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Introduction

UCLH is committed to following a set of principles on how the trust will use routinely collected patient data for research. The principles will enable vital health research to take place, while at the same time protecting and using clinical data as patients would expect.
The principles were produced by patients and researchers working in partnership and cover keeping patient data safe, transparency and patient and public say in research. They were formally adopted by UCLH in October 2023. The principles detailed below are for research studies which use routinely collected clinical and demographic data for research. 

Why the trust has committed to a set of principles for the use of patient data in research

UCLH is now a digitilised hospital with an electronic health record. The principles provide guidance to ensure research can benefit from the valuable data routinely collected at delivery of care.
UCLH’s priority is to facilitate efficient and rigorous health research while ensuring  data is used in ways that are safe and beneficial to the populations the hospital serves and to the health of the public.
Underlying these principles is the acknowledgment that using patient data is necessary for essential health research to improve patient care and the health of the public. UCLH also sometimes needs to work with commercial partners who can provide expertise, technology and resources to do this, and this may require giving them access to patient data.
However, UCLH recognises that the public has concerns about protecting patient data from misuse and invasion of privacy, as well as concerns about commercial collaborations using patient data.
UCLH abides by UK law when using patient data in research. These principles should be read together with the existing UK statutory and regulatory requirements UCLH must adhere to when using patient data in research. You can read how UCLH commits to existing legislation in Appendix 1.

 

1. UCLH commits to the highest level of transparency about: 

  • how and why routinely collected patient data is being used in research 
  • who has access to the data
  • the results of the research
  • how the results are used. 

UCLH will make this information publicly available, clearly signposted and accessible in language and format. 

2. UCLH commits to taking care of patient data used in research and innovation by assessing and approving:

  • who accesses the data
  • appropriateness of studies
  • where data is stored and handled
  • use of the least disclosive data as possible
  • outputs that protect privacy.

These commitments have been developed with reference to the ‘Five Safes’ framework developed by the Office for National Statistics (ONS)’ 

3. UCLH will prioritise the release of routinely-collected patient data for  research to improve the health of the public or to reduce health inequalities. 

4. UCLH will only allow access to routinely collected data for research purposes if there is evidence of patient and public involvement in the design, priority-setting or approval process for the research.

5. UCLH will support wherever possible the public and patients involved in research design, to take into consideration the views of the wider community of current and future patients whose data will be used.

6. UCLH will expect researchers to demonstrate how their research project aligns with the standards set out in the ‘Five Safes’ framework developed by the Office for National Statistics (ONS)’  and this information should be published publicly together with their research proposals, once approved.

7. UCLH commits to ensuring the use of routinely collected patient data for  research does not worsen existing inequalities or exclude relevant communities.

8. UCLH commits to regularly refreshing its data processes as technology and the uses of data develop. However, any changes cannot overrule the current data principles, which can only be amended through co-production with patients and the public. These principles will be reviewed in April 2027

Principles applying to collaborations1  with academic institutions and commercial companies 

9. UCLH will only enter collaborations which share routinely collected data for research, where the primary purpose is to benefit the health of the public or reduce health inequalities and after careful assessment of the commercial opportunity for the Trust and financial value of the data. UCLH will enter collaborations where there may be financial profit only if the collaboration will advance the primary purpose. UCLH will ensure that collaboration arrangements prevent patient data being used for any other purpose than the use specified.  

10. UCLH commits to the highest level of transparency about collaborations involving routinely collected patient data for research and innovation, including

  • what kind of data will be involved
  • who will have access to the data
  • commercial and academic benefits to partners 
  • results of the research and benefits to patients

11. UCLH will only enter external collaborations for studies using routinely-collected patient data where the data is kept as safe as possible, in keeping with the ‘Five Safes’ framework developed by the Office for National Statistics (ONS)’ 

12. When entering a collaboration contract with a commercial company for the use of  patient data for research and innovation, UCLH will take into account the guidance of patients and public contributors.

13. UCLH may charge commercial companies an access fee to use the data.

[1] Defined as “A cooperative agreement of two or more parties to work jointly towards a common goal” – sources Black Law Dictionary online https://thelawdictionary.org/ and The Law Dictionary - https://thelawdictionary.org/?s=collaboration+

UCLH is committed to abiding by the UK legislation that covers when and how information about patients can be processed for research and the safeguards that must be in place when using data in research.

This includes the following legislation

Data Protection Act (2018)

UCLH abides by the UK General Data Protection Regulations (UK GDPR) by:

  • treating patient information, if it is identifiable or has the potential to be identifiable, as personal data
  • only processing patient data where there is a legal basis to do so
  • being transparent to patients about their rights (to view, amend, or under certain circumstances delete personal data that UCLH holds)
  • being transparent about how patients’ data is processed, including when and how data is collected and stored.
  • providing assurance of our data protection compliance through our Records and Information Governance Group, our internal Data Protection policies and procedures, ICO voluntary audit, and Data Security and Protection Toolkit annual submissions
  • having a Data Processing Agreement in place if another organization is going to process patient data
  • keeping a record of information on how data is used
  • having processes in place to manage any personal data breach within 72 hours.
  • having an assigned Data Protection Officer who monitors compliance with the UK GDPR, record keeping and data protection impact assessments.

When processing data for research UCLH abides by UK GDPR by:

  • ensuring the research meets the criteria for research-related purposes, is necessary, has appropriate safeguards in place, and is in the public interest.
  • collecting data only for specified, explicit and legitimate purposes and not further processing data in a manner that is incompatible with those purposes; further processing for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes shall, in accordance with Article 89(1) be considered to be compatible with the initial purposes (‘purpose limitation’)
  • ensuring data processed are adequate, relevant and limited to what is necessary in relation to the purposes for which they are processed (‘data minimisation’)

National Health Service Act 2006 and the Health Service (Control of Patient Information) Regulations 2002.

UCLH complies with what is called the common law duty of confidentiality. Under the common law duty of confidentiality, if information is given in circumstances where it is expected that a duty of confidence applies, for example in a clinical consultation, that information cannot normally be disclosed without patient consent.

When confidential patient information is to be used for research and other important activities without patient consent, UCLH abides by the legal basis  outlined in section 251 of the National Health Service Act 2006 and its current Regulations, the Health Service (Control of Patient Information) Regulations 2002.

Section 251 allows the common law duty of confidentiality to be lifted temporarily to enable disclosure of confidential patient information for medical purposes. For research purposes UCLH will seek patient consent to use data wherever possible. However, there may be circumstances where it may not be possible practically to seek consent for example where there are lots of patients or patients may be too ill. In which case UCLH will apply for the duty of confidentiality to be lifted.

For approval, the application to lift the duty of confidentiality will need to be reviewed by the Confidentiality Advisory Group (CAG). The CAG will consider whether there is sufficient public interest to temporarily lift the duty and enable access to the requested confidential patient information. This is commonly referred to as ‘Section 251’ support

Research using anonymous health information

A member of a patient’s direct care team may make confidential patient information anonymous without breaching the duty of confidentiality. The care team includes registered health and social care professionals and other staff who directly provide or support care to patients.

Anonymised health information can then be used in health and care research without patient consent.

However, UCLH researchers must still seek ethical approval. Normally this approval is sought through the Health Research Authority (HRA). Since March 2022 the HRA has delegated the responsibility of ethical approval for anonymized data-only studies to UCLH and approval is through an internal process at the trust.

The Five Safes framework is a structure for assessing and managing the risk of disclosing confidential information. It involves asking questions in 5 areas in a way that takes into account the context in which data is used, what the data is being used for and the need for transparency and open science. This means it should be easier to work out how to protect the data in an appropriate way.

The framework, which originated from the UK’s Office of National Statistics, has become best practice in data protection.

The five elements of the framework are:

  • Safe projects - research projects are for the public good
  • Safe people - researchers are trained and authorised to use data safely
  • Safe settings - a secure environment prevents unauthorised use.
  • Safe outputs - outputs are checked to ensure they do not disclose confidential information
  • Safe data - data is treated to reduce the risk of disclosing confidential information or identifying an individual.

Safe projects

  • Is the data to be used for an appropriate purpose?
  • What is the purpose? Is it valid as a research aim, does it benefit the public and is it an ethical use of the data?

Safe people

  • Is the researcher appropriately authorised to access and use the data? Can the users be trusted to use it in an appropriate manner?
  • By controlling the way data is accessed, some responsibility is placed on the researcher for preventing re-identification.
  • User authorisation usually requires:
    • training in confidentiality and the conditions of data use
    • proof of the technical skills needed to use the data
    • signing a legally binding undertaking to maintain data confidentiality

Safe settings

  • Does the access environment prevent unauthorised use? Safe places are often called Trusted Research or Secure Data Environments (TREs or SDEs)
  • Is data access and use occurring in a transparent way?

Safe data

  • Has appropriate and sufficient protection been applied to the data itself? Could researchers analysing the data inadvertently learn something about an individual?
  • Most researchers do not need access to direct identifiers such as names and addresses, and national insurance or NHS numbers. Removing these is called de-identification and preserves privacy without degrading the data. Where these identifiers are required, for example, when linking hospital records to GP records to understand an individual’s journey through healthcare, then we would more heavily rely on the other 4 safes. 

Safe outputs

  • Could the statistical results, like tables and charts, accidentally reveal someone’s identity? Will this be checked?

Foundations for this guidance

This guidance was coproduced by public contributors and UCLH information governance and legal teams. The guidance details the kind of things patients and public contributors want contracts to stipulate when UCLH enters collaborations with external organisations to conduct data-only research.

Public contributors wish to make it clear that patient data is an invaluable and powerful resource for essential health research.

Aim of the guidance is to:

  • enable contracts and agreements with external organisations for the use of patient data in research to be drawn up promptly and efficiently but in such a way that also meets the needs and wishes of patients and public contributors
  • ensure UCLH and research partners are fully aware of the wishes and views of patients and public contributors regarding collaborations and contracts with external organisations
  • enable UCLH to develop and improve the templates/standards it uses when drawing up contracts so that the contracts better reflect these wishes
  • provide reassurance to patients and public contributors on the safe and appropriate use of patient data in research when UCLH enters collaborations with external organisations.

What UCLH already does

Public contributors would like UCLH to continue its current good practice when drawing up contracts and would encourage UCLH to continue using its existing template for contracts while developing the template to better reflect this guidance. Public contributors also welcome and are reassured that all contracts adhere to legal requirements under data protection legislation and research ethics regulations.

Purpose of research using UCLH patient data

Public contributors recommend a contract should explicitly state that data cannot be used for purposes beyond the original research without prior agreement of UCLH.

In addition, contracts should include a stipulation that UCLH reserves the right to monitor that the data is not being used in any way that has not been agreed by UCLH.

Intellectual Property (IP)

Patients and public contributors welcomed UCLH’s approach to intellectual property, especially recent contracts where UCLH own the IP of anything developed using UCLH patient data. In addition, patients and public contributors were keen that UCLH should continue to incorporate any IP arising incidentally into clauses about IP generally and that this should be flagged up in the contract development stage

Public contributors were keen that the NHS should not shy away from putting a value on patient data in contracts. They want contractual agreements to reflect the extraordinary value of patient data and for there to be a return on this to healthcare. This return might be IP, financial gain to NHS institutions, or free access to treatments or new treatments. Public contributors were keen for the value of patient data to be a bargaining chip to leverage greater benefit to healthcare.

Public contributors would like to see inclusion of information on intellectual property contractual arrangements in patient information sheets. They also recommended that patients and public contributors advising on a study should be made aware of the IP contractual arrangements at an early stage.

Protecting patient data

Public contributors also welcomed UCLH’s approach and rigorous adherence to regulations on protecting patient data, whether as part of contractual agreements with outside organisations or as part of ethics requirements. This area includes agreements as to how and where data is processed and by whom.

The inclusion of clauses on UCLH’s right to audit and scrutinise data processing by 3rd parties was supported. Public contributors particularly welcomed the inclusion of clauses on the timely notification of data breaches by a 3rd party and advised UCLH to always be mindful of this issue.

Public contributors felt that understanding contractual arrangements should reassure public contributors as to the safety of their data and encouraged UCLH to communicate to public contributors the details of how patient data is kept safe.

They also supported efforts to reduce ‘silo’ working in measures to protect patient data.

Patient and Public involvement in studies using UCLH patient data

Public contributors recommend that wherever possible UCLH include a standard clause in contracts with external organisations, especially for projects using large amounts of patient datasets:

‘UCLH expects patients and public contributors to be actively involved (in line with the definition of Patient and Public Involvement used by the 'National Institute for Health and Care Research’) in the project and that UCLH and the external organization will make reasonable efforts to facilitate and enable that involvement’.

Transparency

Public contributors would wish UCLH to be as transparent as possible about collaborations with external organisations. Wherever possible, especially for projects using large amounts of patient datasets, public contributors recommend that a plain English summary of the contract involved is made available.