Yesterday at London’s Science Museum, something wonderful happened. A conference on clinical research was simultaneously informative, thought-provoking, agenda-defining, and… (whisper it) fun! What is even more brilliant is that the conference was organised by an inspiring group of children and young people.
The group in question was the Medicines for Children Research Network’s (MCRN) Young People’s Advisory Group (YPAG) who devised a conference – titled GenerationR – that focused on the importance of involving young people and their families in the planning and delivery of paediatric research. With support from MCRN staff, the YPAG designed the format and function of the conference – and it showed! From being welcomed at the door by friendly young faces, to being registered (‘first name only, please, Professor Dame…’) by young people in bright red t-shirts, it was clear who was in charge, and very much empowered, here.
Empowerment was a recurring theme throughout the day, both in the style and substance of issues discussed. Members of the YPAG – ably assisted by Dr William van’t Hoff – interviewed guests on their own TV set, including Sir Iain Chalmers, Dr Jonathan Sheffield, Professor Dame Sally Davies, and Simon Denegri. At times, these great and good were questioned harder than any errant politician subjected to a Jeremy Paxman fillet and grill session.
Quite apart from these interviews, the young people’s own views were clearly grounded in realism and pragmatism. One industry representative was told in no uncertain terms that the convenience of the research subjects – and not the pharmaceutical company – has to come first. In a sample of young people, this would mean that research using blood samples which need to be taken at pre-defined intervals in a period of 24 hours would rather scupper any chances of attending school that day! Despite recognising some inconveniences, one YPAG member spoke of the intense satisfaction experienced: “knowing you’re doing something really useful is what keeps you coming back.”
The warm glow of helping to make research ‘better’, however, might also be supplemented by encouraging young people to take part in clinical research through issuing certificates of participation, and increasing awareness in schools. Members of the YPAG expressed their constant surprise about how little is heard about research at school – this perceived dearth may be particularly acute in areas of the UK that are not near an MCRN hub, and perhaps even more so when trying to engage very young children. The last challenge perhaps might be addressed through the continuing involvement of parents in research networks, but these shortfalls illustrate the fact that engagement with young people is still imperfect, and a range of suggestions were made by YPAG that might increase and improve engagement. These included a national project to ascertain how social media can be better used to support clinical research, the possibility of creating an app for research recruitment, and the use of research work experience placements (one such placement was offered by the Chief Medical Officer herself!).
Lunchtime was itself an exercise in engagement as delegates were encouraged to have their hands painted by members of the YPAG. This inspired idea meant that the usual conference lunchtime gauntlet of making awkward conversation while gripping a glass of orange juice for dear life was – wonderfully – avoided, and instead gave me and others an opportunity to ask the young people how and why they had become involved with the network. The clear answer to this question seems simple: it’s because they genuinely care about making clinical research more accessible to their peers.
In light of the fact that half of MCRN studies are funded by the pharmaceutical industry, observations about the occasionally tricky relationships between this industry and its research subjects were also peppered throughout the day. Industry’s obligation to make safe medicines was highlighted as a key duty, but a duty that cannot stand alone without the right and proper engagement with young people. The positive influence of such patient involvement was not denied by representatives of the pharmaceutical industry at the conference who quickly dead-batted a suggestion that patient and public involvement (PPI) could reduce their profit margins. Quite the contrary, industry representatives noted that the best studies are those that are interrogated by the public from the point of their inception, and before a protocol is finalised, as it avoids confusion and complaint at later stages. When pushed as to whether industry should be subject to a mandatory requirement to approach the YPAG, the group stopped short of absolutism, and instead felt that it should be highly recommended; once relationships between industry and young people are forged, but not forced, they will endure.
Financial considerations in the context of an austere economy tempered some suggestions for improvements, although it was felt that it would be perfectly fair for the pharmaceutical industry to lend a helping hand in supporting research networks financially. This sort of support might go towards expanding groups’ membership, and enabling them to hold meetings more frequently. Concerns about how much power this might give private companies were raised, and then tempered by the idea of creating a foundation that accepted funds from so many different organisations that it could not be ‘bought’.
Tough questions were not directed solely at industry; academics were also invited to take a good hard look at their conduct. In particular, they were urged to ensure that competitiveness does not block good research, and were subjected to criticism for a general reluctance to engage in multicentre trials – often with their ‘rivals’ in other academic institutions – that could give more useful results for the good of advances in research. Medical journals too did not escape the YPAG’s scrutiny; concerns were expressed about research results being ‘spun’ to make a better story, and the rejection of research results by publications who feel that the study is not the ‘right’ kind of result. At my own breakout table, a suggestion was made that there is a gap in the market for a Journal of Negative Results.
The tricky subject of assent was also tackled head-on; delegates were told that “assent is not consent. Children need to be asked what they think research is!” One delegate also argued that if children and young people are Gillick-competent, then the idea that they cannot consent for themselves is absurd, making the question of assent an irrelevance. On a related topic, it was also suggested that assent forms (as they currently stand) need to be adapted according to the age of the population of its research subjects. For example, with young children, issues that might be contained in assent forms might be portrayed in cartoon form. The issues of assent and consent are ones which are addressed in the Nuffield Council’s own open consultation on this topic.
Visibility and awareness were also core themes throughout the day, with frustration expressed that although networks exist, the research community as a whole is largely in ignorance about how they can be used. Intra-industry communication to extol the virtues of these networks was highlighted as a key action point. The lack of awareness that some parents have of ‘how things work’ with clinical research in young people was also an area of concern. A video with vox pops from a range of adults highlighted the fact that adult awareness of this area of research may be decidedly patchy, emphasising even more the importance of the ‘red for research’ dress code for staff in MCRN centres.
Further ideas for policies were sought from delegates during the afternoon session where paper tablecloths and felt tips were produced to encourage us all to scribble our thoughts and opinions on a series of ethical questions. These thoughts will be assimilated into a report that will be published by the MCRN later this year. For the time-being though, the agenda that this conference endorses is clear: listen to young people, involve them in designing research protocols, and consider their input when producing patient information leaflets. Given the level of discussion and enthusiasm shown at this conference, this agenda is more than a mere pipe dream.
Find out more about our project on the ethics of involving children in research.