PARTICIPANT PRIVACY NOTICE

 

Further information

Thank you in advance for considering participation in this study. If you have any questions about this research, the trial staff will be more than happy to answer them.

How will we use information about you? 

We will need to use information from you, your child and your child’s medical records for this research project.

This information will include your child’s initials, partial date of birth (only month and year), NHS/CHI number, your contacts details. 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 child’s name or contact details. Your child’s data will have a code number instead.

The University of Southampton is the sponsor of this research. The sponsor is working with Imperial College London to run this trial.

The University of Southampton is responsible for looking after your information. We will share your information related to this research project with the following types of organisations:

  • Sponsor representative, Imperial College London
  • Pharmaceutical company, ALK-Abello
  • MedSearch (app used to track medication adherence)

We will keep all information about you safe and secure by:

  • Aside from Imperial College London and your local NHS site, no one will have access to your personal data. ALK-Abello and MedSearch will only have access to anonymised trial data; this means data will only be identified by a unique code number.

International transfers

We may share or provide access to data about you outside the UK for research related purposes to:

  • Ensure safety monitoring
  • Analyse research samples

If this happens, we will only share the data that is needed. We will also make sure you can’t be identified from the data that is shared where possible. This may not be possible under certain circumstances – for instance, if you have a rare illness, it may still be possible to identify you. If your data is shared outside the UK, it will be with the following sorts of organisations:

  • ALK-Abello, the company who provide the trial medication, based in Demark

We will make sure your data is protected. Anyone who accesses your data outside the UK must do what we tell them so that your data has a similar level of protection as it does under UK law. We will make sure your data is safe outside the UK by doing the following:

  • The country (Denmark) your data will be shared with has an adequacy decision in place. This means that we know their laws offer a similar level of protection to data protection laws in the UK
  • we use specific contracts approved for use in the UK which give personal data the same level of protection it has in the UK. For further details visit the Information Commissioner’s Office (ICO) website: https://ico.org.uk/for-organisations/uk-gdpr-guidance-and-resources/international-transfers/
  • we do not allow those who access your data outside the UK to use it for anything other than what our written contract with them says
  • we need other organisations to have appropriate security measures to protect your data which are consistent with the data security and confidentiality obligations we have. This includes having appropriate measures to protect your data against accidental loss and unauthorised access, use, changes or sharing.

How will we use information about you after the study ends?

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.

We will keep your study data for a maximum of 10 years. The study data will then be fully anonymised and securely archived or destroyed.

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
  • if you choose to stop taking part in the study, we would like to continue collecting information about your health from central NHS records including your hospital and your GP. If you do not want this to happen, tell us and we will stop
  • you have the right to ask us to access, remove, change or delete data we hold about you for the purposes of the study. You can also object to our processing of your data. We might not always be able to do this if it means we cannot use your data to do the research. If so, we will tell you why we cannot do this
  • If you agree to take part in this study, you will have the option to take part in future research using your data saved from this study.

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

You can find out more about how we use your information, including the specific mechanism used by us when transferring your personal data out of the UK:

 

Thank you for taking the time to consider participating in this trial.

If you accept to participate a copy of this information sheet will be given to you.