摘要
知情同意既是伦理审查的关键项，也是保护研究参与者安全与权益的关键手段，更是研究者伦理准备工作中普遍存在的难点。而脑血管病容易导致患者民事行为能力受限，更是大大增大了知情同意的难度。研究团队根据多年工作实践，总结了脑血管病患者作为研究参与者知情同意方面的三大主要困境，并就研究者主观意识和责任追究、伦理管理机构作用加强以及代理知情同意给出了改进建议，希望能够有助于提高脑血管病患者作为研究参与者的知情同意效果，更加有效地保护民事行为能力受限的研究参与者的权益和安全。
Abstract
Informed consent is not only a key item of ethical review, but also a key to protecting the safety and rights of research participants. It is also a common difficulty in the ethical preparation work of researchers. Cerebrovascular disease is easy to lead to patients with limited civil behavioral ability, which greatly increases the difficulty of informed consent. Based on years of practice, the research team summarized the three major dilemmas in the aspect of informed consent of patients with cerebrovascular diseases as study participants, and offered suggestions on the subjective awareness and accountability of researchers, the strengthening of the role of ethical regulatory bodies and surrogate informed consent, hoping to help improve the effect of informed consent of patients with cerebrovascular diseases as study participants, and more effectively protect the rights and interests of participants in research with limited capacity for civil conduct.
基金项目
2023年北京市重大疑难疾病中西医协同攻关项目示范项目(2023BJSZDYNJBXTGG-015)
万方数据