Bajs Maja, Janović Spiro, Henigsberg Neven, Dordević Veljko
Klinika za psihijatriju Medicinskog fakulteta, KBC Zagreb.
Lijec Vjesn. 2007 Oct-Nov;129(10-11):322-6.
Informed consent is a legal procedure when including a person in the treatment, diagnostics or research which includes information, voluntarism and capacity to consent of the participant. Capacity to consent is related to decision-making process and could be influenced by various factors. Assessment of capacity to consent is still clinical, because there are no widely accepted standards and assessment instruments. Persons with mental disorders could have some deficits in capacity for decision-making that could be temporary or permanent. Ethical considerations in the research with participants not able to consent are related to benefit vs. non-benefit studies and risk assessment. Finding of the better methods for capacity assessment and capacity enhancement could improve selection of the research participants. Legal recommendations, including international declarations and conventions, as well as the related Croatian laws are important mechanisms for safeguards of the persons with mental illness in biomedical research.
知情同意是将个人纳入治疗、诊断或研究时的一个法律程序，其中包括信息、自愿性和参与者的同意能力。同意能力与决策过程相关，可能会受到各种因素的影响。同意能力的评估仍然是临床性的，因为没有广泛接受的标准和评估工具。患有精神障碍的人在决策能力方面可能存在一些缺陷，这些缺陷可能是暂时的或永久的。对无法同意的参与者进行研究时的伦理考量与利弊研究和风险评估有关。找到更好的能力评估和能力增强方法可以改善研究参与者的选择。包括国际宣言和公约以及克罗地亚相关法律在内的法律建议是生物医学研究中保护精神疾病患者的重要机制。
