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Chinese Journal of Cerebrovascular Diseases(Electronic Edition) ›› 2023, Vol. 17 ›› Issue (06): 545-548. doi: 10.11817/j.issn.1673-9248.2023.06.003

• Original Article • Previous Articles    

A study on informed consent of cerebrovascular patients as subject in clinical trials

Xue Hong, Yuehong Pei, Yu Fu()   

  1. Office of Research, Peking University Third Hospital, Beijing 100191, China
    Department of Neurology Medicine, Peking University Third Hospital, Beijing 100191, China
  • Received:2023-04-16 Online:2023-12-01 Published:2024-01-12
  • Contact: Yu Fu

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.

Key words: Cerebrovascular disease, Clinical trials, Vulnerable groups, Informed consent

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