Albertine Donker

General Discussion 313 9 of the impact of the study. Such an approach would be in line with the legislation in the United States (US). 56 In the US, different categories of research are identified regarding the risks and the anticipated direct benefits for the subject. In case of a minimal risk study, anticipated direct benefit is not required and a simplified informed consent procedure will suffice. Importantly, the signature of only one parent is required. Procedures under the minimal-risk threshold include collection of blood (3 mL/kg with a maximum of 50 mL) and psychological examinations and tests amongst others. 56 On the basis of these criteria, the study we performed on serum hepcidin values in Dutch children could be classified as such a minimal risk study ( Chapter 7 4 ). However, the Central Committee on Research Involving Human Subjects (Centrale Commissie Mensgebonden Onderzoek (CCMO)) , 57 which is charged with accrediting and supervising the medical ethics review committees in the Netherlands, does not acknowledge such a division of studies with respect to low- or high risk. Therefore the consent of both parents/caregivers is required, regardless of the impact of the study for the child. This is remarkable since the WMO dictates that the stringent GCP standards only apply to pharmaceutical research. 53,54 Our experience (and also the experience of other Dutch researchers 58 ) is that this lack of proportionality hampers the conduction of important research in children. Moreover, we are concerned about the implications of the current developments in the legislation regarding multi-parenting on the possibility to include children in clinical trials. 59 If the recommendations of Wolfsen et al 59 regarding multi-parenting indeed will be followed, a child might have four legal representatives in the future. As yet, the Dutch Government has not accepted this recommendation. 60 However, if they do so, this will render the conduction of pediatric clinical research practically impossible. We think a balance between reasonable legislation and practical feasibility is crucial, by tailoring the rules regarding pediatric research to the impact of inclusion in a clinical study, without compromising the protection of the subject. The very comprehensive Dutch legislation around the inclusion of minors in clinical studies entails the risk that children as subjects are protected in such extent that pediatric research will become impossible, with the inevitable consequence that children have to be exposed to diagnostic and therapeutic procedures without evidence for its effectiveness in this particular age group.