ABSTRACT
Relying only on the ethics committee to protect subjects is not enough, and the construction of the subject protection system is an inevitable trend for the protection of subjects’ rights. This paper elaborated on the current situation of Chinese subject protection system from four aspects: the lack of laws and regulations and administrative supervision, the insufficient attention of hospitals, poor construction of the subject protection system, and the absence of responsibilities of relevant personnel. Then this paper put forward countermeasures from three aspects: improving laws and regulations and strengthening supervision, mobilizing relevant departments to participate, and strengthening relevant training, in order to standardize the construction of the subject protection system and promote the development of the subject protection work.
ABSTRACT
With the continuous improvement of the ethics committee status and the rapid growth of ethical review projects, the ethics committee urgently needs to establish an evaluation mechanism for continuous improvement. In view of a series of problems faced by the ethics committee in its daily management and operation, this paper discussed the concept and measures of introducing quality assurance and quality improvement into the ethics committee. Through comparing the advantages and disadvantages of the three models of quality assurance and quality improvement, this paper summarized the practical experience, further determined the internal evaluation, improvement model and evaluation elements of ethics committee, constantly improve the internal evaluation system of the ethics committee, strengthen the education and training of the ethics committee, and implement the whole chain electronic review, so as to improve the operation efficiency and review ability of the ethics committee, and provide sufficient ethical protection for the protection of the rights and interests of subjects.