It is unlikely that all 224 centres will participate, so some patients will be treated in hospitals not participating in the trial and some will not be asked for nor give assent for the trial.
In view of the observational nature of the study, the relatively small volumes of blood sampled (5 ml on alternate days, see further), and the impossibility of obtaining informed consent prospectively, the investigators requested that neither retrospective patient consent nor formal assent from relatives be required.
This avoids that objection because the academic skeptic is neither assenting to the proposition that her equipment is untrustworthy nor assenting to the claim that there is an argument which shows that her equipment is untrustworthy.
However, the three bishops were reluctant, and told the pope that because Gilbert had not received the royal assent, nor had he sworn fealty to Stephen, they would not consecrate him.
Despite this consensus, the guidelines do not give a clear definition of assent, nor do they provide any good reasons why assent is valuable.
Fifty-six percent of the forms did not address a child's ability to dissent; 49% of the forms addressed neither assent nor the potential for future re-consent at the legal age of majority, while 30% addressed assent with qualifications such as a specific age.
In NIH's proposal, researchers requesting materials are expected not to sign anything that unduly limits academic freedom or publication, nor are they allowed to assent to withholding data or grant reach-through rights.
This brief summary demonstrates that the guidance is inconsistent and that the concept of assent is neither understood nor clearly defined.
Although there is no consensus on a definition, nor the exact circumstances under which assent should be sought from children or adolescents, it is nevertheless the foundation of ethical engagement [ 60].
