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.