Children and clinical research: ethical issues - one year on

It’s a longstanding tradition of ours to gather Working Parties together again roughly a year after a report has been published, to review developments since publication, and discuss further opportunities for follow-up. Last week it was time to reunite our Working Party on children and clinical research with a busy year-and-a-bit to look back on. This post runs through the highlights of developments since the report was published in May 2015.

Statement on paediatricians taking part in research activities

Just last week, the Council published a joint statement with the Royal College of Paediatrics and Child Health (RCPCH) on the protection of time for paediatricians to take part in research ethics committees. The statement – which was developed following a meeting between representatives of the Council, the RCPCH, and NHS Employers in May 2016 – urges NHS workforce planning bodies to acknowledge the importance of building capacity within the workforce to support more high quality research into child health.

Collaboration with life sciences industry

In April this year, we hosted a meeting with the NIHR to explore collaboration between life-sciences industry and young people to improve research – bringing together young people with those involved in promoting involvement from the NIHR, those with expertise in ethics, and industry representatives. The meeting resulted in a ‘statement of aspiration’, signed up to by major life science organisations including AstraZeneca, GSK and Roche, which highlights the importance of active collaboration with children and young people and their parents to improve research. These core messages which arose as a result of the meeting were also reiterated in blog posts by Dr Jacintha Sivarajah of the Association of the British Pharmaceutical Industry (ABPI) and Susan Tansey of Quintiles following the event.

International symposium and ‘pledges’

Although the report focussed on the UK and Europe in its practical recommendations it has also had resonance and value in other contexts.

In March 2016, the Council hosted an international symposium with the Global Health Bioethics Network at the Ethox Centre, University of Oxford, and the Wellcome Trust Brighton and Sussex Centre for Global Health Research to explore how the report’s recommendations might apply in a wide range of environments.Participants included staff from the World Health Organization, the Pan American Health Organization, and the Council for International Organizations of Medical Sciences (CIOMS), as well as researchers from nine low and middle income countries. Together, participants developed practical recommendations and ‘pledges’ to take forward this work. These include plans to develop Young Persons’ Advisory Groups in Kenya and Malawi (a group has already been set up in Cambodia), innovative theatre projects in Thailand and Singapore, and the development of films in low income settings, exploring the involvement and influence of children and young people in research. A report of the symposium is available to download here.

Online training for researchers

Working with the Global Health Network the Council has produced an English and Spanish language online training course aimed at researchers and members of ethics committees. The course is being used to build capacity and confidence in research globally and has been completed over 1,600 times in more than 20 countries so far.

Best practice guidelines

The Council contributed to the development of the RCPCH’s Infants’ Children’s and Young People’s Child Health Research Charter which sets out guiding principles for researchers (echoing some of our own points to consider when carrying out clinical research with children and young people).In January 2016, the Council’s report was also highlighted as a key resource in an INVOLVE / National Institute for Health Research (NIHR) briefing note for researchers on involving children and young people in research.

Translations of animation and written materials

Through a collaboration with the Víctor Grífols i Lucas Foundation, a bioethics organisation based in Spain, the report’s executive summary, magazine version and animation have also been translated into Spanish. Subsequently, the American University of Beirut, Lebanon and the Children’s Hospital Zhejiang University School of Medicine, China have translated the animation into Arabic and Mandarin, making this resource accessible to a much wider audience.

Supporting young people’s groups

The Council is a member of a Steering Committee supporting and developing a strategy for GenerationR, the Young Persons’ Advisory Group (YPAG) network in the UK. It has also had a role in promoting the YPAG model internationally, taking part in the launch summit for the International Children’s Advisory Network (iCAN) in Washington DC (more about that in this blog post by Kate Harvey) and a follow-up iCAN workshop in Barcelona this year.

Resonance of ethical framework

In addition to all of these initiatives, we know from direct feedback that the ethical framework and practical recommendations made in the report are enabling regulators, funders, and researchers to support and carry out good research with confidence. The report has been recognised as an important contribution to the field of paediatric research both in the UK and internationally.In particular, the Working Party’s conclusions on the concept of vulnerability have been influential beyond the particular issue of research with children and young people. For example, the WHO’s forthcoming Ethical Guidance for Managing Epidemic Outbreaks was amended following input from the Council which emphasised that individuals or groups are not necessarily inherently vulnerable, but rather that particular situations can make individuals or groups vulnerable.

The importance of partnerships

As Katharine Wright set out in a previous blog post, partnerships with key stakeholders in the UK and internationally have been an essential part of this project, its outputs and follow-up activities. This gives us confidence that there are many enthusiastic organisations and individuals well-placed to take forward the work that we have helped to initiate in the past yearDownload a full report of developments since the launch of this report.