My Rights

It is intended that the results will be presented in medical journals and conferences with the aim of improving patient care. At no time will you or any other patient be identified. We will share the key results with those participating in the trial.

We will need the following details:

• your contact details (address, mobile phone number),

• your medical history,

• your medicines,

• your measurements,

• your results (pregnancy test, blood tests),

• your questionnaire answers,

• health events of interest that occur during the trial,

• your opinion about the trial.

Any personal data required for this trial will be coded to protect your privacy. The trial team will replace your name with a unique code. This code is used on all information or samples used in the trial. A separate key that links your name to your unique code is saved securely at the site.

Due to EU clinical trials law, all data and the master file will be securely stored for 25 years. This includes written records of focus groups discussions, while audio/video recordings will be deleted after the written records are completed.

The legal basis for this data processing is for scientific research purposes and the public interest (Articles 6(1)(e) and 9(2)(j of GDPR).

You are entitled to:

• object to our use of your personal data or any further use.

• request access to your personal data and to receive a copy of it.

• request inaccurate personal data be corrected or deleted.

• request the restriction of our use of your personal data.

• request deletion of your personal data.

By law, you can exercise the above rights in relation to your personal data, unless the request would make it impossible or very difficult to conduct the trial. For example, if the results are about to be published then we may not be able to delete data as it would impact on the results, or if the data is required to be reported for trial safety reasons or if there is a compelling public health reason. This is in line with Article 17 of the GDPR

Yes, this trial has been approved by the Irish National Research Ethics Committee (NREC). An annual report will be provided to the REC on the completion of the Trial.

This trial is being funded by the Health Research Board, Ireland. They will be provided with an anonymous report. They will not access any personal data.

No, we are not paying you to take part. However, you will be reimbursed for travel expenses if you need to make any visits that you would not normally have made as part of your routine clinical care.

After the trial, with your voluntary consent, data from the trial may be shared and used in other research studies in the areas of cardiovascular health and obesity. This may be with researchers outside of Trinity College Dublin. If your data is used in future research, this is only following ethical approval and in keeping with the GDPR. Your data will be coded so you cannot be identified. You can withdraw your consent to future use at any stage.

You don't have to take part in this trial. If you decide not to take part it won’t affect your future medical care. You can change your mind about taking part in the trial any time you like. Even if the trial has started, you can still opt out. You don't have to give us a reason.

If you have any questions, concerns or to exercise your rights, you can contact:

Principal Investigator: Dr. Cormac Kennedy, support-trial@tcd.ie , (Trial Phone Number)

Trial Sponsor: Trinity College Dublin: TCD, College Green Dublin 2, Ireland. Email: clinicaltrialsponsorship@tcd.ie 

If you have a medical emergency and your treating clinician wants to know if you are on the trial medicine, contact:

• Trial unblinded team: E-mail: Support.Emergency@tcd.ie