Albertine Donker

Chapter 9 312 Dutch legislation regarding minimal-risk pediatric research needs adjustments First of all, we are certainly aware of the important historical roots of the legislation around human research, roots that should never be forgotten. On December 9, 1946, an important conference took place at the Nuremberg Palace of Justice that would define the course and nature of permissible human research. The conference was part of the Nuremberg trials, conducted by a military tribunal, held after World War II by the Allied Forces under international law. This was the start of the so-called Doctors’ trial for war crimes of German doctors, accused of having been involved in human experiments including exposure to simulated high altitudes, freezing, malaria and mustard gas amongst other cruelties. Fifteen of the 23 defendants were found guilty and sentenced to death by hanging. 49 This historical indictment resulted in a list of conditions (Nuremberg Code 50 and later in the Declaration of Helsinki 51 ) required for the conduction of ‘permissible human experiments’, which became the cornerstone of the ethics of human research and a template for all informed consent forms regarding participation in clinical trials. Autonomy, beneficence and justice are leading principles in these documents. Importantly, in pediatric research self- determination is exercised by proxy (parents or guardians), requiring even more careful balancing of the benefits versus the disadvantages of participation in clinical trials. 52 Taking into account the dramatic violations of human rights in human experiments during the past, strict rules regarding research involving human subjects are warranted. In the Netherlands, this legislation is defined in the Medical Research Involving Human Subjects Acts (Wet Medisch Onderzoek (WMO)). 53 Apart from this law, also European legislation regarding conducting human research exists, as the guideline for Good Clinical Practice (GCP). 54 In line with the United Nation Convention of the Rights of the Child (UNCRN) 55 , including minors in clinical trials is subject to stringent rules in order to protect vulnerable children who are not able yet to stand- up for themselves. Against the background of the historical abuses around human research we definitely agree with the strict legislation as defined in the WMO and GCP guideline. We also agree with the even more strict rules regarding research that involves minors since the very important principle of autonomy might be compromised in children. However, in our opinion, research ethics committees should apply various degrees of stringency regarding the relevant ethical and regulatory structures, dependent