2.    Invitation paragraph.

You are invited to participate in this study using a process called group concept mapping, to generate, sort and rate your views on the delivery of clinical research in the nhs.

Before you decide whether or not to participate, 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. Please ask if there is anything that is not clear or if you would like more information. Take time to decide whether or not you wish to take part.

This study is aimed at generating, sorting and rating themes on how Clinical Research Nursing and research delivery is perceived by healthcare professionals operating outside of clinical research teams within NHS organisations. This study is not exploring views regarding nurse led research or research generated by nurses as part of their clinical roles.

Clinical Research is an important part of the care pathway for our patients. By exploring how research delivery is currently viewed by those practicing separate from, yet alongside research delivery roles, we hope to shed light on the mechanisms that lead to different perceptions of research and identify potential solutions to address ongoing challenges.

The aim is to identify how research delivery is best implemented in the NHS and to enable more patients to have the opportunity to participate in research that is relevant to their health.  The information being collected as part of this study will be kept confidential and as such individual participants will not be identified in any publication arising from it.

Please take enough time to read this information carefully.

If you have any questions about this piece of research, please contact

Linda Tinkler (Researcher) ltinkler2@sheffield.ac.uk 

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

3. What is the project’s purpose?

This study is part of a doctoral training programme funded by the Royal College of Nursing (Strategic Research alliance https://www.rcn.org.uk/professional-development/research-and-innovation/research-alliance-with-university-of-sheffield) and sponsored by the University of Sheffield Department of Nursing and Midwifery. The overall study is expected to last for approximately 9 months.

The purpose of this research is to explore the views of NHS staff operating outside of Clinical Research teams, in relation to the Clinical Research Nurse role and research delivery. By exploring your views, we hope to shed light on the mechanisms leading to the different perceptions of research and identify potential solutions to address ongoing challenges.

4. Why have I been chosen?

You have been chosen because your clinical role means that you are likely to interact with Clinical Research Nurses (CRNs) delivering research studies. These interactions may influence how the research projects are delivered in your organisation and how successful they are. Other staff in similar roles, are also being invited to participate.  Your participation will help to improve how healthcare professionals understand of the role of the CRN, and how different perceptions can impact upon the practice of CRNs and clinical teams.  The results of this study will be used to contribute to existing evidence, but also to specifically identify areas for support, change and or development to help CRN teams in the future. The results will also be developed to inform further research.

5. Do I have to take part in the study?

You are under no obligation to participate in the study. It is entirely your decision whether you choose to take part or not. If you do decide to take part, you are free to change your mind and discontinue your participation at any time, without giving a reason.  If you decide not to take part or to withdraw at any time during the study your legal rights will not be affected by this decision.  

6. What will happen to me if I take part? What do I have to do?

This study will involve three stages of participation via a web-based interface. To do this, you will be asked to register with an email address of your choice. You should be aware that if you choose to use a work email address there is a chance that you and potentially your organisation will be identifiable, due to the first name or initial and surname and set up of nhs email addresses. This information is used only for the purposes of contacting you about participation in the study and is not included in any data analysis or publication. The following demographic data will be collected at the beginning:  your profession, specific role, highest level of qualification, band, clinical specialty or area of practice, and your level of awareness of research being delivered in your clinical area.

Stage 1 Ideas generation

You will be invited to respond to a single statement called a focus prompt. This is in the form of an open-ended sentence. You will be encouraged to complete the sentence repeatedly until all of your views on the topic have been expressed.

Following completion of this activity, the statements submitted by all participants will be analysed by the researcher, supported by discussion with the PhD supervisory team. A structured process will be followed to remove duplicate statements and to ensure that all views collected are accurately reflected. The aim of this is to consolidate the range of statements into a manageable set, ensuring all views collected are represented, but without duplication.  The resulting full set of statements is then prepared by the researcher and shared with you again to enable you to participate in the next stage.  

Stage 2. Organising (sorting and rating)

You will be invited to undertake two activities during this stage. The first will involve examining the set of statements and sorting them into groups (themes) of your choosing, based on where you feel particular statements are similar or different to each other. There is no set (right or wrong) approach to this, you will be free to sort in any way you see fit.  

You will then be asked to rate each statement according to your perceptions of how important each is in direct relation to the success of clinical research delivery in your organisation and the subsequent potential impact of each on successful delivery of clinical research, i.e. How important is each of these views, and what is the potential impact of each view on the success of research delivery in my organisation?

Each rating activity will be completed using a simple 4-point rating scale.

The data resulting from the stages described above will then be used by the researcher to construct a range of visual representations, illustrating the sorted statements, similarities and disparities, and participant views on importance and impact. The analysis and representation will be undertaken using the Group Wisdom, Concept Systems Global© software package. 

Stage 3. Interpretation and planning

In this stage, visual representations of the analysis will be shared with you. You will be asked to provide further feedback. This stage of the research is important both to enable a deeper understanding of the collective views and to inform the resulting recommendations.

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

Because of the nature of the study, we do not expect there to be any risk of harm, or injury whilst participating.

8. What are the possible benefits of taking part?

Whilst there are no immediate benefits for people participating in the project, it is hoped that you may find that sharing experiences in relation to your perceptions and understanding of research and seeing the views of other professionals in your field is beneficial. This may inform your practice and understanding of the role of the Clinical Research Nurse, however, this cannot be guaranteed.  Your participation in this study will contribute to addressing important issues in relation to the implementation of the CRN role and will contribute to an increasing body of literature related to the delivery of research in the NHS. Your contribution may also positively impact on the future development of the role.

9. Will my taking part in this project be kept confidential?

All the information that we collect about you during the course of the research will be kept strictly confidential and will only be accessible to members of the research team. You will not be able to be identified in any reports or publications. If you agree to us sharing the information you provide with other researchers (e.g. by making it available in a data archive) then your personal details will not be included unless you explicitly request this.

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

We will need to use information from you for this research project. Personal information about you will be collected only for the purposes of conducting the research. This information will be limited to the email address you choose to use and will only be used to contact you about your participation during the study. We will also ask you to tell us your profession, role and specific area of practice/specialty. This information will aid the researcher in the data analysis; however, it will remain anonymous. 

We will keep all information about you safe and secure. Your personal information (email address) will be deleted at the point of data analysis. According to data protection legislation, we are required to inform you that the legal basis we are applying in order to process your personal data is that ‘processing is necessary for the performance of a task carried out in the public interest’ (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

11. What will happen to the data collected and the results of the research project?

Your participation in the study will remain confidential. Once we have finished the study, we will keep some of the data so we can check the results. We will write our reports in a way that no-one can work out that you took part in the study. 

At the point where the study is completed, written up and submitted for publication, anonymised study related data will be stored securely as described above for a 10-year period as set out in the University’s Standard Operating Procedure for archiving of research data. This is to permit any subsequent inspection of study findings due to questions or queries. After this period, all information will be destroyed.

In certain circumstances your study data may be looked at by authorised members of the University of Sheffield, or regulatory bodies, for the purpose of checking that the research study is being carried out properly.

Due to the nature of this research, it is very likely that other researchers may find the data collected to be useful in answering future research questions. We will ask for your explicit consent for your data to be shared in this way.

12. 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, but we will keep information about you that we already have. 

We need to manage your records in specific ways for the research to be reliable. This means that we won’t be able to let you see or change the data we hold about you. 

The results of this study will be written up forming part of a Doctoral Thesis.  The study will also be written up and submitted to peer reviewed journals and presented at relevant conferences. 

13. Who is organising and funding this research?

This study is being organised and undertaken by the researcher Linda Tinkler. Linda has a background in researching the role of the CRN and Research delivery in the NHS and is a Trust Lead for Nursing, Midwifery and AHP Research in a large NHS Foundation Trust in the North East of England. Linda has been awarded funding from the Royal College of Nursing Strategic Research Alliance with The University of Sheffield to carry out the project. The University of Sheffield is sponsoring this study.

Linda has more than 10 years’ experience of developing, leading and delivering clinical research, and also has experience in undertaking qualitative research. She is being supported through this project by Professor Angela Tod, a Professor of Older People and Care at the University of Sheffield. Linda is also being supported by Dr Steven Robertson from the University of Sheffield.

14. 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. 

15. Where can you find out more about how your information is used?

You can find out more about how we use your information:

• by asking the researcher, Linda Tinkler

• by sending an email to dataprotection@sheffield.ac.uk

16. Who has ethically reviewed the project?

This project has been ethically approved via the University of Sheffield’s Ethics Review Procedure, as administered by the Department of Nursing and Midwifery.

17. What if something goes wrong and I wish to complain about the research?

If you have any questions, concerns or complaints about any aspect of the research study, you should speak to the researcher.

Linda Tinkler BSc (Hons), MClinRes (Leadership), RN

Post Graduate Researcher

The Department of Nursing and Midwifery 

The University of Sheffield 

Barber House Annexe 

3a Clarkehouse Road 

Sheffield 

S10 2LA 

Ltinkler2@sheffield.ac.uk

You may also wish to contact Linda’s Supervision Team:

Professor Angela Tod

The Department of Nursing and Midwifery 

The University of Sheffield 

Barber House Annexe 

3a Clarkehouse Road 

Sheffield 

S10 2LA

a.tod@sheffield.ac.uk

Dr Steve Robertson

The Department of Nursing and Midwifery 

The University of Sheffield 

Barber House Annexe 

3a Clarkehouse Road 

Sheffield 

S10 2LA

s.robertson@sheffield.ac.uk

However, if you feel that your questions or complaint have not been addressed satisfactorily you can contact the Head of Department Professor Tony Ryan on: t.ryan@sheffield.ac.uk who will then escalate the complaint through the appropriate channels.  If your complaint relates to how your personal data has been handled, you can contact Anne Cutler, The University of Sheffield Data Protection Officer dataprotection@sheffield.ac.ukFurther  information about how to raise a complaint can also be found in the University’s Privacy Notice: https://www.sheffield.ac.uk/govern/data-protection/privacy/general If you feel your complaint has not been handled to your satisfaction, you can contact the Information Commissioner’s Office. 

I have read the information, what do I do next?

If you would be happy to participate in this part of the study, we will ask you to log on to the data collection software here where you will be asked to create an account and indicate your consent to participate. We would like to thank you for taking the time to read this information. Please download and keep this information sheet for your records.