Study Of Human Trials Legal Issues

In the last century, especially the recent 30 years, a large number of breakthroughs have been made in biomedical science, where human subject experimentation took a key role. Human subject experimentation (hereafter "experimentation" for short) is of the most importance on the way to conquer diseases and pursue healthy life. Successful biomedical research on human subjects has enormously benefited the health and welfare of those who enjoy modern medical care anywhere in the world. However, as with probably all purposive social action, there have also been some unintended and undesired side-effects in both the medical and the moral realms, chief among which has been the apparent failure to achieve the highest, and in many case even adequate, standards of professional moral concern and behavior with the human subjects used in the experimentation. In the history, this sort of tragedy happened occasionally. In social life, concerned debates also drew the public's attention. In the modern world, it is a pretty popular topic to talk about the protection of human subjects. Particularly, it is a common sense presently to protect the human subjects with legal, ethical, social and other methods in those countries taking a leading role in biomedical research. As a developing country, China acted as not a leader but a follower in biomedical area for a long time, which contributed to the ignorance and absence of such topic. However, because of the improvement of biomedical research in recent years, the amount of experimentation boomed, made it crucial to think about how to regulate human subject experimentation and protect the subjects. This dissertation explores the legal regulation of human subject experimentation, concentrating on the protection of subjects, intending to do some help to establish human subject experimentation legal system in China.This dissertation is divided into 7 charters.The Introduction indicates the aim, subjects and methodology of this dissertation, particularly the definition of "human subject experimentation".Chapter I explores the history, practice and ethics of experimentation. Firstly reviews the history of experimentation and related norms. People used human beings doing experiment for a long history, where the "first do no harm" principle of Hippocratic Oath also applied. However, public awareness of the need for guidelines in dealing with human subjects was only dated to the Nuremberg trial following World War II, where the abuses of Nazi "doctors" revealed the extent to which humans could be exploited in the name of "research". After the war, countries as U.S. began to pay attention to the issue of human subject protection. The Helsinki Declaration and the Belmont Report are the major milestones. Secondly, it reviews the philosophy and ethics combined by teleological utilitarianism, deontological Kantianism, rights-based liberal individualism, community-based communitarianism and relationship-based ethic of care, and of which respect for persons, beneficence, justice, trust and scientifically cordiality are the main principles.Chapter II describes the current legal and ethical norms related to experimentation. At an international level, the international ethical norms such as the Declaration of Helsinki play a pivotal role in regulating of experimentation. Conventions as UN International Covenant on Civil and Political Rights also make contributions on this topic. However, their status of international laws is often questioned. Some regional international organizations such as European Union and Council of Europe also have their regional norms. This chapter then compares the modes of legal framework of experimentation between several major countries and districts, classifies them into 3 categories: statutes, administrative regulations and ethical guidelines.Chapter III explores the legal relationship in experimentation, including the classification of experimentation, subjects and substances of legal of legal relationship. The classification of experimentation decides the extent to which the subjects should be protected. It differs from clinical treatment to experimentation, from therapeutic research to non-therapeutic research, and from interventional research to observational research. Furthermore, there are a lot of debates about the scientific necessity and ethical acceptability for control group, placebo research, blind research and RCT (randomize clinical trial). The subjects of experimentation legal relationship include sponsor, investigator, human subject, and some specific subjects and community as well. Human embryo shall be treated with respect in experimentation as an interim category. Review board and administrative body play an important pole in human subject protection. A conflict of interest resolution should be established to prevent the human subjects being harmed by the sponsor and investigators. The subjects' rights of life, health, decision making, privacy and collective confidentiality shall be respected. There are still a lot of debates about the subjets' property rights of the product from experimentation. Meanwhile, the investigators and sponsors have the freedom of research. However, when there is a conflict between the rights and freedoms above, those of the subjects shall prevail.Chapter IV is directed mainly toward ethical review. Ethical review of experimentation is required by the international norms and national statutes and regulations. There are two types of ethical review institutes, namely Institutional Review Board in the U.S. and the independent review committees of European countries. After a comparative study, it comes to a conclusion that according to the reality of China and for the overwhelming value of independence we should establish independent ethical review committees on both central and local levels, ensuring their representiveness, pluralism and multidisciplinarity. Also we need to modify the current regulations about ethical review committees' operation in accordance with international norms. It is essential to make effective supervision of the ethical review as well as set up an appellate system.Chapter V deals with the informed consent in experimentation. Informed consent is the basic principle for the protection of subjects. Experimentation can only be justified when the subjects decide to participate freely, voluntarily and independently after being properly informed. The content, level and form of information should be adjusted to the nature of the experimentation and the pacific needs of the subjects. There are also a few exceptions of the informed consent. The vulnerable subjects should be offered special protections.Chapter VI explores the remedy for the subjects suffered damages in the experimentation. Tort liability is the usual way for the remedy. This chapter introduces tort liability in both Common Law system and Civil Law system, and then designs the tort liability of experimentation system for China. Insurance is also pretty crucial in experimentation remedy. This chapter mainly explores the experimentation insurance systems in the Netherlands and Germany, etc, argues China should also has a similar insurance system. There are compensation systems in the U.S., some of which are compulsory ones established by the government, while others are voluntary ones by the research institutes. Compensation system may be the supplementary way for our remedy system.Chapter VII discusses transnational experimentation. Transnational experimentation is an outcoming of economically globalization and the vast difference between the north and the south, which bring out a series of ethical and legal dilemma. The chapter analyzes the reality and reason of transnational experimentation, focuses on the ethical debates of it, and gives advice of the counter mattes of the situation.As the conclusion, the dissertation proposes to set up a systematic legal frame of experimentation, with the core of "Human Subject Experimentation Law", and drafts a bill for it.