Data protection & approvals

Approvals

The MCDS Registry was reviewed by London – Harrow Research Ethics Committee, and was given their favourable ethical opinion. The committee consists of a range of clinical and regulatory experts, as well as members of the public, who reviewed all aspects of the study.

Will information about me be kept confidential?

Creating a registry requires the existence of a file containing a patient’s personal and medical data. Your data will be encrypted and stored securely in the UK, under the responsibility of the Principal Investigator. Your data will be stored indefinitely and treated with confidentiality.

How will we use information about you?

We will need to use information from you for this research project.

This information will include your:

First Name
Surname
Date of Birth
City of Birth
Country of Residence

People will use this information to do the research or to check your records to make sure that the research is being done properly.

People who do not need to know who you are will not be able to see your name or contact details. Your data will have a code number instead.

We will keep all information about you safe and secure.

When planning a scientific study or clinical trial, researchers can submit questions about the data contained in the registry to the registry curator and if their ‘enquiry’ is approved by the registry steering committee, they will be given anonymised data in the form of a written report. This may include researchers in other countries. They must follow our rules about keeping your information safe.

Once we have finished the study, we will keep some of the data so we can check the results. We will write our reports in a way that no-one can work out that you took part in the study.

What are your choices about how your information is used?

You can stop being part of the study at any time, without giving a reason, but we will keep information about you that we already have unless you tell us otherwise.

If you decide to stop being part and also want us to erase your data we will do so.

We need to manage your records in specific ways for the research to be reliable. This means that we won’t be able to let you see or change the data we hold about you.

Where can you find out more about how your information is used?

You can find out more about how we use your information:

at www.hra.nhs.uk/information-about-patients/
our leaflet available from www.hra.nhs.uk/patientdataandresearch
by asking one of the research team
by sending an email to the study coordinator at sam.mcdonald@newcastle.ac.uk or
by calling us on 01912418605