The Committee requested the following changes to the Participant Information Sheet and Consent Form: The committee noted that the consent form is drafted on the basis that the child is giving consent and asked therefore asked that the researchers tweak the consent form to reflect that the parent or caregiver is consenting on behalf of the child. Please include a footer that states the version number. Please state approval is given by the Central Ethics Committee. Please include exclusion criteria in lay language. Decision This application was approved by consensus with non-standard approval conditions. Please amend the information sheet and consent forms, taking into account the suggestions made by the committee (Ethical Guidelines for Intervention Studies para 6.22). 7 Ethics ref: 13/CEN/131 Title: R3ACT CTL Study Principal Investigator: Dr Nyree Cole Sponsor: Western Sydney Local Health District Start Date: 12 September 2013 Dr Nyree Cole and Ms Sarah Hunter 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 The main ethical issues considered by the Committee were as follows. This study involves a stem cell transplant (white blood cells) for patients who are immune compromised. The committee was satisfied that patient safety has been taken into account. Dr Cole emphasised for the committee that the donation of outlined in the study protocol is for the committee’s information only and is not part of the clinical trial in New Zealand at this time. This trial relates to the recipients only. The donors are based in Australia. The researchers will manipulate and use cells at the time of collection. Dr Cole advised that they would apply for most closely matched cells to be sent over and used on recipients here in New Zealand. The committee noted that SCOTT approval is pending. Dr Cole advised that they have submitted to SCOTT and are awaiting a response. The study can begin once SCOTT approval is granted.
The Committee requested the following changes to the Participant Information Sheet and Consent Form: The committee noted that the consent form is drafted on the basis that the child is giving consent and asked therefore asked that the researchers tweak the consent form to reflect that the parent or caregiver is consenting on behalf of the child. Please include a footer that states the version number. Please state approval is given by the Central Ethics Committee. Please include exclusion criteria in lay language. Decision This application was approved by consensus with non-standard approval conditions. Please amend the information sheet and consent forms, taking into account the suggestions made by the committee (Ethical Guidelines for Intervention Studies para 6.22). 7 Ethics ref: 13/CEN/131 Title: R3ACT CTL Study Principal Investigator: Dr Nyree Cole Sponsor: Western Sydney Local Health District Start Date: 12 September 2013 Dr Nyree Cole and Ms Sarah Hunter 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 The main ethical issues considered by the Committee were as follows. This study involves a stem cell transplant (white blood cells) for patients who are immune compromised. The committee was satisfied that patient safety has been taken into account. Dr Cole emphasised for the committee that the donation of outlined in the study protocol is for the committee’s information only and is not part of the clinical trial in New Zealand at this time. This trial relates to the recipients only. The donors are based in Australia. The researchers will manipulate and use cells at the time of collection. Dr Cole advised that they would apply for most closely matched cells to be sent over and used on recipients here in New Zealand. The committee noted that SCOTT approval is pending. Dr Cole advised that they have submitted to SCOTT and are awaiting a response. The study can begin once SCOTT approval is granted.
cen-minutes-24-sep-2013.docx