This study involves participants in New Zealand and Singapore. This study is not going to be published in a journal but is for the commercial benefit. This is a first in human study. Summary of ethical issues (resolved) The main ethical issues considered by the Committee and addressed by the Researcher are as follows. The Committee that the application form indicated that Maori research methodologies would be used, however, this is incorrect. Summary of ethical issues (outstanding) The main ethical issues considered by the Committee and which require addressing by the Researcher are as follows. The Committee questioned how many people this procedure has been used in. The Committee questioned how the conflict of interest of the treating clinician being the same as the study doctor will be managed. Please provide more information on how study results will be summarised and sent to participants. Please provide more information on how participants will be recruited. The Committee questioned how the study procedure would help manage discomfort and allow doctors to treat more patients. The Committee requested the following changes to the Participant Information Sheet and Consent Form: Please clarify in the Participant Information Sheet what the purpose of this study is and how many people will be recruited. Please state at the beginning of the Participant Information Sheet that this is an experimental procedure. Please clearly state in the Participant Information Sheet that the potential side effects of participation are not yet known. Any information available on risks must be clearly explained. The Participant Information Sheet indicates that this will not be able to be used after the study unless special arrangements are made. Please clarify what is meant by this. Please be more specific in the Participant Information Sheet about what is involved in participation, including how many ultrasounds and whether an MRI is required. Please clarify in the Participant Information Sheet when participants will have their catheter checked and removed. Please clearly layout in the Participant Information the order of processes involved in participation. Please explain what haematuria means. Please all Māori cultural support person contact details to the Participant Information Sheet. Please note in the Participant Information Sheet that participants’ GPs will be notified of their participation. Please clarify in the Participant Information Sheet that previous human studies were conducted in Chile, please also confirm whether the participants in these studies had the same condition and procedure. Please also provide some information on the outcomes for these participants.
This study involves participants in New Zealand and Singapore. This study is not going to be published in a journal but is for the commercial benefit. This is a first in human study. Summary of ethical issues (resolved) The main ethical issues considered by the Committee and addressed by the Researcher are as follows. The Committee that the application form indicated that Maori research methodologies would be used, however, this is incorrect. Summary of ethical issues (outstanding) The main ethical issues considered by the Committee and which require addressing by the Researcher are as follows. The Committee questioned how many people this procedure has been used in. The Committee questioned how the conflict of interest of the treating clinician being the same as the study doctor will be managed. Please provide more information on how study results will be summarised and sent to participants. Please provide more information on how participants will be recruited. The Committee questioned how the study procedure would help manage discomfort and allow doctors to treat more patients. The Committee requested the following changes to the Participant Information Sheet and Consent Form: Please clarify in the Participant Information Sheet what the purpose of this study is and how many people will be recruited. Please state at the beginning of the Participant Information Sheet that this is an experimental procedure. Please clearly state in the Participant Information Sheet that the potential side effects of participation are not yet known. Any information available on risks must be clearly explained. The Participant Information Sheet indicates that this will not be able to be used after the study unless special arrangements are made. Please clarify what is meant by this. Please be more specific in the Participant Information Sheet about what is involved in participation, including how many ultrasounds and whether an MRI is required. Please clarify in the Participant Information Sheet when participants will have their catheter checked and removed. Please clearly layout in the Participant Information the order of processes involved in participation. Please explain what haematuria means. Please all Māori cultural support person contact details to the Participant Information Sheet. Please note in the Participant Information Sheet that participants’ GPs will be notified of their participation. Please clarify in the Participant Information Sheet that previous human studies were conducted in Chile, please also confirm whether the participants in these studies had the same condition and procedure. Please also provide some information on the outcomes for these participants.
sth-11-april-2017-meeting-minutes.docx