| Summary: | 碩士 === 東吳大學 === 法律學系 === 99 === The life expectancy of people in both advanced and developing countries almost all exceeds seventy years due to the advance of scientific development. Nowadays, what human pursue is not only the prolongation of life but also the improvement of life quality. If reviewing the history, we can find all such progresses just happened in the past eight decades only! The background reason for such extraordinary achievement must be attributed to the research and development of basic medicine; however, further clinical proof of the basic research finding and realizing the academic research outcomes into commercial goods are the key success factors of human life improvement. In the era of evidence based medicine, human clinical trial turns out to be a critical bridge between basic bench work and clinical application.
However, the so called “human clinical trial” is a research which testifies the scientist’s hypothesis with human body as the study material. No matter the researchers or the study participants will take potential risk! It is quite critical to build up a legal system in the modern society to achieve the following goals: maintain the reasonable rights for all stakeholders of clinical trials; facilitate the progress and improvement of medical science; protect the trial participants rights to avoid the loss of the nature of right subject, and even turning to be the objects of a legal event.
The earliest human clinical trial occurred in 18th century when Dr. Edward Jenner prevented from the transmission of small pox with cow pox virus. However, the large scale and systemic development of human clinical trials just happened 60 to 70 years ago when is the time of World War II. From then on, both the clinical trials sponsored by independent academia or pharmaceutical business corporate become more and more common. Unfortunately, there are always cases reports of sacrificing trial subjects’ rights in human clinical trials no matter in developed or developing countries up to now. This facts triggers my personal idea to do this research in order to achieve the followings: I would like to build up a reasonable and doable proposal by studying the relevant legal theories and articles; eventually, there will b a bridge which can connect the natural and human sciences and can make the human life quality get further improvement and progress.
There are six chapters in this thesis. It is summarized in the following paragraphs.
The first chapter focuses on the review of several historical events which turned out to be the milestones for ethics development in human clinical trials. We can figure out the basic principle for protection of trial subjects’ rights by the review of all events and their cor-responding ethics rule. Some brief introduction of our country’s rules and law for execution of human clinical trial will be addressed in this chapter.
The second chapter includes the discussion of infrastructure and classification of human clinical trial in the following perspectives: the classification under the regulation; the scientific nature and key objectives of each kind of clinical trial; the potential risk which must be borne to each kind of stakeholders in different type of clinical trial.
The third chapter will discuss the legal characteristics of human clinical trial. The infrastructure of a human clinical trial is composed by sponsor, trial investigator and his affiliated clinical institution, and study participants (study subjects). Some other personnel in clinical trial include clinical research organization (CRO), trial coordinator, and investigation research committee (IRB)/ethical committee (EC) of the affiliated institution. I would like to discuss the legal relationship of the related stakeholders mentioned above. The other important point is the legal nature of “informed consent” which includes the contents and the process to complete the “informed and consent”.
The forth chapter will cover the rights among all stakeholders – the boundaries of each stakeholder’s rights, the process of right main-tenance, the principle of injury compensation if there is right im-pingement issue. We will define the obligation and legal responsibility of each kind of right subjects in human clinical trial through the above discussion.
The fifth chapter will discuss the compensation for any injuries incurred in the human clinical trial. We will discuss the principle of compensation for those injuries occurred in clinical trial – the model of compensation, application of torts or contract liability law? Should the models of risk responsibility or non-negligence liability be applied to the injury case of clinical trial or not?
The last chapter will discuss the insurance system applied in human clinical trial. We will discuss which kind of insurance can be applied in human clinical trial and the potential expenditure incurred in the insurance system. I would also try to draw a conclusion based on the above discussion and propose a possibly doable compensation system used in our country as a proposal triggering further discussion in the future.
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