[Medical research in children: should the rules be eased?]. 2010

Anna E Westra
Leids Universitair Medisch Centrum, afd. Kindergeneeskunde, Leiden, the Netherlands. a.e.westra@lumc.nl

'Non-therapeutic research' in children, i.e. research that will not directly benefit the patients involved, is indispensable for improving the quality of paediatric care. However, as children cannot give consent, such research is strictly limited. According to the Dutch Medical Research Involving Human Subjects Act (WMO) non-therapeutic studies with children are only allowed if the risks are negligible and the burdens are minimal. A Dutch expert committee ('committee Doek') investigating whether the WMO should be made less rigid, recently recommended discouraging the use of the distinction between 'therapeutic' and 'non-therapeutic' research and maintaining the absolute limit regarding risks and burdens only for observational studies in children younger than 12 years. This paper discusses these recommendations and argues that in principle, the risks and burdens of all research that has no direct benefit for the subjects should be kept to a minimum.

UI MeSH Term Description Entries
D007258 Informed Consent Voluntary authorization, by a patient or research subject, with full comprehension of the risks involved, for diagnostic or investigative procedures, and for medical and surgical treatment. Consent, Informed
D009426 Netherlands Country located in EUROPE. It is bordered by the NORTH SEA, BELGIUM, and GERMANY. Constituent areas are Aruba, Curacao, and Sint Maarten, formerly included in the NETHERLANDS ANTILLES. Holland,Kingdom of the Netherlands
D010372 Pediatrics A medical specialty concerned with maintaining health and providing medical care to children from birth to adolescence.
D012106 Research Critical and exhaustive investigation or experimentation, having for its aim the discovery of new facts and their correct interpretation, the revision of accepted conclusions, theories, or laws in the light of newly discovered facts, or the practical application of such new or revised conclusions, theories, or laws. (Webster, 3d ed) Research Priorities,Laboratory Research,Research Activities,Research and Development,Activities, Research,Activity, Research,Development and Research,Priorities, Research,Priority, Research,Research Activity,Research Priority,Research, Laboratory
D002648 Child A person 6 to 12 years of age. An individual 2 to 5 years old is CHILD, PRESCHOOL. Children
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D018570 Risk Assessment The qualitative or quantitative estimation of the likelihood of adverse effects that may result from exposure to specified health hazards or from the absence of beneficial influences. (Last, Dictionary of Epidemiology, 1988) Assessment, Risk,Benefit-Risk Assessment,Risk Analysis,Risk-Benefit Assessment,Health Risk Assessment,Risks and Benefits,Analysis, Risk,Assessment, Benefit-Risk,Assessment, Health Risk,Assessment, Risk-Benefit,Benefit Risk Assessment,Benefit-Risk Assessments,Benefits and Risks,Health Risk Assessments,Risk Analyses,Risk Assessment, Health,Risk Assessments,Risk Benefit Assessment,Risk-Benefit Assessments
D032984 Ethics, Research The moral obligations governing the conduct of research. Used for discussions of research ethics as a general topic. Research Ethics
D035842 Research Subjects Persons who are enrolled in research studies or who are otherwise the subjects of research. Human Subjects,Human Subject,Research Subject,Subject, Human,Subject, Research,Subjects, Human,Subjects, Research

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