Blog by Working Party members Sassy Molyneux (left) and Vicki Marsh (right), KEMRI Wellcome Trust Research Programme, Kilifi, Kenya & Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, Oxford University, UK.
Earlier this year, the Nuffield Council on Bioethics launched its report Children and Clinical Research: Ethical Issues. Children and young people are central not only to the report’s focus but to the way recommendations were developed. We were both members of the Working Party, and as part of our analysis we listened to hundreds of voices of children, young people and parents.
Nowhere is child health research needed more than in low-to-middle income countries, where children account for a relatively large proportion of the population and rates of illness and death are often high. While primarily focusing on research in the UK, the Nuffield report sets out to have international relevance.
Among the voices we listened to were 57 community members and secondary school students from Kilifi, a coastal town in Kenya. Voices from Kilifi have provided central insights into how adults and young people view research involving children in this setting.
For most, perceptions of the importance of research on child health and fears about the involvement of young children presented a major tension, resolvable only through careful communication to support informed, balanced and free decisions. Most argued that older children and young people should have a greater say in these decisions, best seen as a joint process involving children and their parents with researchers’ support. These shifts within consent processes for children call for greater ‘people skills’ in research teams, rather than increasing levels of documentation.
Over the coming year, the Council will be working with colleagues in the UK and internationally to look at how the conceptual recommendations we make in the report apply to different contexts, especially in low and middle income countries. This week, the report has been discussed at the Oxford Global Health and Bioethics International Conference and, as we write, the Global Health Network are putting the final touches on an online training course, which draws directly on our report, aimed at people who review research with children and young people.
A detailed report of our engagement work in Kilifi is available online, but here is a summary of what we heard:
Is research involving children seen as important?
People valued research on child health as an important part of improving the lives of all children in future. Many students saw research as exciting, part of development and a way of helping others. But all participants had concerns about children participating in research. A child’s age and the perceived risks of research were key issues for acceptability. Young children were seen as particularly ‘vulnerable’ on the basis of being unable to express or defend themselves, physically fragile and having particular risks to potentiality. Research with potential therapeutic benefits was generally more acceptable, but differences between medical research and medical treatment were not always clear. Many students had unrealistic fears about risks, particularly for clinical trials, and were unaware of existing science and ethics review systems to check on safety.
Who should decide about participation in research?
There were no clear cut answers about how this should work. While a child’s capacity to make independent decisions was generally seen to increase with age, the rate would differ from child to child. Important influences were the child’s personality, normal life responsibilities, parenting styles and exposure to formal and informal learning, including internet exposure. Many thought that young people with greater exposure to formal education may be better placed to make decisions than their parents. Equally important was the nature of the decision being taken. The capacity to make independent decisions about research seen as having few burdens, such as a filling a questionnaire, would be gained at an earlier age than for those seen as more ‘risky’, such as a clinical trial.
Given the influences described for developing capacity, there was little clarity or agreement on an age when a young person could take decisions independently. But there was consensus that older children and young people should be given a say or sometimes total responsibility for this decision. At the same time, many students themselves - including some over 17 years – expressed a wish to discuss research decisions with their parents, particularly if the research was seen as involving more risk. Several based a value of listening on their trust in their parents’ judgement and greater life experience. As an 18 year old student explained “You will sit and share your views and at last come up with a decision that is going to be binding.”
What did we learn for policy?
Firstly, there is support for research to improve child health in this setting but concerns must be taken account of. Strong interpersonal communication with families about the value, benefits and burdens of studies is key to ensuing that balanced decisions are taken. More public engagement on these issues could support a climate of openness and build a critical awareness of the importance of research with children.
Secondly, informed consent processes should be adapted to provide greater opportunities for discussion within families, supported by researchers. These processes require careful planning, where possible based on advice from young people about communication on the ground.
Most centrally, there will be a need for more ‘people skills’ rather than more documentation. Research teams must be able to communicate with and sensitively assess relationships between children or young people and their families to support good processes of shared decision making.
We strongly acknowledge the work of Irene Jao, Nancy Mwangome, Isaac Charo and Alun Davies at the KEMRI Wellcome Trust Research Programme in planning and conducting the research on which this account is based.