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Physicians and others conducting medical and dental research involving children as participants face quite challenging questions and responsibilities, especially in developing countries. Age, maturity, cognitive development, previous experience, social and cultural contexts, are all factors involved in a minor’s competence to assent. However, the literature has suggested some age thresholds for children to meet assent requirements and skills that they should have to participate meaningfully in decision-making situations regarding their health. This paper discusses the international regulatory documents regarding children consent in Clinical Research.

Clinical Research involving Children: consideration relating to assent