ABSTRACT
Objective:By analyzing the data of Investigator-Initiated Trials (IITs) in a grade A tertiary hospital and common problems in the initial ethical review, this study puts forward corresponding countermeasures, providing a reference for standardizing the ethical management of clinical scientific research projects in medical institutions.Methods:A causal analysis was conducted based on the statistics of the number of IITs undergoing ethical review in a grade A tertiary hospital from January 2012 to August 2021, and the analysis of the problems in the ethical formal review of 271 clinical research involving human beings.Results:At present, there are some problems in scientific research ethics, such as weak review execution, inadequate supervision, and weak ethical awareness of researchers.7 targeted measures were put forward.Conclusions:Establishing a hospital subject protection system, strengthening the construction of a scientific research ethics supervision system, refining ethical norms and standards, and promoting the institutionalization of scientific research ethics training are of great importance for standardizing investigator-initiated clinical research, improving research quality, avoiding scientific research ethical risks, and effectively guiding the ethical management of clinical research in hospitals.
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.
ABSTRACT
The competence of scientific research ethnical review in domestic hospital was inadequate,which was associated with the development of medical ethnics,values of Chinese traditional society,unsound domestic laws and regulations,weak administrative management,unqualified committee of medical ethnics,the drive of scientific deriving interests and restriction of project funds.Aiming at the above problems,countermeasures were carried out to strengthen the construction of laws and regulations,strengthen the constraint of administrative management,standardize the self-construction of ethnic committee,implement the standard operative procedure,thus to provide a reference for the standardized construction of scientific research ethnical review.
ABSTRACT
Objective:To summarize the opportunities,challenges and countermeasures that China Food and Drug Administration (CFDA) joining ICH-GCP will bring to the construction of ethics committee,so as to provide reference for the standardization construction and review ability of ethical committee in China.Methods:We reviewed and comprehensively analyzed the domestic literatures about the requirement for ethics committee after CF-DA join ICH-GCP.Results:CFDA joining ICH-GCP was conducive to speeding up the construction of Chinese ethics committee.Aiming at the challenge of the standardization construction of ethics committee,it could use the revised policy regulations and guidelines to integrate with ICH-GCP,establish ethics certification system in line with the national condition,clear the composition of members,standardize operational procedures,and establish regional ethics committee and leader the review of the unit system;to improve the review ability,it could strengthen reviewing requirement from the aspects of sponsor responsibilities,researchers qualification,research protocols,informed consent,researcher brochures and documents management.Conclusion:CFDA joining ICH-GCP brings a rapid development opportunity for the ethics committee as well as challenges.We can solve problems from standardization construction and the improvement of review ability,to speed up the construction of ethics committee that meets the requirements of ICH-GCP.
ABSTRACT
As a new branch of subject,pediatric emergency medicine developed rapidly but imbalanced.In this article,we reviewed the current situation of pediatric emergency medicine,analyzed the existed main problems and put forward some proposals about its development.Because we lacked professional and standardized medical team and systems,personnel configuration distributed unreasonably,pre-hospital transport developed relatively backward and scientific researches in this field do not have big progress,we are now still in lack of unified documents which are suitable for our national conditions as a guideline.So it is highly important to organize specialized talent training,introduce some new technologies and strengthen multidisciplinary cooperation for further constitute and promote guideline.
ABSTRACT
Pediatric Critical Care Medicine have developed rapidly and played a big role in the clinical treatment in China in recent years.But we axe now still in lack of unified documents as a guidline because of our late development and difference between regions.We should pay more efforts to formulate and perfect the standardization constructions of pediatric intensive care unit,with the help of The Construction and Management of Critical Care Medicine.In this article,we stated the present situation of development,operational mode,personnel and equipment configuration,monitoring and treatment technology,process specification and quality index in pediatric intensive care unit.And we also offerd some proposal about that.