Children and Clinical Research: Ethical Concerns
Well-conducted clinical research with children and young people is essential if we are to improve our understanding of childhood disease, and provide healthcare based on the best possible evidence. However, professionals and parents often feel uneasy about asking children to take part in research because of potential risks or burden.
In order to try to address these concerns Nuffield Council on Bioethics have relased a new report, Children and Clinical Research: Ethical Concerns. The report looks at the ethics of involving children in research, and at the roles and responsibilities of children, parents/guardians, and professionals. Central to the report is the idea that from a young age, children have a role in determining their own lives and should be seen as active participants in research.
Medicines for children
In many areas of child health, evidence on childhood diseases and treatments remain limited because of a lack of research specifically with children. For instance, many medicines prescribed to children have not been developed specifically for children, meaning that doctors must use their expertise to adapt adult doses.
Research in areas such as childhood leukaemia, where survival rates are now over 80%, demonstrate the crucial role of research in improving healthcare. The Council argues that research with children should become a core part of the NHS.
Roles and priorities
The starting point for most health research is adult needs, leaving children’s research lagging behind. But there are examples where children and parents help set research priorities, and the Council supports these initiatives. For example, the James Lind Alliance has worked with parents, researchers and health professionals to set out the 15 most pressing research priorities in preterm birth.
The role of research ethics committees (RECs) is to assess the value, risks and benefits of all research proposals. However, members of RECs told the Working Party that they can feel anxious about approving research with children. The Council concludes that to make properly informed decisions, RECs should have access to experts in child health who can advise on the risks or burdens of normal practice, and areas where there is a lack of evidence.
Involving children in decision making
The Council concludes that, where possible, decisions to take part in research should be a partnership between researchers, children and their parents; and that children should be as involved in decision making as they are able, and wish to be.
The assumption that all children are necessarily vulnerable in research, which may act to prevent worthwhile research going ahead, needs to be challenged. The risk of children being placed in vulnerable situations can be minimised, by ensuring that researchers engage with children’s and parents’ views and experiences in the prioritisation, design and review of research, and through appropriate scrutiny and governance. Children and parents should be confident that an invitation to take part in research is a ‘fair offer’ where the value of the research, and its risks and benefits, have been independently assessed.
A register of experts
The Council recommends that registers of experts in different areas of child health should be set up and that employers should ensure that doctors’ time to serve on ethics committees is protected. Additionally, RECs should require researchers to have listened to children and parents when developing their studies. An example of this is the UK network of Young Persons’ Advisory Groups (YPAGs). These are groups of 8-18 year olds who advise researchers on whether their proposed studies and information materials are acceptable to children – for example, by commenting on language, the number of blood tests or days off school required.
The Council recommends that industry should help fund YPAGs (Such as ScotCRN YPG), for example through a central fund to protect the groups’ independence.
Access the report
The report is the result of a 2 year inquiry which has heard from over 500 professionals including the ScotCRN, parents, children and young people and is avaiable in a number of formats: as a full report in PDF format, in a magazine format designed with the help of young people’s groups, and as a one page summary which includes a list of points to consider when carrying out research with children and young people.
Young persons’ groups in London (the Great Ormond Street Hospital YPAG), Liverpool, Aberdeen (ScotCRN YPG), and Connecticut (the KIDS initiative) gave detailed feedback regarding the style and content of the magazine version of the report.
Watch the animated film
Nuffield Council worked with Mosiac Films to produce a short animated film entitled Health research: making the right decision for me. The animation conveys some of the key themes of the Council's report from the perspective of Mia – a character who goes through some of the questions and issues that might be raised when a young person is invited to take part in clinical research. The script was developed following a workshop with 14 young people aged 10-18.