How we use your/your child’s information

The Universities of Manchester, Liverpool, Copenhagen and Gothenburg take great care to abide by our legal and moral obligations when handling your personal and healthcare data. Due to changes introduced in the EU General Data Protection Regulation (GDPR), we would like to provide you with information on the lawful basis on which we are processing your data.

The Universities of Manchester, Liverpool, Copenhagen and Gothenburg use personally identifiable information i.e. information that could identify your child, to conduct research to improve health, care and services. As publicly funded organisations, we have to ensure that it is in the public interest when we use personally identifiable information from people who have agreed to take part in research. The legal basis relied upon is article 6.1 e and article 9.2 j GDPR. This means that when you agree to take part in a research study, we will use your data in the ways needed to conduct and analyse the research study. Your rights to access change or move your information may be limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate.

Health and social care research should serve the public interest, which means that we have to demonstrate that our research serves the interests of society as a whole. We do this by following the UK Policy Framework for Health and Social Care Research (2017).

What information will you collect about my child?
In order to participate in this study we will need to collect information about your child that could identify your child, called “personal identifiable information”. The data to be collected includes but is not limited to the following:

  • Parent and Child’s name as part of the consent form
  • Your child’s date of birth
  • Details of your family’s past and present medical history (including mother’s pregnancy)
  • Details of your child’s birth
  • The date of your child’s cleft palate surgery
  • The name of your child’s surgeon
  • A mould of your child’s mouth before their cleft palate procedure and at 5 years after surgery
  • The outcome of speech, language, hearing and development assessments carried out at 12 months, 3 years and 5 years after surgery
  • Photographs of your child’s mouth before surgery
  • Photograph of your child’s face 5 years after surgery
  • Video recording of your child’s speech at 12 months, 3 years and 5 years after surgery

The mould of your child’s mouth, taken before the surgeon performs the cleft palate procedure (known as a Maxillary Arch Impression), will be obtained when your child is asleep during surgery but before the procedure is performed. The mould of your child’s mouth at 5 years after surgery (known as a dental impression), will be taken during their hospital appointment.

The photographs, video recordings and hearing assessment data of your child will be taken at their hospital appointments by a member of the research team. A photograph will be taken of the front, left side and right side of your child’s face. The video recordings will capture your child’s face and speech during their speech assessment in the hospital. A transcript of the video will not be made, instead the video recording is designed to allow researchers to assess your child’s speech following cleft palate surgery.

What are my rights in relation to the information you will collect about me?
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, but you do have a number of rights under data protection law regarding your personal information. For example you can request a copy of the information we hold about your child, including audio recordings or photographs.

Will my participation in the study be confidential and my personal identifiable information be protected?
In accordance with data protection law, the Universities of Manchester, Liverpool, Copenhagen and Gothenburg are the Joint Data Controllers for this project. This means that we are jointly responsible for making sure your child’s personal information is kept secure, confidential and used only in the way you have been told it will be used. All researchers are trained with this in mind, and your child’s data will be transferred and looked after in the following way and as shown in the flow diagram below:

  • The Data Co-ordinating Centre in Liverpool will receive a copy of the completed consent form which contains your and your child’s name, however this will not be stored with any data collected. This means that the member of staff looking at your child’s data will not know your child’s name.
  • Each child who enters the TOPS study will be assigned a unique ID number only known to the research team (this is known as pseudonymisation).
  • Your child’s information (data) collected during the study will be transferred from your local hospital to the Clinical Trials Research Centre (CTRC) at the University of Liverpool, which is acting as Data Coordinating Centre for the TOPS study. Your child’s study data has been transferred to the University of Liverpool via post, encrypted USB and by uploading to a secure server.
  • The moulds of your child’s mouth taken before surgery and at 5 years after surgery will be transferred from your local hospital to the Administrative Centre at the University of Manchester for review. Your child’s moulds will be transferred to the University of Manchester via post.
  • The video and audio recording of the child’s speech will be collected from your local hospital and sent to the Data Coordinating Centre to be uploaded onto a secure server for review and quality checks by the administrative centre staff at the University of Manchester before uploaded back onto the server ready for assessment by the Speech and Language Therapists who are part of the TOPS team.
  • The video and audio recording of the child’s speech will be assessed by the Speech and Language Therapists who are members of the TOPS research team. Some of these Speech and Language Therapists will be based outside the European Union in Brazil and the United Kingdom, but they will make their assessments from a view only, secure server housed in Liverpool.
  • The transfer of this data is carried out under the standard data protection clauses in accordance with article 46.2 c GDPR.
  • All information collected about your child in relation to the TOPS study will have your child’s name removed prior to being sent to the University of Liverpool and your child’s information (data) will only be identifiable by the unique ID number.
  • Study data will be held by the Universities of Manchester, Liverpool, Copenhagen and Gothenburg, as Data Controllers (see the flow diagram), for up to a maximum of 10 years after the end of the study.

Flow diagram of data transfer and processing from local sites to and between the teams working on the TOPS study
Click here for a flow diagram of data transfer and processing

Potential disclosures:

Please also note that individuals from The University of Manchester, Liverpool or regulatory authorities may need to look at the data collected for this study to make sure the study is being carried out as planned. This may involve looking at identifiable data. All individuals involved in auditing and monitoring the study will have a strict duty of confidentiality to you as a research participant.


What if I have a complaint?

If you have a complaint that you wish to direct to members of the research team, please contact the hospital telephone number detailed on the Information for Parents Sheet or from your centre’s website. If you wish to raise a complaint on how we have handled your personal data, you can contact our Data Protection Officers who will investigate the matter. If you are not satisfied with our response or believe we are processing your personal data in a way that is not lawful you can complain to the Information Commissioner’s Office (ICO). For UK, Sweden and Denmark the contact details of the Data Protection Officers (phone / email) are as follows:

University of Manchester
Data Protection Officer: dataprotection@manchester.ac.uk
Privacy notice:http://documents.manchester.ac.uk/display.aspx?DocID=37095

University of Liverpool
Data Protection Officer: LegalServices@liverpool.ac.uk
Privacy notice:https://lctc.org.uk/privacy

University of Copenhagen
Data Protection Officer: dpo@adm.ku.dk
Privacy notice:https://informationssikkerhed.ku.dk/

University of Gothenburg
Data Protection Officer: dataskydd@gu.se
Privacy notice:www.gu.se/personaldata

If you wish to contact us about your data protection rights, please email dataprotection@manchester.ac.uk or write to The Information Governance Office, Christie Building, The University of Manchester, Oxford Road, M13 9PL at the University and we will guide you through the process of exercising your rights. You also have a right to complain to the Information Commissioner’s Office about complaints relating to your personal identifiable information Tel 0303 123 1113