CIOMS Guidelines - Global Health Trials

Guideline 14: Research involving childrenBefore undertaking research involving children, the investigator must ensure that:• the research might not equally well be carried out with adults;• the purpose of the research is to obtain knowledge relevant to the health needs ofchildren;• a parent or legal representative of each child has given permission;• the agreement (assent) of each child has been obtained to the extent of the child`scapabilities; and,• a child`s refusal to participate or continue in the research will be respected.Commentary on Guideline 14Justification of the involvement of children in biomedical research. The participation of children isindispensable for research into diseases of childhood and conditions to which children areparticularly susceptible (cf. vaccine trials), as well as for clinical trials of drugs that are designed forchildren as well as adults. In the past, many new products were not tested for children though theywere directed towards diseases also occurring in childhood; thus children either did not benefit fromthese new drugs or were exposed to them though little was known about their specific effects orsafety in children. Now it is widely agreed that, as a general rule, the sponsor of any newtherapeutic, diagnostic or preventive product that is likely to be indicated for use in children isobliged to evaluate its safety and efficacy for children before it is released for general distribution.Assent of the child. The willing cooperation of the child should be sought, after the child has beeninformed to the extent that the child's maturity and intelligence permit. The age at which a childbecomes legally competent to give consent differs substantially from one jurisdiction to another; insome countries the "age of consent" established in their different provinces, states or other politicalsubdivisions varies considerably. Often children who have not yet reached the legally established ageof consent can understand the implications of informed consent and go through the necessaryprocedures; they can therefore knowingly agree to serve as research subjects. Such knowingagreement, sometimes referred to as assent, is insufficient to permit participation in research unlessit is supplemented by the permission of a parent, a legal guardian or other duly authorizedrepresentative.Some children who are too immature to be able to give knowing agreement, or assent, may be ableto register a 'deliberate objection', an expression of disapproval or refusal of a proposed procedure.The deliberate objection of an older child, for example, is to be distinguished from the behaviour ofan infant, who is likely to cry or withdraw in response to almost any stimulus. Older children, whoare more capable of giving assent, should be selected before younger children or infants, unlessthere are valid scientific reasons related to age for involving younger children first.A deliberate objection by a child to taking part in research should always be respected even if theparents have given permission, unless the child needs treatment that is not available outside thecontext of research, the investigational intervention shows promise of therapeutic benefit, and there