Research On The Rights And Interests Protection Of Drug-testees

Before any new drug to be launched to the mass market, human trials are required to be carried out in order to confirm or reveal the positive effects and side effects, to prove its safety and effectiveness Given the fact that both the safety and effectiveness are unknown before the drugs trial, and that human trial is extremely risky and uncertain, any participant is facing potential health damage during the trial In China, there are lots of cases where clinical trial participant’s rights and interests are not properly protected It is due to the lack of law and regulations that protect the rights and interests of clinical trial participant In judicial practice, a civil action against clinical trial wrongdoing can hardly obtain any support from the court It is mainly due to the difficult of collecting, presenting, and proving evidence as well as the connection between the damage and the trial As a result, cases usually close with court mediation and some financial compensation Therefore, it is an important legal issue to define the rights and obligations for both participants and researchers, the way to protect participant’s legal rights, and the way to remedy the damage done to the participantsThis research is consist of four sections The first section talks about general legal aspect of clinical trial and analysis the rights and obligations of each stakeholder The second section explorers the current status of participant rights protection in some well-developed countries,。The third section introduces of the main issues in the field of human trials test drugs on human rights protection in the presence of the drug present,discusses the major concerns and issues in China regarding participant rights protection break down the civil obligations for clinical trial damage from tort and breach liabilities perspective and discusses ways to protect participant’s right The last section proposes improvement on participant’s right protection from forming ethical review committee, no-fault principle, to establish compulsory insurance mechanism and other aspects...