Study Of The Current Situation Of The Ethical Review To Biomedical Research In One Of Grad Three A Hospital Of Xinjiang

Objective: To analysis and describe the recently situation of biomedical research ethics review in a Grade Three A hospital of Xinjiang, through the investigation on the general situation, the situation of clinical research ethics review, and the records and files of the hospital ethics committee. Method: Using The self-designed questionnaire to classify the information of biomedical research ethical review within 2012—2013. Using constituent ratio to describe enumeration data, and chi square test to comparison between groups, with α=0.05 as the test level. Results: The investigation shows: ①the structural proportion of the members, the times and interval of ethical review meeting, the number of participants and cases in all review meetings were meet the requirements of the ethical committee. ②Within 2012—2013,259 cases were reviewed, 55.6% of them were scientific research cases at all levels,44.4% were others. ③Compared with 2012, the passing rate of ethical review was lower, and modification suggestion was more in 2013. ④In the cases passed ethical review, modification opinions to scientific research cases at all levels were more than other cases. ⑤There are 13 cases of all failed to pass the ethics review, the causes can be divided into: scientific review did not pass, legal review did not pass and other factors. ⑥The more modification opinions was given to 3 observation indexes: the benefit is clear or not, the content cooperating by the subjects is clear or not, the informed consent form is written specification or not. Conclusion: The development of biomedical science and technology is changing every day, and the controversy of the society, law and ethics has become more and more. Within the precondition of abiding specifications on biomedical research ethics and laws, to constantly seek for the unification of the fairness in scientific ethics review and the requirements in specific context of situation, through improving of construction of hospital ethics committee, and perfecting the standards of ethical review and scientific and technological project application.