants are fully informed that this is acceptable. The Committee questioned whether the cell lines could be grown indefinitely. The Researcher explained that they can only grow them a specific number of times and that their use is limited.
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). Steps should be taken to ensure Māori are equally able to participate in the study and cultural concerns are mitigated (Ethical Guidelines for Intervention Studies paragraph 4.7). Consent for Future Unspecified Use of Tissue should also be distinct from consent to collect the sample and distinct from consent to use the sample in specified research (Guidelines for the Use of Human Tissue for Future Unspecified Research Purposes paragraph 2). This following information will be reviewed, and a final decision made on the application, by Dr Nicola Swain and Mrs Kate O'Connor. 8 Ethics ref: 17/STH/154 Title: Understanding human muscle cellular function Principal Investigator: Dr. Troy Sponsor: The University of Auckland Clock Start Date: 31 August 2017 Dr. Troy and a co-investigator 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 ethical issues (resolved) The main ethical issues considered by the Committee and addressed by the Researcher are as follows. The Committee questioned the pain associated with muscle biopsies and whether this caused any issues with recruitment. The Researcher stated their view is that they are not very painful and it won’t cause issues for recruitment. The Committee questioned how long participants would have to consider participation after first receiving the Participant Information Sheet. The Researcher explained that the Participant Information Sheet would be sent to the potential participants after they discussed the research with a member of the research team, then they would also go through it again in person before obtaining informed consent. The Committee discussed the ethical issues associated with growing cell lines for this study, noting that as this is the primary purpose of the study and participants are fully informed that this is acceptable. The Committee questioned whether the cell lines could be grown indefinitely. The Researcher explained that they can only grow them a specific number of times and that their use is limited.