Ethical approval, ethics and patient and public involvement (PPI)
Do I need ethical approval before I start PPI?
Should I have had ethical approval for my PPI before I started my research?
Just need the TDLR? Skip to bottom.
The answer depends on whether the activity you are considering is actually PPI, the timing and nature of the PPI activities, and what you plan to do with the findings of your PPI. Beyond the approvals, it’s also important to consider the ethical implications of your PPI activities as well (whether or not you receive a formal approval from an ethics committee).
Is this activity PPI or is it research?
Research studies involving human participants, tissue or data need ethical approval, whether from an NHS Research Ethics Committee (REC) or an organisational one. The key word here is research – REC committees consider research. They do not routinely consider activity that is not research – and may not be willing to give an opinion on activities that are not research.
Most PPIE activities take place before a research study would typically be submitted for ethical review – to help develop a funding application, draft a protocol or to inform the research ethics application itself. The PPIE activities that are part of the research design are not themselves research.
The HRA has information and a tool that can help you determine whether your PPIE activity would be considered research.
If it falls into the ‘research’ category, you absolutely do need ethics approval.
PPI contributing to quantitative Research
PPI activities aim to make use of public experiences and expertise to improve how research is developed, designed, delivered and disseminated. For most projects using quantitative data collection methods, this will be easy to distinguish from the research itself as the methods used for collecting your research data will be very different from the methods used to involve your public contributors. They will also generally take place chronologically before your research begins – and ideally before the protocol is even fully developed.
PPI contributing to qualitative Research
Where it sometimes becomes unclear or confused is where the research has a qualitative element/work package and/or researchers use language that make it sound like research (easy, since many PPIE activities draw on qualitative techniques!). If your research does contain qualitative elements, it is worth taking deliberate steps from the beginning to clearly differentiate the PPI elements from the qualitative study itself. Timing is often a key indicator, with PPIE related to a qualitative study helping to identify and prioritise what questions should be asked, which methods to use, how to recruit participants etc all BEFORE the study begins.
The table below compares and contrasts qualitative research and PPI to help you determine what category your activity falls into, or to help you explain why your activities fall into either category.
| |
Qualitative research |
Patient and public involvement |
| Purpose |
Aims to generate data to address a research question |
Aims to draw on public expertise and experience to develop, design, deliver and disseminate research |
| Timing |
Activities are data collection. |
Activities start before protocol development and data collection to determine which questions to ask and how |
| Planning |
Follows a pre-defined method grounded in established qualitative theory. |
Uses flexible and responsive methods or combinations of methods to support people to be involved in the way that they choose. |
| Method |
Attempts to limit or reduce variability/maintain consistency |
Builds on questions, responses or leads from earlier activities |
| Inclusion |
Estimates required number of participants using qualitative sampling methods grounded in qualitative methodology (e.g., purposive, convenience, snowball).[1] |
Seeks a broad range of perspectives from public contributors with diverse experiences |
| Outcomes |
Aim to be generalisable or broadly relevant |
May have broader relevance or applicability but primarily relevant to the study the activity was aiming to influence |
Watch your language!
It is useful for researchers, contributors, ethics committees and grant/journal reviewers alike if you avoid using words or terms from qualitative or other research to describe your PPI activities. Be deliberate with how you describe the activities.
| Research words |
PPI words |
| Participants |
Contributors/Experts by experience[2] |
| Data |
Learnings/findings/feedback |
| Protocol |
Plans/strategy |
| Analysis |
Summary/learnings/findings |
| Method |
Activity |
What if I want my PPIE to be research?
Finally, confusion (and frustration) sometimes arises when a research team starts their PPIE activity and the findings are so exciting and interesting that the researchers want to turn them into research. There is no magic process by which information collected through PPIE activities can magically be turned into ‘research’. By definition, findings collected through PPIE activity have not been designed or collected in a sufficiently standardised and rigorous process to be accepted as research with generalisable findings. If your PPIE findings are interesting enough to merit a research project… use them to design a protocol suitable for supporting your PPIE-suggested hypothesis through standard research techniques!
HRA/NHS REC approval
Mostly when (health) researchers ask us about ethics approval, they’re thinking of NHS REC approval. The Health Research Authority (HRA) are clear that you do not need formal ethical approval to involve patients in the planning or design stage of research, even when recruiting those patients from the NHS:
Do I need HRA ethical approval before I work with patients and the public?
No. You do not need to submit an application to a Research Ethics Committee in order to involve the public in the planning or the design stage of research, even if the people involved are NHS patients.
Source: HRA Website, ‘What do I need to do?’ https://www.hra.nhs.uk/planning-and-improving-research/best-practice/public-involvement/what-do-i-need-do/ (You need to scroll right down!)
PPIE activity supporting a funding application or REC submission
The vast majority of PPIE activities take place during the ‘planning and design’ stages of research, and, as such, do not require NHS/HRA REC approval. If you are doing your PPIE activities working toward a funding application or a REC submission for your research project, your PPIE will fall into this category and you don’t need ethics approval specifically for the PPIE activities.
PPIE activity during data collection or analysis
If you plan to involve your public contributors in data collection or analysis after the research begins, it is worth specifically mentioning this as part of your standard REC application, as the REC committee may want to know what training and safeguarding you have in place for the public contributors doing the collection or analysis. There are specific questions in the IRAS form that ask how you will involve patients and the public during the research where you can include this information.
Publishing PPIE findings
‘The university/Really Important Research Journal won’t let me publish the findings of my PPIE activities because I don’t have ethical approval’ is a paraphrase of the email(s) that ultimately led to this information resource!
What do you want to publish, and why?
Including details of the PPIE as part of reporting the study the PPIE relates to
It should not be an issue to report that patients have been involved in a body of research as part of a methods, introduction and/or acknowledgement section of a paper or dissertation/thesis that is reporting the study the PPIE activities contributed to. Many major research journals, such as the BMJ[3], even specifically ask researchers submitting research manuscripts to describe whether patients were involved in the research the manuscript describes, and there are reporting guidelines such as GRIPP2[4] that aim to standardise how PPIE is reported in papers. PPIE reported in this manner is generally summarised and anonymised, without using direct quotes from contributors. It is good practice for public contributors to be invited to review the manuscript that their involvement has contributed to… and even better practice to involve them in the writing!
PPIE as the subject or major part of a publication
Sometimes researchers may consider that the findings from PPIE activities, or the manner in which they were done, or some other aspect of the PPIE plans or outcomes would be of use to the wider research community, and want to publish a paper (or section of their dissertation/thesis) that focuses specifically on the PPIE. Although the HRA is clear about not needing ethical approval to start or do PPIE activities for research, many universities and specialist research journals expect or require ethical approval if you want to publish something that focuses primarily on the PPIE activities or findings themselves (separately or additionally to publishing about the study the PPIE relates to).
If you are planning to publish your PPIE findings or even think that this might be something that you would like the option to do, it might be worth getting a formal ethical opinion from a recognised ethics committee within your university school or department. This can help to clarify organisational requirements and position on what you can publish and keep your options open for later publication. If your local REC agrees that ethics are not required for your particular activity, a written statement to this effect can often be sufficient for a research journal requesting ethical ‘approval’.
There are several research journals that are specifically geared toward the publication of PPIE-related manuscripts, such as Research for All and Research Involvement and Engagement. These journals are familiar with the theory and practice related to PPIE, and do not expect ethical approval for PPIE activities falling under the HRA guidance above. Some of the larger ‘general topic’ journals such as BMA may also be willing to accept PPIE-related manuscripts without ethical approval for the PPIE activity.
Quoting public contributors in publications
If you think it is possible or likely that you might want to use verbatim or even paraphrased quotes that could be recognised by an individual, this should be specifically discussed with your public contributors before they are involved, and recorded as part of a role description or terms of reference. The public contributors should ideally be involved in writing the paper and/or be invited to review the draft.
Watch your language!
As we outlined above, and whether or not you choose to pursue a ‘just in case’ ethics opinion, be deliberate in how you describe the PPIE activities you want to publish to clearly differentiate them from research/data collection.
Identifying and mitigating anticipatable risks in PPIE
Patient and Public Involvement in the designing and planning of research has traditionally been considered a ‘low risk’ activity, and, combined with a general desire to reduce barriers and encourage researchers to involve the public in research this has underscored HRA’s determination that it does not require ethical approval[5].
However, it is increasingly recognised that PPIE does present anticipatable risk of harm in some circumstances, with some populations or through some researcher actions or lack of action, particularly where sensitive topics are being discussed or vulnerable people are involved.
It is important that researchers carefully consider what potential risks and harms might arise for public contributors with lived experience describing or recounting their experiences, hearing others do so or discussing distressing topics and outcomes. This document from the NIHR Applied Research Collaboration North East and North Cumbria has a really useful thinking points and a check list for planning and carrying out PPIE activities with regard to ethical risks – https://arc-nenc.nihr.ac.uk/wp-content/uploads/2024/08/Ethical-Practice-Guidelines-FINAL-July-24.pdf
Privacy, confidentiality and consent
The principles of informed consent apply to PPIE activities, even if they do not take the form of an official ‘consent’ form. It is good practice for public contributors to be given written information about the activities that they will be involved in, what their purpose is, and the options that people have – including that they can withdraw/change their mind about being involved at any time. If you choose to include a form for contributors to sign, the focus should be on articulating what it is that contributors are agreeing to rather than creating a document (and potential personal data) to ‘protect’ your team.
Similarly, it is essential that contributors are given information about how their feedback will be used and how their personal information will be stored and used.
Summary
In
most circumstances, you
do not need ethical approval for PPIE activities.
However, you may need ethical approval for your PPIE activities if:
- You plan to involve your public contributors in data collection or as peer interviewers during the research. If so, you should specifically mention this as part of your routine REC application.
- You plan to publish your PPIE findings or methods as part of your thesis, dissertation or in an academic journal. Even if you just might be interested in publishing your PPI findings, it is worth chatting to your departmental ethics committee for further advice.
- Your department or institution has a specific policy in place that requires it. Some organisations have a local, departmental or school-level REC that can provide a written opinion on what approvals are required for your local situation.
Further reading
Still here? There is a growing body of literature on this topic if you need further guidance or are interested in some of the ethical theory and wider considerations.
NIHR Guidance on reporting PPIE in publications: https://www.nihr.ac.uk/reporting-ppi-publications-guidance
Ethical Practice Guidelines for Public Involvement and Community Engagement (NIHR ARC North East and North Cumbria – https://arc-nenc.nihr.ac.uk/wp-content/uploads/2024/08/Ethical-Practice-Guidelines-FINAL-July-24.pdf
Patient and public involvement and engagement: Do we need an ‘ethical anchor’? – Journal article arguing that PPIE should be done within an ethical framework to mitigate risk (but that approval should still not be required)
Guidance exploring many of the issues outlined above in depth from the CoProduction Collective – https://www.coproductioncollective.co.uk/news/all-about-ethics
Journal article highlighting 10 areas where ethical issues may arise during PPIE activities[6] – https://researchinvolvement.biomedcentral.com/articles/10.1186/s40900-017-0058-y
Public involvement and engagement in scientific research and higher education: the only way is ethics? – Journal article arguing against organisational ethical review ‘just in case’
A case study example of an institutional requirement for PPIE ultimately preventing essential research from taking place – https://adc.bmj.com/content/109/Suppl_1/A266
Journal article exploring ethical issues related to PPIE activity with children and young people https://eprints.whiterose.ac.uk/id/eprint/159830/3/Ethics%20and%20PPI%20v0.3%20clean.pdf
Guidance for Trauma Informed PPIE – https://www.imperial.ac.uk/media/images/non-standard-dimensions/PPI-trauma-informed-guidance-2024-(1).pdf
[1] https://journals.sagepub.com/doi/full/10.1177/14733250211024516 (or your favourite qualitative research reference)
[2] Preferred terms do vary, and it’s good to have a conversation with the people you’re involving to decide what they want to be called… but the important thing is that they’re not ‘participants’!
[3] https://blogs.bmj.com/bmjopen/2018/03/23/new-requirements-for-patient-and-public-involvement-statements-in-bmj-open/
[4] https://www.bmj.com/content/358/bmj.j3453
[5] Some of the references at the end also link this decision to the remit of NHS REC committees as considering research, and since PPI is not research, then it is considered outside of the remit of this committee. If a future reader is able to find a reference or statement from the HRA that further explores their position and reasoning, please let us know!
[6] This framework recommends registering planned PPIE work with your local NHS R&D office as a way of seeking ‘practical and administrative support around local governance arrangements’. Although most R&D teams will be happy to signpost to areas of support it is important to note that it is neither required nor recommended to ‘register’ PPIE activity at CUH!
