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We read with interest Dr Baines's article on assent for children's
participation in research  and were pleased that he has highlighted the
complexities surrounding assent. We agree that the current situation is
confused and legal guidance is inconsistent. This primarily hinges on the
poor definition of assent and its place in the consent process.
We do however challenge Dr Baines's suggestion that assent does...
We do however challenge Dr Baines's suggestion that assent does not
have a place in research with children and can cause harm. The argument
that the current guidance on assent is inconsistent is a valid one, but it
does not necessarily follow that the concept of assent is irredeemably
invalid. The term "assent" gives recognition to the role for children that
lies between no involvement in discussions and full decisional authority
and demonstrates respect for the child. It helps a child to achieve a
developmentally appropriate understanding of the nature of the condition
and allows children a chance to express their views and have these taken
into account to the extent that is appropriate. If the guidance to seek
assent was removed, it might be expected that children would still be
consulted about their research participation and presumably
incompatibility between parent and child could still arise. Therefore,
incompatibility is not a consequence of assent but a consequence of a
situation in which the views of both parent and child are important.
Even if assent is flawed and leads to box-ticking (similar arguments
can be put forward about the limitations of consent), the requirement to
seek assent at least creates a clear expectation that children be
consulted. It also creates an expectation that practitioners, not just
parents, take a role in this. Its removal could be symbolically
significant and lead to less openness with children. In the absence of
assent, practitioners may be less likely to consult with children about
research and the responsibility for consulting with them could be handed
entirely to parents. So the tensions between parent and child regarding
research participation would not disappear, although they might become
less visible. It has been shown that parental understanding of research
can be problematic,  and this would have implications for the quality
of their consultation with the child.
There are some important questions that we currently don't have
answers for. One of these is how frequent and serious are the tensions
that arise between the child and parent regarding research participation?
The RECRUIT study  was a qualitative study examining the consent
process and the views of parents, young people and practitioners during
this process. It cannot answer questions about how often disputes arise
but there was a clear and consistent message from children and parents
that they could usually resolve their differences, and that the tensions
that arose seemed to be a catalyst for helpful dialogue. At the onset of a
trial the practitioner should clearly think about the age and medical
condition of children that they are recruiting. A clear strategy should be
devised for how children may be best involved in the recruitment process
and the documentation that a child has been consulted in the decision
Dr Baines is right that assent, and dissent, as concepts are less
well developed than consent. A definition taking into account all
stakeholders' views with an international consensus would seem a sensible
way forward from this point, with continued debate on the place of assent
in the recruitment process.
1 Baines P. Assent for children's participation in research is incoherent
and wrong. Arch. Dis. Child 2011; 0:adc.2011.211342v1-archdischild211342;
2 Spriggs MP, Gillam LH. Consent in paediatric research: an evaluation of
the guidance provided in the 2007 NHMRC National statement on ethical
conduct in human research 2008; Med J Australia.188:360-2.
3 Featherston K, Donovan JL. Random allocation or allocation at random?
Patients' perspectives of participation in a randomised controlled trial.
BMJ 1998 ;317:1177-80.
4 Shilling V, Williamson PR, Hickey H,et al. 2011Processes in recruitment
to randomised controlled trials (RCTs) of medicines for children
(RECRUIT): a qualitative study. Health Technology Assessment 15:15
We are all members of STAR Child Health standard development group for consent and recruitment