Friday saw the start of the Children’s Commissioner’s Takeover Challenge which puts children and young people in charge. In this guest blog, Kate Harvey from the Nuffield Council on Bioethics reflects on two years of progress in involving children in the design and delivery of medical research.
September 2013 witnessed a milestone moment in the involvement of children and young people in clinical research across the UK: for the first time, young people, parents, researchers, and practitioners gathered at a national event to discuss how children and young people can be meaningfully involved in clinical research.
This discussion took place under the banner ‘Generation Research’ – or, to give it its shorter title – GenerationR. This is a collective of young persons’ advisory groups (YPAGs) located across the UK in Liverpool, Birmingham, London, Bristol, Nottingham, Aberdeen, as well as a topic-focused mental health YPAG based in London. Each YPAG is comprised of around 10-15 members who are aged eight to 19 years old. The groups meet every six weeks either at weekends, in the evenings, or during school holidays. They help researchers – from both commercial and non-commercial sectors – to adapt the design and delivery of research which seeks to involve children and young people, for example by asking for young people’s comments on a proposed study protocol, or asking for their advice about how patient information leaflets should be drafted.
Two years on…
Over two years have now passed and recently young people, professionals, and researchers gathered at Great Ormond Street Hospital to discuss progress since 2013, and what needs to happen next to make sure that young people’s ongoing input to the conception, design and delivery of clinical research continues to be realised.
This meeting highlighted how GenerationR has grown up, and grown up into a model child. This growth can be measured by the development of a dedicated GenerationR website designed by young people; the availability of a start-up tool for other organisations keen to set-up their own YPAG through the Global Research in Paediatrics (GRiP) Network; the establishment of iCAN, an international network of YPAGs launched in Washington, D.C. in June 2015 (more on this launch in my earlier blog); a visit for UK YPAGs to the Centre of the Cell to support team-building; and, of course, the Nuffield Council’s own report on Children and clinical research: ethical issues to which YPAG members and coordinators contributed throughout its period of development.
YPAGs clearly have an important part to play in making clinical research with children better, but this doesn’t come cheap. They are currently funded through public money from the NIHR, but given the current culture of budget cuts in the UK, the organisation’s future is by no means secure. One of GenerationR’s next challenges is, therefore, to make sure that it has enough funding to continue its work: research with children won’t (and shouldn’t) stop, and nor should involving children and young people with how that research gets done. But how can GenerationR make sure that its excellent work has enough funding to continue?
The Nuffield Council’s report suggests that discussions should be initiated with industry to find ways that it could contribute to the costs of YPAGs, without compromising groups’ independence. (Our point was echoed at a meeting of the European Network of Paediatric Research at the EMA (Enpr-EMA) in May 2015.) However, in order for potential new funders to invest in YPAGs, they must first be made more aware of what it is exactly that they would be investing in. The meeting thus highlighted two tasks: first, to audit and make available information as to how YPAGs operate across the world, and what specialisms they offer (for example, disease-specific specialisms); second, to raise awareness levels of GenerationR throughout the research community, and beyond.
Auditing and informing: what young people’s groups are ‘out there’?
Part of the battle that GenerationR faces in encouraging researchers to engage with young people may lie in the fact that many researchers might not know what advice (via YPAGs) is available to them. To address this, GenerationR therefore intends to contribute to the creation of a database which sets out these details (this information will be captured by a survey drafted by Enpr-EMA, which is due to be distributed in December 2015). This directory, once established, could then be accessed by researchers who may wish to, for example, locate their nearest YPAG, or find a YPAG which has particular expertise (where the review reveals gaps, hopefully this will be a spur to action).
Awareness and engagement: spreading the word
The latest meeting of GenerationR highlighted the lack of an outward-looking online forum, which might be used as both a repository for information and an opportunity for discussion and debate. A good place to host such a forum, it was suggested, would be the GenerationR website, which could be used to further spread the word to extend to networks unfamiliar with YPAGs’ work. Participants at the meeting also suggested linking more explicitly with other organisations such as the RCPCH, Testing Treatments, and other stakeholder charities through, for example, a regular news bulletin, and more frequent meetings with other organisations. Moreover, the GenerationR website could contain more interactive elements, including more frequent blog posts and savvier engagement with social networks.
However, Saturday’s meeting made clear that these types of changes cannot magically appear: genuine investment in engaging with new networks needs to be undertaken. This might be, for example, through identifying an Engagement Ambassador in each YPAG, or, should funding become available, the appointment an Engagement Manager for GenerationR.
Building engagement through pre-existing knowledge and relationships
These new suggestions do not mean, however, that engagement hasn’t already been taken very seriously by GenerationR since 2013. Progress in engagement can be seen in GenerationR’s firm links with iCAN; taking part in a Q&A as part of a masterclass in research at Southampton University’s Clinical Research Facility; attending the RCPCH’s conference (where, it was observed, “the most probing questions came from young people”); presenting to participants at an HRA-organised training day for research ethics committee members; and bending the ear of Life Sciences Minister, the Rt. Hon. George Freeman, at an Ethical Medicines Industry Group meeting in April this year.
Using its experience of engaging with this wide range of individuals and organisations, GenerationR might now turn its attention to engaging with other pockets of research endeavour. For example, a participant at the most recent meeting noted that one YPAG supports 60-70 studies each year, but only ten of those were industry studies. Part of this may be due to a lack of awareness on industry’s part but, as one young person noted, engagement is a two-way street: “we shouldn’t sit back and wait for organisations to come to us”. GenerationR therefore might want to be more proactive with making contact with industry research professionals so that they can learn how young people can help with their research endeavours.
The two-way street analogy is also pertinent to considering how to encourage more young people to get involved with GenerationR. It was suggested, for example, that other young people who might consider joining a YPAG need to be able to see that they can get something out of participating. This could be done by creating a system of recognition for their contribution: the NIHR, for example, could create a Young Ambassadors’ scheme; GenerationR could also explore potential links to schemes such as the Duke of Edinburgh’s Award.
Which word should be ‘spread’?
The other theme which stood out for me at the meeting focused on clarifying what GenerationR actually does in a way which is helpful to those inside and outside the research community. One strand of discussion led to the suggestion that GenerationR could benefit from the development of its own manifesto: a core set of points which describes how it works and what it can do for researchers. Assimilating this message would, suggested the young people, make the ‘message’ both clearer, and easier to spread: especially, for example, when talking to others who may not have even heard of GenerationR (such as school students).
The most recent GenerationR meeting highlighted just how much it has achieved in the past two years. ‘Amazing’ barely covers it. But the meeting highlighted that the group’s members want to keep pushing to involve children to make clinical research better through that involvement. To this end, the group has a new name as a result of their latest meeting: The GenerationR Alliance. This new name embodies the spirit of joint enterprise between children, parents, and researchers, which is clearly so important to the young people who are at the heart of GenerationR’s endeavours.
The list of tasks for The GenerationR Alliance is long, but the young people I met at the meeting clearly have the bit between their teeth. Mira, a member of the GOSH YPAG summed it up: “We’ve come so far, but there’s a lot more we can do.”