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Well-conducted biomedical research tells us how best to act in various clinical situations. In order to do so, ethical and legal rules have been developed over time for optimal study conduct, with special attention to the subjects involved in these studies. This includes asking informed consent before including a person in a clinical trial, and protection of fragile and mentally incompetent individuals by restricting and regulating their participation in biomedical research. Apart from the obvious positive effects, these regulations may also lead to unintended restrictions, and as a result not all relevant patient subgroups are sufficiently included in human clinical research. Consequently, important questions on how to optimally treat certain patient groups remain unanswered.The objective of this ‘current opinion’ article is to explore how therapeutic scientific research and procedures can be better exploited, to advance clinical expertise and to discuss ethical issues that need to be considered in that context. For that purpose, we reflect on the challenges and consequences of patient selection, studies in acute care setting, and comparison of established therapies, in the final part illustrated by discussing some relevant recent clinical trials.We all appreciate the fact that biomedical research in humans should be guided by high ethical standards, as outlined in the Declaration of Helsinki,1 among which informed consent of the subject before participation in a trial. Nevertheless, we propose that, in order to obtain optimal scientific and clinical data, certain study types should not require (pre-study) informed consent, while still guaranteeing patients …

Research ethics needs fine tuning, not rigidity: how to promote evidence in neglected patient populations by rethinking informed consent: Figure 1