See, e.g., Zachary M. Harrison, Note, Just Click Here: Article 2B' s Failure to Guarantee Adequate Manifestation of Assent in Click-Wrap Contracts, 8 Fordham Intell.
In what follows, based on our experience conducting trials in low-income settings, we outline nine key factors that will need to be taken into account in any adequate approach to assent in research with children in these settings.
Today, most Security Council nations welcomed Iraq's begrudging assent, calling it adequate to meet a requirement in Friday's resolution, which gave Baghdad seven days to agree to its terms.
Inclusion criteria were: 1) ages 6 to 17 years; 2) self-identified as Yup'ik; 3) ≥2 cm of hair length (to allow for collection of an adequate hair sample); and 4) assent from the minor and parental consent.
The Code of Federal Regulations, for example, states that adequate provisions must be made for soliciting assent from children.
The US Code of Federal Regulations states that, "the IRB must determine that adequate provisions are made for soliciting the assent of the children when in the judgement of the IRB the children are capable of providing assent" [ 5].
If there were certain moral propositions that can be known if adequately understood, then, it is argued, people with an adequate understanding of them would believe them, and there would be universal assent amongst mature, comprehending people.
In our view this modification of personalisation by introducing a suggested requirement of assent starting at a certain age threshold is more adequate.
Conscious patients with adequate mental capacity gave written informed consent prior to enrolment; for others, a close relative/partner gave written assent, with deferred patient consent being obtained during recovery.
This is likely to be led by local ethics committees which is in line with some of the existing guidelines for paediatric research regarding assent e.g. the US Code of Federal Regulations (Part 50) state that "the IRB must determine that adequate provisions are made for soliciting the assent of the children" [ 5].
