Clinical research involves balancing many ethical issues, and when that research is happening in children, the ‘ethics’ become more complex. But, this is no reason to not do this research – and the latest Nuffield Council on Bioethics report provides some excellent advice on the steps we all need to make. The report also has a fantastic 'magazine' and video which make great viewing.
What does the report say?
Clinical research involving children is hard. Research is needed to provide the evidence base for treatment, but by its nature, the results of research are unknown and may carry risk, so asking a child to be involved means finely balancing the benefits to society against the risk to the child. Often, the balance weighs more heavily to ‘protecting’ the child from the research risk – so research stops.
‘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’
These ethical dilemmas are well known to practitioners, but we have been short on solutions – until now. The team at the Nuffield Council for Bioethics have worked extensively with children & young people, parents & carers as well as the ‘usual’ professional experts (including AMRC!)
What do children want?
A strong thread throughout the report is the need to see children and young people as collaborators in the research – so research is done WITH them, not TO them.
‘Alongside appropriate regulation, we need a change in culture to ensure that children have a say in the whole research process.”
This collaboration should not just be limited to looking at information about a study. Children and young people also want to be involved in:
- setting research priorities, such as through priority setting partnerships
- acting as ‘experts by experience’ in review of methodology or ethics
The report also examines the thorny issue of who should give consent for research, and identifies 3 different options, depending on the ability of the child to understand and engage in decision making about being involved in research. It recommends that where children have sufficient maturity/understanding, professionals should seek their consent as well as their parents, even if this is not a ‘legally binding’ consent.
When should this happen?
The report contains many recommendations for different parts of the sector including:
Advice from ‘experts’- including children themselves
- Research ethics committees should ensure they have timely access to expert advice from relevant areas of children/YP healthcare
- NRES and the royal colleges should develop a database of experts to help in review
- Research ethics committees should require researchers to have involved children/young people /parents in the design of studies, and researchers who have not sought advice should have to explain why.
Prioritisation of research
- Funding decision makers should ensure that key stakeholders including children, young people, parents, professionals are involved in funding decisions.
Incentivising medicines research in children
- The European Medicine Agency should seriously consider innovative approaches to incentivise research with children on the use of off-patent medicines
What does this mean for AMRC charities?
Many of our members fund research that involves children, and are well aware of the complexities associated with the ethics of children’s research. This report helps to clarify where consent and assent can be used, and provides a strong steer for involving children, young people and their parents along the research pathway.
AMRC will be discussing this report with our members over the summer – please get in touch with me if you’d like to know more.