ArticleBMC medical ethics2025
Research on issues in the protection of clinical trial human subjects in China: a Delphi study.
Article in BMC medical ethics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
Abstract
backgroundThis study aims to identify current deficiencies in the protection of human subjects participating in clinical trials in China and propose strategies for safeguarding their rights.
methodsWe conducted a comprehensive literature review on the protection of human subjects in clinical trials and gathered insights from experts and scholars among stakeholders. The Delphi expert consultation method was used to analyze and summarize the shortcomings in China’s regulatory framework for human subject protection and to develop strategies for improvement. Two rounds of surveys were conducted with experts from research institutions, ethics committees, regulatory agencies, sponsors, and Site Management Organizations (SMOs). The top three issues and proposed solutions were discussed and addressed based on expert consensus.
resultsA total of 30 articles were reviewed, leading to the identification of 46 distinct issues, which were categorized into three groups: compensation, privacy, and informed consent. Sixteen respondents completed both rounds of the survey, which included 56 questions (10 new questions were proposed in the first round). Compensation-related issues included the absence of a comprehensive “mandatory insurance system,” incomplete insurance systems and compensation procedures, and the lack of clear differentiation between liability for clinical trial infringements and medical harm. Privacy concerns involved inadequate regulations, privacy risks associated with third-party recruitment, and data entry by clinical research coordinators. Problems related to informed consent were primarily due to inadequate awareness and capacity among investigators, a lack of oversight by ethics committees, and the absence of legal standards for broad informed consent.
conclusionsBy improving the details of compensation rights, privacy protection, and informed consent in regulations, all parties involved in clinical trials can be encouraged to more effectively protect the rights and interests of subjects.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.