Placeholder notice. The definitive consent form is presented and signed in the TRipple app before you take part; this page reproduces the wording you will be asked to agree to. Fields shown in angle brackets
< >are populated per trial and must be finalised and ethics-approved before recruitment.
- Trial name: <Insert specific trial name>
- Trial opening date: <Insert date trial opened>
- ClinicalTrials.gov ID: <Insert specific identifier>
- Consent form number and version: <Insert unique number, which must match PIS number>
- Consent form date: <Date consent form was finalised>
- Chief Investigator: Dr William Sedley, Senior Lecturer in Neurology, Newcastle University
By taking part, you confirm that:
- I have read the document 'App-based testing of acoustic tinnitus interventions – Participant Information Sheet', version <version>, dated <date>, and understood the information contained within the document.
- I have had the opportunity to ask questions about the study to a member of the research team.
- I have had at least 24 hours to decide on my participation, between reading the Participant Information Sheet and the present time.
- I am able to make an informed choice about whether to take part. I understand that my participation is entirely voluntary, and I feel under no pressure or obligation to take part.
- I confirm that I have tinnitus, in that there is a persistent sound in one or both ears present all or most of the time, provided it is not masked by other sounds and that I am listening for it.
- I understand that taking part in this study is not a replacement for seeking medical attention for my tinnitus.
- I consent to the storage of all information that I provide as part of the study. I understand that personally identifiable information I provide will be handled with adherence to General Data Protection Regulation.
- I consent to an anonymised form of all research data I provide that is not personally identifiable to me being stored, published in scientific literature and shared with other researchers in the scientific community.
- I understand that I have the right to terminate my involvement in the study at any time.
- I understand that my data will not automatically be deleted if I terminate my participation in the study, and that if I want my data to be deleted then I will need to specifically request this via the research team. I also understand that once the study is completed, it might only be possible to delete my personally identifiable information, and not my anonymised research data.
- I consent to the study app sending me notifications and/or automatic e-mails to prompt me to complete necessary aspects of the study.
- I consent to being contacted by the research team with the results of the study once these are available.
- I take full responsibility for any hearing damage that might result from listening to sounds too loud for too long should this occur in the course of taking part in the study. I confirm that I have read the parts of the Participant Information Sheet highlighting the dangers of listening to sounds too loud and/or for too long, and the fact that the research team cannot assess and guarantee the safety of my listening arrangement. I confirm that I understand the '60/60' principle of safe sound listening, which advises listening to sounds at no more than 60% of maximum volume, and for no more than 60 minutes at a time.
- I understand that there is a chance that my tinnitus could get worse rather than better during the study, either as a result of taking part in the study, or by coincidence.
- I take full responsibility for any changes to my tinnitus that might occur during the study, whether or not these occur as a consequence of taking part in the study.
- I agree to take part in the study.