The Current Situation And Demand Analysis Of Clinical Trial Liability Insurance In China

With the continuous development of medical science, new drugs, new medical devices and new medical technologies are being used continuingly and the number of all kinds of research projects increases a lot. Followed by endless variety of unsafe events, many cases with serious injury related to research are quite common. Clinical trials of medical liability insurance originated in the western countries, which was mainly designed for sharing the risks after serious adverse events occurred during clinical trials. It is also for these subjects to give security of life and property safety. Currently, the awareness and attention of clinical trial liability insurance is not enough in China, while this produced a series of medical disputes.This study aims to understand the status and demands of the liability insurance through data review, expert interviews and questionnaire on sponsors, investigators and participants, analyzing the reasons on being unable to advance clinical research liability insurance. Comparing to other developed countries, this study is going to find out. the gaps and shortcomings in order to strengthen the process of clinical research subjects protection and helping ethics committee to review protocols and informed consent forms. In doing all above, liability insurance for clinical research will ultimately be relevant to state laws and regulations as part of a policy to provide basis and help for decision making.Research content is mainly divided into the following aspects:①through literature approach to understand the domestic clinical trials and liability insurance status; ②through data access approach to understand a level 3 hospital’s(A hospital) clinical trial development situation, to understand the distribution and specific content of the liability insurance;③through questionnaires to select researchers, participants and sponsors from Hospital A, to understand their knowledge and needs of liability insurance;④inductive analyze the types and characteristics of clinical trial liability insurance; ⑤understand the liability insurance for clinical research subjects, sponsor and the investigator role in protection;⑥ find out the problems and difficulties of clinical trial liability insurance, through questionnaires and interviews on experts, leaders to understand the difficulties and problems of liability insurance;⑦explore the impact of clinical trial liability insurance propulsion factors;⑧summarize the future development of clinical trial liability insurance.From the research results, the rate of clinical trial liability insurance among our clinical studies is relatively low. The knowledge of clinical trial liability insurance is significantly different. There is misunderstanding among the meanings of clinical trial liability insurance. For the clinical trial liability insurance demands, the demand of three groups were generally higher objectively. Also, compared to other developed countries and regions, in the hope of a clinical trial liability insurance regulate them, we could truly protect the rights of subjects through laws and regulations and other ways as soon as possible.