Prof advised the Committee that the product would be classed as a medicine if it was sold and SCOTT approval is being sought. The study would begin after both SCOTT and Ethics Committee approval is given. The Committee acknowledged that while sputum is a tissue, it would seek advice on whether the use of sputum in particular would raise cultural issues for Māori. For future reference, please include Pacific Island and other cultures in answers to question f.1.2 on the application form. The Committee noted that 75 percent cold symptoms must be dependent on time of the year and suggested that the researchers may wish to check their power calculations bearing in mind they plan to start in the summer. Prof Crane advised that the researchers are in touch with all of families already as they are enrolled in a larger study and participants would be excluded if they hadn’t had at least one cold over past 12 months. Prof Crane said that rhinovirus infections are not a winter phenomenon alone but noted that they may not have adequate power if they don’t see enough colds. This is a pilot study only and data will be used to develop a larger study. The Committee noted that there is no information about intended home visits in the information sheet and asked that information about the number of visits, duration, and remuneration costs be included. Prof Crane advised that the visits will be done in conjunction with other visits that are part of the larger study and that this information can be added to the participant information sheet. Please include footer and version numbers on the nasal spray instructions and nose swab instructions. The Committee requested the following changes to the participant information sheet: Please include the inclusion and exclusion criteria listed at question f.2.1, page 22 of the application form. Please include the study’s Māori contact person’s details. Decision This application was provisionally approved by consensus, subject to the following information received. Please amend the information sheet, 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 Secretariat. 12 Ethics ref: 14/CEN/10 Title: Probiotic intervention to reduce streptococcal disease burden in NZ children Principal Investigator: Professor Julian Crane Sponsor: Clock Start Date: 15 January 2014 Prof Julian was present in person for discussion of this application. Potential conflicts of interest The Chair asked members to declare any potential conflicts of interest related to this application.
Prof advised the Committee that the product would be classed as a medicine if it was sold and SCOTT approval is being sought. The study would begin after both SCOTT and Ethics Committee approval is given. The Committee acknowledged that while sputum is a tissue, it would seek advice on whether the use of sputum in particular would raise cultural issues for Māori. For future reference, please include Pacific Island and other cultures in answers to question f.1.2 on the application form. The Committee noted that 75 percent cold symptoms must be dependent on time of the year and suggested that the researchers may wish to check their power calculations bearing in mind they plan to start in the summer. Prof Crane advised that the researchers are in touch with all of families already as they are enrolled in a larger study and participants would be excluded if they hadn’t had at least one cold over past 12 months. Prof Crane said that rhinovirus infections are not a winter phenomenon alone but noted that they may not have adequate power if they don’t see enough colds. This is a pilot study only and data will be used to develop a larger study. The Committee noted that there is no information about intended home visits in the information sheet and asked that information about the number of visits, duration, and remuneration costs be included. Prof Crane advised that the visits will be done in conjunction with other visits that are part of the larger study and that this information can be added to the participant information sheet. Please include footer and version numbers on the nasal spray instructions and nose swab instructions. The Committee requested the following changes to the participant information sheet: Please include the inclusion and exclusion criteria listed at question f.2.1, page 22 of the application form. Please include the study’s Māori contact person’s details. Decision This application was provisionally approved by consensus, subject to the following information received. Please amend the information sheet, 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 Secretariat. 12 Ethics ref: 14/CEN/10 Title: Probiotic intervention to reduce streptococcal disease burden in NZ children Principal Investigator: Professor Julian Crane Sponsor: Clock Start Date: 15 January 2014 Prof Julian was present in person for discussion of this application. Potential conflicts of interest The Chair asked members to declare any potential conflicts of interest related to this application.
cen-minutes-30-jan-2014.docx