Table 1.
Research guideline | Text | Jurisdiction |
---|---|---|
The Declaration of Helsinki1 | “… the physician must seek that assent…” | International |
Council for International Organizations of Medical Sciences11 | “Assent 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 Council13 | If 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.