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The Study
Salt Water Nose Drops
More Information (Edinburgh)
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Study Team
ELVIS Kids Consent form: Edinburgh
Participant Number:
Tick if you consent to the below
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1. I confirm that I have read and understand the information sheet (Dated: ____________ and Version Number_______) for the above study. I have had the opportunity to consider the information, ask questions and have had these questions answered satisfactorily.
2. I understand that my participation and my child’s participation is voluntary and that I am free to withdraw at any time without giving any reason and without my child’s medical care and/or legal rights being affected.
3. I give permission for the study team to access my child’s medical records if needed, to collect data on visits to hospital, and treatment received and to check whether they are suitable to take part in the study.
4. I understand that relevant sections of my child’s medical notes and data collected during the study may be looked at by individuals in the study team, from the Sponsor (University of Edinburgh and/or NHS Lothian), from NHS Lothian or other regulatory authorities where it is relevant to my child taking part in this study. I give permission for these individuals to have access to my child’s data and/or medical records.
5. I give permission for my personal information and my child’s personal information (including my child’s date of birth, and my telephone number and email address) to be passed to the University of Edinburgh for administration of the study.
6. I understand that the nose swabs collected from my child will be tested to see which bacteria or viruses have caused my child’s cold.
7. I understand that the nose swabs collected from my child may be tested for human DNA to check the samples have been taken correctly.
8a. I agree to my child’s anonymised data and nose swabs being kept for use in future ethically approved studies and I understand the samples will be held securely in the Lothian NRS BioResource.
8b. I do not agree to my child’s anonymised data and nose swabs being kept for use in future ethically approved studies and I understand the samples will be held securely in the Lothian NRS BioResource.
9a. I understand that as part of future ethically approved studies the samples may be tested for human DNA to identify why some children get more infections or why some children have mild and others have severe illness and consent to it.
9b. I understand that as part of future ethically approved studies the samples may be tested for human DNA to identify why some children get more infections or why some children have mild and others have severe illness and do not consent to it.
10. I agree to my child’s General Practitioner being informed of their participation in the study.
11. I give permission for the trial researchers to contact me by email, phone and text message during the study.
12. I agree that my child will take part in the above study.
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