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China's Civil Code informed consent rules create practical dilemmas for cliniciansNew Rules for Informed Consent in Chinese Medical Practice

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Key Takeaway
Recognize that China's Civil Code informed consent rules create practical dilemmas requiring legal, cultural, and technological solutions.

This is a policy and practice review analyzing the informed consent rules under China's Civil Code (2021) and their impact on clinical practice. The review identifies several practical dilemmas: defensive formalism, ambiguity over the decision-maker, challenges in evidentiary architecture, and the 'inappropriate to explain' exception. These issues affect patient safety, equity for vulnerable populations, system-level trust, and the dispute burden on clinicians and institutions.

The authors note that while the Civil Code consolidates patients' right to informed consent and tightens the duty of disclosure, a gap remains between statutory rule and everyday medical activity. The review does not report any specific effect sizes, sample sizes, or comparative data, as it is a qualitative policy analysis.

Limitations are not explicitly reported in the source, but the review's scope is confined to the Chinese legal and clinical context. The authors propose reconstructing informed consent practice along legal, cultural, and technological dimensions to bridge the gap between legal compliance and patient-centered care.

For clinicians, this review highlights the need to navigate legal requirements while maintaining patient-centered communication, though specific practice recommendations are not provided.

This review examines the informed consent rules established under China's Civil Code of 2021. The study looks at how these laws affect medical staff and patients during clinical practice. While the law strengthens a patient's right to know about their treatment, there is still a gap between these legal requirements and what happens in daily hospital activities.

Several practical problems were identified for doctors and hospitals. These include issues with defensive formalisms, unclear rules on who can make decisions for others, and situations where it is deemed inappropriate to explain certain details. These gaps can create extra burdens for medical staff and institutions when trying to follow the law while providing care.

The review suggests that improving patient-centered care requires looking at these problems through legal, cultural, and technological lenses. Because this is a policy review rather than a clinical trial, it does not provide specific medical outcomes. It focuses on how healthcare systems can better balance legal compliance with clear communication for patients.

What this means for you:
New laws strengthen patient rights to informed consent but face practical hurdles in daily hospital settings.

Common questions

What are the main challenges with informed consent?

The review identifies several practical dilemmas. These include defensive formalism, ambiguity over who can make decisions for a patient, and issues with how evidence is structured. There is also an exception for cases where it is considered inappropriate to explain certain details to the patient.

How does the 2021 Civil Code affect patients?

The Civil Code of 2021 consolidates a patient's right to informed consent and tightens the duty of disclosure for medical staff. However, researchers found that a gap still exists between these statutory rules and everyday activities in clinical practice.

How does this impact medical staff?

The current gaps in how consent is handled can lead to a higher burden of disputes for both clinicians and their institutions. The review suggests that better integration of legal, cultural, and technological factors could help improve the system.

Study Details

Study typeSystematic review
EvidenceLevel 1
PublishedJun 2026
View Original Abstract ↓
China's Civil Code (2021) consolidates patients' right to informed consent and tightens the duty of disclosure owed by medical staff. In clinical practice, however, the substantive provisions of the Civil Code have not dissolved the persistent gap between statutory rule and everyday medical activity. This Policy and Practice Review diagnoses four interlocking practical dilemmas in the operation of the Code's informed-consent rule—covering defensive formalism, ambiguity over the decision-maker, the evidentiary architecture for consent and refusal, and the open-textured “inappropriate to explain” exception—and proposes a corresponding reconstruction along legal, cultural and technological dimensions, drawing on the reasonable-patient standard articulated in Canterbury v. Spence and Montgomery v. Lanarkshire Health Board (1, 2) and reaffirmed by the American Medical Association (3), the doctrine of therapeutic privilege as theorized by Faden and Beauchamp (4), and international guidance on informed-refusal documentation (5). By examining the institutional, cultural and technical factors contributing to these challenges, the article articulates implications for patient safety, equity for vulnerable populations, system-level trust and the dispute burden borne by clinicians and institutions, with a view to harmonizing legal compliance with humanistic, patient-centered care.
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