Organizations involved in human biomedical research should establish ethical review systems based on relevant laws, regulations, and ethical guidelines[1]. Within this framework, all departments and personnel of the organization should support and cooperate with each other to jointly undertake the responsibilities of the ethical review and subject protection. The establishment and improvement of the organization's ethical review system is the basic condition to improve the ability of ethical review. And it is an important way to establish a sound ethical review system through thirdparty certification to improve review capabilities.

WFCMS was formally approved as a certification body by Certification and Accreditation Administration of the People's Republic of Chinain December 2014. And CAP certification in China was initiated[2]. CAP certificationis the only legal ethical certification project of ethnic review in China and the first certification project in the field of ethnic review of Chinese medicine research and in the field of Chinese medical ethics. It is a milestone and is of great importance to the development of the research on ethnic review for Chinese medicine. Based on HRPS/CTS 01-2017 Requirements for Ethical Review of Biomedical Research involving Human, CAP certification regulates and establishes an ethics review system for Chinese medicine research from the four aspects, such as organization, ethics committees,of fice of the ethics committees, and researchers. And in the framework of that system, departments and personnel related follow relevant regulations and requirements and cooperate with each other to achieve the goal of high-quality ethical review and subject protection.

THE DEVELOPMENT OF CAP CERTIFICATION

Government departments issue management regulations

State Administration of Traditional Chinese Medicine(SATCM)deployed a special bureau-level project of research on ethical review and organized experts to carry out the research in 2008. Management Standards of Ethical Review of Clinical Research on Chinese medicine, the first government regulatory document for ethical review of clinical research on Chinese medicine in China,was promulgated in 2010. Ethical expert committee of SATCM was established in 2011. Regulation for Building an Ethical Review Platform for the Clinical Research on Traditional Chinese Medicine and Quality Assessment Points for Building an Ethical Review Platform for the Clinical Research on Traditional Chinese Medicine were launched in 2011. Thus the work on building ethics review system of Chinese medicine was launched.

Industry associations conduct research and develop standards

Under the initiative and promotion of the Department of Science and Technology of SATCM, WFCMS established the Ethics Review Committee in 2010 with Professor XiongNingning from the Jiangsu Provincial Hospital of Traditional Chinese Medicine serving as the president.It also published Assessment of Standard for Ethics Review of Biomedical Research with Human Participants(SCM 0011-2013) of the specialty committee, which is the first international organization standard for ethical review in the field of Chinese medicine and traditional medicine.The issuing of that standard has great influence on the international community and has also received the attention of the World Health Organization (WHO).

说明 设计上述驱动问题并非简单地提示，而意在通过示范强化问题意识，引导学生找准自我反思切入的角度，提升自我调控受阻思维的能力．

The certification activities require a valid certification body and auditor. The certification body must be an organization that has been approved by the management department of accreditation and supervision.And it should have obtained legal status according to lawand can be engaged in certification activities within the scope of approval. The auditor must register and be confirmed by the China Certification and Accreditation Association (CCAA) and has the ability to independently perform audit tasks.

Assessment and accreditation of ethics review system for Chinese medicine

Taking advantage of the improvement of the capabilities of scientific research of the national TCM clinical research base, Department of Science and Technology of SATCM, based on the "Management Standards of Ethical Review of Clinical Research on Chinese medicine", initiated an ethics review system for Chinese medicine national widein 2011. Based on that, the Department of Science and Technology of SATCM entrusted specialty committee of ethical review of WFCMS in 2012 to organize accreditation of ethics review system for Chinese Medicine (referred to as CAP accreditation), and to enhance the level of Chinese medicine through evaluation. Institutions that conduct clinical research on Chinese medicine have strengthened the building of ethical platforms and have received extensive responses. In the beginning of 2015, 37 institutions across 20 provinces and cities, across the country passed the CAP evaluation, including 4 well-known comprehensive western medicine hospitals.

The period of CAP certification is three years. Each certification period includes the procedures as follows:certification application and acceptance, initial certification(document auditing, on-site auditing), certification decision,and supervision audit (the first year and the second year)[4].

The first batch of CAP certification was initiated at Longhua Hospital, Shanghai University of Traditional Chinese Medicine in August 2015. A total of seven hospitals including Hubei Provincial Hospital of TCM, Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Jiangsu Province Hospital of TCM, Guangdong Provincial Hospital of Traditional Chinese Medicine, The First Affiliated Hospital of the Fourth Military Medical University of the People's Liberation Army (Xijing Hospital), The First Affiliated Hospital of the Second Military Medical University (Changhai Hospital) etc. passed the first batch of accreditation. More than 20 large-scale excellent hospitals such as Xiyuan Hospital, Dongzhimen Hospital,Guang'anmen Hospital, Dongfang Hospital, Wangjing Hospital, Eye Hospital, China Academy of Chinese Medical Sciences, and Beijing Hospital of TCM passed the CAP certification in October 2016. By the end of 2017, 33 organizations in China had passed CAP certification.

REQUIRMENT FOR THE CONTENTS OF THE ACCREDITATION PROGRAM OF ETHICS REVIEW SYSTEM

①全面推行河道采砂可行性论证制度。在采砂权拍卖前，要全力推行河道采砂可研论证制度，保证河道采砂的科学性和合理性。

温针灸治疗能够起到运行气血、调节机体活动和协调内部阴阳的功效,艾灸能够对各种寒证、痛症等气血痹阻病症起到扶住阳气的作用,具有十分肯定的治疗优越性;刺络放血可以对表浅静脉直接刺入,让淤血即刻放出,有利于对血管舒张活动进行调节,可以促进局部的血流运行情况,进而达到临床治疗的应用目的[3-4]。

The CAP certification is based on the Requirement for Ethical Review System of Biomedical Research[3](HRPS/CTS 01-2017). It reviews and assesses the conformity of the four components, such as the organization, ethics committee, office of the ethics committee and research staff, to confirm the conformity of its ethical review system building and requirements of CAP certification technical specification.The specific content includes the following four aspects:

Basic requirements for medicalorganizations

(1) Management of ethical review system: It is required that medical organizations should establish an ethical review system, in accordance with relevant laws,regulations, and guidelines, clarifying the responsibilities of departments related, ensuring all the research projects involving biomedical personnel should improve ethical review and protect subjects, and providing support and related management for the operation and quality of the review of ethical review system.

Of the 10 cells examined,7 cells could be observed with enhanced inward current responses induced by capsaicin.Ten cells showed no current response with 0.08,0.16,0.32 and 0.64 mmol/L loureirin B(Figure 1).

(2) Management of the ethics committee: It is required that medical organizations should approve the statutes of the ethical committees in accordance with laws, regulations and guidelines related. And the committee should be in charge of its establishment and election, according to the constitution, and provide the necessary resources for the ethic committees. Systems are established to ensure the independence and transparency of the ethics committee's work.

Basic requirements for the ethics committee

(2) Research implementation. Researchers should follow regulations and plan to carry out research.

World Federation of Chinese Medicine Societies is a CAP-accredited certification body. The Ethics Review Committee of WFCMS has a good working foundation and is rich in expert resources in the field of medical ethics, providing a solid foundation for the CAP certification. Meanwhile, WFCMS pays attention to the building and training of the auditor team. The contents of training are as follows: the requirements for ethics review system involving people of the biomedical research; the guidelines for the research on the certification of ethics review system; process management of certification; the management of certification personnel;certification and accreditation and certification in China accreditation system;terms and definitions related to certification and auditing, principles and characteristics of auditing,planning and preparation for auditing; implementation of on-site auditing and methods and techniques; results of the reports on auditing and following activities.

The ethical review system is established by organizations that conduct human biomedical research (such as clinical medical and health institutions, research institutes,universities, etc.) based on ethical laws, regulations, and guidelines, and is composed of organizations, ethics committees, the ethics committee of fice and researchers.

Basic requirements for ethics committee of fice

(1) Management system, guidelines, and standard operating procedures: it is required that the ethics committee shall be, in accordance with the of fice of the ethical committee of fice, promulgate and implement the management system, guidelines and standard operating procedures of the ethical committee. According to assessment of the work of the ethics committee, the of fice regularly review the relevant systems, guidelines and standard operating procedures, modifying and improving it if necessary.

在此次研究中,AB两组的手术时间和出血情况对比不存在统计学差异性(P>0.05)。AB两组的止痛效率不存在统计学差异性(P>0.0167),ABC三组的止痛效率、肺炎发生率、住院时间、满意度等存在统计学差异性(P<0.05)。AB两组外观满意度、肺炎发生率、住院时间不存在统计学差异性(P>0.0167)。随着肋骨骨折手术的改进,固定材料有了很大的变化,记忆合金和可吸收钉等材料被广泛使用。综上所述,使用内固定方式能够让患者的疼痛缓解,减少患者的住院时间,缩短患者的康复周期,但是骨质疏松和骨折严重患者还是推介TiNi环抱式接骨器内固定,可吸收髓内钉适合不宜进行二次手术患者。

(2) Document archives and information management: Ethics Committee Office is required to respond orderly to the management of files and adopt good security measures to meet the requirements of confidentiality. The files of the ethics committee can be either a paper or electronic file, or both.

Basic requirements for researchers

(1) Subject protection. Researchers should regard subjects' rights, health and safety as the primary concern of the study.

(1) Review: It is required that Ethics Committee should conduct ethical review in accordance with laws,regulations, and guidelines related.

MANAGEMENT OF THE CERTIFICATION ORGANIZATION

Management of certification organization and auditors

Meanwhile, Ethics Review Committee of WFCMS has successively published System and Operational Procedures of the Ethics Committee and Guidelines for the Ethical Review of Biomedical Research involving People,which provide guidelines for the system building of the Ethics Committee and members of the Ethics Committee to carry out research on ethics review. The specialty committee of WFCMS also organized experts to prepare text books for research on TCM ethnic review and training.The ability of the internal auditors has continuously been promoted.by the organizingacademic conferences, carrying outinternational exchanges andtraining for the members of the ethics committee and internal auditors.

(2) Decision procedure: it is required that the ethics committee shall make a decision by voting, based on conference review process and on the thorough discussion of the ethical issues involved in the research project.

Certification process of CAP application

In order to promote better and quicker development of the ethical review system, and make the accreditation results widely recognized by the society and the world, WFCMS was approved by the Certification and Accreditation Administration of the People's Republic of China on December 29th, 2014 as a certification body.Capability Accreditation Program of Ethics Review System for Chinese Medicine is formally upgraded into a program approval by the national government, with an approval number of CNCA-R-2014-175. CAP's development from assessment to certification is a major breakthrough in the regulation of ethical review of TCM clinical research.

Certification application and acceptance

To apply for CAP certification, the following 4 requirement conditions must be met: register as a legal person in China national administrative department for industry and commerce or related institutions; establishment of an ethical review committee, and the scope of its ethical review covering research on Chinese medicine; ethical review activities in line with relevant law and regulations of the People's Republic of China;establishment and implementation of an ethical review system that meets the Requirements for Ethics Review System of Biomedical Research. WFCMS accepts the CAP certification application and reviews the application materials.After deciding to accept the application, it will send the documents to the applicant, such as an audit notice and an audit plan. The application organization is required to do the relevant preparations for initial certification.

Initial certification

The initial auditing is mainly divided into the first and second period. The first stage is mainly document review which mainly standardizes the system document now being used, of the audited part, by using the file the CAP certification standard system. The second stage is on-site auditing whether the actual implementation of the document of the main verification system is effective. By the two different stages of auditing, it is confirmed that the document of organization's system meets the requirements of the certification standard and the effectiveness of its implementation and operation is verified.

After the second period of auditing, the organization, which applied certification, needs to modify according to the auditing report within time limits. After submitting the relevant materials of rectification, the certification body verifies the corrective measures and the effectiveness raised by the organization been audited.

Certification decision

Certification Group of WFCMS, based on the auditing report, conclusions, rectification materials,and other documents, can make three decisions such as passing certification, partially passing certification, and failing certification. Certificates and boards will be issued to organizations passed the certification by WFCMS, and announcement will be put on the organizations' website.The units that have not been approved will be told the reasons of their failure. If the unit submits an application again, it will not be accepted until at least 6 months later.

Supervision and auditing

Supervision and auditing refers to the periodic or irregular reexamination by the certification body of the certified entity within the validity period of the certificate.During the three-year validity period of the certificate,at least supervision and auditing shall be conducted once every year. The supervision and auditing mainly considers operational effectiveness and conformity caused by the changes of the system documents and the changes of the organization. The effectiveness of corrective actions, which is not in line with the report,will be verified. And there may be remaining issues,which may reoccur. We will see whether the continuous improvement of the system is perfect, the usage of the certificates, certification marks etc. According to the results of the supervision and audit, there are three types of results, which are as follows: maintaining certification,suspending certification, and withdrawing certification.

式中，Fj为水资源承载力指数，Fj＞1表示实际承载的农业经济规模大于水资源可承载的最大农业经济规模，表现为水资源超载；Fj=1，表示实际农业经济规模等于最大可承载农业经济规模，水资源承载平衡；Fj＜1，表示实际承载的农业经济规模小于水资源可承载的最大农业经济规模，水资源承载力有盈余。

Re-accrediation

Before the third year of certification expiring, a recertification auditing is required if the certification is needed to maintain. The re-certification review focuses on the operation of the CAP system established by the certified entity during the certification period.Recertification activities are basically the same as initial certification.When there is no significant change in the operating environment of the CAP system, certified organization or CAP system, the activity of the re-certification audit can be exempted from the initial verification of the first stage,otherwise it cannot be exempted.

CAP Certification Flow Chart

CAP CERTIFICATION PROMOTS THE DEVELOPMENT OF CHINESE MEDICINE RESEARCH ON ETHICS REVIEW SYSTEM

The implementation of the ethical review system certification is important to improve the ability of the research on ethics review system in the field of Chinese medicine. The certification promotes the development of the research on ethics review system in China and the continuous improvement of the ability of Chinese medicine research on ethics review.

For agencies applying for certification, CAP certification can further promote the establishment of an ethical review system for the organization, improve the level of the organization's ethical review and subject protection, ensure the quality of ethical review, control the risk of clinical research, and improve the credibility of ethnic review institutions and the research results.For China's administration of Chinese medicine, leaping from sector appraisal to national certification is an innovation and breakthrough in the standardized management of TCM research on ethics review. As a quality assurance and monitoring tool, CAP certification can help the government to strengthen supervision of the organizations of the ethical review and serve as one of the indicators for the government to evaluate the level of scientific research capacity of an institution. CAP certification has become a brand with Chinese characteristics in the field of traditional and modern medicine, and has become a strong guarantee for supporting the achievements of scientific research of Chinese medicine, which are accepted by modern medicine.

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3月份快完了，懊热仍没有消退。一个星期日（星期日人们睡得早），爱德华多从杂货铺回家，看见克里斯蒂安在套牛车。克里斯蒂安对他说：

REFERENCES

1. CIOMS: International Ethical Guidelines for Health-related Research Involving Humans, 2016.

2. Wang ZY, Xiong NN, Li W, etc.Building and certification of ethics review system of Chinese medicine research. Beijing:People's Medical Publishing House, 2017.

3. World Federation of Chinese Medicine Societies.Requirements for ethics review system of biomedical research involving people. 2017.

4. World Federation of Chinese Medicine Societies.Accreditation Rules for ethics review system of biomedical research involving people. 2017.