Before undertaking research involving children, the researcher must ensure that:
- Children do not participate in research that might be carried out equally well with adults.
- The aim of the research is to obtain knowledge relevant to the health needs of children
- The parent or guardian of each child has given proxy consent.
- Having obtained the consent of each child to the extent that their ability allows;
- Always respect the refusal of the child to participate in the investigation unless, in accordance with the corresponding protocol, the child should receive treatment without having another medically acceptable alternative;
- The risk presented by interventions not carried out with the purpose of benefiting the individual child-subject is low and commensurate with the importance of the knowledge to be gained; and
Interventions made to provide therapeutic benefit are likely to be at least as advantageous to the child-subject as any available alternative. |