Safety in research

All research delivered in the Trust has received a national approval from the Health Research Authority (HRA)/ Health and Care Research Wales (HCRW).

Some studies require approval from other governing bodies to ensure safety and efficacy. Studies will only open at Whittington Health if these approvals are in place and have been confirmed by the Research Support Team who are skilled in reviewing governance documents relating to research.

If you wish to learn more about the different regulatory bodies involved in ensuring research is delivered safely in the UK, please visit the Regulatory Bodies and Ethical Approval page for more information.

The HRA website outlines the different types of approvals listed above and provides links to pages which provides more information about the different review bodies and how they ensure patient safety in research.

Your confidentiality

Data Protection in Research

The Trust, supports and participates in research with the aim to improve health and social care.

In relation to research activity, NHS services will only access and process your data if needed and in accordance with strict legal frameworks, including the Data Protection Act 2018, UK GDPR, and the Common Law Duty of Confidentiality and would not share identifiable data with other parties unless required to by law, under Section 251 of the NHS Act 2006 as confirmed by Confidentiality Advisory Group (CAG) approval or due to patient consent.

Before participating in a research study, patients are required to read a Patient Information Sheet (PIS).

The PIS informs you about which data the study team will be able to access, process, and store. If you agree to take part in research, you are required to sign a consent form which outlines what you are agreeing to by taking part in the research and the data processing required for participation.

You will be given a copy of the consent form for your records and a copy placed in your medical records. The research support team will keep your signed consent form and your personal details which will be stored in a secure location by the research team. It will be listed on the consent form and PIS if the study team need access to your personal information.

The research department understands The EU General Data Protection Regulation (GDPR) and the UK Data Protection Act 2018, and the importance of protecting personal data. The Research Support Team includes a Research Governance Manager and Research Facilitator who work alongside the wider team to support data protection and safety. The teams uphold that data processing in research needs to be lawful, fair and transparent.

When studies are approved by a Research Ethics Committee (REC) and the Health Research Authority (HRA) there is a review of data management and processing to ensure the study is lawful and following national guidelines and regulations for research and data processing.

This review and approval are then considered locally by the Research Support Team to ensure the department can support the study and meet the requirements for data protection.

Confidentiality Advisory Group (CAG)

Some studies obtain approval from the Confidentiality Advisory Group (CAG) which is an independent body which providing expert advice on the use of personal and confidential data.

The CAG is made up of specialists in healthcare and data along with lay people who have interests in protecting the interests of the patients and the public.

The focus of CAG is to operate in the interests of the patients and public while also ensuring that only appropriate use of confidential patient information is occurring for purposes beyond direct patient care.

You can read more about the CAG on the HRA website.

For studies that have approval from the CAG, the research delivery team do not need to seek consent, however, this data is used specifically for research purposes and has been approved by REC and HRA along with the CAG.

The approvals have conditions and require data that is transferred to be anonymised. If you have opted out via the NHS data opt out your data won�t be used for research, even if the CAG approval is in p

NHS Data Opt Out

The National Data Opt Out is a service that allows patients to choose in specified circumstances if their health records can be used for research and planning.

In relation to Research the Data Opt Out does not apply when a researcher is processing data for the following purposes where section CAG (251 approvals) would not have been sought:

Consent has been obtained from the patients, as consent overrides the opt out.
Anonymised in line with the ICO Code of Practice on Anonymisation.
There is a legal requirement that overrides the duty of confidentiality.

When a CAG approval is in place, the research team work alongside the information governance team at the Trust to ensure patients who have opted out via the NHS Data Opt out have their information excluded from any data that may be processed for research.

The Research Department works to ensure that patient�s wishes are respected regarding data processing and consent to research

Research Home

Last updated30 Dec 2025