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Decision making in a medical research ethics committee

“Decisions, decisions, a kingdom for a fair, properly balanced and consistent decision in medical experimentation with humans”, paraphrasing a famous statement this sums up the primary task of the Medical Research Ethics Committees (MREC; in Dutch: METc) operating in the western world, including the Netherlands. Sounds clear enough, doesn’t it, but is that really so or is the job set for MREC’s not as unequivocal as it appears and therefore open for multiple interpretations and ways of reaching decisions?

Text by Benjamin Drukarch

Following my appointment as a member to the MREC of the VUmc and taking part in its deliberations for the past 18 months, I have repeatedly asked myself this question and looked for answers. Discussing procedures with members of other MREC’s made it crystal clear that, although drawing legal legitimacy from the same act of Parliament, no two MREC’s in The Netherlands operate in the same manner. This is likely to be the result of different interpretation of (details in) the law, perhaps also influenced by “local” culture.

In the Netherlands, the authority of MREC’s to evaluate, or more correctly, to judge the ethical acceptability of proposed research on human subjects is based on the law on “Medical scientific research with humans”, known in Dutch as “de Wet medisch-wetenschappelijk onderzoek met mensen” or WMO. In this law it is stipulated what kind of research involving human subjects require evaluation by an MREC. First of all, the proposed experiments should entail medical research and include procedures in which the subject is exposed to interventions and/or is to behave in a certain way. Typical examples of these kinds of research are drug trials and studies involving sampling of blood, for instance for biomarker identification, and filling in of questionnaires. Thus, it is clear that, for instance, investigations using only patient records are not subject to the WMO. However, the definition of the term medical research is not circumscribed enough to prevent discussion, whilst there is also an ongoing national debate in MREC’s on how much blood or how many questionnaires does make a study subject to evaluation by a MREC, known in Dutch as “WMO-plichtig”. This discussion is not just of semantic or academic interest, as the outcome has direct implications for the status of the experiments and the rules and regulations to which the investigators must adhere. Just to give a small example, the verdict “WMO-plichtig” generally means more paperwork, which a large majority of the investigators apparently dislikes. So, how to decide and, more important, how to do this in a fair and consistent manner taking into consideration the lawful and ethical rights of the research subjects?

Indeed, the rights of the research subjects, i.e. the large number of patients and others who voluntarily submit themselves to the often burdensome and invasive nature of clinical research projects after giving what is called “informed consent”. Actually, the main obligation set to MREC’s in the WMO, is to protect human subjects from harm induced by clinical research and make sure that the potential participants are informed adequately not only about the advantages but also about the (potential) dangers of participation. To do this, MREC’s have to weigh research benefits against risks and judge the way in which investigators inform research subjects about the nature of the experiments to which they should consent. Again, questions, uncertainties, more discussions, even moral dilemma’s lurk around the corner and may impact on decision making in MREC’s. Whether and how this is the case is open for further (neuro)scientific contemplation.