This application was provisionally approved by consensus, subject to the following information received. Please respond to the outstanding ethical concerns detailed above. 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). This following information will be reviewed, and a final decision made on the application, by Dr Nora Lynch and Miss Tangihaere Macfarlane. 10 Ethics ref: 17/NTB/97 Title: IN.PACT AV Access Study Principal Investigator: Associate Professor Andrew Holden Sponsor: Medtronic Clock Start Date: 25 May 2017 Professor Andrew Holden and Helen Knight 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 This study investigates the use of a drug coated balloon compared to a standard balloon for the treatment of stenoses (narrowing of veins) within AV fistulas. Drug coated balloons are standard therapy in lower limb stenosis, it is hoped that they will also be beneficial for these patients. The Committee commended the high quality of the Participant Information Sheet. Summary of ethical issues (resolved) The main ethical issues considered by the Committee and addressed by the Researcher are as follows. The Committee questioned how participants will be recruited, that not all patients undergoing this surgery will end up being eligible for study participation and it cannot be known in advance which patients will be eligible. The Researcher explained that they will consent all willing patients before surgery and then some will not be included in the study if they do not meet the inclusion criteria. The Committee questioned whether data may be used outside of this study. The Researcher stated that the de-identified study data is sent to the study sponsor who may use this data for other research projects. The Committee noted that the study should not be stopped by the study sponsor for commercial reasons.
This application was provisionally approved by consensus, subject to the following information received. Please respond to the outstanding ethical concerns detailed above. 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). This following information will be reviewed, and a final decision made on the application, by Dr Nora Lynch and Miss Tangihaere Macfarlane. 10 Ethics ref: 17/NTB/97 Title: IN.PACT AV Access Study Principal Investigator: Associate Professor Andrew Holden Sponsor: Medtronic Clock Start Date: 25 May 2017 Professor Andrew Holden and Helen Knight 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 This study investigates the use of a drug coated balloon compared to a standard balloon for the treatment of stenoses (narrowing of veins) within AV fistulas. Drug coated balloons are standard therapy in lower limb stenosis, it is hoped that they will also be beneficial for these patients. The Committee commended the high quality of the Participant Information Sheet. Summary of ethical issues (resolved) The main ethical issues considered by the Committee and addressed by the Researcher are as follows. The Committee questioned how participants will be recruited, that not all patients undergoing this surgery will end up being eligible for study participation and it cannot be known in advance which patients will be eligible. The Researcher explained that they will consent all willing patients before surgery and then some will not be included in the study if they do not meet the inclusion criteria. The Committee questioned whether data may be used outside of this study. The Researcher stated that the de-identified study data is sent to the study sponsor who may use this data for other research projects. The Committee noted that the study should not be stopped by the study sponsor for commercial reasons.
ntb-6-june-2017-meeting-minutes.docx