The Committee requested the following changes to the Participant Information Sheet and Consent Form: The Committee requested that the Participant Information Sheet be reconsidered to improve the readability for lay participants. The Committee requested that the language in the Participant Information Sheet be reconsidered, for example to reword and Demands on Participants’ on the first ‘Methods page. Please ensure accurate compensation wording regarding ACC is included in the Participant Information Sheet. The Committee suggested the wording from the HDEC template: you were injured in this study, which is unlikely, you would be eligible to apply “If 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 automatically be accepted. You will have to lodge a claim with ACC, which may take some time to assess. If your claim is accepted, you will receive funding to assist in your recovery. If you have private health or life insurance, you may wish to check with your insurer that taking part in this study won’t affect your cover” For completeness please provide a copy of the Consent Form. Decision This application was provisionally approved by consensus, subject to the following information trial received. Please make changes to the Participant Information detailed in points 16-19 above. Please provide a copy of the Consent Form and the Māori Consultation response for completeness. This following information will be reviewed, and a final decision made on the application, by Secretariat. 2 Ethics ref: 15/NTA/152 Title: PADDOCK Principal Investigator: Dr Humphrey, W, H Pullon Sponsor: CNS - Clinical Network Services Ltd Clock Start Date: 01 October 2015 Dr Humphrey Pullon and a representative from the Study Sponsor 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 Study
The Committee requested the following changes to the Participant Information Sheet and Consent Form: The Committee requested that the Participant Information Sheet be reconsidered to improve the readability for lay participants. The Committee requested that the language in the Participant Information Sheet be reconsidered, for example to reword ‘Methods and Demands on Participants’ on the first page. Please ensure accurate compensation wording regarding ACC is included in the Participant Information Sheet. The Committee suggested the wording from the HDEC template: “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 automatically be accepted. You will have to lodge a claim with ACC, which may take some time to assess. If your claim is accepted, you will receive funding to assist in your recovery. If you have private health or life insurance, you may wish to check with your insurer that taking part in this study won’t affect your cover” For completeness please provide a copy of the Consent Form. Decision This application was provisionally approved by consensus, subject to the following information received. Please make changes to the Participant Information detailed in points 16-19 above. Please provide a copy of the Consent Form and the Māori Consultation response for completeness. This following information will be reviewed, and a final decision made on the application, by Secretariat. 2 Ethics ref: 15/NTA/152 Title: PADDOCK Principal Investigator: Dr Humphrey, W, H Pullon Sponsor: CNS - Clinical Network Services Ltd Clock Start Date: 01 October 2015 Dr Humphrey Pullon and a representative from the Study Sponsor 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 Study trial
nta-13-october-2015-meeting-minutes.docx