References

Statute and legislative instruments

The Health Service (Control of Patient Information) Regulations 2002 (legislation.gov.uk) (S.I. 2002/1438), as amended by Section 117 of the Care Act 2014

Control of patient information (COPI) notice - NHS Digital

[Withdrawn] Coronavirus (COVID-19): notification to organisations to share information - GOV.UK (www.gov.uk)

Pilot NHS DigiTrials Recruitment Support Services Directions 2021 – NHS England

Government reports

Caldicott review: information governance in the health and care system – National Data Guardian (2013)

Commercial clinical trials in the UK: the Lord O’Shaughnessy review - GOV.UK (www.gov.uk) (2023)

Government response to the Lord O’Shaughnessy review into commercial clinical trials in the UK - GOV.UK (www.gov.uk) (2023)

National Data Guardian for Health and Care 2017 report: Impact and influence for patients and service users (December 2017)

UK data policy and guidance

A Guide to Confidentiality in health and social care - NHS Digital now NHS England (2013)

Code of practice on confidential information (Health and Social Care Information Centre December 2014)

Consent and confidential patient information - NHS Transformation Directorate (england.nhs.uk) (2023)

Data Access Request Service (DARS) - NHS Digital

Information Governance – Scottish Government

Information governance guidance - NHS Transformation Directorate (england.nhs.uk), the Common Law (2023)

National data opt-out - NHS Digital now NHS England (2023)

National engagement on data: Principles of Data Use and Access public engagement programme (Cohort 1 report). NHS England (2024)

National public engagement on the use of health and care data. NHS England (2024)

NHS Data Security and Protection Toolkit

NHS Research SDE Network

Protecting Patients Confidentiality - The Common Law Duty of Confidentiality in practice – NHS Scotland (2023)

Public Benefit and Privacy Panel for Health and Social Care (scot.nhs.uk)

Secure data environment policy guidelines - GOV.UK (www.gov.uk)

The Common Law Duty of Confidentiality | Department of Health (health-ni.gov.uk)

What is personal data? - Information Commissioner’s Office (2022)

Health Research Authority Guidance

Confidentiality Advisory Group - Health Research Authority (hra.nhs.uk)

CAG registers - Health Research Authority (hra.nhs.uk)

HR Good Practice Resource Pack (myresearchproject.org.uk) - Health Research Authority (2021)

People-Centred Clinical Research - Health Research Authority

Introducing the hallmarks of people-centred clinical research | Health Research Authority - Intranet (hra.nhs.uk)

Research passport - Health Research Authority (hra.nhs.uk)

Research tissue banks and research databases - Health Research Authority (hra.nhs.uk)

Research Ethics Service and Research Ethics Committees - Health Research Authority (hra.nhs.uk)

Recovery, Resilience and Growth (RRG) (replaced by the UK Clinical Research Delivery (UKCRD) Programme

Guidance on the managed recovery of the UK clinical research portfolio | NIHR

Saving and Improving Lives: The Future of UK Clinical Research Delivery - GOV.UK (www.gov.uk)

The Future of UK Clinical Research Delivery: 2021 to 2022 implementation plan - GOV.UK (www.gov.uk)

Reports and academic papers

Accessing Patient Data for Research-as-Care Purposes: A Public Dialogue. Welsh Government / National Centre for Social Research (NatCen). (2025)

Annual Report 2022–2023. National Data Guardian. Published January 2024

Annual Report 2023–2024. National Data Guardian. Published December 2024

Can and should the research–therapy distinction be maintained? Reflections in the light of innovative last-resort treatment. Helgesson, G. Research Ethics, 15(2), 2019, Pages 1-14

Developing a Data Pact: The relationship between the public, their data, and the health and care system - The Patients Association (2023)

Engaging under-served communities in commercial research: A scoping exercise. National Institute for Health and Care Research (NIHR). (2023)

Mapping the world of charity-supported patient registries. Association of Medical Research Charities (AMRC). April 2024

Overcoming barriers to recruitment in health research. Hewison J, Haines A. BMJ 2006; 333 :300

Patient Perspectives on Data Sharing. Druedahl, L.C., Kälvemark Sporrong, S. (2024). In: Corrales Compagnucci, M., Minssen, T., Fenwick, M., Aboy, M., Liddell, K. (eds) The Law and Ethics of Data Sharing in Health Sciences. Springer, Singapore

Patients’ and public views and attitudes towards the sharing of health data for research: a narrative review of the empirical evidence. Kalkman S, van Delden J, Banerjee A, et al. Journal of Medical Ethics 2022;48:3-13

Public opinion on sharing data from health services for clinical and research purposes without explicit consent: an anonymous online survey in the UK. Jones LA, Nelder JR, Fryer JM, et al. BMJ Open 2022;12:e057579

Reasonable Expectations of Privacy and Disclosure of Health Data. Taylor MJ, Wilson J. Medical Law Review, Volume 27, Issue 3, Summer 2019, Pages 432–460

The connected patient project: moving towards a population-based primary health care research registry. Coe, D., Birt, A., Forbes, G. et al. BMC Health Serv Res 21, 533 (2021)

The One-Way Mirror: Public attitudes to commercial access to health data. Ipsos MORI. Report prepared for the Wellcome Trust (2016)

The social licence for research: why care.data ran into trouble. Carter P, Laurie GT, Dixon-Woods M. J Med Ethics. 2015 May;41(5), Pages 404-9

The Use of Personal Health Information in Medical Research - General Public Consultation. Final Report. MRC/ Ipsos MORI. (2006)

Using health data to identify and approach people about health and care research: A Public Dialogue. Welsh Government / National Centre for Social Research (NatCen). (2024)

Digital Intermediaries and databases/register organisations

Be Part of Research (nihr.ac.uk)

Clinical Practice Research Datalink | CPRD

Join dementia research - register your interest in dementia research (nihr.ac.uk)

NHS Digitrials

Our Future Health

UK Biobank - UK Biobank

Associations

Association of Medical Research Charities (AMRC)

BMA - Home | British Medical Association

Royal College of General Practitioners (RCGP) - Home

Understanding Patient Data

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9. Next steps