Children and clinical research: ethical issues

These films were produced by Helter Skelter Media as part of a project carried out to support the evidence gathering process for the Council’s project on the involvement of children in clinical research.

This short film gives an introduction to the project and a brief summary of the themes that emerged in the young people’s discussion during workshops held at a junior school, a secondary school, and a sixth form college in the autumn of 2013 (a fuller summary of the discussions is available).

Film one: Processes, Papers and Professors: how clinical research in young people gets approved

This film formed part of materials discussed during the school workshops held as part of this project. It presents a hypothetical case study involving Ruby, a young girl with severe asthma, her consultant Professor Somnath Mukhopadhyay, who is planning a clinical research study involving asthmatic children, and a mock research ethics committee (REC) discussing the ethics application for his study.

Materials

• What's it all about? - sets out the research for a general audience, with details about how it would be undertaken
• Case study - asthma
• Covering letter to parents and guardians - based on the mock trial, this briefly introduces the study and study team for those who care for children and young people (CYP) who might participate in the asthma study
• Information sheet for parents and guardians - an information sheet for parents / guardians which goes into a bit more detail than the covering letter
  
• Information sheet for CYP - an information sheet aimed at young people who might participate in the mock trial
  
• Assent form (CYP) - an assent form for CYP who might be invited to take part in the mock trial (one of the discussion points might be whether this form should be an assent form, or a consent form, and what difference choosing one over the other might make – for example, discussing whether it’s appropriate to ask young people from across the very wide age bracket to assent, rather than consent).
  
• Consent form (parents) - a consent form for parents / guardians of CYP who might be invited to take part
  
• Application to the REC - an application for REC approval to carry out the mock trial
  
• What about the research ethics? - a document which sets out some questions on the research ethics of the trial, including some discussion points for workshop participants

Film two: Be a part of it: what young people think of clinical research

This film summarises the key themes that emerged from the young people’s discussions.

Read the report of this project: “What we think about what adults think”: Children and young people’s perspectives on ethics review of clinical research with children