Participant Information

Version 1.2 2025-09-29

Key things to know

• We are exploring the development and implementation of the Patient Safety Specialist and Patient Safety Partner programmes in the NHS in England.
• This project aims to understand how best to support and improve these two roles and provide recommendations for future policy and strategy regarding patient safety.
• As part of this project, we seek to interview people who have been involved in the design, delivery and implementation of the Patient Safety Partner programme.
• Participation is entirely voluntary. If at any time you decide you do not want to take part, that’s not a problem – just let us know.
• If you take part in an interview, we will ask for your consent to record it.
• The researchers will maintain your confidentiality at all times. When reporting findings from the study, the researchers will take care not to include information that could allow participants to be identified.
• This leaflet explains the study in more detail.

About this study

Patient safety remains a major challenge in the United Kingdom and globally. Accounting for recent developments in the theory and evidence behind patient safety, the National Health Service (NHS) in England has introduced two new roles: the patient safety specialist and the patient safety partner. Together, the two roles represent a major investment for the NHS. They have much promise but they have yet to be subjected to sustained evaluation, which this project seeks to provide. The project as a whole involves an evaluation of the two roles and the interactions between them to help optimise the roles, support role-holders and secure best value from the NHS’s investment.

As part of the wider project, this study focuses on developing an understanding of the background to the role of patient safety partner. As such, it includes interviews with people involved in developing, managing and supporting the programme and the patient safety partners themselves.

What will happen and how will you be involved?

We would like to invite you to take part in an interview. If you agree to participate, we will arrange the interview on an online platform such as Microsoft Teams or by telephone. In advance of the interview, we will ask you to sign an electronic consent form.

During the interview, we will ask questions about the thinking behind the Patient Safety Partner role and its responsibilities, the development and ‘roll-out’ of the role since it was first introduced, and opportunities and challenges identified to date for role-holders in practice. The interview will be recorded and it will take 45–60 minutes. It may be that you are only able to answer some of the questions – that is fine! We will focus the interview on the aspects of the programme that you feel comfortable talking about.

To create an accurate written record of the discussion for data analysis, the recorded interview will be transcribed. This will be done by a third-party transcription service which is subject to the data protection processes of the University of Cambridge. The transcripts will have any identifying details removed prior to data analysis. Quotations from the transcripts may be used in reports, but it will not be possible to trace back any particular statement to you.

Your contribution will not be attributed to you personally or the organisation you work in. No one in your organisation will be told whether or not you have taken part.

What are the benefits of this study?

There will be no payment or direct benefit to you from taking part in this study. However, the study will inform ongoing work in the NHS in England and potentially other healthcare systems to improve patient safety and its management.

Are there any risks?

No harm is anticipated as a result of participating in this study. It is not an assessment of individual performance, and we will seek to ensure that no information is reported that could identify individuals. The risks in this study are minimal. It is unlikely the content of the interview will cause any distress and, if there are topics you would rather not discuss, we can skip questions you would rather not answer. You can also stop the interview at any point.

In a rare scenario where serious and current concerns are raised in the course of interview, the research team may be obliged to break confidentiality. If it appears that the issues discussed pose significant current safety risks and you are reluctant to raise concerns within your organisation, the research team will consider whether the concerns are of a nature that requires disclosure.

What do I do if I want to withdraw from this study?

If you change your mind about taking part in the study, you can withdraw without giving a reason. If you want to withdraw from the study after completing the interview, please email the research team at pss-psp@thisinstitute.cam.ac.uk. Please note that you cannot withdraw from the study once data analysis has started; this will begin no sooner than two weeks after the completion of your interview.

How will my information be kept confidential?

The University of Cambridge is the sponsor for this study based in the UK. We will be using information from you in order to undertake this study and will act as the data controller for this study. This means that we are responsible for looking after your information and using it properly. This information will be stored securely by The Healthcare Improvement Studies (THIS) Institute, University of Cambridge.

The audio-recorded interviews will be transcribed (written out) and anonymised (identifiable information removed) by a third-party transcription service which is subject to the University’s data protection processes. Interview recordings will be stored on the University of Cambridge safe haven. Once data collection is completed and transcripts have been checked, the recordings will be permanently deleted. Anonymised transcripts from the interviews will be retained for a period of seven years after the study has ended (defined as the point at which data collection has finished). These will be stored on the University of Cambridge secure server. Identifiable information (consent form and information such as job role and organisation name) will be kept for up to two years after the study has ended on the University of Cambridge safe haven.

Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the study to be reliable and accurate. If you withdraw from the study, we will keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personally identifiable information possible. You can find out more about how we use your information here: https://www.medschl.cam.ac.uk/research/privacy-notice-how-we-use-your-research-data/

If you agree to take part in this study, the information we gather may be shared anonymously with academic and commercial researchers external to the study in and outside the UK. This is so that our work can be used to support other likeminded researchers. Any partners will hold a data agreement with THIS Institute and will be bound by the same ethical requirements.

What will happen to the results of this study?

In addition to summaries of findings for key groups involved, such as patient safety specialists and patient safety partners themselves, we hope the results of this study will be reported in peer-reviewed journals and presented at conferences. We will email you these publications if you wish to be kept informed. No personally identifiable information will be included in any reports or other outputs of the study: any quotations used in reporting will be completely anonymised.

Who is organising and funding the study?

This study is run byan independent and highly experienced team from the University of Cambridge, University of Leicester, Loughborough University and the University of Nottingham. The wider project is led by Professor Graham Martin and Dr Robert Pralat from THIS Institute at the University of Cambridge. The project is funded by the National Institute for Health and Care Research’s Health and Social Care Delivery Research programme (reference NIHR164453). THIS Institute is supported by the Health Foundation, an independent charity committed to bringing about better health and healthcare for people in the UK.

Who has reviewed this study?

As a service evaluation, this part of the project is not eligible for formal ethical approval. However, it has been peer reviewed as part of the funding application process.

Get in touch

If you have any queries about this study, please email the research team at pss-psp@thisinstitute.cam.ac.uk.

For any complaints or concerns

If you have a complaint about any aspect of the study, please contact the director of THIS Institute, Professor Mary Dixon-Woods (mary.dixon-woods@thisinstitute.cam.ac.uk). If you are still not satisfied, you can contact the University of Cambridge Data Protection Officer at dpo@admin.cam.ac.uk. If you are not happy with their response, or believe they are processing your data in a way that is not right or lawful, you can complain to the Information Commissioner’s Office (www.ico.org.uk or 0303 123 1113).

Researchers

Professor Graham Martin
THIS Institute, University of Cambridge

Professor Jane O’Hara
THIS Institute, University of Cambridge

Dr Robert Pralat
THIS Institute, University of Cambridge

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