The following changes were requested to the participant information sheet and consent form: Please state that this study has received ethical approval from the Central Health and Disability Ethics Committee. Please include the relevant exclusions, in lay language, in the participant information sheet, particularly the exclusion of pregnant women. Decision This application was provisionally approved, subject to the following information being received. Please confirm whether SCOTT approval is required (Ethical Guidelines for Intervention Studies paras 5.50 5.51). – Please amend the participant information sheet and consent forms, taking into account the suggestions made by the Committee (Ethical Guidelines for Intervention Studies para 6.22). The response from the researcher will be reviewed, and a final decision made on the application, by Dr Patries Herst and Mrs Sandy Gill. 2 Ethics ref: 13/CEN/150 Title: STEP-UP Principal Investigator: Dr Mark O'Carroll Sponsor: Uptake Medical Corporation Clock Start Date: 10 October 2013 Dr Mark O’Carroll, Mr Matt Godden and Mr Robert Barry were 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 ethical issues The main ethical issues considered by the Committee were as follows. The Committee noted that they need evidence of favourable peer review. The Committee queried the status of the submission to the UK MHRA and asked whether MHRA review included a scientific peer review. Dr O’Carroll confirmed that this was at final approval stage, with one more question on informed consent to be answered. The Committee advised that they would like to view documentation of this review once it is complete in order to satisfy the requirement that favourable peer review had been granted. Mr advised that ethics approval had been received in Germany and Australia. The Committee explained that there is a distinction between peer review and ethics approval, with ethics approval being given once evidence of peer review, among other things, has been provided.
The following changes were requested to the participant information sheet and consent form: Please state that this study has received ethical approval from the Central Health and Disability Ethics Committee. Please include the relevant exclusions, in lay language, in the participant information sheet, particularly the exclusion of pregnant women. Decision This application was provisionally approved, subject to the following information being received. Please confirm whether SCOTT approval is required (Ethical Guidelines for Intervention Studies paras 5.50 – 5.51). Please amend the participant information sheet and consent forms, taking into account the suggestions made by the Committee (Ethical Guidelines for Intervention Studies para 6.22). The response from the researcher will be reviewed, and a final decision made on the application, by Dr Patries Herst and Mrs Sandy Gill. 2 Ethics ref: 13/CEN/150 Title: STEP-UP Principal Investigator: Dr Mark O'Carroll Sponsor: Uptake Medical Corporation Clock Start Date: 10 October 2013 Dr Mark O’Carroll, Mr Matt Godden and Mr Robert Barry were 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 ethical issues The main ethical issues considered by the Committee were as follows. The Committee noted that they need evidence of favourable peer review. The Committee queried the status of the submission to the UK MHRA and asked whether MHRA review included a scientific peer review. Dr O’Carroll confirmed that this was at final approval stage, with one more question on informed consent to be answered. The Committee advised that they would like to view documentation of this review once it is complete in order to satisfy the requirement that favourable peer review had been granted. Mr advised that ethics approval had been received in Germany and Australia. The Committee explained that there is a distinction between peer review and ethics approval, with ethics approval being given once evidence of peer review, among other things, has been provided.
cen-minutes-22-oct-2013.docx