Ethical review
If your research requires review by a Research Ethics Committee, then public involvement at this stage of your project can be highly beneficial, but should happen before you submit the proposal. That's because the IRAS review process requires you to upload all completed patient-facing documents and research tools (e.g. questionnaires, surveys or interview discussion guides) that will be used, and any changes made after approval may require you to resubmit.
Why involve the public/patients at this stage?
Involving the public/patients in the design of research helps to ensure that the research outcomes are clear and relevant, and that the research methods accommodate the needs of the people taking part in the research and those for whom the research could benefit.
How your research could benefit
Involving patients and/or the public in designing and planning your research can:
- Improve the relevance, clarity and feasibility of your research design and outcome measures
- Improve accessibility for participants and reliability of tools by field-testing them with the public, e.g. ensure your patient information sheet, informed consent forms and questionnaires are understandable and appropriate for potential participants
- Improve the diversity of those participating
- Improve the recruitment process, participant experience and response/retention rate
- Reduce experimental bias in yor design, validate your assumptions and identify potential issues that might have been missed
- Speed up HRA approval by reassuring the Research Ethics Committee that the research respects the rights, safety and dignity of participants
How you could benefit
Involving patients/the public in your work at the research design stage can have a positive impact on you too:
- Improve interpersonal skills and sensitivity towards research participants
- Reflect on your assumptions and concepts of research design
- Gain respect and recognition for your 'lay' expert knowledge and work with patients, communities and/or the general public
- Gain greater motivation/momentum to conduct research
Ways to involve the pubic at this stage
- Develop credible and appropriate outcome measures, clinical trial placebos etc with people relevant to the population/topic you are researching
- Invite people to review your research protocol for potential difficulties or participant burden, and offer possible solutions
- Invite people to review your research material, such as participant information sheets and informed consent forms, data protection and confidentiality clauses, for understanding and accessibility
- Give patients/the public an active part in developing and reviewing your research tools (e.g. questionnaires) for accessibility, understanding and relevance, i.e. making sure the right language is used; improving the way questions are phrased; including subject areas and exploring nuances
- Work with the public on your recruitment strategy to get novel ways to access more diverse groups
- For systematic reviews people could help by: prioritising topics; refining the scope of the review; or developing the review protocol (including search strategy and inclusion/exclusion criteria)
Here are a few real-life examples for inspiration:
3 real-life examples
Accordion item
- Staley K., & Elliot J. Public involvement could usefully inform ethical review, but rarely does: what are the implications? Res Involve Eng 2017, 3:30.
- Paterson C., et al. A pilot study of therapeutic massage for people with Parkinson’s disease: The added value of user involvement. Complement Ther Clin Pract 2015, 11(3):161-171.
- Ali K., Roffe C., & Crome P. What patients want: Consumer involvement in the design of a randomized controlled trial of routine oxygen supplementation after acute stroke. Stroke 2006, 37(3):865-871.
- Donovan J., Mills N., Smith M., et al. Improving design and conduct of randomised trials by embedding them in qualitative research: ProtecT (prostate testing for cancer and treatment) study. BMJ 2002, 325(7367):766-770.
- A 2013 report of PPI in the development of a study on haemorrhoids
- Consulting parents about the design of a randomized controlled trial of osteopathy for children with cerebral palsy
- Consumer involvement in consent document development: a multicenter cluster randomized trial to assess study participants' understanding
- REACT2: Covid Antibody Instruction V18
Next steps
If you're interested in the benefits of public involvement at this stage, here's how to getting going:
3 column colour block - next steps
Go to the next research stage - Undertaking and Analysing - or use the navigation bar at the top to explore where else public involvement could help.
Read our blog
All posts- Why did nobody ask us?! Reflections and findings from co-produced research into children’s vaccine uptake.
- Three key takeaways from our participation in the Research Engagement Network (REN) community roadshows
- You and Your Health Data: Results of our Great Exhibition Road Festival activity
- “I sound like Darth Vader and I cough up fur balls” How people living with Airway Stenosis have informed my research career so far.
- How public involvement changed our research question exploring experiences of people with Long Covid
- Celebrating public involvement in NIHR Imperial BRC supported research
