涉及精神障碍患者临床研究项目知情同意告知及签署的相关问题研究

Discussion on Issues Related to Informed Consent Notification and Signature in Clinical Studies of Patients with Mental Disorders

精神障碍疾病对患者的知情告知能力会产生一定的影响,进而对其是否自愿参与临床研究的能力产生影响。而临床实验必须经过患者的同意,由患者自主、自愿决定是否参与临床研究,临床研究只有在患者知情同意的条件下才能进行。对于不能正常开展知情同意的精神障碍患者,应进行伦理审查。通过对精神障碍患者临床研究的伦理审查要素进行分析,讨论精神障碍患者知情同意权伦理的正当性,并提出相应的完善途径,以期更好地开展临床研究,保护精神障碍患者的权利。

Mental disorders have a certain impact on the informed ability of patients,and then intervene the ability of voluntary participation in clinical research.The clinical experiment must be approved by the patients,and the patients decide whether to participate in the clinical research independently and voluntarily.It can be said that clinical studies can only be conducted with informed consent of the patient.Ethical review should be carried out for patients with mental disorders who can not fully give informed consent.This study analyzed the ethical review elements of the clinical research of the patients with mental disorders,discussed the legitimacy of the ethics of informed consent right of the patients with mental disorders,and put forward the corresponding improvement ways,which can better carry out the clinical research and safeguard the rights of the patients with mental disorders.