Table 2

Definition of assent in research guidelines

Research guidelineTextJurisdiction
Code of Federal
Regulations4
Assent 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.