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 thanked the researchers for the well written application on an important topic and congratulated them on receiving HRC funding. The Committee noted that good evidence of the peer review process had been provided. Summary of ethical issues (resolved) The main ethical issues considered by the Committee and addressed by the Researcher are as follows. The Committee questioned how participants would be identified. The Researchers explained that GPs will be approached and informed of the study and asked to send an invitation letter to any of their patients who they feel would be suitable for the study. The Researcher also noted that a previous study had recruited participants directly by accessing their medical records and stated that this was their backup plan if recruitment through GPs was not successful. The Committee noted that if it was decided to approach participants directly then an Amendment should be submitted for HDEC approval, the Researcher agreed and stated that this was their plan. The Committee questioned whether following the sending of the invitation letter if interested parents would need to phone the researchers for more information or to enrol. The Researcher confirmed that interested parents would phone the researchers and be sent a participant information sheet as well as discussing the study over the phone with the researchers. The Committee noted that participants are children 8-17 years old and that any participants aged 16 or over must provide their own consent, and younger participants who are deemed competent to provide informed consent should be asked to do so. For younger participants unable to provide their own informed consent, their parent or guardian must provide informed consent on their behalf and the child must provide assent. The Committee questioned whether the researchers believe they have suitably addressed the concerns raised in the peer review. The Researcher stated that they believe they have adequately rebutted these comments in the rebuttal provided to the committee. The Committee questioned the question regarding suicide in the questionnaire. The Researcher stated that this question was included as a means of measuring the stress levels of participants. The Committee stated that they did not believe this question is suitable or appropriate, especially as it asks for the name of this person or their relationship to the child, and request that it is removed. The Committee suggested that another standardised and validated stress measurement question or tool would be suitable to include. Summary of ethical issues (outstanding) The Committee requested the following changes to the Participant Information Sheet and Consent Form:
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 thanked the researchers for the well written application on an important topic and congratulated them on receiving HRC funding. The Committee noted that good evidence of the peer review process had been provided. Summary of ethical issues (resolved) The main ethical issues considered by the Committee and addressed by the Researcher are as follows. The Committee questioned how participants would be identified. The Researchers explained that GPs will be approached and informed of the study and asked to send an invitation letter to any of their patients who they feel would be suitable for the study. The Researcher also noted that a previous study had recruited participants directly by accessing their medical records and stated that this was their backup plan if recruitment through GPs was not successful. The Committee noted that if it was decided to approach participants directly then an Amendment should be submitted for HDEC approval, the Researcher agreed and stated that this was their plan. The Committee questioned whether following the sending of the invitation letter if interested parents would need to phone the researchers for more information or to enrol. The Researcher confirmed that interested parents would phone the researchers and be sent a participant information sheet as well as discussing the study over the phone with the researchers. The Committee noted that participants are children 8-17 years old and that any participants aged 16 or over must provide their own consent, and younger participants who are deemed competent to provide informed consent should be asked to do so. For younger participants unable to provide their own informed consent, their parent or guardian must provide informed consent on their behalf and the child must provide assent. The Committee questioned whether the researchers believe they have suitably addressed the concerns raised in the peer review. The Researcher stated that they believe they have adequately rebutted these comments in the rebuttal provided to the committee. The Committee questioned the question regarding suicide in the questionnaire. The Researcher stated that this question was included as a means of measuring the stress levels of participants. The Committee stated that they did not believe this question is suitable or appropriate, especially as it asks for the name of this person or their relationship to the child, and request that it is removed. The Committee suggested that another standardised and validated stress measurement question or tool would be suitable to include. Summary of ethical issues (outstanding) The Committee requested the following changes to the Participant Information Sheet and Consent Form:
ntb-5-april-2016-meeting-minutes.docx