Please combine consent forms into a single document. Please lay out exactly what participants are consenting to in a clear manner. Decision This application was provisionally approved by consensus subject to the following information being received. 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 following information will be reviewed, and a final decision made on the application, by Dr Charis Brown and Mr John Hancock. 6 Ethics ref: 16/NTA/113 Title: Treatment of mild-moderate Impetigo Principal Investigator: Dr Alison Leversha Sponsor: Clock Start Date: 28 July 2016 Dr Alison Leversha 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. Dr Karen Bartholomew declared a potential conflict of interest, and the Committee decided to allow her to remain present, but not participate in the discussion or decision making processes. Summary of Study The aims to add screening for impetigo onto an already extant rheumatic fever screening process in place in low decile schools. They will assess the efficacy of standard wound care versus that of an antibiotic cream. The schools and students are familiar with the screening process and were concerned about skin infections as rheumatic fever rates have been found to be low. The Committee asked for incidence rates of impetigo. The CI explained that around 25% of children will have skin infections. Summary of ethical issues (resolved) The main ethical issues considered by the Committee and addressed by the Researcher are as follows. The Committee queried how consent would be obtained. The Ci explained that parents consent for their child when their child goes to school. If any form of treatment is required then they call the parents and seek consent. The Committee asked how parents wanting to time to think about their choices would be managed. The Ci explained that parents will be able to think about this overnight. Parents coming into the school to collect medicine will be able to discuss with staff.
Please combine consent forms into a single document. Please lay out exactly what participants are consenting to in a clear manner. Decision This application was provisionally approved by consensus subject to the following information being received. 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 following information will be reviewed, and a final decision made on the application, by Dr Charis Brown and Mr John Hancock. 6 Ethics ref: 16/NTA/113 Title: Treatment of mild-moderate Impetigo Principal Investigator: Dr Alison Leversha Sponsor: Clock Start Date: 28 July 2016 Dr Alison Leversha 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. Dr Karen Bartholomew declared a potential conflict of interest, and the Committee decided to allow her to remain present, but not participate in the discussion or decision making processes. Summary of Study The aims to add screening for impetigo onto an already extant rheumatic fever screening process in place in low decile schools. They will assess the efficacy of standard wound care versus that of an antibiotic cream. The schools and students are familiar with the screening process and were concerned about skin infections as rheumatic fever rates have been found to be low. The Committee asked for incidence rates of impetigo. The CI explained that around 25% of children will have skin infections. Summary of ethical issues (resolved) The main ethical issues considered by the Committee and addressed by the Researcher are as follows. The Committee queried how consent would be obtained. The Ci explained that parents consent for their child when their child goes to school. If any form of treatment is required then they call the parents and seek consent. The Committee asked how parents wanting to time to think about their choices would be managed. The Ci explained that parents will be able to think about this overnight. Parents coming into the school to collect medicine will be able to discuss with staff.
nta-9-august-2016-meeting-minutes.docx