Publication: Consent and assent in paediatric research in low-income settings.
Issued Date
2014-03-05
Copyright Date
2014
Resource Type
Language
eng
ISSN
1472-6939 (electronic)
Rights
Mahidol University
Rights Holder(s)
BioMed Central
Bibliographic Citation
Cheah PY, Parker M. Consent and assent in paediatric research in low-income settings. BMC Med Ethics. 2014 Mar 5;15:22.
Suggested Citation
Cheah, Phaik Yeong, Parker, Michael Consent and assent in paediatric research in low-income settings.. Cheah PY, Parker M. Consent and assent in paediatric research in low-income settings. BMC Med Ethics. 2014 Mar 5;15:22.. doi:10.1186/1472-6939-15-22. Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/854
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Title
Consent and assent in paediatric research in low-income settings.
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Abstract
BACKGROUND: In order to involve children in the decision-making process about
participation in medical research it is widely recommended that the child's
assent be sought in addition to parental consent. However, the concept of assent
is fraught with difficulties, resulting in confusion among researchers and ethics
committees alike.
DISCUSSION: In this paper, we outline the current international debate
surrounding pediatric consent and assent, and its unique challenges arising in
low-income settings. We go on to propose some key requirements for a
fit-for-purpose assent model in these difficult settings. The paper recommends
that children who are competent, that is, children who are judged to be able to
understand and retain relevant information, weigh this information in making a
mature judgment, come to a decision and communicate the decision, should be able
to consent for themselves. Our proposal is that where the decision about whether
to participate in a study is of comparable complexity to the decisions the child
is used to making in other aspects of his or her life, it should be made by the
child him or herself. The relevant level of complexity should be judged by local
standards rather than standards of the developed world. In the paper we explore
some of the practical challenges and counter arguments of implementing this
proposal. As in high-income settings, we argue that in the case of children who
are judged to lack this level of competence both parental consent and assent from
the child should be sought and go on to define assent as involving the child to
the extent compatible to his or her maturity and with cultural norms and not as
obtaining the child's permission to proceed.
SUMMARY: The concept of assent in the current guidelines is confusing. There is
an urgent need for clearer guidelines that can be adapted for all types of
paediatric research wherever it is to be carried out and an evidence-base
concerning good assent/consent practice. This paper argues that a context
specific approach should be adopted when assessing whether consent or assent
should be sought from children in low-income settings.