Study On The Implementation Of Informing Consent System For Hospital Drug Clinical Trials

The consent informed in the drug clinical trials means that before a drug clinical trial is conducted,the investigators must not only fully explain the research process to the subjects,but also gain their understanding at the same time.And then the subjects should freely express their willingness to participate under conditions out of threats and inducements,including signing the informing consent form and getting familiar with the consent process.With the continually development of pharmaceutical research,people become more aware of their rights,the implementation of the informing consent system for subjects in the management of clinical trials is becoming more and more important.Compared with Western countries,the management of informed consent for drug clinical trials in China started a little later,but has developed very rapidly.Government health administration departments and hospital management departments attach great importance to the management of informed consent for clinical trials in hospitals,and have invested a large amount of financial,material and human resources to conduct in-depth and rigorous research,which has achieved effective results.In recent years,China has promulgated regulatory documents such as the Guidelines for Ethical Review of Drug Clinical Trials,the Measures for Ethical Review of Biomedical Research Involving Human Beings,and the Code for Quality Management of Drug Clinical Trials.The documents made the request for the content of the informing consent and the process of how to obtain it,aiming to strengthen the protection of subjects in the drug clinical trials in terms of regulatory guidelines.Nevertheless,we are well aware of that many problems still exist in the implementation of the informing consent system in drug clinical trials of China.The level of management of drug clinical trials varies greatly among different regions and different levels of hospitals.And the informing consent in clinical trials often caused the controversies,with some cases are even made public on social media,suggesting the loopholes in the informing consent system.Thus,implementing the informing consent system for subjects could ensure the legality and validity of clinical trial conduct and reduce the occurrence of clinical trial disputes.Meanwhile,it also reflects the respect on the autonomy of the subjects.This study adopted the method of literature analysis,expert consultation and questionnaire survey.Wanfang,CNKI and other databases as well as the management platform of national drug clinical trial regulatory authorities have been used understand the latest policies,regulations and implementation status of informing consent system for drug clinical trials at domestic and overseas.Two questionnaires were designed to investigate the clinical trial investigators and subjects in a public hospital in Lucheng District,Wenzhou City,at the medical institution and the social level.The survey was conducted to obtain the information on the current status of implementation of the drug clinical trial policy and analyze the reasons.Meanwhile,the in-depth interviews with health administrators,hospital clinical trial managers and sponsors were conducted and the results were analyzed to summarize the problems and factors affecting the implementation of the informing consent system for hospital drug clinical trials.The improvement countermeasures were provided at three levels of government,healthcare institutions and society(subjects).The government should strengthen the legislation on clinical trials,improve the clinical trial management norms and technical standards in hospitals,monitoring of clinical trial implementation processes,and refine informing consent procedures.At the hospital level,the government should focus on the cooperation among various departments,strengthen the construction of clinical trial teams,establish a comprehensive drug clinical trial assessment and evaluation system,promote the training of investigators and improve the construction of the subject protection system.At the social level,we focus on the promotion and education of subjects,use the power of industry and the media to create a harmonious environment for the implementation of informing consent,ultimately build a "government-hospital-society(subjects)" linkage platform,which bring into play the role of government guidance,implementation by medical institutions and supervision by the public.Thus,it is better to implement the informing consent system,protect the rights and interests of subjects,promote the healthy development of drug clinical trials,and better benefit the people.