ABSTRACT
Objective To promote the Institutional Review Board(IRB) construction and development via paying more attention to the detail management and providing better protection of subjects' rights and interests in ethical review of clinical trials and scientific research projects.Methods Assessment criteria were established according to the domestic and international laws and regulations on the management of ethical and scientific research project.Ethical site visit was performed on the 37 clinical trials/scientific research projects approved by IRB during the year 2012-2015.Results Clinical trials/scientific research projects were divided into tree types:the registered clinical trials,the post-marketing clinical trials and the researcher initiated scientific research project.All the types met with the following assessment criteria:satisfy the requirement of equipment,facilities and qualifications of drug preservation required for conducting clinical research;subjects were given compensation according to the protocol;informed consent were obtained.Among them,the registered clinical trials meet more criteria than other research types.Regarding to the standard of informed consent implementation,all types met with the following assessment criteria:all the subjects enrolled signed informed consent forms,informed consent forms are well documented;investigators and subjects/ the guardian signed the forms.However,during the site visit,some other criteria were also neglected more or less.Particularly,only few project recorded the consent process and time spots singed the forms.Conclusions Investigators should pay more attention to the activities and behaviors taken place during the research implementation process.Researchers and management staffs should pay attention to ethical detail management to guarantee better protection of subjects' rights and interests.
ABSTRACT
With the widely development of psychiatric clinical researches,the ethical issue has been concerned gradually.Although the ethical review has strict rules on informed consent,there are many problems and challenges on informed consent implementation because of the special mental illness population.According to the relevant laws and regulations,combined with the characteristics of clinical psychiatric researches,this paper discussed the protection of subjects' fights and interests during the implementation of informed consent in psychiatric clinical researches,from the following aspects:providing a quiet,comfortable,and relatively independent environment for the participants to ensure informed consent,guaranteeing full informed consent time,choosing qualified researchers for informed consent,ensuring the effective process of informed consent,and guiding the subjects to correctly sign their names and the date.