Togni Elena, Dierickx Kris, Porteri Corinna
Bioethics Unit, IRCCS San Giovanni di Dio Fatebenefratelli, Brescia, Italy.
Int J Geriatr Psychiatry. 2014 Jul;29(7):670-81. doi: 10.1002/gps.4059. Epub 2013 Dec 16.
Biobanks for research and genetic research are important opportunities to create new understanding of complex disorders, such as psychiatric disorders and dementia. The management of biobanks for subjects with psychiatric disorders or dementia raises additional challenges because of the ethical issues regarding the potentially impaired decision-making capacities of the subjects. The aim of this paper is to study (i) how guidelines address the matter and (ii) how they can be implemented in real research situations with patients suffering from psychiatric disorders and dementia.
We collected and analysed all the relevant guidelines and position papers from national and international organizations dealing with research on biological materials and selected documents mentioning the participation of incapacitated adults in genetic research and biobanks.
Eighteen of the 30 analysed documents contain explicit references to adults who are unable to give consent. The main topics addressed by the guidelines are the following: (i) informed consent; (ii) principles of non-therapeutic research; and (iii) ethics committee review.
In biomedical research, guidelines are an important instrument for facilitating research while promoting subjects' rights and well-being. Compared with legally binding documents, guidelines are more flexible and can be more easily revised according to evolving research situations and for adaptation to real persons and research settings. We suggest measures to implement the analysed guidelines taking into consideration the case for the participation of patients with neuropsychiatric disorders, who can have impairment of decision-making capacities without being obviously incompetent, in genetic research and biobanks.
用于研究和基因研究的生物样本库是增进对复杂疾病（如精神疾病和痴呆症）新认识的重要契机。由于涉及精神疾病或痴呆症患者潜在受损决策能力的伦理问题，管理此类患者的生物样本库面临更多挑战。本文旨在研究：（i）指南如何处理该问题；（ii）如何在针对患有精神疾病和痴呆症患者的实际研究中实施这些指南。
我们收集并分析了国家和国际组织发布的所有与生物材料研究相关的指南和立场文件，以及提及无行为能力成年人参与基因研究和生物样本库的选定文件。
30份分析文件中有18份明确提及无法给予同意的成年人。指南涉及的主要主题如下：（i）知情同意；（ii）非治疗性研究原则；（iii）伦理委员会审查。
在生物医学研究中，指南是促进研究同时保障受试者权利和福祉的重要工具。与具有法律约束力的文件相比，指南更具灵活性，能够根据不断变化的研究情况以及适应实际人群和研究环境而更轻松地修订。我们建议采取措施实施分析得出的指南，同时考虑到神经精神疾病患者参与基因研究和生物样本库的情况，这些患者可能存在决策能力受损但并非明显无行为能力的情况。
