Clinical trials (CTs) aimed at vulnerable groups, such as patients with mental disorders, create ethical complexity. The patient information sheet (PIS) should provide all of the information about the CT that is relevant to the subject's decision to participate. After being informed, the subject will decide freely whether to take part in the CT and will read and sign the informed consent form (ICF). The objective was to assess the quality of PISs/ICFs from a hospital neurology service. The assessment was made using validated and reliable checklists of the information included in the PISs/ICFs of CTs with medicinal products.

中文翻译：

---

在医院神经病学服务处评估患者信息表和知情同意书的质量，以进行临床试验。

针对弱势群体（例如精神障碍患者）的临床试验产生了道德上的复杂性。患者信息表（PIS）应提供与CT有关的所有与受试者决定参加相关的信息。被告知后，受试者将自由决定是否参加CT，并将阅读并签署知情同意书（ICF）。目的是评估医院神经病学服务所提供的PIS / ICF的质量。评估是使用经过验证的可靠清单的带有药品的CT的PIS / ICF中包含的信息进行的。