Conflict Of Interest In Clinical Trials And Protection Of Subjects’ Rights And Interests

Clinical trial play an important role in the breakthrough progress of human biomedical field.With the increasingly close relationship between biotechnology companies and research institutions,the number of drug clinical trials funded by biopharmaceutical companies is also increasing.On the one hand,it is conducive to the transformation of scientific and technological achievements,promoting the development of Science and technology and economy,on the other hand,it also makes medical The interest relationship in clinical trials is becoming more and more complex,which leads to the conflict of interest.The researchers of clinical trials are not only the producers of scientific and technological achievements,but also the holders of market economic interests.The main interests of maintaining the rights and interests of subjects,safeguarding the safety of clinical trials,and the secondary interests of personal business,such as income and reputation,are prone to conflict,making them make unreasonable judgments and decisions that harm the rights and interests of subjects.This will seriously affect the objectivity of the test results and pose a great threat to the life and health of the subjects.In recent years,the level of biological research in China has been improving,the number of clinical trials has been increasing rapidly,and there are also problems such as conflicts of interest that damage the rights and interests of subjects.How to standardize the implementation of clinical trials and protect the legitimate rights of subjects has become an urgent legal problem.In the United States,the legal regulation system for the protection of subjects’ rights and interests has developed earlier than that in China.Many government departments have issued normative documents to regulate the interests in clinical trials,but there are still deficiencies.The problems exposed in its development process,the follow-up measures and the formulation and improvement of relevant laws and regulations are worthy of our thinking and reference.This paper will take the death of Jesse Gelsinger in the United States as an example,which is a typical case of conflict of interest in clinical trials in the United States.Through the study of the legal issues reflected in the event,this paper combs the background andspecific norms of the legal regulation of the conflict of interest in clinical trials in the United States,absorbs the experience and requirements of the legal norms,and discusses the relevant legislation and issues in China,so as to make suggestions for the improvement of the relevant laws of the protection of the rights and interests of the subjects in China.In the future,we can learn from the experience of foreign countries to improve the legal system of our country,define the conflict of interest clearly,improve the mechanism of public disclosure in advance,and strengthen the accountability mechanism of scientific research misconduct.For the occurrence of the conflict of interest,we should clarify the legal responsibility of the relevant personnel,so as to ensure the objectivity of the test results and effectively maintain the legality of the subjects.