Are human subjects in clinical trials fully protected in China? An empirical study of court judgments.
- 1Law School of Central South University, No. 932 South Lushan Road, Changsha Hunan 410083, P.R. China.
- 2Law School and Institute of Cultural Heritage of Central South University, Changsha, P.R. China.
Abstract
Clinical trials are indispensable to biomedical innovation, yet their experimental nature exposes human subjects to heightened and often unforeseeable risks. Since 1978, China has continually sought to strengthen statutory protections for trial subjects. However, it remains unclear whether judicial practice has effectively enforced these protections. Drawing on an original dataset comprising all publicly available Chinese court judgments involving clinical-trial disputes, this study offers the first systematic empirical assessment of judicial protection for subjects' rights concerning compensation for trial-related physical harm and informed consent. We code key trial characteristics and examine how these characteristics, along with courts' protective adaptations, shape judicial outcomes. The analysis yields three principal findings. First, courts overwhelmingly subsume clinical-trial disputes under conventional medical tort liability, reflecting a persistent conflation between clinical research and therapeutic treatment. Second, trial subjects face significant obstacles in prevailing at trial due to stringent evidentiary burdens. Third, while some courts have introduced protective judicial innovations, such as contractual reframing, burden-shifting mechanisms, and substantive review of informed-consent practices, these measures remain fragmented and unsystematic. Together, these findings underscore a significant disparity between law on the books and law in action regarding the protection of clinical-trial subjects. To address this discrepancy, we propose reforms to strengthen the protection of human subjects in clinical trials.
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BibTeX
@article{chen2026human,
title = {{Are human subjects in clinical trials fully protected in China? An empirical study of court judgments.}},
author = {Fanhong Chen and Hongjiao Zhang and Caisi Fu},
journal = {Journal of law and the biosciences},
year = {2026},
month = jul,
doi = {10.1093/jlb/lsag029},
url = {https://europepmc.org/article/MED/43011911},
note = {CC BY-NC-ND},
}
RIS
TY - JOUR
TI - Are human subjects in clinical trials fully protected in China? An empirical study of court judgments.
AU - Fanhong Chen
AU - Hongjiao Zhang
AU - Caisi Fu
PY - 2026
DA - 2026/07/01
JO - Journal of law and the biosciences
DO - 10.1093/jlb/lsag029
UR - https://europepmc.org/article/MED/43011911
AB - Clinical trials are indispensable to biomedical innovation, yet their experimental nature exposes human subjects to heightened and often unforeseeable risks. Since 1978, China has continually sought to strengthen statutory protections for trial subjects. However, it remains unclear whether judicial practice has effectively enforced these protections. Drawing on an original dataset comprising all publicly available Chinese court judgments involving clinical-trial disputes, this study offers the first systematic empirical assessment of judicial protection for subjects' rights concerning compensation for trial-related physical harm and informed consent. We code key trial characteristics and examine how these characteristics, along with courts' protective adaptations, shape judicial outcomes. The analysis yields three principal findings. First, courts overwhelmingly subsume clinical-trial disputes under conventional medical tort liability, reflecting a persistent conflation between clinical research and therapeutic treatment. Second, trial subjects face significant obstacles in prevailing at trial due to stringent evidentiary burdens. Third, while some courts have introduced protective judicial innovations, such as contractual reframing, burden-shifting mechanisms, and substantive review of informed-consent practices, these measures remain fragmented and unsystematic. Together, these findings underscore a significant disparity between law on the books and law in action regarding the protection of clinical-trial subjects. To address this discrepancy, we propose reforms to strengthen the protection of human subjects in clinical trials.
SN - 2053-9711
ER -