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Reply to Moser and Röggla

2007, Intensive Care Medicine

Intensive Care Med (2007) 33:1484 DOI 10.1007/s00134-007-0702-3 T. C. Jansen E. J. O. Kompanje C. Druml D. K. Menon C. J. Wiedermann J. Bakker CORRESPONDENCE unauthorized use of the obligation to seek consent. If there would be no such obligation, then a deferred consent procedure would be equal to a complete waiver of consent. We disagree that implementing a time limit of 72 h would be impractical. This is illustrated by the questionnaire among clinicians in the Reply to Moser and Röggla field of neuro-critical care [3], and by the experiences in the early lactateAccepted: 16 April 2007 directed therapy study, in which the Published online: 1 June 2007 median time from randomization to © Springer-Verlag 2007 consent was only 1 day (interquartile range 0–3 days) and in which none of This reply refers to the comment the deceased patients without consent available at: http://dx.doi.org/10.1007/ had to be excluded due to overshoots00134-007-0701-4. ing the time limit [2]. It is clinically practical to approach relatives within Sir, We thank Moser and Röggla for a time period of 72 h. We support initiatives to explore their comments [1]. We agree that alternatives for solving this ethical it is preferable to use study data of dilemma. In our opinion, instead of patients who died before deferred using a 72-h threshold, consultation consent could be sought. As we described, not only does discarding data of an independent physician could probably jeopardize study results by also ascertain whether sufficient care introducing selection bias, it also has has been taken to seek consent prior to death, in order to legitimately use the other negative scientific and ethical data. Although the idea of Moser and effects [2]. However, implementing a policy Röggla to create a research objection that allows the use of all data of de- registry might seem attractive, we ceased patients without any consent, remind the research community that principally assuming that patients or objecting to organ transplantation is relatives do not object, can be unde- of post-mortem importance, whereas sirable, in our opinion. If a time limit experimental emergency research may have serious risks during life [4]. for seeking deferred consent (72 h is our recommendation) is not used, Furthermore, individuals can make valid predictions and considerations this might prevent researchers from seeking consent as early as possible, regarding organ-donation decisions, whereas in a research registry it provided there are no other laws in a specific country for such situations. would be impossible to assess the From a researchers’ point of view, it risk/benefit ratio of a particular future would be beneficial to postpone seek- research project beforehand. Lastly, we doubt that such a registry would ing consent, as this would increase be more cost-effective and practical the chance of including data in the analysis. The only importance of the than using data of patients who died early (within 72 h) without consent. time limit of 72 h is to prevent References 1. Moser B, Röggla G (2007) Not using data of patients who die before deferred informed consent potentially jeopardises emergency medical trials. Intensive Care Med 10.1007/ s00134-007-0701-4 2. Jansen TC, Kompanje EJ, Druml C, Menon DK, Wiedermann CJ, Bakker J (2007) Deferred consent in emergency intensive care research: What if the patient dies early? Use the data or not? Intensive Care Med 33(5):894–900 3. Kompanje EJ, Maas AI, Hilhorst MT, Slieker FJ, Teasdale GM (2005) Ethical considerations on consent procedures for emergency research in severe and moderate traumatic brain injury. Acta Neurochir (Wien) 147:633–640 4. Freeman BD, Danner RL, Banks SM, Natanson C (2001) Safeguarding patients in clinical trials with high mortality rates. Am J Respir Crit Care Med 164:190–192 T. C. Jansen · E. J. O. Kompanje (✉) · J. Bakker Erasmus MC University Medical Center, Department of Intensive Care, P.O. Box 2040, 3000 CA Rotterdam, The Netherlands e-mail: e.j.o.kompanje@erasmusmc.nl C. Druml Medical University of Vienna, Ethics Committee of the Medical University of Vienna and the Vienna General Hospital, Borschkegasse 8b, 1090 Vienna, Austria D. K. Menon University of Cambridge, Addenbrooke’s Hospital, Division of Anaesthesia, Box 93, CB2 2QQ Cambridge, UK C. J. Wiedermann Central Hospital of Bolzano, Department of Medicine, L. Böhler Street 5, 39100 Bolzano, Italy