■中国的伦理委员会无法满足日益增长的对人类参与者保护的需求。近年来的几起丑闻表明,中国在保护人类参与者方面存在弱点。
■本研究的目的是总结中国人类研究保护计划的现状和问题,并探讨其在国家和医院层面的建立建议。
■进行文献检索,中国国家知识基础设施,中国生物医学文献数据库,和英文数据库WebofScience和PubMed进行了搜索;法律,指导方针,谷歌和中国搜索引擎百度也在网上搜索了法规。
■没有从人类参与者收集数据,道德审查是不需要的。
■中国的人类研究保护计划存在问题,如相关法律制度薄弱,行政监督不够,和无能的道德委员会能力。为了充分保护人类参与者,中国应促进人类研究保护计划的发展,可以制定与道德相关的法律,完善保护人类参与者安全和权利的法规,加强监督,并强制补偿人类参与者。由于中国医院招募人类参与者的频率,医院可以利用现有的伦理委员会,建立数据和安全监测委员会,质量控制,基金和合同管理,和利益冲突管理办公室。
■作为一个不断发展的计划,有必要借鉴发达国家的高伦理标准的经验,并重新制定适合中国国情的经验,以探索潜在的未来发展。该计划也将成为其他发展中国家的经验。
■人类研究保护计划可以加强医院各部门之间的沟通与协调,以有效保护人类参与者的权利和福利。
UNASSIGNED: China\'s ethics committees alone are unable to meet the growing need for human participant protection. Several scandals in recent years indicate weaknesses in the protection of human participants in
China.
UNASSIGNED: The aim of the study is to summarize the status and problems of human research protection program in
China and to explore its establishment proposals at national and hospital levels.
UNASSIGNED: To conduct literature retrieval, Chinese National Knowledge Infrastructure, Chinese Biomedical Document Database, and English databases Web of Science and PubMed were searched; laws, guidelines, and regulations were also searched on web by Google and Chinese search engine Baidu.
UNASSIGNED: No data were collected from human participants, and ethical review was not required.
UNASSIGNED: There are problems for
China\'s Human Research Protection Program, such as weak relevant legal systems, insufficient administrative supervision, and incompetent ethics committee capacities. To fully protect human participants,
China should promote the development of Human Research Protection Program, which can formulate ethics-related laws, improve regulations for the protection of the safety and rights of human participants, strengthen supervision, and enforce compensation for human participants. Owing to the frequency with which human participants are recruited in hospitals in China, hospitals can utilize existing ethics committees and establish data and safety monitoring committees, quality control, fund and contract management, and conflict of interest management offices.
UNASSIGNED: As a growing program, it remains necessary to learn from the experience of developed countries with high ethics standards and reformulate them to fit China\'s conditions to explore potential future development. The program will also be an experience for other developing countries.
UNASSIGNED: Human Research Protection Program can strengthen communication and coordination among various hospital departments to effectively protect the rights and welfare of human participants.