Please amend the participant information and consent form, taking into account the suggestions by the Committee (Ethical Guidelines for Observational Studies, para 6.10). This following information will be reviewed, and a final decision made on the application, by the HDEC Secretariat. 5 Ethics ref: 15/NTB/37 Health and wealth in chronic kidney disease Principal Investigator: Dr Tonya Kara Sponsor: Kidney Health Australia Clock Start Date: 19 February 2015 Dr Tonya Kara was present in person 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 Committee thanked the researcher for attending in person. Dr Kara explained that 200 children had been recruited to this in Australia and the researchers want New Zealand to be involved as they want to look at the disparity in transplant rates. Dr Kara advised that they know that chronic illness makes people poor but there is nothing objectively published to show this. Summary of ethical issues (resolved) The main ethical issues considered by the Committee and addressed by the researcher were as follows. Dr Kara explained that Starship does not look after patients over the age of 15 due to funding constraints. Dr Kara confirmed that parents will not be interviewed. The Committee advised that parents are also participants in this study as parts of the children’s questionnaires are for parents to complete. Dr Kara advised that in Australia, they found children over 10 were completing the questionnaire. The Committee advised that there needs to be a fuller PIS for children and an assent form. The Committee advised that the children’s questionnaire should be grouped into the questions that children can answer. The Committee asked if the Weschler IQ testing was part of this study. Dr Kara explained that it would not be done in this study in New Zealand but that it was part of normal clinical care. She said that this study will not have interviews or IQ testing. This was because the testing had different clinical justifications and because these were not ready in time. The Committee advised that as the participants are likely to be the same, this may be able to be submitted as an amendment rather than a separate application. Dr Kara advised that she was told to wait until after the HDEC meeting before consulting with Māori. She noted that Dr Helen Wihongi would provide consultation, along with a paediatrician in Dunedin.
Please amend the participant information and consent form, taking into account the suggestions by the Committee (Ethical Guidelines for Observational Studies, para 6.10). This following information will be reviewed, and a final decision made on the application, by the HDEC Secretariat. 5 Ethics ref: 15/NTB/37 Health and wealth in chronic kidney disease Principal Investigator: Dr Tonya Kara Sponsor: Kidney Health Australia Clock Start Date: 19 February 2015 Dr Tonya Kara was present in person 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 Committee thanked the researcher for attending in person. Dr Kara explained that 200 children had been recruited to this in Australia and the researchers want New Zealand to be involved as they want to look at the disparity in transplant rates. Dr Kara advised that they know that chronic illness makes people poor but there is nothing objectively published to show this. Summary of ethical issues (resolved) The main ethical issues considered by the Committee and addressed by the researcher were as follows. Dr Kara explained that Starship does not look after patients over the age of 15 due to funding constraints. Dr Kara confirmed that parents will not be interviewed. The Committee advised that parents are also participants in this study as parts of the children’s questionnaires are for parents to complete. Dr Kara advised that in Australia, they found children over 10 were completing the questionnaire. The Committee advised that there needs to be a fuller PIS for children and an assent form. The Committee advised that the children’s questionnaire should be grouped into the questions that children can answer. The Committee asked if the Weschler IQ testing was part of this study. Dr Kara explained that it would not be done in this study in New Zealand but that it was part of normal clinical care. She said that this study will not have interviews or IQ testing. This was because the testing had different clinical justifications and because these were not ready in time. The Committee advised that as the participants are likely to be the same, this may be able to be submitted as an amendment rather than a separate application. Dr Kara advised that she was told to wait until after the HDEC meeting before consulting with Māori. She noted that Dr Helen Wihongi would provide consultation, along with a paediatrician in Dunedin.
ntb-3-march-15-meeting-minutes.docx