Data Protection

Who is undertaking this research project?

The research project is being undertaken by a research team based in the Leeds Institute of Health Sciences:

Leeds Institute of Health Sciences
Level 10, Worsley Building
Clarendon Way
Leeds
LS2 9NL
United Kingdom

Leeds Institute of Health Sciences is situated within the Faculty of Medicine and Health at the University of Leeds:

Faculty of Medicine and Health
Leeds
LS2 9JT
United Kingdom

Any queries or concerns about the way personal data has been processed should be sent to the University of Leeds Data Protection Officer using any of the following details:

Email: DPO@leeds.ac.uk

General Postal Address: University of Leeds, Leeds LS2 9JT, UK

Postal address for data protection issues: University of Leeds, Room 11.72 EC Stoner Building, Leeds, LS2 9JT

Telephone number: +44 (0)113 243 175

The University of Leeds data controller registration number provided by the Information Commissioner’s Office is Z553814X.

Individuals whose data are held at the University of Leeds who are not satisfied with the response to any queries or complaints, or believe their data is being used unlawfully, have the right to take their concerns to the  Information Commissioner’s Office.

What are the purpose(s) for which data are being processed within this research project?

The overall aim of FReSH START is to identify functions of self-harm from the individual’s perspective in order to develop a new approach that can take account of the full range of potential motivations and allow therapists and people who self-harm to identify, and work with, valued (positive) functions.

FReSH START is funded by the National Institute for Health Research (NIHR) – Programme Grants for Applied Research – Award ID – RP-PG-1016-20005

For further information visit: https://www.dev.fundingawards.nihr.ac.uk/award/RP-PG-1016-20005

What is the legal basis under which data is processed within this research project?

By law, we are required to identify a ‘lawful basis’ for dealing with people’s personal data.

For FReSH START, the lawful basis is ‘task in the public interest’, or in other words, we are collecting data that we need in order to complete our research, which aims to improve healthcare for the general public. The different studies within the FReSH START programme are ethically approved, and the programme receives funding from a public body. We also people involve with lived experience of self-harm in how the studies are designed and run.

For FReSH START we need to collect data about people’s health, which is by law a ‘special category’ of personal data. We need an additional lawful basis to justify collecting and using this. In our case, this lawful basis is that the use of the data is necessary for scientific research purposes.

What are my rights in relation to the data?

Because we use personal data to support scientific research in the public interest, people participating in our research do not have the same rights regarding their personal data as they would in other situations. The laws mentioned above say that data being used for research needs to be protected to make sure the research results are reliable and useful to the public. This means that the following rights are limited for individuals who participate or have participated in our research:

  • The right for an individual to access data held about them
  • The right for an individual to have data about them corrected
  • The right for an individual to restrict how data about them are used
  • The right for an individual to object to their data being used (as long as they previously said it could be)
  • The right for an individual to ask for data held about them to be deleted

We provide detailed information to people about our purposes for processing personal data at the time they choose to take part in our research.

For further information visit:
https://ico.org.uk/for-organisations/guide-to-data-protection/guide-to-the-general-data-protection-regulation-gdpr/lawful-basis-for-processing/

Which sources of data are being used by this research project?

FReSH START will use data from the following sources:

  • People with personal experience of self-harm
  • Therapists and mental health nurses with experience of self-harm
  • NHS health records

How is the data being collected within this research project?

  • A card-sorting task known as Q methodology
  • Interviews undertaken by a project researcher
  • Self-completed questionnaires given online, in paper format, or by SMS
  • FReSH START will also use NHS data collected from recruited patients that records healthcare contacts and the reasons for them

What categories of data will be obtained from these sources?

FReSH START will obtain different data from each of the data sources.  The data that will be obtained has been identified by the research team as necessary and sufficient to robustly answer the research question. The following data will be obtained:

  • Responses from a card sorting task (how much people agree or disagree with statements about self-harm)
  • Audio recordings and transcripts of interviews
  • Coded responses to standardised questionnaires
  • Coded entries in healthcare records

How will my privacy be protected?

Personal identifiers will be removed from all responses from participants and either destroyed or kept in a separate secure location in the University. They will not be available to others outside the research team unless a participant gives explicit consent for sharing.

Each participant will be given a unique study number from which they cannot be personally identified except by the research team – who will be able to link study number to personal details so that they can make contact for follow up purposes.

All data received at the University of Leeds will be securely stored within a secure computer environment known as an IG-Toolkit approved facility (see https://www.igt.hscic.gov.uk, Reference: ECC0010), and will be managed in accordance with the Data Sharing Agreements that govern the use of the data obtained from the different sources.  Access to the data will be restricted to a small number of named and approved members of the research team.

Sharing data when the research has finished

Collecting data for research takes a lot of time and money to do. One way we can get the most benefit from this work is to make data available, when the research has finished, to other researchers who would like to use it for other research projects. These other researchers may be at the CTRU or University of Leeds, or in other organisations such as universities, NHS organisations or companies involved in health and care research. They may be in the UK or abroad.

If we get requests to use our research data, we will only agree to share it for valid and worthwhile research projects in healthcare or medicine. The data we share does not identify individuals and is not combined with other data in a way that means individuals could be identified. We only share data with qualified researchers who agree to store data securely.

Any data we share cannot be used to contact individuals and does not affect anyone’s care. It is not used to make decisions about future services available to individuals, such as insurance.

How long will my data be retained by the research project?

Data will be retained by the research project for five years after the end of the project to facilitate the publication of reports.

What approvals have been obtained by the research project?

Favourable opinion from the Leeds West NHS Research Ethics Committee (Ref: IRAS 269176 FReSH START Feasibility Study)

Favourable opinion from the Cambridgeshire and Hertfordshire NHS Research Ethics Committee (Ref: IRAS 297939 FReSH START RCT)

What if I have further questions?

Any questions regarding FReSH START can be directed to the research team at the Leeds Institute of Health Sciences, who can be contacted by emailing freshstart@leeds.ac.uk

 

 

Programme Governance

Programme Management Board

The programme management board meet every two months. The programme management board is made up of the Principal Investigator, the co-investigators and members from the University of Leeds Clinical Trials Unit, NIHR, Leeds and York Partnership NHS Foundation Trust, Medipex, and PPI representatives.

Programme Steering Group

The Programme Steering Group is a group of independent experts, who meet twice a year to provide advice and oversight of the programme, as well as ensuring the project is maintaining patient safety and adhering to protocol.

Programme Steering Group members:
Prof Richard Morriss (Chair)
Prof Richard Emsley (Statistician)
Dr Maureen Twiddy (HSR)
Jenny Groves (Expert by experience)
Dr Barbara Barrett (Health economist)
Sponsor: Faculty of Medicine Research Governance Officer – Claire Skinner.

Data Monitoring and Ethics Committee (DMEC)

The DMEC is made up of three independent experts. The role of the DMEC is to safeguard the interests of trial participants, monitor safety and monitor the overall conduct of the trial. The DMEC will receive and review information on the progress and accruing data of the trial and provide advice on the conduct of the trial to the Programme Steering Committee.

DMEC Membership:
Dr Alex Thomson
Prof John Norrie
Dr Nora Turjanski

Please contact Claire Skinner if you have any concerns regarding the FReSH START project.

Ethical Approval

Ethical approval has been granted for the Q Sort Study which forms part of Work Package One :
Leeds East Research Ethics Committee, approval number 253754

Ethical approval has been granted for the Feasibility Study which forms part of Work Package Three:
REC 19/YH/0409
IRAS 269176
ISRCTN 16049211

Ethical approval has been granted for the therapist interviews which form part of Work Package Three:
Faculty of Medicine and Health approval ref. 19-015

Ethical approval for the Clinical Randomised Controlled Trial will be sought in due course.