The Nuffield Council on Bioethics, located in London, has committed itself to examining and reporting ethical issues in biology and medicine. It was founded in 1991 and is funded by the Nuffield Foundation, the Wellcome Trust, and the Medical Research Council.1
Currently, the Nuffield Council on Bioethics is working on two projects, one of them being on the topic of "children and clinical research: ethical issues".2
This project includes a survey on the recruitment of children to clinical research. For this purpose, the Nuffield council on Bioethics discusses ethical dilemmas on their website, concerning the responsibilities of researchers and clinicians, as well as the involvement of parents, children and the government in the decision-making process.
Who decides if a child should take part in clinical research?
The Nuffield Council on Bioethics explains that there is no law in the UK about research decisions regarding children, except one about clinical trials of new medicines. This law distinguishes between toddlers not older than three, children and teenagers to the age of 15 and young adults between 16 and 17. The involvement of children in the decision making process therefore depends on the age of the child. In the UK for example, the "informed consent" of a child aged 16 or less is necessary, however the final decision is made by the parents. Yet, a child's explicit refusal should be considered by the researcher. Children aged 16 or older are considered adults and are therefore able to make a decision themselves.3
However, each country has differing views on this topic. Inform yourself carefully about your country's regulations, before making a decision!
The survey questions
After reading through the explanations, one can contribute to the Council's research by responding to these 6 questions:
- What do you consider to be the main obstacles to recruiting children to research? How might these be overcome?
- Who should make the final decision as to whether a child participates, or continues to participate, in clinical research when parents and child disagree? What responsibilities do health professionals or researchers have in such cases? (You may wish to distinguish between children at different stages of development and/or the different ways in which disagreement may arise or be expressed.)
- How useful is the concept of assent? Is it helpful to distinguish between consent and assent for young people?
- A 'shared' or 'collaborative' decision-making model is often advocated for decisions about a child's research involvement, involving the child, relevant family members and professionals. Is it a helpful approach? How might any problems arising in this model be overcome?
- Parents' views on whether (and how) children should be involved in decisions vary enormously both within and beyond the UK. How should the law and professionals take account of such different parenting approaches?
- Rewards (such as vouchers) for children participating in research may be welcomed as an appropriate way of saying 'thank you', or criticized as a form of undue incentive (to either child or parent). What forms of compensation/reward/expression of gratitude for research involvement do you think acceptable, and why?
Read more about the project on this site.