The Chair noted that the meeting was quorate. The Committee noted and agreed the agenda for the meeting. Confirmation of previous minutes The minutes of the meeting of 16 August 2016 were confirmed. New applications 1 Ethics ref: 16/STH/108 Title: Reducing bladder stones using Potassium Citrate after acute SCI Principal Investigator: Dr Peter Aspell Sponsor: Canterbury District Health Board Clock Start Date: 20 July 2016 Dr Peter Aspell 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 Most patients in the spinal unit require a catheter and due to their reduced mobility and other risk factors they have increased chances of developing bladder stones or debris. Between 10 and 20% of these patients are expected to develop stones or debris. Currently Potassium Citrate is frequently used to bladder stones or debris in this patient group, among others, and is considered very safe. This study proposes providing Potassium Citrate to some patients in the spinal unit to determine whether this reduces their risk of developing bladder stones or debris. Summary of ethical issues (resolved) The main ethical issues considered by the Committee and addressed by the Researcher are as follows. The Committee noted that the current application includes non-consenting participants, who are enrolled in the study before they are able to provide consent. The Committee questioned whether it was necessary to include participants who did not consent prior to their inclusion. The Researcher stated that they expected this to be a very small number of potential participants and it would not reduce the feasibility or compromise the results of their study to exclude these patients. The Committee agreed to consider the study going forward as only including participants who could provide informed consent prior to their enrolment in the study. The Committee noted that, if a benefit is found, a future study including participants unable to provide informed consent may be possible but would need
The Chair noted that the meeting was quorate. The Committee noted and agreed the agenda for the meeting. Confirmation of previous minutes The minutes of the meeting of 16 August 2016 were confirmed. New applications 1 Ethics ref: 16/STH/108 Title: Reducing bladder stones using Potassium Citrate after acute SCI Principal Investigator: Dr Peter Aspell Sponsor: Canterbury District Health Board Clock Start Date: 20 July 2016 Dr Peter Aspell 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 Most patients in the spinal unit require a catheter and due to their reduced mobility and other risk factors they have increased chances of developing bladder stones or debris. Between 10 and 20% of these patients are expected to develop stones or debris. Currently Potassium Citrate is frequently used to bladder stones or debris in this patient group, among others, and is considered very safe. This study proposes providing Potassium Citrate to some patients in the spinal unit to determine whether this reduces their risk of developing bladder stones or debris. Summary of ethical issues (resolved) The main ethical issues considered by the Committee and addressed by the Researcher are as follows. The Committee noted that the current application includes non-consenting participants, who are enrolled in the study before they are able to provide consent. The Committee questioned whether it was necessary to include participants who did not consent prior to their inclusion. The Researcher stated that they expected this to be a very small number of potential participants and it would not reduce the feasibility or compromise the results of their study to exclude these patients. The Committee agreed to consider the study going forward as only including participants who could provide informed consent prior to their enrolment in the study. The Committee noted that, if a benefit is found, a future study including participants unable to provide informed consent may be possible but would need
sth-20-september-2016-meeting-minutes.docx