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
【Objective:】 To understand the differences in motivation of different groups to participate in phase I clinical trials, and to provide suggestions for the recruitment and management of healthy subjects in research institutions, so as to improve the quality of clinical trials and protect the subjects’ rights and interests. 【Methods:】 Questionnaire survey was conducted among healthy subjects and potential community subjects in phase I clinical trials being carried out in a tertiary A hospital in Beijing from 2020 to 2021. SAS 9.2 was used for statistical analysis of data. 【 Results:】 There were many dimension differences between phase I ward subjects and community potential subjects in demographic and sociological characteristics, motivation to participate in the trials and influencing factors of motivation to participate in the experiment. Subjects in phase I ward paid more attention to the trial compensation, health care, social interaction and making friends, and the attitude of family or friends towards their participation in the trials. Community potential subjects were more concerned about trial quality, future potential benefits (contributing to the medical profession), and the impact on their own health and life. 【Conclusion:】 Research institutions should be aimed at different social background population stratification for recruitment, informed consent, personnel management system and the standard operating procedure, and pay attention to the subjects’ psychological and physiological needs from several aspects to standardize the management of subjects, improve the compliance of subjects to participate in the trial and the quality of clinical trials, and give more humanistic care and help to subjects.
ABSTRACT
Taking a class A tertiary hospital in Shanghai as center, this paper understood the awareness of the subjects of drug clinical trials on their participation in the research and their own rights as subjects after the end of research (6～18 months) by questionnaire survey completed by telephone interview, analyzed the problems existing in the process of informed consent, compared with the foreign status, and summed up a variety of feasible ways of subject' s own right to be informed, to put forward feasible suggestions for the development and improvement of medical scientific research management and the ethical work in China.