Section 2 – What is Patient and Public Involvement?

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Patient and public involvement, engagement and participation definitions

This PPI Researcher Guidance focuses on PPI –  ‘patient and public involvement.’

Below is the NIHR definition of the ways people get involved in research, showing how ‘involvement’ is distinct from ‘public engagement’ and ‘participation’:

• Involvement is research done with or by patients and the public, not to, about or for them. It is about working collaboratively with patients and the public and sharing decision-making
• Engagement focuses on raising awareness, sharing research knowledge and findings
• Participation is about people giving formal consent and taking part in a trial or study

The term ‘patients’ includes, current, former and potential patients, carers, people who use health and social care services, and people from organisations who represent those using these services. The ‘public’ includes anyone else, people who may be patients in the future or recipients of public health services such as vaccines, weight management services and smoking cessation. 

In the UK and internationally these terms are not always used consistently in research. PPI is more commonly referred to as ‘patient engagement’ across Europe, the USA and in pharmaceutical or commercial trials.

In this Guidance the term ‘PPI contributor’ is used to mean a member of the public or patient who is taking part in PPI work.

Other commonly used terms across PPI are:

• Expert by experience
• Lay representative/member
• Lay researcher
• Patient (or carer) representative/member
• Patient research consultant
• PPI representative/member
• Public representative
• Research partner    
• User/service user    

Find out more
A 2- minute film by the Medical Research Centre – Clinical Trials Unit at University College, London University explaining what PPI is in practice.	What is Patient & Public Involvement? | MRC Clinical Trials Unit at UCL
Cochrane Learning Live and International PPI Network series (2019). Three presentations on how involvement in research differs from participation in research and practical examples of how to do it.	Patient and public involvement in research: What, why and how?   Please Note INVOLVE has now been replaced by the NIHR Centre for Engagement and Dissemination. Many of their resources are still very relevant and available online.

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Why involve the public in research?

PPI work across research has developed over the last 20 years from being regarded as, ‘a nice idea to do if possible’, to a funding requirement for key funders.

The push has come from researchers and their funders, but also from patients and public;  there is increasing evidence that health research conducted with PPI achieves better outcomes for patients.

PPI benefits include:

• Patients and the public prioritise topics for research that are different to those of academics and health professionals (Boers et al 2015; Crowe et al 2015).

• People living with a health condition are often in a better position to know what questions remain unanswered about their treatment or condition, and what research would most likely improve their quality of life (Evans et al 2011).

• Patients can advise on the most meaningful and relevant outcome measures in clinical trials (COMET Initiative 2016).

• PPI right at the beginning of a project helps researchers to identify new research topics and to modify their research questions (Whear et al 2012).

• It can help shift the focus of the research design to become more in line with the public’s interests and concerns. Working with members of the public means researchers have to be clearer about why they want to conduct their research and how it is relevant to the public (Staley 2016; Boers et al 2015).

• It may challenge researchers’ aims and assumptions. PPI can also influence what research outcomes are measured as well as how they are measured (Andrews 2015; Ennis and Wykes 2013; Boers et al 2013) helping to make the research findings more relevant and valuable to the people who want to use them (Blackburn et al 2015; Carter et al 2013).

• Taking part in research that is more likely to benefit the participants and / or other patients and society more generally is a more respectful and ethically acceptable use of people’s time (Staley 2016; Cossar and Neil 2015; Blackburn et al 2010).
  (Source for the above examples: nihr.ac.uk/documents/briefing-notes-for-researchers-public-involvement-in-nhs-health-and-social-care-research/27371#Ethics)

• PPI is likely to improve recruitment to clinical trials (Crocker, Ricci-Cabello, Servet, Parker, Hirst, Chant, Petit-Zeman, Evans, Rees, 2018).
  (Source: bmj.com/content/363/bmj.k4738)

• Investment in PPI can lead to significant cost savings due to the time saved getting a drug to market (Levitan, Getz, Eisenstein, Goldberg, Harker, Hesterlee, Patrick-Lake , Roberts, DiMasi, 2018).
  (Source: pubmed.ncbi.nlm.nih.gov/29714515/) 

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Funding body requirements: NIHR, UKRI and Wellcome

Medical and social care research funders increasingly have an expectation of meaningful PPI in grant funding applications. PPI contributors are members of NIHR funding boards and commissioning panels, and they are highly unlikely to fund research which does not have PPI embedded throughout.

UKRI and Wellcome are also committed to PPI that is inclusive and diverse, and accessible to people from all backgrounds. Smaller charity funders usually require statements on PPI impact and dissemination, even if detailed PPI is not requested throughout the research proposal.

Researchers are strongly advised to check the PPI requirements of the specific funder they are applying to before submitting a grant application. For example, the NIHR asks applicants to describe PPI in the design and planning of their study as well as their plans for further involvement throughout the research, and if not, to explain why not.

For NIHR applications it is mandatory that there is a budgeted and resourced PPI lead role.

‘There should be a named person with appropriate skills and experience who is responsible for leading the PPI element within the project. The role of the PPI lead can be undertaken by any of the co-applicants within the research team (or a named member of the team), who has the relevant skills, experience, and authority to be accountable, represent, manage and embed patient and public involvement in all aspects of the research study/programme. This role should be a budgeted and resourced research team member.’

(Source: Definition and role of the designated PPI (Patient and Public Involvement) lead in a research team (nihr.ac.uk)

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Academic literature requirements

Researchers need to check the guidance for authors on PPI before submission. Currently the BMJ and BMJ Open require authors to provide a short paragraph as a subsection within the Methods section of their papers entitled Patient and Public Involvement detailing how they involved the patients and the public in their research.

BMJ Open also asks patients and public to peer review randomised controlled trials and other relevant studies. The section should provide answers to the requirements below about the involvement of patients and public in a research project.

 If they were not involved in any way this information should be formally documented in the Patient and Public Involvement section. Papers will still be considered where patients and the public were not involved but this will need strong justification.

Other medical and healthcare journals do not have these defined PPI requirements currently. However, this may change as it is good practice to include PPI in a study.

PPI contributors should always be acknowledged in the acknowledgements of contributorship statement, and if they are co-applicants they should be on the author list.

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PPI strategies

Health research organisations in Oxford and the Thames Valley often have their own PPI strategy – some key strategies are listed below. Departments in the University or research themes in the BRC Oxford may also have their own.

Find out more
NIHR Applied Research Centre Patient and Public Involvement Strategy for Oxford and the Thames Valley	arc-oxtv.nihr.ac.uk/pdf
Oxford BRC Patient and Public Involvement and Engagement Draft Strategy (2022-2027)	oxfordbrc.nihr.ac.uk
Oxford Health BRC Patient and Public Involvement Strategy	oxfordhealthbrc.nihr.ac.uk/patient-and-public-involvement/ppi-strategy/

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Standards and best practice

Standards and best practice for PPI are developed nationally and internationally. The NIHR is one of the UK PPI policy and practice leads as well as being a key funder of health research.

The UK Standards for Public Involvement were produced to improve the quality and consistency of public involvement in research. Developed over three years by a UK-wide partnership, the standards are a description of what good public involvement looks like. The 6 standards are:

Find out more
More information about the standards can be found at the UK National Standards website

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Why patients and the public want to get involved

PPI contributors in research say they are motivated by both personal and social reasons to get involved in health research.

These are some of the reasons people get involved:

• They want to make a positive difference to the quality of care or to improve treatments, either for themselves or for others with a similar condition. This is often motivated by personal experience of health and social care services, both positive and negative.
• Some people have had difficult experiences and appreciate being able to do something positive with that experience.
• People want to learn more about their condition and the research that is going on.
• Others have had very good experiences and see their involvement as an opportunity to ‘give something back’.
• People want to ensure the voices of their communities are represented in research.
• People want to use their professional skills and experience to improve health research.
• PPI contributors can benefit from increased confidence, knowledge, and skills.
• They find the PPI work and research topics interesting.

Researchers say that building PPI into their research:

• Strengthens the quality of their grant applications
• Improves the quality of their research
• Increases their understanding of how their research will benefit patients
• Contributes to their CV building
• Enhances their funder required feedback on research outcomes and impact

Find out more
The Healthtalk website has videos of researchers’ and patients’ experiences of patient and public involvement. These are a useful resource to find what researchers said about their reasons for involving people, the impact, some of the problems and how it can be better implemented and supported.	Health Talk topics

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Involving people from diverse and ‘under-served’ groups

There is increased evidence and understanding within primary health care and social care services that the needs and experience of specific patient groups are not being heard and met; the reasons are various and complex and beyond the scope of this Guidance. It is the same story for health research: specific groups, populations or communities are not included and are therefore ‘under-represented’ as participants and as public contributors.

The preferred terms for these groups are:

• Under-served or
• Under-represented

You may also hear the following terms, but these are used less now:

• Hard to reach
• Seldom heard

Who are under-served groups?

The NIHR INCLUDE project, which was tasked to improve the inclusion of under-served groups in health research, says there is no single, simple definition for an under-served group.

The definition of ‘under-served’ is highly context-specific: it will depend on the population, the condition under study, the question being asked by research teams, and the intervention being tested. However, there are some key common characteristics:

• Lower inclusion in research than one would expect from population estimates.
• High healthcare burden that is not matched by the volume of research designed for the group.
• Important differences in how a group responds to, or engages with healthcare interventions compared to other groups, with research neglecting to address these factors.

Examples of some under-served groups who may need extra support to take part are:

Why people from under-served communities need to be included

Funders including NIHR, UKRI and Wellcome want to see positive action taken by health researchers to support and promote the involvement of under-served communities, so that the broadest possible range of people contribute to PPI.

The profile of those who usually get involved tends to be white, middle-class, retired, some of whom have a health or research background – they are over-represented. Consequently, the knowledge, experiences and opinions of many groups who could contribute to health research, are not heard. This matters because these under-served groups are often the ones most affected by health conditions being researched.

It is important to note that PPI is not about having a representative sample, but about bringing different perspectives and improving research by making it more accessible and relevant to the population it is intended to benefit.

At least part of the answer lies in greater equality, diversity and inclusion (EDI) in PPI.

• Equality is about the fair treatment of everybody and, for example, ensuring everybody has an equal opportunity and is not treated differently or discriminated against because of their characteristics. Some characteristics are, protected by law in the Equality Act 2010. See Equality and Human Rights Commission web link below for details.   

• Diversity is about the mix of people, taking account of the differences between people and groups of people, and placing a positive value on those differences.

• Inclusion is about the culture in which the mix of people can take part and join in and be valued for being themselves.

Find out more
NIHR We always aim to be a diverse and inclusive funder, both in terms of the people who lead and run the NIHR and the people who lead, deliver and are involved in our research.	nihr.ac.uk/about-us/what-we-do/equality-diversity-and-inclusion.htm
Equality and Human Rights Commission, set out the nine protected characteristics in the Equality Act 2010.	equalityhumanrights.com/en/equality-act/protected-characteristics

How to include under-served groups

Including a more diverse range of people to become PPI contributors means that researchers need to:

• understand the barriers to PPI that these groups experience
• make targeted efforts to find and engage with them
• build relationships
• create solutions for inclusion of under-served groups in a context-specific way

There can be numerous barriers which need solutions, some of the most common are below.

Barrier	Solution
Unaware of opportunities for involvement and how valuable their experience is	Hold engagement events and build relationships with the community • Be specific to the Community i.e. Caribbean, African, South Asian • Get the communities involved with tasks i.e. cooking, invitations • Hold events at familiar, supportive community venues • Get a health professional to speak on the topics e.g. Diabetes
Adverts haven’t reached them	It’s easier to go through existing community leaders • Outreach health workers or support group co-ordinators who are often the ‘gate keepers’ to communities and trusted figures. • Be proactive and build a wider network of community contacts that can then help you reach the most vulnerable and underserved communities.
Lack of time – the requirements are too time consuming	Start building up relationships with the communities before you submit your research application • Speak to members of a specific community, outreach workers and people with experience of the community before putting together your PPI for research application • You need to understand what will need to be in place to meaningfully involve contributors in a research study • This work should be started as early as possible to start building up partnerships with the community
Additional costs of parking, travel, childcare, and lost work time to attend meetings – worry them	Communication! • Make sure that you have been in touch with people well in advance of an event to ask about specific requirements • Do they need help with transport? • Can they only attend at specific times? • Offer financial reimbursement such as paying for childcare or a carer’s time
Lack of confidence – researchers seem to know it all and have the power in the room	Build relationships from “common interests” and use this to create conversations and develop shared understanding • Use active listening skills to ensure you get the correct feedback and views from your groups • Meet with people where they are comfortable, such as their community centres, schools and church – neutral territory • Show your contributors how their feedback and suggestions have made a difference in your research and how you have acted on it
Lower levels of literacy and numeracy than the researchers so they can’t access the materials they need to read	Easy read formats for all communication, plain English and short sentences • Try to avoid leaving heavily worded leaflets • When and where possible use alternative formats such as DVDs, audio and visual cues e.g. waving a green object when you want to speak
Unable to travel to meetings on public transport perhaps due to a disability	Understand your contributor’s needs before you invite them to a meeting • Be organised and  arrange how you can support your contributors to attend meetings and involvement activities • This should be considered at the research application stage • Ask them how they want to be included e.g. would they prefer to virtually attend some meetings but occasionally attend face-to-face
Poor communication about the research and lack of time given to help contributors understand their role or research methods and terminology	Understand the background of the groups you are trying to involve • For example, will you need translators if the specific group don’t speak English as a first language? Or are there low levels of literacy in the community? • Think about this at the time of putting together your research application •This should form the basis of thinking through what PPI will be needed for a project so appropriate time and budgeting can be accounted for
Meeting times in standard office hours may exclude some people who work	Ask what will be the best times for your PPI contributors to be involved? • Consider holding some meetings outside of standard office hours • Catch up with PPI contributors in advance to ask for their feedback before a meeting and arrange to brief them about a meeting afterwards at a time to suit them • Have options to join a meeting digitally which may be possible for some contributors during a working day.
Lack of resources to support PPI, including researcher time and an adequate budget	Your PPI is an essential part of your research proposal or funding bid! • Planning your PPI is as essential to your research bid as thinking about statistics or methodology • Speak to appropriate people at the time of putting the bid together such as, key community contacts, PPI professionals and importantly the specific patient or community groups • Ask what will be important to be able to do the PPI well, and factor the time and budget needed to do this work as part of the application
Researchers seem unapproachable	Trust, communication and flexibility • Be respectful of cultural practices and ask the community how they wish to be involved – don’t make assumptions • Continuity of contact – try to have a main point of contact for your contributors • Speak in plain language and check understanding. Make information enjoyable and engaging.
Using terminology that does not feel right for the communities being engaged	Don’t be afraid to ask the community how they want to be described • Members of a particular community will not expect you to know all about their specific cultural practices, but it is respectful to ask them how they wish to be described • Use interpreters and members of the community with whom you already have a relationship to understand the clearest terminology to use.

Adapted from PPI useful documents (emahsn.org.uk)

Find out more about how to include people from under-served communities
INCLUDE Guidance (General): National Institute for Health and Care Research (2020) Improving inclusion of under-served groups in clinical research: Guidance from the NIHR INCLUDE project. UK: National Institute for Health Research.	nihr.ac.uk/documents/25435
INCLUDE Guidance (COVID-19 specific): National Institute for Health and Care Research (2020) Ensuring that COVID-19 Research is Inclusive: Guidance from the NIHR CRN INCLUDE project. UK: National Institute for Health Research.	nihr.ac.uk/documents/25441
A philosopher’s approach to equality Dr Sapfo Lignou, Department of Psychiatry, University of Oxford	Videos: Patient and Public Involvement – NIHR Oxford Biomedical Research Centre
East Midlands AHSN Guides to involving specific, under-represented groups. Some useful, practical tips	PPI useful documents (emahsn.org.uk)

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Ethical approval

Ethical approval by a Research Ethics Committee (REC) is not needed for the PPI element of the research study. This is because PPI contributors are involved in the design, implementation and management of the research process itself, rather than being participants or subjects of the research. They are acting as specialist advisers, providing valuable knowledge and expertise based on their experience of a health condition or public health and social care issue.

Although formal ethical approval is not required, the principles of informed consent apply in PPI. PPI contributors need full information about what they are being asked to do, to have the opportunity to ask questions, and the option to withdraw from the work. Their personal contact details should remain confidential, and they may be asked to formally agree to keep details of the study confidential.

For most research it is not appropriate for PPI contributors to also be participants in the study or trial, as that can compromise both the researcher and the person involved.  However, many participants do go on to become actively involved as PPI contributors when their participation in the study or trial is over.

Where PPI may raise ethical concerns

There are some situations where PPI involvement may raise ethical concerns. Examples are when PPI contributors are involved with collecting and analysing data, such as helping to analyse survey data, conducting interviews with participants, or facilitating focus groups. In these situations please see guidance from the Health Research Authority below.

Find out more
Dr Mark Sheenan BRC Ethics Fellow – focus on ethics	ndph.ox.ac.uk/team/mark-sheehan
Guidance from the Health Research Authority and INVOLVE (full version of document)	Impact of public involvement on the ethical aspects of research. (.PDF)

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Costing and funding patient and public involvement

Effective PPI takes resources – both staff time and money – and it is essential to have an adequate budget for both. Funders such as the NIHR expect PPI to be adequately costed in research proposals. It is extremely difficult to obtain funding for PPI work after a research grant applicationhas beenfunded.

Key costs will include: 

• Advertising
• Care costs
• Travel expenses
• Payment for time
• Refreshments
• Training
• Translation or interpreting
• Venue hire

Current PPI contribution payment policies are in Section 4

Large-scale long-term projects such as clinical trials are likely to have a project manager to support this work and a PPI lead. Smaller scale projects will not have this support; the PPI work is the role of a small research team or of an individual researcher. Within departments there will be experienced project managers and PPI staff who can offer advice and support with costing this work, Section 5 has some contact details.

Grant applications

Funding opportunities for PPI outside of a main grant application are limited, details are in Section 5

Reimbursing PPI contributors for their time on a grant application at the development stage of research can be difficult. There is a small fund in the NIHR Research Design Service (see below) to support this but if the grant development is being supported in part by one of the big research programmes e.g. the BRC or the ARC there might be a small amount of core funding to support this. It is always worth asking the PPI manager associated with the funding programme. It may be appropriate to factor in the cost of the pre-application PPI into the PPI budget for the research project itself so that contributors can be reimbursed if the project is funded. Whether this is appropriate will be very dependent on your PPI contributor themselves.

NIHR – Research Design Service South Central

Researchers applying to the NIHR grant programmes or themed calls can access the support of their regional Research Design Service (RDS) – for Oxford this is RDS South Central. The RDS helps in identifying suitable PPI contributors, facilitating initial meetings, advice on long term PPI strategy and supporting the PPI contributor costs throughout the application process via a small grant scheme. This funding covers only the application process and not the full costs of PPI throughout a research project.

See the RDS website rds-sc.nihr.ac.uk and choose the ‘Request support’ option to get in touch with an advisor.

 

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