District (county) hospitals are leading institutions delivering primary health services, which are responsible for providing local healthcare services, teaching and training medical talents, and carrying out medical research. However, their high-quality development has been restricted by limited scientific and technological innovation capability.

To review the studies published in recent 10 years on the treatment of clinical trial protocol violations, providing evidence for exploring paths to solve such violations during the cultivation of practical sci-tech innovation talents in district (county) hospitals.

In January 2022, studies on clinical trial protocol violations published between January 1, 2010 and December 31, 2021 were searched in databases of CNKI, WanFang Data, CQVIP, Baidu Wenku, PubMed, Medline, the Cochrane Library, Embase, and ClinicalKey using "临床试验" "医学伦理" "违规问题" as search terms in Chinese, and "Clinical Trial" "Ethical Issues" "Clinical Trial" "Ethical Problems" as terms in English. Clinical trial protocol violations were extracted and classified according to the nature of the violations. Systematic clustering algorithm was used to implement cluster analysis of the violations according to inter-cluster connection. Root cause analysis was used to explore the root causes of the violations.

The violations were divided into five classes (covering 27 subclasses) , and the first three were human subject protection (n=42, 33.6%) , clinical trial protocol (n=33, 26.4%) and informed consent (n=31, 24.8%) . Cluster analysis showed that the 125 violations could be grouped into two categories: authenticity (academic fraud) and compliance (violations) . The root causes of academic fraud and violations were as follows: insufficient research capability and low level of ethical knowledge in individuals or institutions; unsatisfactory punishment on individuals or institutions committing academic fraud; inadequate supervision of the sci-tech innovation achievements assessment and the ethical review system.

To solve academic fraud and ethical violations in trials, it is suggested to provide sci-tech innovation talents with practical ideology education on medical ethics that they should abide by in carrying out clinical trials by hospitals and colleges.

区（县）级医院是基层卫生服务的牵头医院，负责当地医疗及其教学、培训、研究工作。科技创新能力不足是影响其高质量发展的"瓶颈"。

总结近10年文献中出现的临床试验违规问题，以此为基础探讨区（县）级医院培养实用新型科技创新人才的路径。

于2022年1月，以"临床试验" "医学伦理" "违规问题"为中文关键词，"Clinical Trial" "Ethical Issues" "Clinical Trial" "Ethical Problems"为英文关键词，分别检索中国知网、万方数据知识服务平台、维普网、百度文库，以及PubMed、Medline、the Cochrane Library、EmBase、ClinicalKey数据库，获取发表时间为2010-01-01至2021-12-31的关于临床试验违规问题的相关文献。从文献中提取临床试验伦理违规问题并依据问题性质进行归类。采用系统聚类方法依据组间连接对违规问题进行聚类分析。采用根因分析确定主要问题的根本原因，并找出相应对策。

共纳入71篇文献，提取出125个临床试验伦理违规问题。125个问题依据相互之间关联度归类整理得出27小类，5个类别问题，其中排在前三位的类别问题为受试者保护问题（42个，33.6%）、临床试验方案问题（33个，26.4%）及知情同意方面的问题（31个，24.8%）。聚类分析结果显示，125个问题可聚类为真实性（造假）与合规性（违规）两大类问题。根因分析结果显示：导致造假、违规问题的根本原因是研究者科研能力不足，伦理知识欠缺；其次是对造假行为的惩处力度不够、科技创新成果评价及伦理审查体系不完善的监管问题。

未来解决造假与违规问题，可采取医教协同开展科技创新伦理思政实践教育的方法。