Consent in paediatric research: an evaluation of the guidance provided in the 2007 NHMRC National statement on ethical conduct in human research

The new statement tries to address the concerns about competence to consent with extra guidance about levels of maturity. The aim is to assist in determining when a young person’s consent is necessary, in addition to parental consent, or as sole authorisation without a requirement for parental consent (Box). This clarification may assist researchers and ethics committees. It provides a framework for thinking, without being too rigid. Researchers can expect ethics committees to use these categories, and can frame their research proposals accordingly.

Unfortunately, this improvement may be undermined by a change in terminology, which may have unintended ramifications. Throughout the 2007 statement, the term “capacity” has replaced “competence”. There is no acknowledgement of or explanation for this change. There may be a good reason, but without a definition of its meaning we cannot know. In the 1999 statement, “competence” referred to the ability to give consent.2 Competence was understood as shorthand for competent to consent. In the revised statement, “capacity” is used in more ways: for example, it includes “capacity to understand” and “capacity to be involved in the decision”, as well as “capacity to consent”. Hence, we cannot use the term “capacity” without specifying precisely what it refers to. The significance of capacities to understand, to be involved in discussions and decisions, and to consent to give full and valid sole consent are different (see Box, levels of maturity). This is likely to lead to confusion.

The 2007 statement still does not address whether formal assessments of children’s competence or capacity should be carried out by a person with particular expertise, or whether the researcher’s own intuitive judgement is sufficient. This is presumably to be left to the judgement of individual ethics committees, which could result in different requirements at different research sites. In addition, no guidance is provided to ethics committees on what factors to consider when deciding about assessments of competence or capacity. It does not identify the potential conflict of interest involved when capacity is assessed by researchers wanting to recruit research participants, let alone suggest how to resolve it. Nor is guidance given on whether the intrusiveness or potential harms involved in determining a child’s capacity to consent should be considered a valid ethical reason for not doing a formal assessment in some circumstances.

“Vulnerability” is another new term that has been introduced (Box). The presence of vulnerability appears to be another way to assess a child as lacking competence, indicating that the child’s consent is not sufficient to authorise participation. This is a potentially helpful concept, as well as an ethically important one. However, the lack of explanation as to what the child can be vulnerable to means that it is likely to cause confusion.

The 1999 statement dealt with sole authorising consent from the young person in terms of “exceptional circumstances” that would permit parental consent to be omitted. No specific description of what counts as exceptional circumstances was given. The 2007 version uses levels of maturity and the concept of vulnerability. The provisions are presented as a set of conditions, which are presumably an attempt to spell out the idea of exceptional circumstances. The conditions are complex, which may cause difficulties in interpretation. In addition, the concept of vulnerability seems to get lost, because it is permissible to have sole authorising consent from a vulnerable young person when these conditions apply. There is likely to be quite a settling-in period as researchers and ethics committees work their way through this.

Children’s refusal is not taken as seriously in the 2007 statement as it was in the 1999 statement (Box). This could be ethically problematic, as it raises the prospect of an unwilling child being forced into participating in research (eg, research involving an experimental drug for a child for whom all else has failed). Despite lack of capacity to consent, a child might reach a point where he or she wants nothing more to do with hospitals, medications and medical procedures. Arguably, these children should not be forced to take part in research which involves additional procedures and hospital visits done primarily for the sake of research.

The idea of levels of maturity goes some way to addressing this matter. It recognises the developing capacity of children and young people to be involved in decisions about research participation, which goes beyond the all or none approach. However, it does not sufficiently capture the idea that providing information to children demonstrates respect and has value in itself apart from its role in consent. This might be because the word “consent”, which emphasises decision making, is used to refer to both the actual informed consent of mature minors and children’s mere involvement in discussions.

Use of the term “assent” might help distinguish these different senses of consent and help show that there are different values at stake. Although a child’s assent does not have the moral authority of informed consent, it does have a different kind of value. Children benefit from being involved in discussions and from being given information about what will happen if they participate even when they do not have decision-making authority. “Assent” or a similar term may assist in providing recognition for the value of and the role for children that lies between no involvement in discussions and full decisional authority.

One submission did suggest consideration be given to including “assent” or a similar term in the guidelines, but noted that some people find “assent” confusing because “most dictionaries regard it as a synonym for consent” (RACP Working Group, first round submission). However, it could hardly be worse than using the word “consent” to mean two different things. “Assent” is widely referred to in the research community and is established in the literature. It is referred to in United States, United Kingdom, New Zealand and Canadian research ethics guidelines.4-7 It would make sense for those who conduct and review paediatric research in Australia to be using this internationally recognised term, providing of course that its meaning and application are well defined.