Nursing Law and Ethics

children is proposed [82]. Guideline 14 of the draft CIOMS guidance [83],Research
Involving Children,provides that prior to undertaking research involving children
the researcher must ensure that:

`± children will not be involved in research that might equally well be carried

out with adults;

± the purpose of the research is to obtain knowledge relevant to the health

needs of children;

±aparent or legal guardian of each child has given permission;

± the consent of each child has been obtained to the extent of the child's

capabilities;

± the child's refusal to participate in research must always be respected

unless, according to the research protocol, the child would receive therapy

for which there is no medically acceptable alternative;

± the risks of participation are justified, and should not be greater than the

risk attached to routine medical or psychological examination, unless an

ethical review committee is persuaded that slight or minor increases above

such risk are permitted because the object of the research is sufficiently

important.'

Researchers should note that it is important to take account of the different
capabilities of children. Thus, older children who are capable of giving informed
consent should be selected ahead of younger children, unless there are significant
age-related scientific reasons to include younger children [84]. The CIOMS
guidance suggests that it may be assumed that children over the age of 13 will
normally be competent to give consent. However it adds that their consent should
be complemented by that of a parent or guardian, although it is not strictly
necessary in law. The recent European Directive also stresses that minors should
receive, from staff with experience with minors, information pertaining to the trial
and its risks and benefits article 4b)). Where a child or young person lacks the
requisite maturity to consent herself, the researcher should obtain proxy consent
from the person with parental power. However, it is highly questionable whether a
child may be compelled to be involved in a clinical trial, even if the proxy decision-
maker consents [85].

12.4.2 The mentally incapacitated adult

Although incompetent adults differ from children in many ways, similar issues are
raised by proposals to carry out research on these groups. Once again the
competence of the incapacitated person will have to be carefully assessed in
relation to the particular procedure. As discussed in Chapter 7, a patient may be
competent to consent to one form of treatment but not to another. This applies
equally in the research context. The DoH Guidelines provide in para 4.7 that:

`Research on mentally disordered people requires particular care and sensitivity

bearing in mind that they are vulnerable and some may not be able to give

consent. There is a need to weigh the rights of an individual to consent or to

refuse to take part in research and the particular status of those unable to

Clinical Research and Patients 265