These notes have been written in response to requests by researchers and are intended as quick reference guides to resources and sources of help, both internal and external.They will be further developed as new requests are received.
Please note that patient and public involvement in research does not need ethical approval. Patients and the public involved in this way are acting as specialist advisers, not as research participants. NIHR INVOLVE and the Health Research Authority (formerly the National Research Ethics Service) have issued a joint statement to confirm that ethical approval is not required, available here: Patient and public involvement in research and research ethics committee review.
In addition, the Health Research Authority has a decision tool to help you check – see here: Is my study research?
Please let us have any comments on these resources by contacting email@example.com
► 1. When can I do PPI in the research cycle?
PPI can be part of the research cycle at any stage. The Research Design Service (RDS – see note 3) has produced a handbook for researchers which shows how to incorporate PPI at the following stages:
- Identifying and prioritising research
- Study design
- Development of the grant proposal
- Undertaking/managing research
- Analysing and interpreting data
- Dissemination of findings
- Implementation of findings
- Monitoring and evaluation
The handbook, entitled “Patient and public involvement in health and social care research”, can be downloaded here: Research Design Service PPI Handbook. There are also links to other resources and information about the services that the RDS can provide. Page 14 of the handbook has a schematic showing the research cycle.
The James Lind Alliance Priority Setting approach is a well-regarded and robust way to involve patients and carers in identifying and prioritising research (see Briefing Note 2; How do I know what research matters to patients?).
It’s easy to think you need to do PPI at every stage of all projects. This may not be so, and it’s always worth thinking through what you want your PPI to achieve and hence at what stage(s) it will be most useful. Indeed, you may usefully make these very decisions in partnership with patients and the public.
At whatever stage you want people to take part, you need to find them. You can do this by advertising what you need for your study on the Patients Active in Research in the Thames Valley website at patientsactiveinresearch.org.uk as well as via INVOLVE’s People in Research website at peopleinresearch.org The former covers all health research across the whole of the Thames Valley, while the latter is nationwide. We can help you search for patients who have registered on the Thames Valley site as well as posting your study there and letting them come to you.
There are also condition-specific sites such as:
These are specific to dementia but there are others, often linked to condition-specific charities. The Association of Medical Research Charities (amrc.org.uk ) may be able to help you.
If you are looking for young people to get involved, you may find Generation R helpful. It is a National Young Persons’ Advisory Group made up of local groups across the country, funded by the NIHR; see generationr.org.uk – you will need to provide clear information explaining what you are looking for and how they can be involved.
► 2. How do I know what research matters to patients?
Involving patients in identifying and prioritising research will help you to find out what matters most to them. The James Lind Alliance (JLA) offers a method for setting research priorities involving patients, carers and health and social care professionals in a given condition or health area. These Priority Setting Partnerships (PSPs) are not the only way that research priorities can be set, but they follow a clear process (set out in the JLA guidebook), are co-ordinated by NETSCC (the NIHR Evaluation, Trials and Studies Co-ordinating Centre) and are guided by an independent JLA Adviser.
PSPs take about a year to 18 months to carry out, cost approximately £20-35k (but this is very variable depending on support available) and produce a “Top 10” set of research questions that matter most to patients/carers and clinicians. Research funders are increasingly keen to consider JLA-identified research.
If a PSP has already been conducted in an area of interest to you, you can address the resulting research priorities even if you were not involved in the partnership. If a PSP has not been carried out in your area, why not think about setting one up?
More information about the JLA, previous/current PSPs and “top 10s” is available here: jla.nihr.ac.uk
During 2012-2017 the NIHR Oxford Biomedical Research Centre (BRC) supported a range of PSPs led from within, or linked with, Oxford. From 2017, the BRC will concentrate its JLA activity on turning JLA-identified priorities (from Oxford and non-Oxford based PSPs) into funded studies.
► 3. What guidance is available to help me do PPI?
Two key organisations providing help and guidance are the Research Design Service (RDS) and INVOLVE.
RDS South Central covers Oxford – see rds-sc.nihr.ac.uk – and offers “a number of resources to help researchers achieve meaningful PPI in their projects”. Given enough time in advance of your application deadline, they can offer support on a range of aspects, such as statistics, health economics and PPI. You will need to register on their database using the link below and they will then contact you.
One of the issues often raised by researchers wanting to do PPI at an early stage is the cost of working with patients (both expenses and payment for time where this is made – see note 5). RDS South Central have limited resources to help with reimbursement for PPI expenses and time. To request support you will need to use this link rds-sc.nihr.ac.uk/request-support
INVOLVE offers resources on a range of PPI topics – see invo.org.uk; these include a cost calculator for those who want to work out how much to budget for PPI, a document on Senior Researchers doing PPI, briefing notes for researchers, case studies of involvement, a database on training and support, and templates of documents such as job descriptions and terms of reference for committees and steering groups.
One frequently asked question is how to handle difficult situations in meetings where patients and the public are involved. Some of the INVOLVE guidance may help, but there are skills to chairing or facilitating all meetings. It may be a good investment to get an external facilitator if there are likely to be especially challenging issues raised or if you don’t yet feel confident in your facilitation skills. We can connect you with freelance facilitators working in the field of patient involvement if you ask us and/or may be able to help with training.
We are building a library of local case studies, available on the Patients Active in Research website, where you can also advertise opportunities for involvement in the Thames Valley. Opportunities can also be advertised nationally via INVOLVE’s People in Research database.
You may also find this blog and journals helpful:
► 4. How do I record what PPI I have done?
This is an area of growing interest and activity in PPI and is necessary both to enable others to follow your methods, and to identify what sort of PPI practices are most effective – you cannot measure the impact of a given process unless you know what it has been.
INVOLVE provides some information on this – invo.org.uk/document-and-record-public-involvement-in-your-research – and we are also awaiting publication of the final version of the Guidance for Reporting Involvement of Patients and Public (GRIPP). You can see the first steps towards the production of this checklist here: ncbi.nlm.nih.gov/pubmed/22004782. There is also a local working group, co-ordinated by the Oxford Academic Health Sciences Network looking at reporting across research, service delivery and training and education.
► 5. How and what do I pay patients who get involved?
The NIHR Oxford Biomedical Research Centre (BRC) has a policy on paying for patient involvement. There are two documents: one that sets out guidance on rates of pay for activities such as taking part in meetings and reviewing documents. It is based on similar national guidelines and provides details on how to manage payments through the OUH, and what to do about tax/national insurance etc. A second document is available that can be given to involved patients explaining what payment is on offer. Both can be downloaded here:
Payment for time is separate from payment for expenses such as travel or for carers to support the person getting involved. Expenses should always be reimbursed as no-one should be out of pocket from PPI activities or prevented from getting involved because they cannot afford the associated costs. Payment for time should, as set out above, be offered; however, many people choose not to accept as they see their PPI role as something they wish to do on a voluntary basis or do not want to complicate e.g. tax affairs with additional income. Again, the basic principle is that financial constraints should not prevent people from getting involved.
INVOLVE has created a resource concerned with payment and recognition here: http://www.invo.org.uk/resource-centre/payment-and-recognition-for-public-involvement/
There are special considerations that apply to people who receive benefits accepting payment for their time. A free national helpline has been set up offering individual advice to people on benefits who are involved with NIHR projects – see here: Benefits Advice Service for members of the public.
The service also advises researchers who want more details about benefits and PPI payments – see here: Benefits Advice Service for involvement.
► 6. How do I write information for patients?
Much is said about writing for lay audiences, and many guidelines have been written, but there is little evidence about what actually works best.
The main thing to remember is to write as simply as you can – and get a non-expert (or a few) to read your work before making it public. The language that you use on a daily basis may well not be understandable to non-experts so you need to think carefully about how to phrase complex terms, and avoid jargon and acronyms unless you spell them out and/or explain them.
Clear information is needed in a number of different places e.g. lay summaries in grant applications and for ethical approvals, clinical trial summaries (at the start and the end of a trial) and patient information sheets.
In respect of clinical trials, it is recommended that lay summaries for all new BRC-sponsored trials be checked by the Oxford BRC Patients Active in Research (PAIR) Group. Turnaround time is about 2 weeks. Please contact firstname.lastname@example.org
Lay summaries of clinical trials are our current priority because once your trial is registered (now a requirement), this summary will automatically be taken from the registry and put onto the UK Clinical Trials Gateway (UKCTG). However, this is currently a very poor system as the Gateway contains a lot of information that is not suitably “lay” – see Making It Even Clearer. This is why we strongly recommend patient review of trial lay summaries. Polly and PAIR members will help wherever possible with other lay summaries and are always happy to be asked.
INVOLVE has a section on its website about plain English summaries.
Overall, involving patients and the public in your research gives you the chance to get their help in ensuring that your written material is in plain English.
► 7. How do I know what patients and researchers think about PPI?
Health Talk (healthtalk.org) provides free, reliable information about health issues, by sharing people’s real-life experiences. You can read about or listen to people sharing their stories about cancer, autism, motor neurone disease, pregnancy, drugs, depression and much more. Created in 2001, Health Talk comes from a unique partnership between a charity called DIPEx and The Health Experiences Research Group or ‘HERG’ at The University of Oxford’s Nuffield Department of Primary Care. The website is managed by the charity and the research that appears on the site is produced by the HERG team.
► 8. What is “good” PPI?
NIHR and other funders increasingly ask to see evidence of PPI, either in the lead up to making a grant application, in the planned studies themselves, or in both. There is a growing PPI “industry” to support this: many groups in Oxford that do health research have PPI leads, strategies and plans, and much is said about the need to ensure “best practice” is followed.
However, while there have been numerous studies that in some way evaluate the impact of PPI, we know very little about what “works” to make research better for patients. There are many reasons why it’s hard to pin this down – in part because of the length of time between research and outcomes, and the very variable ways in which PPI activity is reported in published papers (see briefing note 4). You can read more here: Health care: Bring on the evidence. As we say there: “One of the knottiest problems in PPI is how to best weigh up anecdotes and evidence.”
All that said, the resources highlighted in this pack should help you to make a good start with PPI based on sound principles and much experience. For some, the moral arguments for doing PPI are enough to ensure that it happens; meanwhile, we are part of the growing efforts to assess the impact of PPI on research for patient benefit, including through the work of our OxBRC PPI Impact Assessment Fellow Dr Joanna Crocker, and are always happy to discuss this with you.
There is also some hesitancy to say what is “good” as there is no one size fits all, and PPI should be context specific. INVOLVE has a Good Practice Guide, and their “Putting it into Practice” Library can be searched using key words. Other useful resources include:
- INVOLVE’s Exploring Impact – whilst it doesn’t define what good PPI is it does sketch out areas where there is impact;
- Research Design Service PPI Handbook
- PPI Resources for Researchers from Parkinson’s UK
- An Introduction to PPI in Ophthalmology Research, NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Opthalmology
► 9. What’s the difference between engagement, involvement and participation and how can people move between them?
INVOLVE defines public involvement in research as research being carried out ‘with’ or ‘by’ members of the public rather than ‘to’, ‘about’ or ‘for’ them. This includes, for example, working with research funders to prioritise research, offering advice as members of a project steering group, commenting on and developing research materials and undertaking interviews with research participants.
Engagement is about researchers raising awareness of research, sharing knowledge or engaging and creating a dialogue with the public; and participation is when patients or members of the public are recruited as participants (or volunteers) in research.
Of course, they are all linked and people can move between them. For example, a researcher might give a public talk (engagement) that results in patients or members of the public becoming involved e.g. as a co-applicant on a study, or as a member of a study advisory group (involvement). In another example, someone might choose to volunteer to take part in a clinical trial (participation) and as a result of that experience might later choose to get involved with the design of a study (involvement).
See INVOLVE’s What is public involvement in research? for more information.
► 10. How do we incorporate PPI into grant applications?
The National Institute for Health Research (NIHR) has a range of research funding streams. The NIHR Research Design Service (RDS) South Central offers a Funding Overview, a list of latest NIHR funding opportunities and links to other funding opportunities.
As a general rule, when developing your application, whether to NIHR, a medical research charity or other funder, you may be asked to describe how you have involved patients and the public in developing your research proposal, as well as plans for involvement in the research study.
Example questions about PPI that might be asked:
These questions come from one funder, but similar questions are usually asked:
- Describe the ways in which you have involved patients and the public. Where appropriate, provide names of individuals and/or groups, outline the activities they have been involved in and how this involvement has, or has not, influenced or changed this application. (350 words max)
- Please give more details, including how patient and public involvement will benefit the research, the reasons for taking this approach and arrangements for training and support. Describe the way in which patients and the public will be involved in 1) Design of the research, and 2) Management of the research (e.g. steering/advisory group). Where appropriate, provide names of individuals and/or groups and outline the activities they will be involved in. In addition, what plans are there for providing training and support? Please note that a budget line for the costs of patient and public involvement is included in the finance form. (350 words max)
- Please describe how people with xxx have been/will be involved in the research cycle. This could include: identification and prioritisation of the research question; help design study protocols and patient information; inputting into the application and/or ethics approval; help carry out elements of the study, rather than simply participating as a subject; evaluating the research findings; and dissemination and implementation of outputs and outcomes. This section has a limit of 300 words.
Resources to help you
- If you are at an early stage of the research cycle, then the local RDS might be able to help you e.g. to run a focus group with patients/carers to inform your study design – register on their website here: rds-sc.nihr.ac.uk
- The RDS PPI Handbook offers an overview of the research cycle on p14 and ideas of how to incorporate PPI at each stage.
- The James Lind Alliance (JLA) website shows in which health conditions/ contexts a JLA Priority Setting Partnership has taken place, and lists the priorities that emerged as important to patients, carers and health and social care professionals.
- The Association of Medical Research Charities has information on PPI here: amrc.org.uk/search/site/PPI, and individual research charities may provide guidance e.g. Parkinson’s UK: PPI Resource for Researchers.
- Don’t forget that you will also need to provide at least a Lay Summary – some research charities may ask for more e.g. Arthritis Research UK Lay Case Guidance.
- See also Briefing Notes 1 (When can I do PPI in the research cycle?), 2 (How do I know what research matters to patients), 3 (What guidance is available to help me do PPI), 6 (How do I write information for patients?) and 8 (What is “good” PPI?).
Depending on the specifics of your study, you may want to consider:
- asking relevant patients/carers to be co-applicants; and/or
- including relevant patients/carers in a stakeholder and/or steering group; and/or
- setting up a PPI group to inform the study and/or your wider research group/programme/theme.
► 11. Who else is doing PPI locally?
The BRC has set up a Researchers’ PPI Network with representation from research groups who do PPI. For example, there are PPI Groups in Genetics, Early Phase Cancer Clinical Trials, Biobanking and Trauma. If you would like to join this network and receive information about workshops, who else is doing PPI, and other items of potential interest, please contact email@example.com
The NIHR Oxford CLAHRC provides resources to support PPI in research here: Information for Researchers; the Oxford Academic Health Science Network provides information here: Patient and Public Involvement, Engagement and Experience (PPIEE) ; the CRN Thames Valley and South Midlands also works with PPI (contact Alison Monk Alison.Monk@nihr.ac.uk), and the University of Oxford Medical Sciences Division has an Engagement Officer who links with involvement activities (firstname.lastname@example.org)
► 12. Is ethical approval needed to do PPI?
No. Patients and the public involved in this way are acting as specialist advisers, not as research participants. NIHR INVOLVE and the Health Research Authority have issued a joint statement to confirm that ethical approval is not required, available as a PDF on the Invo website.
In addition, the Health Research Authority has a Decision Tool to help you check.
However, there may be ethical issues that you would like to consider, for example around the involvement of young people. See this INVOLVE paper: Ethical issues in the involvement of young service users in research.
Also, you need to be clear that your PPI activities are distinct from your research activities. For example, you may have a PPI Advisory Group helping you to design and deliver your research – this is involvement. You may also have a qualitative research element to your study that seeks input from members of the public/patients. Even if you intend to use this data to inform the design of a subsequent stage of your study, this is deemed as research.
► 13. What do I need to be aware of with regard to data protection?
As with any personal data, you must keep your PPI contributors’ details in accordance with the information governance and data protection policy of the relevant organisation. For OUH NHS FT staff there is an Information Governance section on the intranet here: ouh.oxnet.nhs.uk/InformationGovernance/Pages/Default.aspx, and for University staff there are information security pages here infosec.ox.ac.uk/guidance-policy.
If you want to record a PPI meeting, you must ask the groups’ permission and tell them why you want to do so. The same applies if you want to take photographs.
► 14. What do I need to be aware of when involving young people?
Consult with them on the most appropriate ways to reward them – see this INVOLVE document: Reward and recognition for children and young people involved in research – things to consider.
- assume that you know what they want;
- be patronising;
- ask them to read long documents
Do check out INVOLVE’s resources for involving young people:
- Involving children and young people
- Involving children and young people in research: top tips and essential key issues for researchers and
- the section on young people in their Frequently Asked Questions.
Also, you may find Generation R helpful. It is a National Young Persons’ Advisory Group made up of local groups across the country, funded by the NIHR; see generationr.org.uk – you will need to provide clear information explaining what you are looking for and how they can be involved.