ABSTRACT
For multi-center clinical research, how to ensure the quality of ethical review and improve the efficiency of ethical review through cooperation among centers is an important direction for clinical research management departments and research parties to explore. By combing and analyzing the existing pattern of multi-center ethical review at home and abroad, combining the current situation of the ethical review and management development in China, taking cancer clinical research as the breakthrough point, it was advocated to establish a cooperative review led by professional institute in domestic, on the basis of extensive and in-depth training exchanges and effective communication on the same platform, collaborative review, ensure quality and efficiency, so as to promote and implement the "mutual recognition" of ethical review. Then, this paper further put forward the concept of "whole-process linkage" in the ethical management process of multi-center clinical research, and pointed out that all research parties should clarify their responsibilities, enhance their awareness and ability, and jointly and comprehensively implement the protection of subjects among clinical researchers.
ABSTRACT
Objective To discuss appropriate strategies of site visits in ethical committees ,to enhance the supervision of clinical trials effectively ,and standardize the implementation of clinical research .Methods In consideration of the lack of de-tailed normative description of site visit in ethical guidelines and relevant articles ,as well as the varying degrees of implementa-tion and understanding of site visits among different ethical committees .This article discussed the procedures ,contents and considerations of site visit based on the analysis of numerous site visits cases conducted .Results Site visit is one of the crucial procedures to more comprehensive ,in-depth and truly understanding of the implementation of clinical trials .It is helpful to help sponsors/investigators enhance awareness and compliance with the good clinical practice .It also helps to correct problems time-ly during the implementation process to assure the standardized implementation of follow-up studies ,and finally ,effectively protect the rights and interests and safety of subjects .Conclusions Standardized and efficient site visit strategy of the ethical committee is one of the important regulatory strategies in the implementation of clinical trials and is an effective supplement to the regular review of ethical materials .
ABSTRACT
At present,China has not formed a complete ethical review agency certification system,actively participating in international certification and seeking external quality assessment is of great significance for the improvement of standard management and review capacity of ethics committee.Combined with the experience of Peking University Cancer Hospital applying for SIDCER international certification,this paper expounded the responsibilities of ethical secretary in international certification from the overview of international certification system and the work practice during the certification process,to promote the progress ethics committee applying for certification and achieve satisfactory quality assessment results.
ABSTRACT
To explore ethical issues related to the protection of AIDS patients' rights in the prevention and treatment of AIDS.This paper elaborated in detail the importance of protecting personal privacy of AIDS patients and protecting them against discrimination and unfair treatment in the prevention and treatment of AIDS.It also expounded the relevant ethical,legal and regulatory basis of AIDS patients'rights protection,and how to protect the individual rights of AIDS patients in AIDS prevention and control,while protecting the public health.
ABSTRACT
AIM:To investigate apoptosis and the expression of death receptors of TRAIL, TNF and Fas on hepatic veno-endotheliocyte ED25 cell strain induced by dengue virus type 2(DV2).METHODS: Flow cytometric analysis was used to detect the number of apoptotic cells and the expression levels of TRAILR1-4 ,TNFR1-2,Fas on ED25 cells before/after DV2 infection. RESULTS: The numbers of apoptotic cells of ED25 increased after DV2 infection, there were only about 5.7%?1.2% of apoptotic cells before virus infection while there were approximately 27.3%?1.6% of apoptotic cells after virus infection. At the same time the expression level of Fas also increased, before virus infection about 44.3%?2.2% of ED25 cells expressed Fas while 63.0%?2.3% of ED25 cells expressed Fas after virus infection. CONCLUSION: DV2 infection can induce apoptosis of ED25 cells, and it suggests strongly that Fas/FasL may be involved in the apoptotic signal transduction.
