Table 2

Definition of assent in research guidelines

Research guidelineTextJurisdiction
Code of Federal Regulations4Assent means a child's affirmative agreement, to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as consent.”USA
American Academy of Pediatrics9“… active agreement by a minor, not qualified to give consent, to participate in a research study. This generally applies to children who have reached an intellectual age of 7 years or greater.”USA
Council for International Organizations of Medical Sciences11“Such knowing agreement, sometimes referred to as assent…”International
Confederation of European Specialists in Paediatrics6“Informed assent means a child's agreement for medical procedures in circumstances where he or she is not legally authorised or has insufficient understanding to be competent to give full consent.”European
Royal College of Paediatrics and Child Health5“… ‘assent’ refers to acquiescence…”UK
Medical Research Council13“… affirmative agreement to participate. Failure to object should not be construed as assent” but later on “Does the child actively object?” and if no, “research may proceed”*UK
The Royal Australasian College of Physicians12“… the term assent for concurrence or agreement, without the formal and legal expectations of informed consent.”Australia and New Zealand
  • * The apparent contradiction may be explained by children of different ages being considered. Older children may be expected to express assent, with the dissent of younger children being respected. This is not commented on in the document.