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

The University of Leeds is registered as a data controller with the Information Commissioner’s Office (Registration Number: Z553814X).

The Data Protection Officer for the University of Leeds is David Wardle who can be contacted by email on or by post to the University of Leeds, 11.72 EC Stoner Building, Leeds, LS2 9JT, United Kingdom.

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?

Under the General Data Protection Regulation (GDPR), a legal basis is required for processing of personal data. The legal bases under which data is processed within FReSH START are:

  • Article 6 (1) (a) the data subject has given consent to the processing of his or her personal data for one or more specific purposes;
  • Article 6 (1) (e) – “processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller;”

Processing of data concerning health (and other ‘special categories’ of data) requires the fulfilment of an additional condition under GDPR.  The specific conditions fulfilled by the processing of such data within FReSH START are:

  • Article 9 (2) (a) the data subject has given explicit consent to the processing of those personal data for one or more specified purposes, except where Union or Member State law provide that the prohibition referred to in paragraph 1 may not be lifted by the data subject;
  • Article 9 (2) (j) – “processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.

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?

FReSH START will only collect data for which participants have given their written consent.

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.

What are my rights in relation to the data?

The General Data Protection Regulation provides the following rights for individuals in relation to their personal data. However, the law also states that data being used for research needs to be protected to make sure the research results are reliable and useful to the public and so some of the following rights may be limited for individuals who participate in our research:

  • The right to be informed
  • The right of access
  • The right of rectification
  • The right to erasure
  • The right to restrict processing
  • The right to data portability
  • The right to object
  • Rights in relation to automated decision making and profiling

We provide detailed information to people about our purposes for processing their personal data, and their rights in relation to the project, at the time they choose to take part in the research.

For further information on your data rights, see: https://ico.org.uk/for-organisations/guide-to-data-protection/guide-to-the-general-data-protection-regulation-gdpr/individual-rights/.

Will my data be transferred to any organisations outside of the University of Leeds?

Data will only be transferred outside of the University of Leeds for the purposes of off-site backup. Off-site backup locations are designated by the University of Leeds and located within the United Kingdom.

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)

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 using the details provided above.

Additionally, any queries or concerns regarding the processing of personal data can be made to the Information Commissioner’s Office.

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 Ellen Townsend (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.

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.