who determines the age of assent at an institution
Informed assent However, 45 CFR 46 does not specify an exact age at which informed assent must be obtained. Instead, it places responsibility for this determination with hospitals’ own Institutional Review Boards (IRBs). Increasingly, many such IRBs are adopting the ‘Rule of Sevens,’ which has formed part of common law for centuries and divides a child’s life into three sections: birth to seven, seven to fourteen, and fourteen to twenty one years old. Before 7 years old children are said to lack the cognitive development necessary for autonomous decision-making. At age 7 years children are considered able to distinguish right from wrong. Adolescents 14 years old and above are legally and socially accountable for their actions. Although not law, meaning physician can choose to ignore it, the rule of sevens is recommended by organizations including the American Academy of Pediatrics and in some areas, such as the state of California, has been written into local law.[4]