Investigation on Construction Status of Biomedical Research Ethics Committee Involving Human Beings in Medical Institutions in Guangzhou
10.12026/j.issn.1001-8565.2022.11.05
- VernacularTitle:广州医疗机构涉及人的生物医学研究伦理委员会建设现状调查
- Author:
Jing XU
1
;
Guanglie HUANG
2
;
Yu LUO
1
;
Siyi LIU
1
;
Yujun DONG
1
;
Junrong LIU
3
Author Information
1. Ethics Committee Office, Guangzhou First People’s Hospital, Guangzhou 510180, China
2. General Office of Guangzhou Municipal People’s Government, Guangzhou 510030, China
3. School of Marxism, Guangzhou Medical University, Guangzhou 511436, China
- Publication Type:Journal Article
- Keywords:
Medical Institutions;
Biomedical Research Ethics Committee Involving Human Beings;
Ethical Management;
Standardization Construction
- From:
Chinese Medical Ethics
2022;35(11):1196-1201
- CountryChina
- Language:Chinese
-
Abstract:
【Objective:】 To investigate the construction status of biomedical research ethics committee involving human beings in medical institutions in Guangzhou, and to provide the basis for the standardized management of ethics committee. 【Methods:】 The convenience sampling method was conducted to investigate the construction status of biomedical research ethics committee involving human beings in 58 medical institutions in Guangzhou. The SPSS 21.0 statistical software was used to analyze the data, and the chi-square test was used for difference analysis. 【Results:】 58 medical institutions had set up biomedical research ethics committee involving human beings. 50.00% of the ethics committees hired full-time secretaries, 33.96% of the ethics offices were administratively independent, 52.83% of the ethics offices were equipped with full-time staff, 79.17% of the ethics committees submitted paper documents for review, and 48.61% of ethics committees organized training irregularly. Comparison of the management of ethics committees of drug clinical trials and non-drug clinical trials was statistically significant (P<0.05). 【Conclusion:】 The management of ethics committee is generally good, but the standardization construction still needs to be further strengthened. It is recommended to strengthen the discipline construction and informatization construction of ethics committee, standardize the special training of ethics, improve the supervision systems of ethics committee, unify the construction standards of ethics committee, so as to improve the ability of ethics review, and effectively protect the safety, rights and interests of subjects.
