Subjects in clinical trials,either patients with the target disease or healthy volunteers,inevitably run a risk of injury or even death.To protect human subjects’rights to life and health,the Declaration of Helsinki has been developed as“a statement of ethical principles for medical research involving human subjects”[1].Though widely regarded as a milestone in human research ethics,it is not a law or regulation,and is unable to effectively protect human subjects’rights.In this context,China beefs up its legal protection of clinical trial subjects.

Legal regulations in China

Legal protection of clinical trial subjects is stated in national laws of China.Article 26 in Law of the People’s Republic of China on Medical Practitioners(implemented on January 5,1999)provides that physicians should obtain the approval of the hospitals and the consent of the patients themselves or their family members for experimental treatments.Article 29 in Drug Administration Law of the People's Republic of China(implemented on January 12,2001)stipulates that the dossier on anew drug research and development including the manufacturing process,quality specifications,results of pharmacological and toxicological study,and the related data and the samples,in accordance with the regulations of the drug regulatory department under the State Council,should be truthfully submitted to the said authority for approval,before clinical trial is conducted.Article 29 in Law of the People’s Republic of China on Progress of Science and Technology(implemented on January 7,2008)provides that the state should prohibit scientific research and technological development which undermine national security,harm public interests,endanger human health or violate moral principles and ethics.

In China,no specific laws on protection of human subjects have been legislated.Enforcement agencies at all levels have laid down general or specific rules and regulations.It can be said that a roughly complete legal system dominated by administrative rules and normative legal documents has been established for the protection of clinical trial subjects in China.Legal regulations on the protection of human subjects’rights are listed in chronological order in Table 1.Yet,some of the rules or documents have such lower legal authority and they cannot exercise legal sanctions,like administrative penalty and criminal responsibility,on illegal activities,which in turn weakens the effects of these regulations[2].

All the related regulations in China attach more importance to the subjects’rights than progress of medical science.The ultimate goal of medical research is to improve humans’health and quality of life.Article 8 in Good Clinical Practice for Pharmaceutical Products stipulates that in the course of drug clinical trials,the rights and interests of the subjects must be adequately safeguarded and the scientificity and reliability of the trial should be ensured and the rights,interests,safety and health of subjects must be higher than the consideration of scientific and social interests.

岩屑处置一直是海上钻井的大难题。仅一座平台钻至目的层时，一天就能产生近2吨岩屑。海洋钻井公司规定，岩屑的含油量测定由地质人员确定。按照政府部门的检验制度执行，确认不含油污的钻屑方可排海。

姜辣素（Curcumin）是姜的主要辣味成分，其含量直接影响姜的食用口味、品质和产品的功效。姜辣素是一种酚类衍生物，酚类极易被氧化，具有还原性，可还原铁氰化钾—三氯化铁试剂成为普鲁士蓝，在一定浓度范围内，姜辣素含量与蓝色的深度呈正相关，以香草醛为标准溶液，于波长660 nm处进行比色测定[7-8]。

Table 1　Legal regulations on the protection of human subjects’rights

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Rights of human subjects

To protect human subjects’rights,the first thing is to define their rights,which include the right to life and heath,right to informed consent,right to privacy,right to treatment and right to compensation for damage.

Right to informed consent is critical in safeguarding the realization of right to autonomy.Great importance must be attached to individual autonomy.However,there are still some deficiencies in legislation,notification system and consent system,etc.A good informed consent form is a necessary way to help ethics committee improve the quality of protocol review.Researchers should not only inform the subjects,but also accept their consent.Appropriate language expression is important as well.

Right to informed consent implies that subjects must voluntarily participate in a clinical trial,and be given sufficient time to consider whether to take part in the trial.When a subject lacks legal capacity,his or her legal representative should be informed.Informed consent should use understandable language and words to inform the subjects of the purpose,process and deadline,inspection operation,expected benefits,risks and so on.Subjects’right to agree or disagree should be respected and safeguarded.Performing the informed consent procedures shall strictly avoid deception,luring,intimidation and other illegal deeds.

Subjects’right to privacy must be protected according to laws.The storage,usage and security of privacy information should be informed to the subjects,private data should not be exposed to irrelevant third party or media.Revealing subjects’privacy will infringe their dignity and interests.

Meanwhile,China has not fully established a damage insurance system.Once facing physical damage due to trials,subjects need powerful law guarantee and social support.Since subjects have difficulty in providing evidence,“the principle of no fault liability”can be followed[8].Lawyers involved in medical cases assume that informed consent does not mean that the sponsors and researchers should be exempted.They also insist that sponsors and researchers should bear fault liability for their breach of duty.

China has also clarified the validity of international and domestic regulations on the protection of human subjects’rights.First,foreign organizations and individuals carrying out clinical trials in China must complywith the international and Chinese regulations at the same time.For instance,Article 26 in Ethical Review of Biomedical Research involving Human Beings provides that any overseas institution or individual that conducts medical research involving human subjects must submit the research programs for review and approval to Chinese ethical review committee as well as that of their own country or region.Second,the validity of international regulations is superior to that of Chinese regulations in some areas,with the exception of the provisions on which China has announced reservation.For example,Article 4 in Good Clinical Practice for Pharmaceutical Products stipulates that all research involving human subjects must conform to the Declaration of Helsinki of World Medical Association i.e.fairness,respect of human integrity,maximize the benefits and minimize any harm to the human subject.Third,the laws and regulations across different legal systems within China adhere to the principle of mutual recognition and co-management.For example,Accreditation of Hong Kong Drug Clinical Trial Institutions and Recognition of Clinical Trial Data was approved and signed by the China Food and Drug Administration and the Department of Health,the Hong Kong Special Administrative Region after joint review.

As is prescribed in the law,minors in clinical trials should show their agreement.However,GCP for minors to participate in trials is more principled,lacks interoperability and has no detailed regulations meeting ethical review standards[11].In addition,Mental Health Law of the People’s Republic of China stipulates that only specialists in mental hospital have the right to diagnose mental disorders.If trials must be carried out,mental hospitals should strengthen the construction of ethics committee,and strictly comply with GCP and Mental Health Law of the People’s Republic of China.

Legal regulation enforcement

As China has not yet enacted independent legislation for the legal rights of subjects,it is generally believed that the ethical review censorship can safeguard clinical subjects’rights.The ethical committee ensures the subjects’safety and interests from the perspective of ethics[4].Whether the ethics committee works normatively or not directly affects the scientificity,authenticity,accuracy and reliability of clinical trials,so ethical review must be effectively supervised.Yet,supervision is not satisfactory.

The scope of compensation is determined by personal damage criteria based on civil law and regulations.Consideration should also be given to appropriate compensation for subjects’mental damage.Fairness doctrine of reasonable share should be executed for loss.According to various causes of the loss,we should clarify the responsibility of subjects,sponsors,insurance company or the foundation[9-10].

Right to life and health,a fundamental human right con firmed by Constitution of the People’s Republic of China and Civil Law of the People’s Republic of China,is the foundation of all other Human Rights and the legislation on clinical trials.In Chinese laws,right to life and health encompasses right to life,right to body and right to health.

When adverse events occur,subjects should have the right to receive timely and appropriate treatment.The sponsor and researcher must guarantee this right,which is of great significance to protect their life and health.If personal injury or even death occurs in clinical trials,subjects or their family members or close relatives have the right to ask for economic compensation.In addition,subjects also have the right to claim compensation under the following circumstances:(1)informed consent is invalid;(2)drugs or equipments are replaced without the agreement of the ethics committee;(3)damage to subjects is due to fault in clinical trials;(4)abnormal damage to subjects occurs unexpectedly after the trials[3].

Many problems exist in ethics committee review,such as loose organization structure,unreasonable personnel composition,little training,incapability,non-standard recruitment of members,weak supervision and management mechanism,and unqualified informed consent system,etc[5-6].Therefore,an independent supervision system should be set up to ensure the efficiency of the ethics committee.It is also necessary to establish ethical review project records for tracking and management[7].

Legal protection for special subjects

Special subjects in clinical trials should be treated differently.Female subjects in pregnancy and lactation should be paid special attention.Restrictions should be imposed on minors and patients with mental illness and disabilities.Physicians can carry out experimental treatment on subjects for their benefits who temporarily lose decision-making ability due to illness or accident in an emergency.Prisoners,soldiers and subjects’subordinate staff are strictly restricted to join clinical trials due to their restricted right of self-determination.

Although special subjects have limited capacity for civil conduct,medical trials on them are still justified.Informed consent of special subjects is different from the general one.It is closely related to subjects’age and mental condition,as well as their cultural background,physical health and freedom of action.Besides informed consent,there should be rational and strict protective measures for special subjects.

Above all,the content and scope of the subjects’rights are comprehensive,which can protect them and strike a balance between human rights’protection and medical science promotion.Meanwhile,the legal right system is open,so new rights needing legal protection can come forth along with the progress and enrichment of social life.

5)贮养穴的管理。除在埋穴时施入过磷酸钙和尿素外，在花后、新稍停长和采后3个时期，每穴再各施50～100克复合肥或尿素，随即浇水。在雨季，土壤瘠薄地可增加施肥浇水次数。铺膜后，自萌芽期开始至新稍旺长后期(5月中旬)，每10天浇水一次，每穴3.5～4升，由膜孔浇入，如遇雨可少浇或不浇。自5月下旬至雨季前，每7天浇1次。

Conclusion

Legal protection of human subjects’rights in China is still not satisfactory.On one hand,it is necessary to perfect the existing general laws and special regulations.On the other hand,it is more appropriate to enact special laws to protect the rights of human subjects.Some scholars have drawn up drafts of human trials law.In general,institutionalized protection of subjects’rights,explicit scope of rights,improvement of ethical review and informed consent,and determination of remedy approach can further protect subjects’rights.

本篇文章对肺癌肿瘤实性区的CT强化程度的影响因素分析,相关研究数据使用统计学软件SPSS18.0进行处理,计量资料采用t检验;计数资料采用X2检验。P<0.05是有显著差异,P<0.05是有显著差异,具有统计学意义。

开发基于IP控制技术的新海岸电台中控系统，并基于新系统改造广州和三亚海岸电台中控台，使其满足接入多个收发信台的功能。逐步改造各海岸电台收发信台，将收发信台中原基于硬交换的收发信设备更新为具有IP控制功能的设备。此外，将汕头、湛江、北海海岸电台的收发信台设备和南海收发信台的收发信设备接入广州海岸电台中控系统，将海口、八所海岸电台的收发信设备接入三亚海岸电台中控系统，实现两广地区和海南地区海岸电台中高频通信设备的深度融合。

This article was funded by the National Social Science Foundation of China(Grant No.14BFX161).

曹爽搭班底时，很自然就想到了交情不错的何晏，拔擢何晏为吏部尚书，把人事大权揽在己方手里。何晏在两任先帝手里都没讨过好果子吃，现在终于翻身把歌唱，理所当然紧跟曹爽，可要说他担任吏部尚书，任人唯亲，也不尽然。

References

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