"Illegal human trials of the criminal law of our country should"

[Abstract] the punishment of illegal human trials of the international consensus, China's illegal human test status of corporate governance, unlawful human test on human life and health seriously infringed upon, the medical field of new drug R & D speculation in punishing and transnational experimentation intrusion is unincorporated body test of crime evidence. China's current illegal human researchThe criminal lawTo take"According to the regulation mode", difficult to effectively punish illegal human trials, it is necessary to take"A separate regulation mode"The establishment, unlawful human experimentation. China's criminal law should be unlawful human experimentation diversified harmful behavior, medical standard and identification, crime, epidemiology causality and judgment of illegality on concrete unlawful human experimentation settings.

[keyword] unlawful human experimentation; the basis for conviction; separate regulation mode; the victim consent

The main character, human trials

Human trials (Human Experimentation), also known as biomedical research or human biomedical research involving human subjects. The definition for human testing theory, there are many view the field all over the world. In Japan, the implementation of human testing is"In order to medical problems, using past experience does not have, unknown way, on the subject of some physical assault, observe the effect and reaction of the behavior."Scholars in China regard human trials expressed as"Directly to the human subjects, experimental artificial, a human experiment for social actions of others, it is a study of the intermediate links, before and after the study of basic theory and animal experiment, clinical application, it is the center of the pillars of modern biomedical."Human trials are"To develop, improve the medical technology and the increase of new medicine, and medical technology, medicine or medical equipment research on human behavior."

Human trials has the following main features: (1Human trials) to the human body as the subjects. The concept of human body in the human body experiment is a special system composed of the body, living, individual and group. The subjects of human testing is the only person itself, which makes the human testing is different from animal experiment. (2Human trials with ethics). Not only involve medical research involving human trials, but the human ethics. In human trials of legitimacy to moral rationality on human trials were evaluated in human trials, contrary to human ethics should ban human trials, for violation of human ethics. The obtained conclusions caution. (3Human trials) to obtain new medical knowledge, determine the technology, medical field for health care has no benefit and whether it has the expected performance.Human testing is different from the general medical behavior, the main objective is to obtain a medical knowledge, development, improve the medical technology, medicine etc..(4)Human trials of the means and ways have tried. Human trials is a tentative work, this attempt is the recognized existing medical treatment methods, have greater risk, the participants in the risk assessment process benefits measurement.To sum up, human body test is for the acquisition of new medical knowledge, to the human body as the tentative research subjects of.

Two, human trials of crime of illegal evidence

Human trials of biomedical research is an essential aspect of new technology, new drugs, medical field although after several animal test, but because there is a difference between human and animal, so before the large-scale clinical application, must pass through the human body medical verification test. Human trials for understanding, grasp the efficacy of medical technology in the field of new drugs, and toxic side effect has the irreplaceable significance. Human trials are medical progress and development in the middle part of impassable. However, human trials is a double-edged sword, used properly medicine and human double hurt. The crime of illegal human trials, to use criminal law to conduct effective investigation of illegal human trials, has important significance:

PeopleWho were deeply felt the illegal human trials brings the pain of cutting one's body is the Second World War, the name of Nazi Germany, the Japanese invaders from human trials, killing tens of thousands of civilians, prisoners of war and other innocent people. Illegal human testing smoke brings the pain of the body and spirit to individuals and the nation. In the face of the human body in the second world war brings pain test,1949Years in Switzerland and Geneva signed the four Geneva convention explicitly prohibited for biological experiment to protect personnel, and clearly defined the illegal criminality of human test.1977The two Protocol Additional to the four Geneva conventions years reaffirmed on international and non international armed conflict in the illegal crime condemnation and prohibition of human test.20Century70In the "International Convention on Civil and political rights" and "European Convention on human rights and biomedicine",1993World Conference on human rights through the "Vienna declaration and programme of action" and other international documents on illegal human trials made provisions. The illegal human trial criminal punishment is the consensus of the international community. Historical unbearable pain remind people to human trials, illegal crime, the use of criminal law on the illegal conduct effective investigation of human test.

In the present China, unlawful human test is a serious threat to the health of the public.In our country every year800A variety of new drugs for human trials, involving a population of about50Million people. Illegal for human trials event related drugs are emerging, it has gradually become a target for all. Human trials and illegal behavior technology is more hidden, compared with illegal human trials about drugs, illegal for human testing technology greater harm, and it is difficult to identify. The ultimate goal of criminal law is to give a sense of security in the country citizen reasonable. But because of our lack of criminal regulation of illegal human trials, the health of the public is exposed in the illegal human trials of haze.

With the progress of human civilization, the protection of human rights has gradually become the common pursuit of the goal of building the rule of law. The progress of human civilization makes people rethink the value of life, andIllegal human testing is in disregard of human life and health and other basic human rights, is carried out in the name of science the persecution of human rights behavior. Illegal human trials directly infringes or threatens human test subjects to life and health. Human trials have tried and risk, in order to fully protect human life and health, human trials should follow the principle of informed consent, income is greater than the risk criteria,The subjects of risk assessment, balancing of interests. Illegal human trials is the violation of the above criteria, it is harmful to human health choice retains the right to life, damage to the subjects' life and health. On the other hand, unlawful human test through the clinical use of new technology and new drugs and medical field, violate or threaten the life and health of patients.If you do not use criminal law to conduct effective investigation of illegal human trials, a large number of illegal behavior between human testing and test results of epidemiology causality would lose transparency, questionable science medical data through the illegal human trials of the. These medical field of new technology, new drugs entering clinical large-scale practical application, will seriously violate or threaten the life and health of patients.

With the economy and science and technology makes the technology into productivity to further accelerate the development of new drugs, new technology, the medical field more market. Based on the research and development of new drugs and medical fields as template, analysis of illegal crime on the basis of human test. The test is an important step to complete the new drug in clinical mass before practical application, the test object, test method, test period and other factors directly affect the cost of research and development of new drugs. Illegal operation in human trials as an important way of developing a new drug to reduce the cost of. Due to the development of medical technology, intellectual property protection, drug pricing system reform and other reasons, in a considerable period of time in China in the new high prices of medicines, and illegal human trials in new drug development process greatly reduces the cost, the increase in illegal human trials of new drug research profits will suddenly. In the interest of maximizing the spring tide of market economyIf not, use criminal law to conduct effective investigation of illegal human trials, will be on the new drug R & D through illegal human test cost reduction behavior guide bad, induced a large number of serious harm to society of illegal human test behavior.

From the international illegal human trials of punishing situation, transnational human testing has become a thorny issue in punishing illegal human trials. Causes of transnational human trials are in many aspects, the rule of law behind human trials, leading to lower cost countries human trials from developed countries under the rule of law to the rule of the backward transfer of state is not reasonable is one of the most important reasons. In a certain sense, the rule of backward nation for a test law developed country. Developed countries under the rule of law on illegal human test behavior to use criminal law to investigate, if China does not use criminal law to conduct effective investigation of illegal human trials, unlawful human trials in China costs will be much lower than the developed countries under the rule of law, resulting in illegal human testing a large number of foreign transfer to china. The illegal human trials of crime, improve the system of cost of human testing, is of great significance for the protection of our national from transnational human trials against.

The foreign model of criminal law to deal with three, unlawful human trials

Can foreign mode of illegal human trials of criminal law should be divided into two categories: one is the illegal human trials is not a separate crime, but a reference against the healthy life of crime punishment"According to the regulation mode"The two is a crime; illegal human trials alone, the criminal law stipulated explicitly illegal human trials of crime"A separate regulation mode".

(a) reference regulation mode

The stability of criminal legislation, based on the conservation of the country for illegal human testing, on the basis of multi damage people's health and life penaltyThe lawAre punished.In Nuremberg criminal trial, the judge can't find special laws or regulations in the country, he quoted the Hippocratic oath "and""Crimes against humanity"The principle of criminal punishment for illegal human trials.

Germany is the earliest one of the countries develop human body test. Early in the1900Years of Prussia introduced "human trials regulations", to create a national precedent for regulation of human test.1931Years, the German Empire Department of Health issued relevant treatment methods and human trials of more detailed guidelines. These Provisions even than the subsequent "Nuremberg code", "the World Medical Association" Helsinki Declaration on human trials international documents more strictly. However, the German criminal law and no special provisions unlawful human experimentation alone, other provisions of criminal law in the health and life of the injured but the criminal provisions of punishment on illegal human trials.

1979Years, Japan formulated the "Pharmaceutical Affairs Law", for testing the drug problems of human were preliminary provisions;1990Years and1992Years, the Japanese were issued "the implementation of the benchmark" for pharmaceutical products in clinical trials and "benchmark" implementation of clinical trials of medical appliances, were carried out on human test more specific provisions. Although the Japanese law to carry on the detailed provisions, to human trials but, for illegal human trials of criminal punishment, the Japanese at all levels court in accordance with the general assault, murder and other charges and punishment, no unlawful human experimentation independent.

In addition, the Argentina, Portugal legislation prohibits doctors switching operation and other human trials, doctors switching operation and other human trials will be sentenced to assault.

(two) a separate regulation mode

With the highlight various body in the process of test questions,Legislation set up experimental offenses punished illegal human individual is taken by some countries. The current penal code of France, Hungary's criminal code and Australian penal code specified on the illegal human trials of crime.

The French penal code article2Volume"The felony and misdemeanor assault"In section3Chapter"Put a person in danger crime"In section4Festival"Experiments were carried out with personal crime"The crime of illegal human testing alone. The article223-8The provisions,"In the "public health law" provisions of the occasion, has not obtained the parties, have parental authority or the guardian of free, clear expressly agreed, in person or by others for biomedical research, office3Years of imprisonment and Science45000Euro fine. Originally agreed but occasions has been cancelled, continues to biomedical research, is subject to the same penalty."Article223-9Article1The provisions of paragraph,"Legal person in accordance with Article121-2Under the conditions of article, declared on the223-8The criminal responsibility of the crime."The French Criminal Code with the person of the experimentation mainly violates the principle of informed consent and illegal human testing behavior. The establishment of the crime of violation of the requirements of the "public health law" provisions, which should be administrative illegal behavior. Crime of experimentation with personal of behavioral offense, as long as there are violations of informed consent principle of crime in the human body or incite others to biomedical research.

1978By the Hungarian penal code article12Zhang Di2Festival"On medical procedures, medical research order and violate the medical procedures in the autonomous rights of crime"Article173/DThe provisions of"Violation of the rules of human subjects of crime". Its provisions,"Did not obtain or contrary to "health law" provisions of the permit for human medical test, a felony, shall be sentenced to five years imprisonment."Article173/ERegulations"In violation of a human embryo or experimental study of gamete rules of crime". Its provisions,1Any person who fails to obtain or contrary to "health law" the implementation of the provisions on human embryos or gametes test or the creation of human embryos for scientific purposes, a felony, at five years imprisonment."Article173/FRegulations.1For control objective human embryo genetic structure and the implementation of human embryos for scientific experiments, a felony, sentenced to five years imprisonment."The Hungarian penal code provisions on the crime of illegal human trials, but also specifically for human embryos and gametes test of two kinds of special human trials provided the corresponding charges, its provisions detailed, operable. Among them,"Violation of the rules of human subjects of crime"And"In violation of a human embryo or experimental study of gamete rules of crime"Set the act violates medicalAdministrative lawRegulations, namely the guilty must have administrative illegality. According to the provisions of the penal code, the crime of illegal human testing is a felony, as long as the doer illegally human testing behavior without requiring any actual harm results occur can be identified crime.

1995Years of the promulgation of the current Australian penal code article8Chapter"And the related crime against humanity"In section268.27The provisions of a crime in the crime of war--Biological experimentation. Its provisions,"(1) if the perpetrator (criminal) to implement the following acts constitute a crime: (A) criminal implementing specific biological tests on one or more; and (B) test a serious threat to one or more physical or mental health, physical integrity and (C) the behavior of crime people not from drugs, dentist or hospital treatment of reason, nor to the one or the many personal interests and the implementation; and (D) one or more people in the "Geneva Convention" under the protection of one or more, or for the "Geneva Convention" the first protocol (protection; andEThe criminal protection) so for one or more by the fact is knowingly or negligently; and (F) crime occurs in international armed conflicts, or related. Penalty: imprisonment for twenty-five years. (2For the ()1)DApplication of strict liability."Biological tests crime Australian penal code has the following characteristics: first, in"International armed conflicts, or related"Occasion. Second, the crime of dangerous crime, crime posed a serious threat to people's physical or mental health, physical integrity, that the crime was established. Third, eliminate the special cause crime of drugs, including for the dentist or hospital treatment of reason, and the implementation of or to the interests of the test. Fourth, "Geneva Convention" shall respect and "Geneva Convention" the first protocol. Criminal who respect "Geneva Convention" or "the Geneva Convention" the first protocol, the cognizance of strict liability. Fifth, subjective sin may be intentional or negligent crime.

To sum up, the extraterritorial criminal illegal for human testing with the"According to the regulation mode"The illegal human test behavior was convicted and punished according to the provisions of the criminal law against the people's health, the important reason lies in the stability of criminal legislation and the conservative. With the development of human medicine development challenges constantly malignant disease, human trials of the expansion will normalization, diversification, harmfulness of illegal human trials this double-edged sword will increase sharply. Normal human trials, diversification decision"According to the regulation mode"Problems in the illegal behavior of human trials, unlawful human test"A separate regulation mode"Gradually take the criminal legislation of some countries.

Reflection on the current situation, China's criminal law to deal with illegal four human trials

Our country 1994"Medical Institutions Management Ordinance",1998"Licensed physician law of the people's Republic of China",2003Years "clinical trials" and quality management specification2007Year "relates to the ethical review of biomedical research methods (Trial)" and other legal provisions on human trials in detail the provisions. However, there is no clear provisions of China's criminal code punish illegal behavior of human test.Because the test does not belong to the treatment of behavior in nature, so the accusation of crime of medical accident, crime of illegal medical practice and can not be used to carry out punishment illegal human testing behavior. In our country, the punishment of illegal acts in accordance with human trials to criminal punishment of murder, intentional injury crime against life and health, the current criminal law of our country take illegal human test response is"According to the regulation mode". Criminal illegal human trials in China to deal with the"According to the regulation mode"According to the health and life of the injured, the crime punishment illegal human trials, it is difficult to carry out effective punishment on the illegal behavior of human testing, the reasons are as follows:

Illegal human test behavior presents diversification trend.Illegal acts against human trials include not only our existing criminal law the crime life health behavior, but also including tester to conceal the truth, on the subjects of false statements and inform, with dependent subjects and test the subjects make the meaning expression is not real, or with the subject who signed a written informed consent to deceive, or with the authorization of law subjects on behalf of complicity in damage subjects interests mean behavior. The infringement of the subjects of the right of informed consent, seriously infringed or threatened the subjects' life and health, have certain social harmfulness, the use of penalty shall be punished, and our existing criminal law on the illegal behavior to human trials were punished effectively.

According to the regulations on infringement of health crime in Chinese criminal law, for although not caused by the legal consequences but a serious threat to human test subjects illegal behavior of life and health is difficult to find the basis of penalty.Human trials have tried, in order to guide and regulate the right of this endeavor, human body test shall conform to the principle of informed consent, income is greater than the risk principles and ethical evaluation principles, if human trials in violation of these principles and risk of the serious harm the interests of the subjects of life, health is under imminent threat on the damaged.At the same time, the subjects of human testing with the group and not specific, damage of illegal human trials is not just one person's life and health, and is often the most or not specific to the life and health. Therefore, regarding the illegal human testing is not required for the actual serious consequences, and shall be in serious danger against profit in law is the case, the existence of the crime.

The criminal law of our country on the basis of healthy life to punish the illegal crime against human test behavior, the causal relationship between the participants' behavior and harmful consequences of judgment according to the identified violations health crime conditions, causal relationship theory of. Although human testing is different from general medical behavior, but the causal relationship between the operating law, human trials of human trials and subjects body reactions also restricted by epidemiology causality. The traditional way to determine the causal relationship between the illegal human trials in criminal punishment to play its due role, illegal criminal punishment in human trials of the causal relation judgment should follow the disease causal relations judgment method.

Proper behavior is to exclude illegal reasons.If the acts were justified, then behavior because of not having the law and does not constitute a crime.An important principle of criminal illegality judgment of illegal human trials is informed consent, the primary standards of informed consent is the voluntary principle.This requires the individual as a human test subjects must be voluntary, not based on human test subjects to voluntary are illegal. The subjects took human test belongs to voluntary standards in subjective, can the human body experiment is divided into voluntary test, test and forced test cheating.Volunteer test subjects in the case of informed consent, medical test to accept voluntary, in accordance with the principle of informed consent.Generally speaking, cheating test against subjects informed consent principle, has the criminal illegality.However, for some drug test, deceive test is necessary for human trials. Therefore, under certain conditions, in violation of the principle of informed consent is allowed in the drug test. Forcing is contrary to the subjects of the will, through political or violence, forced human test subjects participated in. Its a serious breach of the subjects gave informed consent principle, violations of the rights of the subjects of criminal law, with serious. Has the particularity of illegality judgment illegal human trials of crime in our criminal law, the status is hard to punish the illegal behavior of human test.

To sum up, in the face of human test behavior is normal, the trend of diversification, and comprehensive exhibits obvious weakness of Chinese criminal law to punish acts of illegal human trials in the long run.Take the current criminal illegal human experiments in China to deal with"According to the regulation mode",It is difficult to effectively punish illegal human trials, it is necessary to take illegal human trials"A separate regulation mode"Set up a separate, unlawful human experimentation.

Specific analysis of the criminal law of our country five, establishing a crime alone to deal with illegal human trials

The criminal law of our country to set up a separate unlawful human experimentation be imperative. The author thinks, the so-called unlawful human experimentation is refers to the human body test implementation intentionally violating the medical administrative law for human trials, a serious threat to human life and health behavior. The concrete analysis of the unlawful human experimentation a separate crime:

(a) harmful acts unlawful human experimentation

Harmful acts unlawful human experimentation is violating the provisions on medical administrative law to the human body as the tentative research subjects of. Shall constitute unlawful human experimentation behavior must violate medical administrative law. Medical Administrative Law refers to various kinds of relation medical administrative body in the exercise of administrative powers and accept medical management process of legal supervision and supervision between the relative person or body, as well as the general laws of various relations between the internal medical administrative body.2003China's State Food and Drug Administration issued the "drug clinical trial quality management standards" article4The clear provisions,"All research involving human subjects must comply with the "Helsinki declaration" world medical assembly,Such as justice, respect personality, in order to make the subjects to maximize the benefit and avoid harm.""The World Medical Association" provisions of the Helsinki declaration of principles of informed consent, income is greater than the risk principle and ethical principles of evaluationThe basic principle to begin human testing etc..In accordance with the provisions of the administrative law of medical disputes in China, start human trials must follow the principles of law.

Harmful acts specifically unlawful human experimentation for: (1The principle of informed consent) against illegal human testing behavior.This kind of behavior is mainly for the test of the subjects to conceal the truth, false statements and inform, with dependent subjects and test the subjects make the meaning expression is not true, or with the subjects signed a written informed consent to deceive, or authorized by law the subjects represented the complicity of damage subjects interests mean, a serious threat to human life and health behavior.(2) violates the benefits outweigh the risks for human testing principle illegal behavior.Income is greater than the risk requires the risk prevention for the idea, to measure of interest as a means of exploring human testing, analyzing, adopt different legal countermeasures. Specifically, behavior violates the principle of illegal benefits outweigh the risks for serious breaches of human testing, from the practice of medicine, contrary to conventional medicine, a serious threat to the life and health of human subjects testing behavior.(3Violation of Ethics) evaluation principles of illegal behavior of human test. "The world medical conference the Helsinki declaration", before the start of the study, research procedures must be submitted to the ethics committee, for their consideration, criticism, guidance and agree.The committee shall have the right to supervise the study. American Ethics Review Committee (legal requirementsInstitutional Review BoardAbbreviationIRB) must be comprehensive review report significant, at the meeting, and detailed records of their ideas, including the controversial problem solution.IRBAlso review the informed consent, to ensure that all the required information for subjects clearly expressed. Violation of ethical principles of evaluation of illegal human test behavior is mainly ethical evaluation tests to violate ethics committee and its staff on human trials, ethical evaluation or testing person making a false conclusion human trials, a serious threat to the life and health of the behavior subjects. In addition, any modification test scheme of illegal human trials shall be approved by the ethics committee approval; serious adverse events occurred in the test, should report to the ethics committee in a timely manner. Adverse events (Adverse Event) is the patient or clinical trial subjects received a drug adverse medical events, but not necessarily a causal relationship with this treatment. Timely reporting of adverse events for the correct, scientific, timely assessment of the risk of human testing, take effective measures to prevent the occurrence of subjects of group events. Therefore, if the occurrence of adverse events reporting or falsely, delaying the rescue, the circumstances are serious, shall be punished according to unlawful human experimentation.

(two) unlawful human experimentation medical standard and identification

The establishment of unlawful human experimentation must meet certain medical standards. Judge unlawful human experimentation medical standardsThe first is behavior whether to have"Try"The judge.Human test means and methods could be, if the behavior does not have a try in the medical standards, but a way to cure has been recognized by the medical profession, the behavior is not human trials, but will not constitute unlawful human experimentation. In addition, judge the medical standard unlawful human experimentation is also reflected in the design, test scheme for human test in the process of implementation and modify the compliance with medical criteria. For the protection of human test subjects to life and health, test scheme is scientific and effective implementation requires medical standard, design, test and modify the program should have a scientific and reasonable in medicine.

According to our countryCriminal Procedure LawThe provisions of the criminal trial by the peopleCivil lawInstitute. As our main unlawful human experimentation is of course the people's court. Because of the establishment of unlawful human experimentation must meet certain medical standards, and in accordance with the professional knowledge structure of people's court in the trial personnel, it is difficult to scientific, accurate to the medical criteria, the people's court in illegal human experimentation, need conclusion trial identified by neutral, with medical professionals organizations. The author thinks, the ethics committee to provide expert conclusions about medical standard has the feasibility to the people's Court of unlawful human experimentation. "The World Medical Association Helsinki declaration" in the provisions on respect for ethical principles that, beginning in the body of research, research procedures must be submitted to the ethics committee, for their consideration, criticism, guidance and agree. The ethics committee has become the advanced countries in the world are an important power in the rule of illegal human trials. China Medical Law are defined on the role of ethics committee in the human body in the testing process.Our country2003Standardize the quality management of drug clinical trial implementation of "",2004Years of implementation of the "provisions for clinical trials of medical devices" and2007Year issued "biomedical research ethics review measures (Trial)" and other legal documents stipulate to human trials are reviewed by the ethics committee.According to the "way of biomedical research ethics review (Trial)", the Ministry of health to set up expert committee of medical ethics, health administrative departments at the provincial level the establishment of ethical review of the administrative region of guidance and counseling organization. Compared to institutional ethics committee set up in the development of biomedical research involving human subjects and related technology activities in the institutions, the establishment of medical ethics committee of experts, the Ministry of health set up by the provincial administrative department of public health ethics review guidance counselling organization is neutral good, whose members include the biomedical professional personnel, can grasp the unlawful human experimentation medical standards more scientific, accurate, so as to provide identification conclusions about medical standards for the people's Court of unlawful human experimentation.

(three) crime of unlawful human experimentation

Crime of unlawful human experimentation should be prescribed for the offense, at the same time the aggravated consequential offence form.The Japanese criminal law in constitution should be"Result"To investigate the result crime, dangerous crime and crime in the settings section. German criminal theory in the form of objective elements of behavior elements should be in the result crime, dangerous crime, investigate and act crime, crime objective form. A major factor in the decision of crime is the harm degree acts against the interests of law. According to the damage degree of acts against the interests of law, the crime can be divided into the crime, dangerous crime and crime. The crime is harmful behavior actual benefit harm result crime that established the objective form. Dangerous crime is harmful behavior dangerous crime law is objective form established. Act crime is only to implement the constitution described the behavior, without requiring a behavior harm interests results or dangerous crime law that established the objective form. Under normal circumstances, unlawful human experimentation should be set as the dangerous crime, namely human trials to people's life and health caused a serious violation of the dangerous crime is established, and no need to wait for the actual consequences. Human trials have tried and risk, any violation of the principle of informed consent, income is greater than the risk principles and ethical principles of evaluation are serious enough to threaten the life and health of the subjects. The subjects of human testing with the group and not specific, unlawful human test threat is not only a person's life and health, and is often the most or not specific to the life and health. Therefore, the criminal law shall be unlawful human experimentation is dangerous."Human trials are necessary, but the subject of life or health protection also is quite important, is based on human test subjects should be in no danger or only a minimum of dangerous situations, it can be quasi its implementation, it should not be performed with human quite dangerous test."Unlawful human experimentation in the provisions of dangerous criminals, to seriously damage the subjects health or causing higher legal punishment subject death behavior rules, in order to reflect the principle of suiting punishment.

(four) in the causation of illegal human experimentation

The establishment of a crime must have a causal relationship. The causal relationship between the traditional criminal theory in continental law system identification theory mainly includes the conditions, reasons and the theory of causal relationship, the causal relationship is. To determine the causal relationship between causal relationship with behavior generally people may be aware of the fact and combined with the behavior of known facts as the standard of harm behavior and harm result. Theory of Anglo American criminal law theory of causality includes the proximate cause, foresight and function of punishment, the proximate cause is the traditional view.Theories about the causal relationship between civil law and common law in the theory of criminal law have something in common, such as between the behavior and result causes only with the relationship of cause and be caused when it established causal relationship.However, between the behavior and the result caused by human trials with epidemiology characteristics and relationship be caused, so that the judgment method for unlawful human experimentation should adopt the epidemiology causality."In Japan, even in criminal matters, also to epidemiology of proof methods, to identify the facts of the crime, especially the causal relationship between the harmful behavior and the means of proof."You can set up causality of epidemiology as long as have the following four conditions:This factor had a role in certain period before onset of action; the factor of the more significant, the higher the prevalence. The factor of the distribution and fluctuation and the epidemiological observation records of the epidemic characteristics are not contradictory; the factor as a cause of action, and biology is not a contradiction. A causal relationship between human testing behaviors and consequences, even if it is not scientifically proven, but according to the statistics method a lot of, can explain the behavior of a high degree of probability of consequences between, to be sure of the causal relationship.

(five) the judgment and the unlawful human experimentation illegal approval

The intention of illegal crime"Acts in violation of law, that is, not allowed by law."Behavior"In violation of the provisions of the common life of law and order, destruction or damage to legal interests in entity law". In Japan, the German criminal law theory and practice, the consent of victim as proper behavior is obstructing the illegal behavior of important reasons. The consent of the victim is also known as the victim's commitment, refers to the subject of criminal law protection of personal rights of his decision to give up the choice based on legal meaning, so that it was excluded from the object of the criminal law, even if the violations of the law also obstruct illegality, crime is not established.

Japan as a ground for elimination of misfeasance"The consent of the victim"Reference theory. Admit that the Japanese criminal law as a ground for elimination of misfeasance"The consent of the victim"Generally refers to the behavior for the purpose to treat patients with the disease.A simple test for the purpose of human trials for not treating behavior,So the subjects as the victim commitment effective only in a limited range can be admitted that very small, only within the scope of victim's commitment in the test of human body could be the ground for elimination of illegality. There are essential differences between human test behavior and treatment behavior here. Japanese scholars have on the human body and test"Treatment test"The distinction between. That human trials is not for the purpose of treatment, but in order to medical problems are action and reaction produced by the body to observe the behaviour of subjects."Treatment test"In the treatment of patients with the occasion, has exhausted all the way, no other effective treatment at the time of the medical level lower, with the informed consent, use at that time has not yet been established in the treatment phase of the study in order to verify the effectiveness and the implementation of the act. In Japan, human trials if participants agreed, but do not meet the treatment behavior and medical appropriateness of two elements, resulting in the majority of human trials have been identified as illegal. Although human test subjects based on the body damage obviously with some elements of crime, this case to damage does not belong to the punishment of illegal range, can stop the illegal. Human trials in subjects agreed and so on the physical abuse control at a lower limit is obstructing illegality.

Be allowed to human trials, in a limited range and not to treat the actions for the purpose of not encroach on health of body and mind of the conversion operation, breast and a nose purely cosmetic operation and sports behavior, because the behavior is in"Considerable social"Be allowed within the scope of the act. So, at the risk of life or amputation height as such have a significant impact on the physical integrity of the intervention, even if subjects had actual consent but not in law allowed. The society is refers to the certain behavior, although is illegal in normal circumstances, but because these acts in accordance with the existing national order and life and social, so do not have the illegal behavior. Transformation of encroach on health of body and mind, breast augmentation rhinoplasty operation and purely cosmetic operation and sports behavior are permitted for social considerable theory, therefore the denial of these illegal behavior, no specific environment should be placed on the human body in the test of. At the same time, because the victim consent only involves no agreed to give up life or agree to significant damage, therefore, human trials could not be risked his life or significant risk of injury to the victim consent as the implementation of obstructing illegality defenses.

For human trials risked his life or serious injury risk implementation needs to explain. Human trials with clinical therapeutic trials and non clinical therapeutic trials. For non clinical therapeutic trials, involving risk of life or serious risk of injury of the victim's consent and of course can not be used as a ground for elimination of misfeasance. Human trials of non clinical treatment is carried out to explore the purely medical knowledge for the purpose, and the subjects I recovery or cure is not directly related to the inevitable, the subjects I from human trials directly with the interests of probability. Therefore the non victim to life-threatening or serious damage risk of human clinical trials in the treatment of consent cannot be used as a ground for elimination of misfeasance. For human clinical trials of therapeutic, if a subject's life and health has been facing a serious threat, is still difficult to cure in the exhausted all other means of treatment, the subjects of life or serious damage health is difficult to avoid, then relates to danger or great risk of injury of the victim's consent should be allowed as a ground for elimination of misfeasance. Because in this case the victim's life or serious health damage is inevitable, the existing medical conditions could not provide effective treatment, if not allowed to clinical treatment of human trials, the victim is unfair, contrary to the principle of benefit and risk measure.

 

[author]

Yanfang, lecturer, Shandong University School of law, political science, Shandong University post doctoral flow station researchers.

Notes.

Kato Kuxiong: "Introduction" medical Criminal Law Press, Tokyo2002Year edition, No.76Page.

Qiu Shichang: "the moral essence and its ethical principles" about human body experiment, load "medicine and philosophy"1986No.10Period.

Huang Dingquan: "the medical, legal and ethics", Law Press2004Year edition, No.235Page.

The four Geneva conventions including "to improve the condition of the wounded and sick in armed forces in the field of Geneva Convention", "to improve the marine wounded and sick in armed forces in the Geneva Convention for the", "about the treatment of prisoners of war" and "the Geneva Convention on the protection of civilians in time of war of the Geneva Convention".

The two Protocol Additional to the four Geneva conventions including "Geneva four" additional protocol to the Convention on the protection of victims of international armed conflicts and the "four Geneva Convention on the protection of victims of non international armed conflicts of the additional protocol".

See Zhou Kaili: "protection"The medicine man""," Youth Daily "Chinese load2010Years10Month27Day.

For example, the new human trials of Zhejiang province Haining farmer Shen Xinlian illegal to (see Yang Tao: "can the farmers as any reagent mice? ", Justice NetworkHttp://review.jcrb.com/zyw/n568/ca361879.htm The last access date2010Years10Month30Day) and new human trials in Anhui Wangjiang dozens of farmers illegally carried out (see Li Guangming, Zhang Huowang: "Anhui Wangjiang dozens of farmers sense become"Drug trial""," Legal Daily "load2010Years10Month29Day).

For example, human trials in radioactive substances in Shandong Ren Chuanlan of the illegal conduct relating to technology. See Zhang Jing: "Shandong human nuclear test survey", "Xinmin weekly" load2004Years11Month6Day.

See Zheng Yanpu: "theory of criminal law DOSOMETHINPREVIOUSLYUNRELEASED Co.--Coordination of "criminal law mission and limitations under harmonious context, load" politics and law "2010No.2Period.

SeeH * M *Sass: "in the field of biomedical research ethics and crime", translated by Dai Qingkang, contained "jianghaiacademic journal"2003No.5Period.

After the Second World War, the German Nuremberg organized the International Military Tribunal for trial of Nazi war criminals. "Nuremberg" is the code1946A portion of the annual trials of Nazi war criminals in Nuremberg military court decisions.

2008Years10Vol.59World Medical Assembly adopted the "Helsinki declaration" World Medical Association revised version. "Helsinki declaration" Declaration of the World Medical Association since1964The Sixth Amendment years since the release of the.

See Gao Jinzhu: "judgement" interests and criminal law crime, according to Yuan Publishing Co. Ltd.2003Year edition, No.138Page.

"The French New Criminal Code", translated by Luo Jiezhen, China Legal Publishing House2003Year edition, No.74Page.

"Criminal Code of the Republic of Hungary"

"Criminal Code Act 1995(Australian Criminal Code)"

See "The Declaration of Helsinki 1999"

SeeGreg Koski: "supervision American human research ethics and regulation:" in the development of science, philosophy and medicine carrier ""2001No.22No.12Period.

See note17,"The Declaration of Helsinki 1999".

See Nishida Norino: "the Japanese general provisions of criminal law", Liu Mingxiang, translated by Wang Zhaowu, Renmin University of China press2007Year edition, No.62-64Page.

See gaunt·Shitelateng Waite, Lothar·Kulun: "general provisions of criminal lawI --Theory of crime ", translated by Yang Meng, publishing house of law2004Year edition, No.90-105Page, the400-408Page.

Cai Dunming: "medical criminal law on", Taiwan John Reed Publishing Co. Ltd.2005Year edition, No.322Page.

See DouglasNHusak: "philosophy of criminal law", translated by Xie Wangyuan, Chinese People's Public Security University press2004Year edition, No.3Page.

Ceng Shuyu: "medical negligence and causation", Taiwan John Reed Publishing Co. Ltd.2007Year edition, No.402Page.

See Zhang Mingkai: "Outline" of foreign criminal law, Tsinghua University press1999Year edition, No.128Page.

Otsuka Hito: "criminal law" (in general), translated by Feng Jun, Renmin University of China press2003Year edition, No.345Page.

Lester, Schmidt: "the German criminal law revised textbook", translated by Xu Jiusheng, publishing house of law2006Year edition, No.201Page.

See note1The book, Kato Kuxiong76Page, the78Page.

See note1The book, Kato Kuxiong76-77Page.

 

Hou Yanfang