Informed consent in pediatric research

Differences in culture, resources, demand, level of development, and cultural and religious differences may alter ethical approaches around the world. The principles of medical ethics are beneficence, non-malfeasance, autonomy, disclosure of information, and social justice. In order to maintain a desirable patient-physician relationship, we need to continue our efforts to cultivate the idea of informed consent and to promote better communication. The doctrine of informed consent in pediatrics requires that health care providers disclose to patient parents the nature of procedures to be performed and the attendant risks, benefits, and alternatives. Equipped with an understanding of their options, parents then have the right to consent to treatment or to refuse it. In addition, there are some instances in which consent by minor patients is necessary. Pediatricians as experts in childcare are privileged to be able to advocate the expansion of invaluable research while simultaneously speaking for the children who are to be involved. Clinical research may relate to the causes of disease, improvement in diagnosis, improvement in treatment, and the mechanisms of human biology. In the development of ethical drug research, the children's well being and empowerment can be realized. Difficult decisions as to who to admit and who to exclude are faced by physicians internationally. Differences between countries are seen in the withdrawal and withholding of treatments and in the obtaining of informed consent in emergency circumstances. The moral imperative to expand pediatric research is urgent but the enterprise is not without risk. Research abuses in the pediatric setting, mistakes, regulation, minimal investment, and professional misconceptions may contribute to children becoming therapeutic orphans. Safeguarding children requires a conscientious effort to envision children's understanding of events, their potential reactions, and the possible immediate and long-term consequences. A shared commitment will help to ensure that in the future we will be better able to provide safe and effective medication and so greatly enhance the care of children.
Category: Review
Volume: Vol. 47, No 1, january - march 2003
Authors: M. Harjaček
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