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). 10 Ethics ref: 18/STH/79 Title: Comparison of low versus high dose of nebulised salbutamol in acute severe and life-threatening asthma in the Emergency Department. Principal Investigator: Dr Saptarshi Mukerji Sponsor: Medical Research Institute of New Zealand. Clock Start Date: 29 March 2018 Dr Saptarshi Mukerji was present by teleconference 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 study investigates a higher dose against a lower dose of nebulised salbutamol in acute severe and life-threatening asthma presentations to the emergency department. Outcomes measured will be improvement in lung function, length of hospital stay, rates of admission to hospital and adverse events Summary of ethical issues (resolved) The main ethical issues considered by the Committee and addressed by the Researcher are as follows. The committee noted the proposed use of a brief PIS for unwell patients in A&E and commented this was appropriate and useful. The Committee noted that the study is important and that the application was of high quality The Committee noted that patients who are too unwell to be approached will not be invited to participate. The Committee noted that while it is best practice to have different people making the initial research approach to those treating the patient. This approach was deemed not necessary due to the study setting and it would not be appropriate to delay treatment to find an independent clinician. The Committee requested the following changes to the Participant Information Sheet and Consent Form: For the title of the information sheets, please use an alternative term than “life-threatening” as this may distress participants. The Committee suggested a better wording than for the longer information “transient” The Committee requested the compensation wording is updated for accuracy, they suggested the following statement: you were injured in this study, which is unlikely, you “If would be eligible to apply for compensation from ACC just as you would be if you were injured in an accident at work or at home. This does not mean that your claim will
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). 10 Ethics ref: 18/STH/79 Title: Comparison of low versus high dose of nebulised salbutamol in acute severe and life-threatening asthma in the Emergency Department. Principal Investigator: Dr Saptarshi Mukerji Sponsor: Medical Research Institute of New Zealand. Clock Start Date: 29 March 2018 Dr Saptarshi Mukerji was present by teleconference 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 study investigates a higher dose against a lower dose of nebulised salbutamol in acute severe and life-threatening asthma presentations to the emergency department. Outcomes measured will be improvement in lung function, length of hospital stay, rates of admission to hospital and adverse events Summary of ethical issues (resolved) The main ethical issues considered by the Committee and addressed by the Researcher are as follows. The committee noted the proposed use of a brief PIS for unwell patients in A&E and commented this was appropriate and useful. The Committee noted that the study is important and that the application was of high quality The Committee noted that patients who are too unwell to be approached will not be invited to participate. The Committee noted that while it is best practice to have different people making the initial research approach to those treating the patient. This approach was deemed not necessary due to the study setting and it would not be appropriate to delay treatment to find an independent clinician. The Committee requested the following changes to the Participant Information Sheet and Consent Form: For the title of the information sheets, please use an alternative term than “life-threatening” as this may distress participants. The Committee suggested a better wording than “transient” for the longer information The Committee requested the compensation wording is updated for accuracy, they suggested the following statement: “If you were injured in this study, which is unlikely, you would be eligible to apply for compensation from ACC just as you would be if you were injured in an accident at work or at home. This does not mean that your claim will
sth-10-april-2018-meeting-minutes.docx