form? The Committee noted that the reason it is asking is that it knows of participants in research in New Zealand who have been injured in trials where sponsors won’t offer compensation and they have had protracted battles in court with sponsors. The Committee would like the researchers to check that ACC equivalent compensation is in place and asked the researchers to check with the sponsor to qualify and make sure and then to let the Committee know. The Committee requested the following changes to the participant information and consent Main PIS/CF Please spell out HCV in full the first time it is mentioned. Please refer to sof/val as the drug”. “study Page 9, trial sentence under the heading Reaction”: please include the word “Allergic at the end of the sentence. “previously” The Committee noted that it is generally agreed that contact names are better placed at the end of the information sheet to avoid the risk that they get lost in the main content. Please place the contact names at the end of document. FUR PIS/CF Page 2, third paragraph: please remove the statement that says participants need to notify their study doctor in writing of any decision to withdraw their consent. Page 8 agreement for study spell pharmacogenomics under number 3 PIS for FUR – sheet. Decision This application was approved by consensus (with non-standard conditions). 3 Ethics ref: 16/CEN/210 Title: Is the usage of antibiotics in early childhood related to obesity? Principal Investigator: Prof Wayne Cutfield Sponsor: Clock Start Date: 19 January 2017 Prof Cutfield 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 The researcher gave a summary of the study and explained how participants would be recruited to the study. Studies published looking at antibiotic usage and obesity have shown an association between use and risk of childhood obesity among otherwise healthy
form? The Committee noted that the reason it is asking is that it knows of participants in research in New Zealand who have been injured in trials where sponsors won’t offer compensation and they have had protracted battles in court with sponsors. The Committee would like the researchers to check that ACC equivalent compensation is in place and asked the researchers to check with the sponsor to qualify and make sure and then to let the Committee know. The Committee requested the following changes to the participant information and consent Main PIS/CF Please spell out HCV in full the first time it is mentioned. Please refer to sof/val as the “study drug”. Page 9, sentence under the heading “Allergic Reaction”: please include the word “previously” at the end of the sentence. The Committee noted that it is generally agreed that contact names are better placed at the end of the information sheet to avoid the risk that they get lost in the main content. Please place the contact names at the end of document. FUR PIS/CF Page 2, third paragraph: please remove the statement that says participants need to notify their study doctor in writing of any decision to withdraw their consent. Page 8 agreement for study – spell pharmacogenomics under number 3 PIS for FUR sheet. Decision This application was approved by consensus (with non-standard conditions). 3 Ethics ref: 16/CEN/210 Title: Is the usage of antibiotics in early childhood related to obesity? Principal Investigator: Prof Wayne Cutfield Sponsor: Clock Start Date: 19 January 2017 Prof Cutfield 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 The researcher gave a summary of the study and explained how participants would be recruited to the study. Studies published looking at antibiotic usage and obesity have shown an association between use and risk of childhood obesity among otherwise healthy trial
cen-31-jan-2017-meeting-minutes.docx