Further reading

Research articles

• This review discusses some of the important considerations of using health systems data for randomised trials, including the regulatory and ethical arguments around consent and health systems data.
• This article provides guidance on linking NHS data using non-consent approaches in England.
• This commentary describes a model of consent that emphasises the digital rights and digital identity of an individual, and how consent in research can be used to respect and honour these characteristics.
• This article describes how dynamic consent can be used to improve public opinion on the use of health systems data in research.
• This article outlines a framework for the evaluation and reporting of a dynamic consent approach.
• This research considers the perspectives of individuals on layered consent in a complex pragmatic trial.
• This report addresses approaches used by researchers of seeking consent to use record linkage data.
• This article describes the experiences of using dynamic consent over a 10-year longitudinal study.
• This article describes the use of a dynamic consent model that allows participants to change consent preferences through an online participant portal.
• This article discusses the i-CONSENT recommendations for improving the informed consent process.

Guidance and legislation

• Guidance for using patient data – NHS Health Research Authority
• Guidance on applying for identifiable data – NHS England
• Guidance for Confidentiality Advisory Group applications – NHS Health Research Authority
• Guidance on consent and participant information – UK Research and Innovation Medical Research Council
• Guidance for Public Benefit and Privacy Panel for Health and Social Care data access – Research Data Scotland
• Guidance for accessing research data in Northern Ireland – Honest Broker Service
• Guidance on the implementation of electronic informed consent – European Contract Research Organisation Federation
• Guidance documentation to support the national data opt-out policy – NHS England
• Approval standard on the lawful processing of personal data under UK General Data Protection Regulation – UK Health and Security Agency
• Guidance on the legal basis for processing data – NHS Health Research Authority
• Approval standard on the processing of confidential patient information – UK Health and Security Agency
• Guidance defining public benefit regarding the use of personal data for purposes other than personal care – National Data Guardian
• Guidance on the common law of confidentiality and consent – NHS England
• Schedule 4, Annex 1 (provisional at the time of writing) of the Data (Use and Access) Act 2025 provides disclosure for purposes of processing in Article 6(1)(e) UK GDPR
• Chapter 1, prospective 68  (provisional at the time of writing) of the Data (Use and Access) Act 2025 clarifies the right of a data subject to consent only to processing for part of the research
• This amendment to Schedule 1 (provisional at the time of writing) of the Medicines for Human Use (Clinical Trials) Regulations 2004 makes provisions for simplified arrangements for obtaining and evidencing consent
• General Data Protection Regulation – lawfulness of processing – Article 6
• General Data Protection Regulation – processing of special categories of personal data – Article 9
• General Data Protection Regulation – the right to object – Article 21
• Guiding Principles for data linkage in Scotland
• Guidance for researchers on complying with GDPR
• Adults with Incapacity (Scotland) Act 2000 – Scotland
• Mental Capacity Act 2005 – England and Wales
• Mental Capacity Act (Northern Ireland) 2016 – Northern Ireland
• Principles of Good Clinical Practice
• This framework gives guidance on involving adults with impaired capacity to consent
• The PeRSEVERE principles offer guidance for if participants change their mind about the way they are involved with research projects
• Clinical Trials Regulation
• This dashboard provides information on NHS numbers with opt-out preferences and can be filtered by region (England only)
• Understanding what is meant by public good – Research Data Scotland
• Understanding research involving data and data linkage in Northern Ireland - Public Health Agency
• Independent report on how the use of health data in research can benefit patients and the healthcare sector
• UKRI resource describing how to use personal data for research purposes
• Security considerations and guidance on compliance with research data security principles in Scotland
• Guidance for accessing the Honest Brokers Service for research in Northern Ireland
• These templates offer guidance on wording in participant information sheets to ensure compliance with GDPR
• This website contains a number of resources to support researchers conducting research with impaired capacity to consent
• This project discusses what should happen when participants choose to change their involvement in a trial, such as reducing or withdrawing participation.

Other resources