Department of Epidemiology, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, The Netherlands.
Int J Neuropsychopharmacol. 2013 Apr;16(3):677-82. doi: 10.1017/S146114571200048X. Epub 2012 May 21.
In psychiatric practice, pharmacogenetics has the potential to identify patients with an increased risk of unsatisfactory drug responses. Genotype-guided treatment adjustments may increase benefits and reduce harm in these patients; however, pharmacogenetic testing is not (yet) common practice and more pharmacogenetic research in psychiatric patients is warranted. An important precondition for this type of research is the establishment of biobanks. In this paper, we argue that, for the storage of samples in psychiatric biobanks, waiving of consent is not ethically justifiable since the risks cannot be considered minimal and the argument of impracticability does not apply. An opt-out consent procedure is also not justifiable, since it presumes competence while the decisional competence of psychiatric patients needs to be carefully evaluated. We state that an enhanced opt-in consent procedure is ethically necessary, i.e. a procedure that supports the patients' decision-making at the time when the patient is most competent. Nevertheless, such a procedure is not the traditional exhaustive informed consent procedure, since this is not feasible in the case of biobanking.
在精神科实践中，药物遗传学有可能识别出药物反应不佳风险增加的患者。基于基因型的治疗调整可能会增加这些患者的获益并减少伤害；然而，药物遗传学检测尚未成为常规做法，需要在精神科患者中开展更多的药物遗传学研究。此类研究的一个重要前提条件是建立生物库。在本文中，我们认为，由于风险不能被认为是最小的，并且不适用不切实际的论点，因此在精神科生物库中储存样本时，放弃同意在伦理上是站不住脚的。选择退出同意程序也站不住脚，因为它假设了决策能力，而精神科患者的决策能力需要仔细评估。我们指出，强化的同意程序在伦理上是必要的，即一种在患者最具能力时支持患者决策的程序。然而，这种程序并不是传统的详尽知情同意程序，因为在生物库的情况下，这种程序是不可行的。
