Participant Information Leaflet for Research Participants

Study Title:	Experiences of power in the co-production of health research
Investigator:	Emily Ahmed

Introduction

You are invited to take part in a research study. Before you decide, you need to understand why the research is being done and what it would involve for you. Please take the time to read the following information carefully. Talk to others about the study if you wish.

Please ask us 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.

Who is organising and funding the study?

This is a PhD doctoral research study, funded by the University of Warwick and the National Institute for Health and Care Research (NIHR) West Midlands Applied Research Collaboration (ARC).

What is the study about?

This study asks, ‘how do public contributors experience power and power-sharing within the co-production of UK health research?’.

We want to understand the ways in which power is experienced and shared (or not shared) within co-produced UK health research. You will be asked about your experiences as a public contributor (a patient or member of the public) involved in the co-production of UK health research.

The research will explore understandings, perceptions and experiences of power and power-sharing; exploring how and whether issues of power are identified and addressed; the context or support required to enable power-sharing within a research context; and how systems and structures intersect with experiences of power within co-production.

The NIHR (National Institute for Health and Care Research) describe co-production as “an approach in which researchers, practitioners and the public work together, sharing power and responsibility from the start to the end of the project, including the generation of knowledge. The assumption is that those affected by research are best placed to design and deliver it and have skills and knowledge of equal importance” (NIHR Glossary, 2023)

The value of co-production is becoming increasingly recognised and there is growing interest in embedding co-production within UK health research. Whilst there are many definitions of co-production, a key principle is sharing power and addressing power inequalities. Yet there is limited evidence and understanding of the ways in which power is experienced and shared (or not shared) within co-produced UK health research and how this has been experienced by public contributors.

The study is being carried out by Emily Ahmed, a PhD Researcher at Warwick Medical School. The study has been approved by: Biomedical & Scientific Research Ethics Committee (BSREC) at University of Warwick, BSREC 119/22-23.

What would taking part involve?

This Patient Information Leaflet has been created to provide you with further details about project and what you can expect from taking part. If you still have any questions you can contact the researcher directly emily.ahmed@warwick.ac.uk

The participant journey picture below shows what you can expect to happen if you choose to take part and is explained in detail below:

Sees recruitment poster or hears about the project: You may have seen a recruitment poster, social media post, received an email or heard about this research project through word-of-mouth.

Looks at the website: The recruitment poster and this Participant Information Leaflet is provided online on the University of Warwick Website https://warwick.ac.uk/fac/sci/med/research/hscience/coproductionphdLink opens in a new window

Reads participant information leaflet: You may want find out more, and we’d suggest you read this participant information leaflet. We will also send you a link or copy to this leaflet if you choose to take part.

Fills in EOI form: If you would like to take part in the research you can fill in a 'Take Part EOI' Expression of Interest FormLink opens in a new window which is available on the University of Warwick Website. You will be asked to fill in a short form with your contact details and preferences. You will also be asked optional 'about you' questions to help us reach a wide range of people. As this research will be looking at themes of intersectionality and inequity, we will consider diversity of representation.

Contacted by WhatsApp or Email: After we receive your EOI we will contact you to thank you for your interest. As this is a PhD research project we will only be able to interview a limited number of people.

Invited to interview: If you are invited to take part we will send you a WhatsApp message and/or email (depending on your preference).

Sent consent form and participant information leaflet: If invited to take part we will send you a links to a consent form and a copy of this participant information leaflet. It is essential that all participants fill in the consent form. You’ll then be asked to choose a preferred interview time and date.

Interview: Once we have agreed a date and you have completed the consent form you will be sent a link to an online interview using Zoom, from a secure University of Warwick account.

The day before the interview I will send you a reminder message with the Zoom meeting link. I will also ask you to have a pen and blank paper ready for the interview (a felt tip pen is ideal, but you can bring whatever you have).

The interview may take 1 to 2 hours (depending on your preference), with breaks if needed. During the interview I will ask you questions about your experiences of being involved in co-production.

I will also invite you to do some simple drawing activities during the interview. This is offered to enable greater accessibility. Creative methods such as drawing can be helpful in remembering, reflecting and communicating. It may feel right for some people and not for others, the drawing activity is optional (you can decide on the day) and if you choose not to do so it will not affect your participation in the research.

At the end of the interview I will ask you you’d like to choose a pseudonym (this is a fictitious name which used to de-identify participants in research).

On the day of the interview you can choose to turn your camera on or off, to have live captions, to take short breaks. If there are any other reasonable adjustments please let me know at least a week in advance and where possible I will make arrangements.

The interview will be audio and video recorded. This will be used for transcription, and once the transcription is completed and checked for accuracy the recording will be deleted.

Thank you and feedback form: After the interview you will receive a message of thanks for taking part and a link to an optional feedback form.

Invitation to ‘What do you think’ validation workshop (optional): Once the research collection is completed and analysed, all research participants will be invited to take part in an optional follow-up workshop in which we will share key themes and findings of the research and ask for your thoughts. Your participation is optional and if you choose not to attend it will not affect your earlier participation in the research. The workshop will take approximately 2 hours, it will be online using Zoom, from a secure University of Warwick account.

Sent link to publication and learning dissemination: Once completed, you will receive an easy-read summary report of the research.

Do I have to take part?

No. Participation in this study is completely voluntary and choosing not to take part will not affect you in any way. You can also choose to withdraw your participation without giving a reason by contacting one of the research team. Further details about withdrawing from the study are provided later on in this document.

What are the possible benefits of taking part in this study?

There are no direct benefits to you in taking part. We do not expect there to be any direct disadvantages to you taking part.

The findings from this research will be written up into a final thesis and an easy-read summary report that will be shared with you, researchers, relevant organisations and members of the public. By taking part in this study you will be contributing to a greater understanding of how power is and can be shared with public contributors in the co-production of health research. It is hoped that the learning gained will support the implementation of co-production and the ways in which we involved the public within this.

Communication – WhatsApp and email

You will be given the option of communicating with the researcher through WhatsApp and/or email. You will be able to choose which you prefer to use (and can change your mind at any time). WhatsApp an/or email will be used to contact you to arrange an interview date, for the researcher to send you weblinks to participant information, an online consent form, feedback form and to share further engagement opportunities and publications about this research project. If you choose to, you will also be invited to use WhatsApp or email to share any drawings done within your interview. WhatsApp is being offered due to its ease of use and accessibility and because it will mean you can see all communication and information easily and in one place. We will be using a secure and encrypted account approved by Warwick University, linked to a project specific phone number managed by Warwick University It has secure end-to-end encryption and has been approved for use within this research project by Warwick University IT services.

Expenses and payments

Unfortunately, we are not able to pay participants for their contribution to this study. We hope this does not create a barrier to participation. As all activities are online there will be no travel expenses incurred.

Will my taking part be kept confidential?

Identifiable data will be collected directly from participants to enable recruitment and participation within the research. This will be used to contact to arrange participation, send communication and information (as described within this document) and to enable suitability for participation in relation to the research questions. This will include their name, email address, and phone number for administrative purposes. Background information collected to inform the study will include their gender ethnicity, age range, and their experience of co-production in health research.

Data will be collected using an online expression of interest from, embedded within the Warwick University Website. Identifiable data will only be stored temporarily on a password protected encrypted files and stored on the University of Warwick server for the purpose of contacting participants for interviews and workshops, or the sending of study information, reports and dissemination opportunities about the study. Contact will be through Warwick University email, Zoom (using a secure University of Warwick account) and/or WhatsApp (using a secure and encrypted account approved by Warwick University, linked to a project specific phone number managed by Warwick University).

Consent forms will be collected using an online expression of interest from, embedded within the Warwick University Website. Participants may request an MS Word document version of the consent form to complete, this will be sent over Warwick University email and stored using a Warwick University password protected drive.

Identifiable data will only be stored temporarily on a password protected encrypted files and stored on the University of Warwick server for the purpose of contacting participants for interviews and workshops, or the sending of study information, reports and dissemination opportunities about the study. While the research team will be involved in identifying possible participants, only EA will be involved in the participant selection and invitation stages of the project and any identifiable data will be destroyed as soon as possible, depending on the extent of the potential participant engagement.

Following transcription all interviews and workshops transcribed will be pseudonymised with all identifying information removed and a participant number and/or pseudonym assigned. Any identifiable data that is no longer required will be destroyed immediately. This means all direct and indirect identifiers will be removed from the research data and will be replaced with a participant number and/or pseudonym. The key to identification will be stored separately and securely to the research data to safeguard your identity.

Recordings of interview and workshop data will be transcribed using Warwick approved transcription services. Once each interview or workshop is transcribed it will be checked for accuracy, the recordings will then be deleted.

All data will be stored on password protected encrypted files and stored on the University of Warwick server. Pseudonymised paper transcripts may be used for analysis (with no identifying information and kept separate from re-identification codes). The key to the re-identification codes will be deleted when it is no longer required. It is possible to withdraw data up until the point the point that identification codes are deleted and/or data is anonymised and no longer linked to a re-identification code.

Direct quotes and reproductions of drawings created during interviews and workshops may be used in the research report/publications/dissemination, in these cases quotes and drawings will be been a pseudonym and or de-identified.

The study is supported by a Lived Experience Advisory Panel (LEAP) a group of people have lived experience of co-production (as public contributors, researchers, academics, funders, co-production facilitators and Voluntary Sector representatives). They are involved in co-designing ethical considerations, research processes, discussion and reflection on emerging themes, theory and dissemination. The Lived Experience Advisory Panel for this project will have access to data extracts but not entire transcripts to protect confidentiality.

Confidentiality will be maintained, however if participant were to disclose that they, and/or others, may be at risk of harm, there is a duty of care to report this to the relevant authorities.

What will happen to the data collected about me?

As a publicly-funded organisation, the University of Warwick have to ensure that it is in the public interest when we use personally-identifiable information from people who have agreed to take part in research. This means that when you agree to take part in a research study, such as this, we will use your data in the ways needed to conduct and analyse the research study.

We will be using information from you in order to undertake this study and will act as the data controller for this study. We are committed to protecting the rights of individuals in line with data protection legislation. The University of Warwick will keep identifiable information about you until the study has finished.

Data will be retained in electronic format as appropriate, normally for a period of at least ten years from the date of any publication which is based upon it, as per University of Warwick’s Research Code of Practice.

Data Sharing

Data collected during the study, may be looked at by individuals from The University of Warwick and regulatory authorities, where it is relevant to my taking part in this study. The Lived Experience Advisory Panel (LEAP) for this project will have access to data extracts but not entire transcripts to protect confidentiality.

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 research to be reliable and accurate. The University of Warwick has in place policies and procedures to keep your data safe.

This data may also be used for future research, including impact activities following review and approval by an independent Research Ethics Committee and subject to your consent at the outset of this research project.

For further information, please refer to the University of Warwick Research Privacy Notice which is available here: https://warwick.ac.uk/services/idc/dataprotection/privacynotices/researchprivacynotice or by contacting the Legal and Compliance Team at infocompliance@warwick.ac.uk 

What will happen if I don’t want to carry on being part of the study? 

Participation is voluntary, and a decision to withdraw participation from the study without giving a reason, will not affect you in anyway.

If you decide to withdraw participation (leaving the study) after an interview has taken place, all video recordings, transcripts and notes taken during your interview will be destroyed. If you decide to withdraw participation after taking part in a workshop we will remove any data directly attributed to you from the workshop transcripts and notes. Requests to leave the study can be made directly to the researcher.

Please note that if you withdraw from the study, it will not be possible to withdraw your data after which point the data has been anonymised. To safeguard your rights, we will use the minimum personally-identifiable information possible and keep the data secure in line with the University’s Information and Data Compliance policies.

What will happen to the results of the study?

 The last phase of this study will include validation ‘what do you think?’ workshop in which all research participants will be invited to take part (this is entirely optional). During this workshop we will share key themes and findings of the research and ask for your thoughts.

The research will be written into a final report and doctoral thesis which will be submitted to the University of Warwick. An easy-read summary report that will be shared with you, researchers, relevant organisations and members of the public. Research methods, reflections and findings may also be used in dissemination activities, written publications and submitted to relevant journals.

Who has reviewed the study?

This study has been reviewed and given favourable opinion by the University of Warwick’s Biomedical & Scientific Research Ethics Committee (BSREC) BSREC 119/22-23 

Who should I contact if I want further information?

Lead researcher:

Emily Ahmed emily.ahmed@warwick.ac.uk

Research project supervisors:

Kate Seers kate.seers@warwick.ac.uk

Sophie Staniszewska sophie.staniszewska@warwick.ac.uk 

Who should I contact if I wish to make a complaint?

Any complaint about the way you have been dealt with during the study or any possible harm you might have suffered will be addressed. Please address your complaint to the person below, who is a senior University of Warwick official entirely independent of this study:

Head of Research Governance

Research & Impact Services

University House

University of Warwick

Coventry

CV4 8UW

Email: researchgovernance@warwick.ac.uk

Tel: 02476 575733

If you wish to raise a complaint on how we have handled your personal data, you can contact our Data Protection Officer who will investigate the matter: DPO@warwick.ac.uk.

If you are not satisfied with our response or believe we are processing your personal data in a way that is not lawful you can complain to the Information Commissioner’s Office (ICO).

Thank you for taking the time to read this Participant Information Leaflet