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Acta Neurochir Suppl. 2012;113:15-9. doi: 10.1007/978-3-7091-0923-6_3.

Ethical considerations in hydrocephalus research that involves children and adults.

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The Sandra and Malcolm Berman Brain & Spine Institute, Sinai Hospital of Baltimore, Baltimore, MD, USA.


Those who conduct clinical research in hydrocephalus face ethical challenges. Research subjects include infants, children, unborn fetuses, and adults with diminished decision-making capacity. The aim of clinical research is to acquire knowledge that will improve the health of future patients, and one of the goals of research ethics is to prevent the exploitation of research subjects.The history of hydrocephalus treatment is marked by innovation. Surgical innovation should be followed by surgical research so that the innovation is proven to be better than existing treatments before it becomes accepted practice.Because the long-term effects of genetic, pharmacologic, and stem cell therapies on the developing brain are unknown, researchers have an obligation to conduct short- and long-term research on children. Children should be asked for their assent or dissent. Assent is a child's affirmative agreement to participate in research. Absence of the child's objection is not sufficient; the child must say yes to participation in the research. A child's refusal to participate in research should be respected.In disorders with dementia, such as normal pressure hydrocephalus, decision-making capacity of the research subject should be assessed. If the subject lacks decision-making capacity, a surrogate or guardian must provide consent. Assent to participate in research should also be obtained from adults with cognitive impairment.

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