give consent themselves. Mr Kepple noted that the researchers considered this group an important one that would also need protection and stated that any sensitive issues such as the pregnancy aspect will need to be considered carefully. The committee asked that the researchers provide it with information on how the researchers intend to handle the 13-16 year olds who are unable to give consent. Mr Kepple advised that the consultation process is ongoing and the committee requested evidence once the process is completed. The committee confirmed that an indemnity certificate was included with the application. The committee asked what restrictions the research team intended to place on the publication of study results and also that the research team record their interpretation of what the researchers have agreed with the sponsor and provide this record to the committee. The committee noted that there is no data safety monitoring committee (DSMC) for this trial and asked how the researchers intended to stop the study if a DSMC is not in place. Mr Kepple advised that standard data monitoring is being conducted. The committee sought further clarification about who will make the decision to stop the study and how will it be made. Mr Kepple advised a sponsor and medical monitor assigned by the sponsor will make the decision. Participant Information Sheet and Consent Form Please make the language more understandable to a New Zealand audience. Please include the information trial storage and destruction of human tissue given at r3.7 on the application form in the participant information sheet Page 9 there other influenza medications? Please add you do not want to ‘Are “if be part of this study” to the first sentence. Decision This application was provisionally approved by consensus, subject to the following information being received. The Committee requires information on how you intend to advise and protect the 13-16 year olds who are unable to give consent to take part in this study. 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). This information will be reviewed, and a final decision made on the application, by the Chair Etuate and Shamim. 4 Ethics ref: 13/NTA/74 Title: therapy to support the well-being of young people with intellectual disability Principal Investigator: Dr Daphne J. Rickson Sponsor: IHC Foundation Clock Start Date: 27 May 2013 Dr Daphne Rickson was present by teleconference for discussion of this application.
give consent themselves. Mr Kepple noted that the researchers considered this group an important one that would also need protection and stated that any sensitive issues such as the pregnancy aspect will need to be considered carefully. The committee asked that the researchers provide it with information on how the researchers intend to handle the 13-16 year olds who are unable to give consent. Mr Kepple advised that the consultation process is ongoing and the committee requested evidence once the process is completed. The committee confirmed that an indemnity certificate was included with the application. The committee asked what restrictions the research team intended to place on the publication of study results and also that the research team record their interpretation of what the researchers have agreed with the sponsor and provide this record to the committee. The committee noted that there is no data safety monitoring committee (DSMC) for this trial and asked how the researchers intended to stop the study if a DSMC is not in place. Mr Kepple advised that standard data monitoring is being conducted. The committee sought further clarification about who will make the decision to stop the study and how will it be made. Mr Kepple advised a sponsor and medical monitor assigned by the sponsor will make the decision. Participant Information Sheet and Consent Form Please make the language more understandable to a New Zealand audience. Please include the information storage and destruction of human tissue given at r3.7 on the application form in the participant information sheet Page 9 ‘Are there other influenza medications? Please add “if you do not want to be part of this study” to the first sentence. Decision This application was provisionally approved by consensus, subject to the following information being received. The Committee requires information on how you intend to advise and protect the 13-16 year olds who are unable to give consent to take part in this study. 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). This information will be reviewed, and a final decision made on the application, by the Chair Etuate and Shamim. 4 Ethics ref: 13/NTA/74 Title: therapy to support the well-being of young people with intellectual disability Principal Investigator: Dr Daphne J. Rickson Sponsor: IHC Foundation Clock Start Date: 27 May 2013 Dr Daphne Rickson was present by teleconference for discussion of this application. trial
nta-minutes-11-jun-2013.docx