Five pointers to ensure your patient engagement activities contribute to a successful UK ethics submission
Engaging patients and the public in the design and review of health and care research is essential for gaining research approvals from UK Research Ethics Committees (RECs). Emily Pickering , Specialist Commercial Services Lead at the NIHR, shares her experience and insights gained from helping life science companies to engage in direct dialogue with patients, carers and members of the public.
Since December 2023, it has been mandatory to demonstrate meaningful engagement that meets the Health Research Authority’s (HRA) ‘Quality Standards’ and ‘Design and Review Principles.’ These standards focus on placing participants at the heart of research by ensuring clarity, accessibility, and thoroughness in information provided, to enable fully informed consent.
Our Patient Engagement in Clinical Development (PECD) Service, which I lead, is designed to support life science companies to meet these standards. To date, we've helped more than 29 companies on 78 engagement projects. Activities we have facilitated range from early engagement on research priorities, to protocol design and document review. So if you're planning your next research project, here are five pointers to enhance your patient engagement work and help strengthen your ethics submission.
1. Bringing together the right people
Engaging the right public partners is key to meaningful involvement and to crafting a credible ethics submission. By collaborating with individuals who bring specific, relevant experiences, you can ensure feedback is diverse, actionable, and closely aligned with your study’s goals. This engagement enhances the ethical validity of your research and reflects a commitment to inclusivity, which is crucial for satisfying REC expectations.
Our PECD service excels at helping you identify ideal public partners by creating detailed personas. These personas outline the characteristics, experiences, and insights needed to make the engagement effective. Leveraging our extensive network, including NHS clinics, charities, and research-engaged public members, we aim to find contributors tailored to your needs—from seasoned patient advocates to those newly diagnosed. Involving this spectrum of perspectives ensures that study materials are relevant, comprehensible, and engaging for all potential participants, which strengthens the ethical standing of your submission.
2. Embed involvement wherever you can
We believe patient engagement is most impactful if it takes place throughout the entire research lifecycle, ideally beginning before you draft your protocol. But we also know that practical barriers like budget constraints may prevent this level of involvement. REC committees will also recognise this but will appreciate visible efforts to capture patient insight wherever feasible.
Our advice is to find the best solution for your study. We are happy to work with you at any stage of your research and have a range of options available. We can assist with:
3. Ask the right questions
Effective patient engagement hinges on asking the right questions at the right time. Our team works with you to tailor a question set that aligns with your study’s objectives, ensuring feedback is both actionable and specific. Thoughtfully developed questions guide each engagement session and ensure REC-ready insights that meet ethical standards.
For instance, during protocol reviews, we ask probing questions that identify areas for improvement, while focus group sessions use empathetic, open-ended questions to uncover recruitment barriers. For document reviews, our questions are mapped against HRA standards, helping to ensure that all required information is presented in an accessible, participant-friendly format. This approach not only improves your materials but also builds an evidence base for your ethics submission.
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4. Optimise the environment
Creating a comfortable, inclusive environment is essential to successful public engagement and strengthens the ethical foundation of your study. Demonstrating that you've taken an inclusive approach in engaging the public is also a significant factor in REC reviews.
Our facilitators specialise in creating a safe space where participants feel valued and confident in sharing their views. Before each session, we consult with contributors to understand their needs, make accessibility accommodations, and ensure all feel respected and included. By encouraging broad participation—regardless of individuals' research experience—our sessions bring out diverse ideas and perspectives. This inclusivity enriches your engagement process and demonstrates to the REC that all voices were considered in the study design.
5. Articulate actionable insights
After each engagement, it’s essential to translate participant feedback into clear, actionable insights. Demonstrating how these insights informed study design or participant materials is an important part of preparing for your REC submission and assures them of your patient-centred approach.
Our post-engagement reports go beyond summarising comments; they highlight significant feedback and provide actionable recommendations for improvements. We also identify areas that were less well-received and suggest ways to address these concerns constructively. Implementing these insights not only enhances the patient-centricity of your research but also demonstrates an ethically sound approach to the REC, helping ensure smoother approval.
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Related information:
Health Research Authority’s (HRA) ‘Quality Standards’ and ‘Design and Review Principles.’