Children and clinical research: ethical issues

Children and research Iain Chalmers Co ordinator James Lind InitiativeThe Council would like to thank everyone who contributed to our various evidence gathering activities for this project.

Stakeholder group

At its first meeting, the Working Party decided to establish a Stakeholder Group of young people and parents. Some of these young people had direct experience of research participation, whereas others had none. The members of this group met twice, once at the outset of the project and later to assess the direction of the project. The group also gave feedback on the Working Party’s thinking and writing at various stages of the project.

Call for evidence

The Council’s call for evidence on children’s involvement in clinical research took two forms, the first was aimed at professional organisations, researchers and others with a specific interest in this topic. A version of this consultation was distributed globally with help from the Global Health Reviewers‘ community and KEMRI network. The second part was made up of two online surveys, one aimed at parents and one aimed at young people.

• Download a summary of consultation responses
• Download the consultation paper
• Download a summary of responses from parents to the online survey
  
• Download a summary of responses from young people to the online survey

Consultation responses

Organisations

• Academy of Medical Sciences
• AstraZeneca
• British Medical Association
• Children and Young People Oral Health Research Group, School of Clinical Dentistry, University of Sheffield
• Christian Medical Fellowship
• Ethical Medicines Industry Group
• Felicity Shenton, Development Manager, Investing in Children
• Health Ethics and Law, University of Southampton (HEALS UoS)
• Health Research Authoritytituto Nacional de Salud del Niño del Peru; Instituto de Investigación Nutricional del Peru; Hospital Nacional Edgardo Rebagliatti Martins; US Naval Medical Research Unit No. 6, NAMRU-6
• NIHR Clinical Research Network: Children
• Oxford Vaccine Group
• Paediatric Emergency Research in the United Kingdom & Ireland (PERUKI)
• Paediatric Oncology Reference Team (PORT)
• Teenage Cancer Trust
• The Association of Medical Research Charities (AMRC)
• The British Society of Paediatric Dentistry
• The Wellcome Trust
• Together for Short Lives and Association for Paediatric Palliative Medicine Joint Research Group
• U.S. Presidential Commission for the Study of Bioethical Issues
• University College London and the European Network for Cancer research in Children and Adolescents
• University of Cambridge Department of Paediatrics

Personal

• Anne Elmer
• Dr Ayesha Ahmad
• Dr Daniel E. Lumsden
• Dr Janice Allister
• Hector Velarde, MD, Mexico
• Iain Chalmers, Co-ordinator, James Lind Initiative
• Melody Redman
• Nigel Monaghan
• Professor Andrew Tomkins, Institute of Global Health, UCL, London
• Professor Caroline H. D. Fall
• Professor Faith Gibson
• Professor Jane C. Davies
• Professor Jo Bridgeman
• Professor Kathryn Maitland
• Richard Hain

Anonymous

• Anonymous 8
• Anonymous 16
• Anonymous 33
• Anonymous 41
• Anonymous 51
• Anonymous 61
• Anonymous 71
• Anonymous 91
• Anonymous 212

Fact-finding meetings

The Working Party held a series of ‘fact-finding’ meetings as part of its work. A wide range of people were invited to give presentations and discuss their views and experiences, including on:

• Making research decisions – who decides and how?
• Setting the paediatric research agenda
• The role of clinicians and researchers
• The role of ethical review
• Drivers of research
• Vulnerability
• Risk

School and community consultation in Kilifi, Kenya

With the support of our Working Party members based in Kenya, we were able to draw on the views of school children and community representatives in Kilifi, Kenya. Download a report of this consultation.

School-based activities in the UK

To hear the views of children and young people without direct experience of clinical research, the Working Party also ran two school-based projects:

• The ‘Youth-REC’ project in Brighton- find out more
• The ‘Chocolate trial’ in Wimbledon – read a blog post