Clinical Pharmacy and Pharmaceutical Care Unit, Department of Pharmacy and Pharmaceutical Technology and Physical Chemistry, Faculty of Pharmacy and Food Sciences, University of Barcelona, Barcelona, Spain.
Research Ethics Committee (CEIm) Idcsalud a Catalunya, Hospital Universitari General de Catalunya, Barcelona, Spain.
Eur J Neurol. 2020 Oct;27(10):1825-1831. doi: 10.1111/ene.14420. Epub 2020 Jul 20.
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.
The study comprised analyses of compliance with the checklists of 21 PISs and ICFs reviewed/approved during 2016-2017 by a medicinal research ethics committee.
All PISs/ICFs were from multicenter CTs sponsored by pharmaceutical companies in different therapeutic areas, mainly Parkinson's (52.4%) and Alzheimer's (38.1%) diseases. The PISs from the neurology service demonstrated good compliance (≥80%) with the checklist, whereas ICFs should be improved. Sponsors omitted some relevant information, such as the study title or that the participant be informed of any information arising from the research that may be relevant to the subject's health, although this information may be in the PIS.
The PISs/ICFs of CTs of medicinal products that are currently used need improvement. PISs and ICFs should be separate documents for each CT. In particular, the PISs/ICFs should consider the criteria related to the decision of participants, protect their rights and ensure that the information received is complete.
针对精神障碍等弱势群体开展的临床试验（CT）会带来伦理复杂性。知情同意书（ICF）应提供与患者决定参与 CT 相关的所有信息。知情后，患者将自行决定是否参与 CT，并阅读和签署知情同意书。本研究旨在评估某神经内科临床试验的知情同意书/知情同意过程（ICF）质量。评估采用经过验证和可靠的、包含 CT 用药物的 PIS/ICF 信息的检查表。
本研究对 2016-2017 年某医学伦理委员会审查/批准的 21 份 PIS 和 ICF 进行了分析，以评估其是否符合检查表要求。
所有 PIS/ICF 均来自不同治疗领域的制药公司赞助的多中心 CT，主要是帕金森病（52.4%）和阿尔茨海默病（38.1%）。神经内科的 PIS 符合检查表的要求（≥80%），而 ICF 则需要改进。申办方遗漏了一些相关信息，如研究标题，或告知参与者任何可能与自身健康相关的研究信息，尽管这些信息可能在 PIS 中。
目前使用的药物 CT 的 PIS/ICF 需要改进。每份 CT 都应单独制定 PIS 和 ICF。特别是，PIS/ICF 应考虑与参与者决策相关的标准，保护其权利，并确保收到的信息完整。
