Table 1

Requirement for assent in international guidelines

Research guidelineTextJurisdiction
The Declaration of Helsinki1“… the physician must seek that assent…”International
Council for International Organizations of Medical Sciences11Assent of the child. The willing cooperation of the child should be sought…”International
Code of Federal Regulations (Part 50)4“… the IRB must determine that adequate provisions are made for soliciting the assent of the children…”USA
American Academy of Pediatrics9“Assent should be obtained from children who are competent to understand”USA
Confederation of European Specialists in Paediatrics6“All children, even those not judged as competent, have a right to receive information given in a way that they can understand and give their assent or dissent”European
The Royal Australasian College of Physicians12“Agreement to participate should usually be sought… from those children who are capable of understanding decisions and their consequences”Australia and New Zealand
Medical Research Council13If the child is able to give assent to decisions about participation in research, the investigator must obtain that assent…”UK
  • IRB, institutional review board or ethics committee.