Presentation by Simon Denegri (NIHR) and Jennifer Preston (MCRN) to the Nuffield Council on Bioethics Working Party on Paediatric Research

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  • Background to the group – currently has 88 members from 8-18 yrs old
  • Back in March, HRA representatives came to our group for our views on the newly proposed research approval system.A series of workshops were carried out in order for us to generate informed opinions on the proposed new structure.Key topics the HRA wanted our views on included:How young patients should be recruited and consented for clinical trials.The extent to which we might feel protected by the newly proposed approval process or even at riskThe measures needed to ensure trust in the system and a feeling of safety.And generally, how best to include young people and families in researchAfter much discussion, our group decided that to feel safe in a clinical trial young people have to feel in control of their situation at every stage.This can be achieved by giving the young person clear, understandable information and by having an organised system with informed researchers who can answer the patient’s questions.If the professionals can’t clearly explain the process, what hope do we have?Patient involvement is key for ensuring researchers generate easy to understand information and ways to keep young people engaged.Our group felt that the HRA should make answering the open question on patient involvement mandatory because patient involvement is vital for the success of a trial.I am sure most people would agree that the current approval system takes too log and may even put researchers off carrying out research in the UK. Especially when one researcher was required to have a chest x-ray and a measles vaccine in order to carry out a survey only trial.There were concerns that removing any stages in this process could make us feel less safe. However our group did not feel that removing unnecessary steps from the structure would compromise our safety in any way.Reviewing the research approval process in the NHS and how it might be improved. The HRA carried out a series of workshops to get people’s views on:health research and clinical trialshow patients should be recruited and consentedThe extent to which they might feel protected by the approval process or at riskWhat needs to be in place for them to have trust in the systemHow we should work with patients and the public in the future.
  • Overall our group felt a new streamlined system would be quicker, more efficient and much less arduous. As long as the quality of research is not affected, speeding up the approval process could only be a good thing. As I mentioned earlier, patient involvement is key to the success of a trial. Part of patient involvement is getting groups like ours to review patient information sheets and make them suitable for young people.A few years ago Patient Information Leaflets we reviewed were terrible. Adults struggle to read 17 pages of mostly irrelevant text.The consistent tedium we were faced with drove us to act.Our group has worked with NRES to generate guidance for researchers to use when designing patient information sheets. After all, no one should have to read let alone write these dreaded leaflets!This is the simple guidance sheet our group designed and it outlines what we do and don’t want to know as young people. Ideally, Patient Information Leaflets should be no more than two sides of A4 paper. Remember that we have busy lives and don’t have the time or patience to read any more than that.We urge the HRA to make sure researchers read this clear guidance before they draft their patient information sheets. These are assent forms, not consent forms.Researchers seem to forget that they are not legally required to put in information about the ethics, funding, other medicines, or what will happen afterwards. All we want is information relevant to us in a clear, colourful and concise format. 


  • 1. Public involvement, health research and young people Nuffield Council Working Party on Children and Clinical Research, September 2013 Simon Denegri, Chair, INVOLVE; NIHR National Director for Public Participation and Engagement in Research Jenny Preston, Consumer Liaison Manager, NIHR MCRN
  • 2. Citizen driven health and wealth “In the future the public will be more technically sophisticated, inquisitive and informed than ever before.” Professor Samuel Thier, Harvard University Speaking at the launch of the UK eHealth Informatics Research Centres and Network, May 2013
  • 3. Citizen driven health and wealth 0 1 2 3 4 5 6 7 2012 2014 2015 Growth
  • 4. NIHR leadership in public involvement in UK health research • Core principle of National Institute for Health Research (NIHR) • NIHR leadership based on evidence of public involvement driving research quality • NIHR funding for national advisory group has given agenda strong platform • Success built on ‘partnership’ working • Clear expectation set with research community • £M investment
  • 5. A working definition of public involvement 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, undertaking interviews with research participants.
  • 6. Adding value to research Five pillar framework being taken forward by NIHR with patients and the public: • relevant and important research questions • appropriate methodology • timely and efficient delivery • fully accessible publication of findings • useable and useful outputs
  • 7. Adding value to research ‘Only 9% of patients wanted more research on drugs, yet over 80% of randomised controlled trials in patients with osteoarthritis of the knee were drug evaluations.’ ‘Relations between the agendas of the research community and the research consumer’ Tallon et al, Lancet 2000 as cited by Iain Chalmers and Paul Glasziou, The Lancet, 2009
  • 8. Relevance, reach, recruitment, results • 15 James Lind Alliance (JLA) Priority Setting Partnerships completed, approx. 10 on the way • Almost 40,000 hits per month on the INVOLVE website and 1,000 on ‘People in Research’ • Growing ‘research active’ communities in specific disease areas (89 diabetes studies had lay input into design and delivery during 2012/13) • 630,00 people recruited to take part in clinical research in 2012/2013, triple the number six years ago • 425 members of the public involved in NIHR review panels, many more reviewers! • Increasing number of NHS Trusts with research ambassadors
  • 9. Public appetite • 82 per cent of people believe it is important for the NHS to offer opportunities to take part in healthcare research. • Less than 7% said they would never take part in a clinical research study. NIHR Clinical Research Networks Survey May 2012 • Over 70% of patients look for information about clinical trials ecancer 5 235 2011 ‘Information needs of cancer patients’ Patient experience • National Cancer Patient Experience Survey 2012 – 1 in 3 patients had a discussion about research with a health professional – > 53% who were not asked, would like to have been • Discussion much less likely if happening at all for patients with other conditions (i.e. 1 in 5 for type 1 diabetes) • 91% of Trusts do not provide information to support patient choice in research: NIHR CRN CC Mystery Shopper 2013 From willing to active research citizens
  • 10. IPSOS MORI Poll for Association of Medical Research Charities, 2011 From willing to active research citizens
  • 11. “Our vision is for real collaboration with young people and parents/carers at every feasible stage of the research process” meeting_2013.shtml
  • 12. “I was very impressed by the group. They gave serious consideration to some complex issues and were clearly very well informed about research. It was a pleasure to work with them”. Amanda Hunn HRA Key topics the HRA wanted our views on included: How young patients should be recruited and consented for clinical trials. The extent to which we might feel protected by the newly proposed approval process or even at risk The measures needed to ensure trust in the system and a feeling of safety. And generally, to get our views on the proposed process and ask us how best to include young people and families in research
  • 13. How long will it take? What is the aim? What is the drug? What will I have to do? Do we have to go ahead with it? Who will it benefit? Are there any side effects? Ethics Invitation Paragraph Other medicines Who is funding the study What happens when the study ends What is research Why were we chosen Leaflets or A5 booklets Colour Relevant pictures Concise text Break it down No acronyms Don’t lie to us. Don’t patronise. What we do and don’t want to know:
  • 14. International Clinical Trials Day • International Clinical Trials Day on 20 May 2013 – Theme: “It’s OK to ask”… – Encouraging patients to ask their clinician about clinical research (and log response/suggestions) – Encouraging clinicians to consider their response if a patient does ask: how to channel interest – Asking other stakeholders to show their support by using the campaign badge
  • 15. Newman et al (June 2012) Medicines for Children: reflecting on how young people improve research in this area. The Active Involvement of Children and Young People in Health and Social Care Research. (Routledge)
  • 16. Thank you Twitter: @SDenegri Blog: Twitter: #generationr