Westra Anna E
Leids Universitair Medisch Centrum, afd. Kindergeneeskunde, Leiden, the Netherlands.
Ned Tijdschr Geneeskd. 2010;154:A2275.
'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.
儿童的“非治疗性研究”，即不会直接使所涉患者受益的研究，对于提高儿科护理质量而言不可或缺。然而，由于儿童无法给出同意，此类研究受到严格限制。根据荷兰《涉及人类受试者的医学研究法》（WMO），只有在风险可忽略不计且负担极小的情况下，才允许对儿童进行非治疗性研究。一个荷兰专家委员会（“多克委员会”）正在调查是否应放宽WMO的规定，该委员会最近建议不再区分“治疗性”和“非治疗性”研究，对于12岁以下儿童的观察性研究，仅维持对风险和负担的绝对限制。本文讨论了这些建议，并认为原则上，所有对受试者无直接益处的研究的风险和负担都应降至最低。
