Ethics management of clinical research application and self-evaluation of ethics from applicant in 2007 Capital Medical Development Scientific Research Fund / 中华医学科研管理杂志

ABSTRACT

Objective To evaluate the ethical management status quo of Capital Medical Research Fund in 2007.Methods Cross-sectional study was applied to analyze the ethics management and ethics self-evaluation in applications.Results There were 652 applications,covering with 14 districts and 2 counties in Beijing,from 128 Hospitals.Applicants have some knowledge of the ethical issues in clinical research accounted for 88.7％ ; informed consent of subjects considered in 72.5％ ;the potential risk and protection involved in application accounted for 62.0％; personal privacy protection of subject accounted for 49.4％.Unfortunately,the benefit vs risk assessment was only involved in 28.7％ applications.Applicants from general hospitals had more ethical issue knowledge (90.2％) than those from community hospitals (84.6％).Applicants from university hospitals had more ethical issue knowledge (93.9％) than those from military hospitals (80.2％).Applicants aged 55 0r over had less ethical issue knowledge (70.0％) than other applicants (89.2％).The applicants to study on descriptive research and etiological research had less ethical issue knowledge than others.578 applications filled out the approval from ethics committee or research management department.62.6％ of the written were acceptable.Conclusion The applicants for clinical research had preliminary understanding for ethical issues in Beijing in 2007.Hospital ethics committees or research management departments had conducted clinical research ethical review applications for funds management.It has taken place the external conditions to carry out the ethical management in clinical research fund management.