A Lancaster University Law School academic has played a key role in a new report which calls for cultural change to enable young people’s opinions to help shape how children’s health research is prioritised, designed and reviewed.
Dr Sara Fovargue, a Reader In Law at Lancaster University, is a member of the Nuffield Council on Bioethics expert Working Party which produced the report (Children and clinical research: ethical issues) out today.
The report says that unless ethical concerns about asking children to take part in research are addressed, the understanding of childhood disorders and the ability to provide evidence-based care will remain limited.
The report is the result of a two-year inquiry, which has heard from more than 500 professionals, parents, children and young people in the UK and internationally. The Working Party included members with expertise in paediatric medicine, nursing, law, social science, ethics and psychology.
In many areas of child health, evidence on childhood diseases and treatments remains 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.
“It was absolutely fascinating research,” said Dr Fovargue, who was asked to sit on the working party because of her knowledge and expertise in ethics and medical law. “And it was extremely moving listening to children with long-term conditions expressing their desire to be involved with medical research even though it might not help them. This should be a core part of the NHS and excluding children from that does them a disservice.”
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.
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. 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, for example through a central fund to protect the groups’ independence.
Under UK law, young people aged 16 or above can give their own consent if they want to take part in research. Under 16, parents consent on behalf of their children. While there is usually a requirement to provide information to children, there is little agreement on how children should be involved in decisions to take part in research under the age of 16.
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.
“It will always be easier to say ‘no’ to research with children on the grounds that it’s too difficult, but we should challenge the idea that it is acceptable to continue to offer healthcare to children without seeking to improve the evidence base for many of the treatments provided,” added Professor Bobbie Farsides, Chair of the Nuffield Council on Bioethics Working Party.