Over the last three quarters of a century, international guidelines and regulations have undergone significant changes in how children are problematised as participants in biomedical research. While early guidelines enacted children as vulnerable subjects with diminished autonomy and in need of special protection, beginning in the early 2000s,…

In many institutions, the institutional review board/research ethics board (IRB/REB) uses the traditional audit approach that emerged from the biomedical community (e.g., Nuremburg Code, Belmont Report) to review the ethical acceptability of research using humans as participants. This approach is guided by participant protection and risk…