The importance of Patient and Public Involvement and Engagement (PPIE) throughout a research project is well established and becoming more and more of a foundation for both successful grant funding and favourable NHS Research Ethics Committee (REC) opinion. Good quality PPIE involves centring the experiences of people with dementia, for instance by co-designing the study and identifying and addressing ethical challenges with them.
The Health Research Authority (HRA) Participant information design and review principles (updated August 2023) make clear that public contributors should be involved in designing relevant, understandable, tailored and appropriately formatted research information. Where public involvement does not meet these principles (e.g., takes more of a ‘tick box’/less collaborative approach), the HRA say that studies will ‘not normally receive a favourable opinion from an NHS REC.’ It is important therefore, that dementia researchers share learning on navigating the NHS ethical review process, with PPIE. In this blog I aim to show the value of good quality PPIE throughout the ethical review process, which I hope will help other researchers.
Thinking about ethics from the start of a research idea
In 2022-2023, I co-produced a research proposal with a diverse group of people with dementia and carers, leading to a successful funding application (you can read about it in our paper). Involving a range of voices with lived experience from the very start of an idea led to identification of ethical challenges early on, and a plan for how PPIE would underpin the project throughout, placing me in a strong position to tackle an NHS ethics application later. For instance, we developed an Equality, Diversity and Inclusion strategy, acknowledging potential concerns of diverse communities around confidentiality, with distrust often deep rooted in historical stigma, racism and discrimination. Whilst not pretending to have come up with all the answers, working with a PPIE group representing minoritised communities to develop trust-building recruitment strategies was the ethical way forward. This pre-funding application stage was funded by a National Institute for Health Research (NIHR) Dementia Career Development Award. The Research Support Service can provide advice on support for PPIE in developing research funding applications.
NHS ethics application
Fast forward to starting my funded project ‘Communication Aspects of Personalised care Planning in Dementia: CAPPD’ in January 2024. My first task has been to submit an NHS research ethics application. Here are three examples of tricky areas where PPIE work helped shape the application.
- Participant information: The approach I took to designing dementia inclusive information resources and consent forms was to first create draft versions. These were informed by a. existing ethically approved materials, shared by other researchers, using accessible language and images to support key points, b. Innovations in Dementia guidance on easy read information to support those with communication and sensory difficulties related to dementia, and c. my previous experience of recruitment, and wishing to avoid overly detailed and text heavy resources.
Draft versions were shared with the study PPIE group and amended based on their feedback. For example, a former carer who is gay, and cared for his partner, suggested using the word ‘chosen’ in the following phrase to be more LGBT inclusive: ‘You may want to talk about this with a friend or chosen family member.’ Rather than sending research materials in advance of a meeting, I have found that allowing plenty of time in a meeting to expose people to them for the first time, gives a researcher important insights into their level of understanding and emotional reactions in real time.
Crucially, I explained in the study protocol why and how the materials were designed to be accessible and cited Innovations in Dementia guidance (above) as well as outlining how the PPIE group had contributed to the design.
- Mitigating risk in recording video calls: My study includes a Conversation Analysis (CA) workstream, involving video-recording care planning conversations between primary care practitioners, people with dementia and carers. Whilst in person conversations are the preferred format, there may be occasions where conversations take place via video call. I needed to ensure that processes were in place to mitigate the risks of a confidentiality breach, which were acceptable to potential participants. I problem solved this aspect with PPIE contributors, practitioners and fellow researchers grappling with the same issue (thank you An Kosurko and Hannah Wheat). The result was a set of procedures deemed acceptable to all, including the researcher acting as meeting host, use of end-to-end encryption settings, passcodes for joining meetings and online waiting rooms, and the researcher assisting participants to set up an anonymised name on their Zoom screen.
- Video data pseudonymisation: CA involves the close examination of video interactions, often to identify verbal and non-verbal aspects of communication that will inform an area of healthcare practice. In my study, CA will inform the development of primary care workforce training on having care planning conversations with people with dementia and their carers. The role of PPIE contributors in CA studies increasingly includes getting involved in data interpretation. Access to the video data therefore needs to be ethically approved. Initially, my ethics application stated that videos would be pseudonymised through the use of animation software, to protect participant confidentiality when shared outside the research team. However, two PPIE encounters led to me changing this. Firstly, at a DemiQual meeting, researchers and people with lived experience of dementia discussed the involvement of public contributors in qualitative data analysis. The public contributors highlighted how obscuring details of videoed interactions can make it challenging for them to process what is going on and contribute their analytic insights. Some researchers at the meeting shared that they had obtained ethical approval without this need to alter videos. Secondly, I ran this idea past my PPIE group, and they wholeheartedly agreed with the opinions shared at the DemiQual meeting. I amended the protocol and ethics application to state: ‘With participants’ consent, voices will not be altered nor faces obscured for conversation analysis, for which voice, expression and gaze are important analytical categories.’
Success
Fast forward again to June 2024 and I received confirmation of HRA approval. I enjoyed the Research Ethics Committee meeting I attended because by that time I felt confident that the protocol was firmly grounded in the lived experiences of people affected by dementia, who had scrutinized and helped to shape the methods. The panel commented on how well the study considered the experiences of people with dementia and carers throughout the research process.
Involving people with dementia and carers in the development of an NHS ethics application is expected by the HRA and in this case, has led to developing fit for purpose, inclusive and accessible processes and materials. This makes me feel confident about embarking on recruitment, although there will still be much learning to do along the way.
Researchers are good at informally sharing ethics related advice and materials, but writing this blog has made me think that a repository would be helpful, for sharing resources like Participant Information Sheets and Informed Consent Forms, which have been HRA approved, along with examples from protocols, tackling tricky aspects of ethics. Adam Smith and I are investigating the potential for such a repository on the new NIHR Dementia Researcher app, so watch this space!
With many thanks to all the public contributors I have worked with so far.
Authors
Dr Sarah Griffiths has a background in speech and language therapy and has been involved in aphasia research. For 14 years she was a senior lecturer on a BSc Speech and Language Therapy course at Plymouth Marjon University. Now Sarah is is a Senior Research Fellow in the Centre for Ageing Population Studies, Research Department of Primary Care and Population Health at University College London.