Background The European Union aims to optimize patient protection and efficiency of health-care research by harmonizing procedures across Member States. Nonetheless, further improvements are required to increase multicenter research efficiency. We investigated IRB procedures in a large prospective European multicenter study on traumatic brain injury, aiming to inform and stimulate initiatives to improve efficiency. Methods We reviewed relevant documents regarding IRB submission and IRB approval from European neurotrauma centers participating in the Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury. (...) Documents included detailed information on IRB procedures and the duration from IRB submission until approval. They were translated and analyzed to determine the level of harmonization of IRB procedures within Europe. Results From 18 countries, 66 centers provided the requested documents. The primary IRB review was conducted centrally or locally and primary IRB approval was obtained after one, two or three review rounds with a median duration of respectively 50 and 98 days until primary IRB approval. Additional IRB approval was required in 55% of countries and could increase duration to 535 days. Total duration from submission until required IRB approval was obtained was 114 days and appeared to be shorter after submission to local IRBs compared to central IRBs. Conclusion We found variation in IRB procedures between and within European countries. There were differences in submission and approval requirements, number of review rounds and total duration. Research collaborations could benefit from the implementation of more uniform legislation and regulation while acknowledging local cultural habits and moral values between countries. (shrink)

In a thought-provoking article – or how she herself named it, ‘a thought experiment’ – the philosopher-medical ethicist Anna Smajdor analyzed in this journal the idea of whole-body gestational donation (WBGD) in brain-dead female patients, as an alternative means of gestation for prospective women who cannot or prefer not to become pregnant themselves. We have serious legal, economical, medical and ethical concerns about this proposal. First, consent for eight months of ICU treatment can never be assumed to be derived from (...) consent for post-mortem organ donation; these two are of an incomparable and entirely different medical and ethical order. Moreover, the brain-dead woman is very likely to be medically unfit for high-tech surrogacy and the brain-dead state poses a high risk for deficient embryo/fetal development. Second, from a scarcity perspective, occupying an ICU bed for eight months appears to be unjust. The costs for eight months of ICU treatment are far too high compared to the costs of surrogacy for a living, selected, and healthy woman. Neither insurance companies nor prospective parents will want to pay these exceptionally high costs for a dead woman if a living surrogate mother can be hired for a considerably lower amount. Third, there is an increased risk for harm of the child to be in WBGD. And finally, WBGD risks violating the brain-dead woman’s dignity and harming the interests of her loved ones. In short, there is simply no need for brain-dead women as surrogates. (shrink)

We anticipate a further decline of patients who eventually will become brain dead. The intensive care unit (ICU) is considered a last resort for patients with severe and multiple organ dysfunction. Patients with primary central nervous system failure constitute the largest group of patients in which life-sustaining treatment is withdrawn. Almost all these patients are unconscious at the moment physicians decide to withhold and withdraw life-sustaining measures. Sometimes, however competent ICU patients state that they do not want to live anymore (...) because of the severity of their illness or the poor prognosis and ask for withdrawal of life-sustaining measures like mechanical ventilation. Do we consider the unconscious patient as potential organ donor before withdrawal of mechanical ventilation? This is paradoxically rare in the case of the conscious ICU patient. Is it practically possible and ethically feasible to obtain consent for organ donation from this group of patients? (shrink)

Severe Traumatic Brain Injury (TBI) remains a major cause of death and disability afflicting mostly young adult males and elderly people, resulting in high economic costs to society. Therapeutic approaches focus on reducing the risk on secondary brain injury. Specific ethical issues pertaining in clinical testing of pharmacological neuroprotective agents in TBI include the emergency nature of the research, the incapacity of the patients to informed consent before inclusion, short therapeutic time windows, and a risk-benefit ratio based on concept that (...) in relation to the severity of the trauma, significant adverse side effects may be acceptable for possible beneficial treatments. Randomized controlled phase III trials investigating the safety and efficacy of agents in TBI with promising benefit, conducted in acute emergency situations with short therapeutic time windows, should allow randomization under deferred consent or waiver of consent. Making progress in knowledge of treatment in acute neurological and other intensive care conditions is only possible if national regulations and legislations allow waiver of consent or deferred consent for clinical trials. (shrink)