The Tort Liability Of The Human Medical Trail

The human medical trail is gradually developing with the development of medical technology. In china human medical trail began in the nineties of last century. The main medical trail is performed in the patients who are going to hospital for treating. It is not very widespread. So in practice the court treats the infringement of human medical trials as the general medical tort. The common point between the medical trail and the general medical practice is that they may cause the patients’personal injury. The general medical practice is that doctor treats the patients with the medicine and program which have been proven safe and effective. The result of the general medical includes that the patient is been cured or treatment. But purpose of human medical trail is to test the safety and effective of the medicine and medical devices. The result is not uncertain. There is a greater risk in the human medical trail. The main participants in the medical activities are patients, medical institutions and medical personnel. The human medical is also the manufacturers of medicine and medical devices. So the tort liability of the human medical trail is an independent liability. This is the biggest innovation of this article.The case of a large part of human medical trials are infringing on the right to informed consent of participants against. Sometimes informed consent of the participants are violated, their life and health are not compromised. The legitimate interests of the subjects will suffer damage if only authorized to life and health as the basis for damages claims. In practice the courts have recognized the right to informed consent of human subjects in medical experiments judgment. But in the theory has not been formed a systematic requirement. Human medical trials right to informed consent is no clear theoretical and legislative basis. First I need to explore their origins, as well as the necessity and the particularity of human medical trials in tort exists in theory.Informed consent includes the right to know and agree that the basic right to know the scope of the specific content that is owed by the experimenter toldobligations. Right to know is the source of this obligation, the realization of the right to informed consent when the premise of this obligation. Only by fully understanding the scope of the right to information, the participants can truly know its consent. Exercise of whether the principal has full capacity to consent, and the agent into the patient himself exercised the right to exercise informed consent. In exercise of the agency and specific issues related to the guardian, and therefore need to be clear in different situations, guardian permission. Human medical trials compared to other right to informed consent and informed consent rights, rights to fulfill the requirements more stringent. Compared to conventional medical practices in informing the content, inform the content of human medical trials need more refinement, clarification, and comprehensive. Includes not only the part of Participants participating in the trial should also include information on Participants did not participate in the Description section, such as test sources of funding, such as specific processes throughout the trial. In addition, China’s current law, the right to informed consent of the subjects in this obligation, the duty of disclosure requirements of the target range is chaotic, not unity. Therefore, to further clarify the need for the two parts in order to clarify human medical trials from the legal right to informed consent. Through the above analysis and practical cases difficult to find, the current human medical trials informed consent of the court has been recognized. There is no appropriate support. Informed consent is not just right, the whole human medical trials tort liability are in an awkward land. Therefore, in the third part of this article will be reconstructed human medical trials tort liability rules.We have previously demonstrated that human medical trials tort liability as the necessity of an independent tort liability, but in practice they found that the lack of appropriate legal and legislative basis. Therefore, a clear under our tort law system, the constituent elements of human medical experimentation tort liability is a priority. This article from the four elements constituting the tort liability, combined with existing law, to establish independent, constitutive elements of human medical trials clearly tort liability. Due to the lack of a clear legal basis and the complexity of human medical trials, special, constitutive elements of human medical trials in tort liability, causation and fault is the difficult part. Due to human medical trials and medical damage tort liability tort liability to a certain degree of similarity. Therefore, this part of the main constituent elements of medical damage through tort liability, the spirit of the principle of maximum protection to the subject, parse out the responsibilities in line with human medical trials Elements infringing features from existing legislation and theory. Second, the human medical trials needed to clarify its tort liability related issues. It is also in the theory and practice can most directly affect the protection of the subject section. Because participants, the experimenter and the sponsor of the three main human medical trials exist, so the responsibility is more complex morphology. Joint responsibility not only to most effectively protects Participants repayment. But also to better regulate the test and sponsor burden-sharing, reduce disputes arising. Second, the test for vicarious liability by the actual operator of medical institutions that vicarious liability for the medical staff, although Participants damage directly caused by the medical staff, but the existence of an employment relationship between medical institutions and medical personnel, so by the medical tort liability agency. In addition to these two responsibilities forms, tests and sponsor may also constitute a liability by shares. When the test and no-fault contact sponsor constitute a common virulence, their size and influence of the size of its fault results generated assume corresponding responsibility. Of course, the human medical trials tort liability exemptions also exist. Based on the particularity of conventional medical practices in the medical side exemptions human medical trials in this does not apply only to explore from the general tort law provisions. Voluntary consent of subjects is absolutely necessary condition for human medical tests to be carried out, but that does not mean there informed consent, subjects volunteered to take risks, experiment and sponsor exemption on the course. This is precisely the denial of conventional medical practice, the medical staff before treatment can fulfill this obligation to exercise informed consent defense. Overall, the human medical trials tort liability, the trial sponsor exemptions are intentionally or negligently cause harm to Participants and experimenters, the sponsor no-fault, third person at fault and why, force majeure. Finally, a clear infringement of human medical experimentation in damages and compensation rules scope of the problem.This article explains the necessity of human medical trials as an independent tort liability. In a clear test of the independence of the human medical tort liability, the constituent elements of human medical trials to establish tort liability theory and existing law. In order to clarify the issue of liability assumed, so as to achieve maximum protection for Participants.