涉及精神障碍患者临床研究的伦理审查要素

Ethical Review Elements for Clinical Research in Patients with Mental Disorders

精神障碍疾病可能会影响患者理解知情告知的能力,也可能会影响其做出是否自愿参加临床研究的理性决定能力。而临床试验规定需在受试者知情同意的情况下才能开展,因此在对涉及精神障碍患者参与临床研究,但不能充分给予知情同意时,严格的伦理审查显得尤为重要。通过对涉及精神障碍患者临床研究的伦理审查要素进行分析,以期更好地开展精神障碍患者参与临床研究的伦理审查工作。

Mental disorders may affect patients＇ ability to understand informed consentand may affect their ability to make rational decisions about whether they voluntarily participate in clinical research. However, the clinical trial requirements must be conducted with the informed consent of the subjects. Therefore, rigorous ethical review is particularly important when the patients with mental disorders participate in clinical research but can＇ t adequately give informed consent. This paper analyzed the ethical review elements of clinical research involving patients with mental disorders, in order tobetter carry out ethical review for patients with mental disorders participating in clinical research