Inspection of ethical issues in multicenter clinical trails in China: A survey of current status / 第二军医大学学报

ABSTRACT

Objective: To investigate the inspection mode of ethical issues for multicenter clinical trails in China, and to make analysis and give suggestions while taking into consideration of the international conventions. Methods: Representatives from 21 general hospitals and specialized hospitals from Liaoning province, Jiangsu province, Sichuan province, Guangdong province and Shanghai participated in a training course on promotion of ethical review capability; they were surveyed by anonymous questionnaire. Another 20 clinical trial agencies and ethical committees were interviewed by telephone. The questionnaires were collected and valid questionnaires were subjected to statistical analysis. Results: We found that 65.1% of the interviewees never used a central institutional review board (IRB); the main reasons included that they could not assess the quality of central IRB, they wanted to protect the subjects, they had a poor communication with the IRB, and they could not obtain a satisfactorily-localized informed consent forms. There were 34.9% of the interviewees used a central IRB, because they wanted to shorten the inspection time, avoid influence to the research progress, and to have satisfactory quality of IRB. Conclusion: Central IRB is not widely accepted. The related system needs to be further completed so as to improve the outcome of the inspection. The communication and cooperation between the central and local IRBs should be strengthened.