Participant Information Sheet (clinical observation)

Patients’ experiences of using GP urgent care hubs study v.1.1 (28/04/2025)

You are being invited to take part in a research study. Before you decide it is important for you to understand why the research is being done and what it will involve. Please take time to read the following information carefully and discuss it with others if you wish. Ask us if there is anything that is not clear or if you would like more information and please take time to decide whether or not you wish to take part.

1. What is the project’s purpose? 

We are researchers from the School of Medicine and Population Health at the University of Sheffield. We research how patients experience care received in the extended access hubs in order to improve services. This research is being conducted in collaboration with Primary Care Sheffield a company set up by GPs to deliver primary care in Sheffield. 

2. Why have I been invited? 

We are asking you to take part in our study because you are planning to attend an appointment at the extended access hub. 

3. Do I have to take part? 

It is up to you to decide whether or not to take part. You will receive the same level of care whether or not you decide to take part

4. What do I have to do and what will happen to me if I take part? 

• We would like to observe your consultation with the GP. We are interested in how the consultation is managed and how we can help improve services.

• The researcher will make handwritten notes to gather their impressions of the observation.  

• The process will be similar to having a medical or nursing student present during your consultation. The researcher is female and has experience of working in the NHS settings. She will not have any role in the consultation process. 

• You can stop the observation at any time, and your data will be deleted or kept according to your preference.

5. What are the possible disadvantages and risks of taking part? 

We do not anticipate there being any disadvantages / risks to being observed. However, we consider that the medical issue you seek help with may be something that is potentially upsetting for you. In the event that you become upset during your consultation we have professionals available to discuss the issue.

6. What are the possible benefits of taking part?

By taking part in this research, you will contribute to our understanding of strategies for service improvement. 

7. How will we use information about you?

• No identifying details (such as your name or contact information) will be included in the observation transcripts.

•  People who do not need to know who you are will not be able to see your name or contact details. Your data will have a code number instead.

• All data will be securely stored and accessible only to the research team.

• Your words may be quoted in publications, reports, web pages and other research outputs. It will not be possible to name you in these outputs.

8. What are your choices about how your information is used?

• You can stop being part of the study at any time, without giving a reason, and the researcher will immediately destroy any recordings or notes taken up to that point.

• However, once the observation has been transcribed and anonymized, it will not be possible to remove the notes from your observation because no personal identifiers will be linked to the data.

9. What is the legal basis for processing my personal data?

We are collecting and storing this personal identifiable information in accordance with UK data protection law which protects your rights.  These state that we must have a legal basis (specific reason) for collecting your data. For this study, the specific reason is that it is “a public interest task” and “a process necessary for research purposes” (Article 6(1)(e)).

Further information can be found in the University’s Privacy Notice https://www.sheffield.ac.uk/govern/data-protection/privacy/general. As we will be collecting some data that is defined in the legislation as more sensitive (about your health), we also need to let you know that we are applying the following condition in law: that the use of your data is necessary ‘for archiving purposes in the public interest, scientific research purposes or statistical purposes' (9(2)(j)).

10. Potential disclosures

While we make every effort to maintain your confidentiality, there are specific circumstances where we are required to share information:

• If, during the course of the study, we become concerned about your safety or the safety of others, we may need to inform your GP, and the GP Practice Manager.

• If anybody involved in the study observes any malpractice they can report this to Cara Brazier, the Head of Primary Care Sheffield so that she can investigate. 

• If you disclose information regarding serious misconduct by a healthcare professional, we report this to their employer so that they can investigate..

• If you disclose criminal activities, we have a legal duty to report this to the police

• Authorized individuals from the University, the Primary Care Sheffield or regulatory bodies may review study-related information for monitoring, auditing, or investigation purposes.

11. Who is organising and funding the research?

The University of Sheffield is the sponsor of this research, and it is being organised and coordinated jointly by the School of Medicine and Population Health and Primary Care Sheffield. This research is funded by the National Institute for Health and Care Research (NIHR) Applied Research Collaborations (ARC). 

12. Who is the data controller?

The University of Sheffield will act as the Data Controller for this study. This means that the University is responsible for looking after your information and using it properly. 

13. Who has ethically reviewed the project?

The project has been reviewed by experienced researchers and approved by the HRA and an NHS Research Ethics Committee. Approval/ID number XX/XX/XX

14. What if something goes wrong?

If you would like to raise a complaint about the study, you should contact Dr Joanne Coster (email: jo.coster@sheffield.ac.uk) (Principal Investigator). If for any reason you do not feel satisfied with the outcome you can contact Professor Mark Strong, Dean of School of Medicine and Population Health (email: m.strong@sheffield.ac.uk).

15. Contact for further information

If you have any questions regarding any aspect of our research, please feel free to contact Dr Jo Coster of the research team by phone (0114 2220854) or via email (jo.coster@sheffield.ac.uk).

Thank you for taking the time to read the information sheet. 

If you feel happy with the information provided to you and you are willing to participate in the research, please inform the practice staff or the researcher