Informed consent & ethical issues in paediatric psychopharmacology.

ABSTRACT

Issues relating to informed consent and ethics in paediatric psychopharmacology limit research in this population. Children vary in their levels of cognitive development, and presence of psychiatric disorder may further impair their ability to give informed consent. In decisional impairment subjects, various methods used for consent are assent/dissent; inclusion of advance directives; and/or alternative decision-makers. India is emerging as a new market for clinical trials in recent years. Moreover, in India the sociocultural realities are different from those in the western countries making it necessary for professionals to be cautious in conducting drug trials. In this review, issues regarding informed consent in children and adolescent with psychiatric diagnosis are discussed for information, discussion and debate by professionals, parents, society and legal experts to create awareness and to facilitate development of guidelines that are appropriate and applicable to the Indian system.