Children as research participants: assessing competence

I was brought to writing about this topic after reading an interesting post by Virginia Hughes titled: Personhood Week: Do Kids Count? Among the various points raised in that article was some discussion about minors having medical autonomy and how this might impinge on areas outside of just medical decision-making. It also reminded me about something which was raised on more than one occasion when I undertook a stint on a University Ethics committee...

Most people involved in the medical or social care of children in the UK will probably have heard about Gillick competence or the Fraser guidelines. Coupled together under the heading of assessing competency to consent to treatment, these guidance derived from judgements in law offer details on how and when a child under the age of 16 years old is able to consent to his or her own medical treatment without parental input and/or knowledge. Contraception was the test case upon which such guidance was first introduced, but the guidance has subsequently been more widely applied to cover many areas of childhood competence in medicine.

You wouldn't eat your spinach

Gillick competence has also drifted into the arena of research (as members of any University ethics committee might know), alongside questions about whether child participation in research should be similarly governed by such guidance [1].

The recent paper by Irma Hein and colleagues [2] adds to the discussion in this area, specifically with their analysis of the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) and the question of when competency to participate in research studies might actually come about in the paediatric population. I will also direct you to some of the preamble about their study by the same authorship group [3] (open-access).

Hein et al based on data derived from some 160 children aged between 6-18 years of age, concluded that the MacCAT-CR is a pretty good instrument when it comes to its use as a tool for assessing children's competence to consent to clinical research involvement. Perhaps more importantly however based on their results: "[in] children younger than 9.6 years, competence was unlikely (sensitivity, 90%); in those older than 11.2 years, competence was probable (specificity, 90%)". Further that: "The optimal cutoff age was 10.4 years (sensitivity, 81%; specificity, 84%)".

Acknowledging that there is quite a bit more to do in this area, including whether there may geographic variations in the age cut-off described (this was a study conducted in The Netherlands), I found these results to be potentially very important. Not only because "consent may be justified when competence can be demonstrated in individual cases by the MacCAT-CR" suggestive that the MacCAT-CR can be administered to paediatric populations, but also because of the implications for whole disciplines involving children under the age of 16 as research participants.

And on the basis of this being a blog about autism research, the question is: what influence the Hein findings might have on top of previous other ethical issues [4]?

Music to close. Mr Pharmacist by The Fall.

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[1] Hunter D. & Pierscionek BK. Children, Gillick competency and consent for involvement in research. J Med Ethics. Nov 2007; 33(11): 659–662.

[2] Hein I. et al. Accuracy of the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) for Measuring Children’s Competence to Consent to Clinical Research. JAMA Pediatrics. 2014. October 13.

[3] Hein IM. et al. Assessing children's competence to consent in research by a standardized tool: a validity study. BMC Pediatr. 2012 Sep 25;12:156.

[4] Hoop JG. et al. Ethical issues in psychiatric research on children and adolescents. Child Adolesc Psychiatr Clin N Am. 2008 Jan;17(1):127-48, x.

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Hein IM, Troost PW, Lindeboom R, Benninga MA, Zwaan CM, van Goudoever JB, & Lindauer RJ (2014). Accuracy of the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) for Measuring Children's Competence to Consent to Clinical Research. JAMA pediatrics PMID: 25317644