2017
DOI: 10.1007/s11673-017-9826-5
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An Exploration of the Protective Effects of Investigators’ Ethical Awareness upon Subjects of Drug Clinical Trials in China

Abstract: Up till now, China has not enacted any legal mechanisms governing certification or supervision for ethics committees. This article analyses deficiencies in the protection of subjects in clinical drug trials under China's current laws and regulations; it emphasizes that investigators, as practitioners who have direct contact with subjects, play significant roles in protecting and safeguarding subjects' rights and interests. The paper compares the status quo in China in this area to that of other countries and d… Show more

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Cited by 3 publications
(2 citation statements)
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“…Consequently, the demand for clinical trial resources, such as subjects, has witnessed a substantial annual upsurge. The quantity of registered clinical trials in China approached nearly 10,000 ( 2 ), yielding an impressive output value of 700 billion US dollars from 2016 to 2020. According to data from Informa Pharma Intelligence, the average annual growth rate for Phase I to Phase IV clinical trials stood at 20% ( 3 ).…”
Section: Introductionmentioning
confidence: 99%
“…Consequently, the demand for clinical trial resources, such as subjects, has witnessed a substantial annual upsurge. The quantity of registered clinical trials in China approached nearly 10,000 ( 2 ), yielding an impressive output value of 700 billion US dollars from 2016 to 2020. According to data from Informa Pharma Intelligence, the average annual growth rate for Phase I to Phase IV clinical trials stood at 20% ( 3 ).…”
Section: Introductionmentioning
confidence: 99%
“…A number of authors consider the ethical responsibilities that health professionals may have as a result of knowledge, be it knowledge that a prescribed drug might be used to end a patient's life (Duckett 2018) or knowledge that a patient will be returned to a harmful environment after discharge (Essex and Isaacs 2018). Other articles discuss the obligation of professionals to have and use knowledge in particular contexts, including the importance of ethical awareness amongst research investigators in China (Zhang, Huang, and Chen 2018) and the need to incorporate ethical and legal knowledge as an integral component of clinical decision-making (Parker et al 2018). The power and limits of information derived from clinical testing and the rights of (potential) parents to use this information is also a common thread.…”
mentioning
confidence: 99%