Researchers' Knowledge About the Ethical Norms of National Natural Science Foundation of China Funded Medical Research:Current Status and Suggestions / 中国医学科学院学报

Objective To understand the current status of Chinese medical researchers' knowledge regarding the ethical norms of the research involving humans or laboratory animals,and provide reference for further improving the ethics review norms. Methods The questionnaire method was employed to survey the applicants for the 2019 projects supported by the Department of Medical Sciences,National Natural Science Foundation of China (NSFC) about their knowledge of ethical requirements.Furthermore,the ethical supervision of the NSFC and affiliations at the project application and implementation stages was analyzed. Results The survey showed that 29.9% medical researchers were familiar with NSFC's ethical requirements for research involving human or laboratory animals.During the project application stage,59.0% affiliations adopted the simplified review method.Regarding the ethical supervison,95.5% medical researchers believed that the affiliations should fulfill the ethical supervision obligations and take relevant measures during the project implementation period.In addition,55.0% medical researchers fully agreed to discuss with the review experts about the ethical issues involved in the project. Conclusions The NSFC should establish rules and regulations to improve institutional management responsibilities and institutionalize the training about research ethics to comprehensively strengthening the training.Taking the management of research project ethics as a starting point,the NSFC should form a multi-party linkage between project funding and management and establish an accountability mechanism for ethics management.Furthermore,the NSFC should double the endeavors at the review of ethical issues during expert review and process management and attach importance to the research,judgment,and prevention of ethical risks.

Thinking from the Perspective of Medical Institutions on Measures for Ethical Review of Life Science and Medical Research Involving Humans / 中国医学伦理学

From the perspective of medical institutions, this paper sorted out the background of the promulgation and important changes of Measures for Ethical Review of Life Science and Medical Research Involving Humans, and summarized the changes that may significantly affect the ethical review of medical institutions. It involved terminology changes and expansion of the scope of ethic review, clarification of the responsibilities and independence of the ethics committee, the refinement of the ethical review process, the emphasis on the protection of personal information and the rights and interests of subjects, and first proposal to exempt from ethical review. In addition, based on the concept of strengthening the ethical governance of science and technology in the new version of regulations, this paper shared the consideration on the governance of ethical review within medical institutions, including safeguarding the dignity and rights of subject, clarifying the role and position of ethical review, exempting the implementation of ethical review, and managing entrusted ethical review. With a view to providing a certain reference for the ethics practitioners and researchers in various medical institutions.

Reflection and Practice on the Implementation of "Exemption from Ethical Review" in Medical Institutions / 中国医学伦理学

From the perspective of medical institutions, this paper sorted out the contents of Article 32 of the Measures for Ethical Review of Life Sciences and Medical Research Involving Human regarding "exemption from ethical review". At the same time, combined with domestic and foreign regulations, this paper deeply considered and analyzed the applicable premise and special circumstances of the provisions from the implementation level, and then put forward suggestions from the perspective of practical operation of medical institutions, with a view to providing some practical guidance and reference for ethical practitioners of medical institutions.

Challenges and Implementation Suggestions for Exemption from Ethical Review / 中国医学伦理学

To reduce the burden of researchers, Article 32 of the Measures for Ethical Review of Life Sciences and Medical Research Involving Human issued in February 2023 proposed that the review could be exempted. Normative exemption from review can not only relieve the burden of researchers, but also reduce the work pressure of the ethics committee, and devote limited time and energy to the review and supervision of high-risk research. This paper analyzed the four criteria for exemption from review first, and then summarized the situation of exemption from ethics review in the International Ethical Guidelines for Health-related Research Involving Humans and in the United States. In view of the fact that there are no relevant regulations on exemption from ethics review, though some medical and health institutions have implemented exemption from ethics review for some studies, the ethics committee often lacks standard operating procedures, corresponding documents, and experience for exemption from ethics review, researchers lack training for exemption from ethics review, and institutions have no supporting measures for exemption from review. To effectively implement the exemption from review, this paper proposed the following suggestions:developing standard operating procedures for exemption from review, and clarifying the review process, which can be simplified to secretary reviews, with senior secretaries or office directors judging whether they meet the exemption criteria, and the chairman reviewing and signing to convey the review decision. Refining the criteria that meet the exemption from ethics review, and providing cases and explanations as necessary, which will help researchers accurately understand the connotation of each criterion, and also provide reference for researchers to make their own preliminary judgments. Strengthening the training of researchers’ exemption from review criteria. The study should obtain the project proposal first, and provide scientific demonstration opinions. To explore the implementation of continuing review, institutions should accelerate the standardized construction of biological sample banks and databases to ensure the provision of compliant sources of biological samples and information data. Exemption from ethics review should not be abused, and the relationship between reducing the burden on researchers and ensuring the quality of ethical review should be balanced.

Research on the Strategy of Improving the Efficiency of Multi-departmental Operation in the Ethics Review System of Traditional Chinese Medicine after CAP Certification / 中国医学伦理学

Capability Accreditation Program of Ethics Review for Chinese Medicine Research (CAP Accreditation) is the first medical ethics certification project in China. Institutions can further improve their ethics review work level after passing the CAP accreditation. However, the operational efficiency of each department in the ethics review system needs to be further improved when performing relevant functions in accordance with the certification requirements. Based on the experience and summary in the work of the ethical review system, this paper analyzed the main factors that affect the efficiency of the ethical review system and put forward improvement strategies from six aspects: organizational leadership, incentive policies, quality supervision, system construction, talent training, and promotion through evaluation, with a view to providing reference for improving the efficiency of ethical review, and promoting multi-department coordination and system integration.

Analysis on key points of ethics review of horizontal scientific research projects: Based on the ethics review management system of horizontal scientific research projects in a tertiary hospital / 中华医学科研管理杂志

Objective:This paper aims to promote the standardization of ethics review of horizontal scientific research projects and improve the ethics review quality by analyzing the current ethics review practice in a certain tertiary hospital, identifying common problems during the review process, illustrating relevant causes and proposing corresponding solutions.Methods:Through introducing the current situation of ethics review of horizontal scientific research projects in a tertiary level hospital, the differences between the main points of ethics review of horizontal scientific research projects and government-funded scientific research projects were analyzed, so as to sort out the common problems and possible causes in the process of ethics review of horizontal scientific research projects, and then explore the possible corresponding solutions.Results:Based on the characteristics of horizontal research projects, ethics review should focus on their scientific and social values, potential conflicts of interest, protection of subjects′ rights and interests, and whole-process management and quality assurance. At present, there are still many problems, such as a large number of projects, but not many projects with high research value, inadequate project process management, and ineffective implementation of ethics review opinions.Conclusions:The hospital should further improve the management system of horizontal scientific research project approval, bring in more comprehensive review regarding to both scientific and ethics review, engage more experts at the outset of project funding decision-making, set up ethics specialists, strengthen the process management of horizontal scientific research projects, strengthen ethical publicity and education, and improve the ethical awareness of researchers to fully protect the rights and interests of subjects and promote the high-quality development of clinical research.

Research ethics committees in Manila Schools: Exploring the reasons for its non-existence

Objectives@#This study aimed to explore the reasons behind the “resistance” of higher education institutions (HEIs) located in the south Manila area in creating research ethics committees (RECs). It also examined the proportion of researches in these HEIs with human participation. @*Methods@#Research directors underwent key informant interviews while faculty researchers participated in focus group discussions. Universal sampling was employed on all researches in the schools to determine the proportion with human participants and to know if they are ethically “high risk“ or “low risk” in terms of the participants’ involvement. @*Results@#We included ten higher education institutions in this study. Research directors and faculty researchers agreed that their school should have a REC and that studies should undergo ethical evaluation before commencement of data collection. Half of all researches were found to have human participant involvement and, after developing a tool to determine the risk level to participants, this study found that ethically high risk researches are found to represent 10% as a proportion of the total researches done in the schools. @*Conclusion@#Almost all respondents in this study agreed that RECs should be created; however, there are financial challenges that schools face in establishing RECs.

Caracterização de comitês de ética em pesquisa de um município baiano / Caracterización de comités de ética en investigación de un municipio de bahía / Characterization of ethics committees in research of a municipality of bahia

Objetivo caracterizar o perfil dos Comitês de Ética em Pesquisa de um município baiano. Método estudo de abordagem quantitativa, com análise descritiva dos resultados, realizado em cinco Comitês de Ética em Pesquisa. A coleta de dados deu-se por questionário autoaplicado na Plataforma Google Forms. Resultados evidenciou-se maioria de membros do gênero masculino, com curso de pós-graduação stricto sensu, ingresso por convite e capacitação prévia para atuarem nos Comitês. Foram implantados há mais de 8 anos; composição varia de 8 a 25 membros efetivos; predomina a utilização da página eletrônica no processo comunicativo. Os projetos avaliados são multidisciplinares, distribuídos para apreciação considerando a área de formação, perfil e expertise do membro. Conclusão os Comitês de Ética em Pesquisa estudados atuavam há mais de oito anos, o que demonstra experiência consolidada em pesquisa. A recondução do mandato contribui para o aprofundamento das discussões, capacitação de novos membros e fortalecimento do sistema CEP/CONEP

Objetivo caracterizar el perfil de los Comités de Ética en Investigación de un municipio de Bahía. Método estudio de aproximación cuantitativa, con análisis descriptivo de los resultados, realizado en cinco Comités de Ética en Investigación. La recolección de datos se basó en un cuestionario autoadministrado en Google Forms Platform. Resultados se evidenció la mayoría de los miembros varones, con curso de posgrado stricto sensu, admisión por invitación y capacitación previa para trabajar en los Comités. Fueron implantados hace más de 8 años; la composición oscila entre 8 y 25 miembros de pleno derecho; predomina el uso del sitio web en el proceso comunicativo. Los proyectos evaluados son multidisciplinarios, distribuidos para su consideración considerando el área de capacitación, perfil y experiencia del miembro. Conclusión los Comités de Ética en Investigación estudiados llevaban más de ocho años activos, lo que demuestra una experiencia consolidada en investigación. La renovación del mandato contribuye a la profundización de los debates, la capacitación de nuevos miembros y el fortalecimiento del sistema (CEP/CONEP en Portugués).

Objective to characterize the profile of the Research Ethics Committees of a municipality of Bahia. Method quantitative approach study, with descriptive analysis of the results, conducted in five Research Ethics Committees. Data collection was based on a self-administered questionnaire on the Google Forms Platform. Results a majority of male members were evidenced, with stricto sensu graduate course, invitation admission and prior training to work in the Committees. They were implanted more than 8 years ago; composition ranges from 8 to 25 full members; the use of the website in the communicative process predominates. The projects evaluated are multidisciplinary, distributed for consideration considering the area of training, profile, and expertise of the member. Conclusion the Research Ethics Committees studied had been active for more than eight years, which demonstrates consolidated experience in research. The renewal of the mandate contributes to the deepening of discussions, training of new members and strengthening of the system (CEP/CONEP in Portuguese).

A ética e o controle social em pesquisa científica no Brasil / The Ethics and Social Control in Scientific Research in Brazil / Ética y control social en la investigación científica en Brasil

Objetivo/Contexto. A pesquisa científica contribui para o bemestar social, mas persistem condutas de caráter ético duvidoso. Quando interesses se conflitam, ocorrem incertezas de autonomia do pesquisador e cuidados com o pes-quisado. Este artigo analisa aspectos relacionados a aspectos éticos das pesqui-sas que envolvem seres humanos no Brasil e a participação do Controle Social nesse processo. Metodologia/Abordagem. O artigo desenvolve mediante análise qualitativa inter e multidisciplinar que verifica assimetrias, limitações e progressos presentes dentro do sistema normatizador e executor dos parâmetros éticos para a pesquisa com humanos no Brasil e a participação do Controle Social. Especialmente, aborda conflitos de orientação avaliativa de aspectos éticos em pesquisas com humanos. Resultados/descobertas. Condutas avaliativas divergentes dos aspectos éticosna pesquisa com humanos não se limitam aos diferentes comitês de ética estão presentes dentro dos próprios comitês e necessitam ser pacificadas. O representante dos participantes da pesquisa tornase presença obrigatória como membro dos comitês e reflete a necessidade de formação continuada para o exercício da função. Discussão/Conclusões. No Brasil, a Comissão Nacional de Ética em Pesquisa (CONEP) foi criada no ano de 1996. Com função consultiva, deliberativa, normativa e educativa, busca implementar normas e diretrizes regulamentadoras de pesquisas com humanos no Brasil, mediada por uma rede sistêmica e descentralizada de comitês de ética. A CONEP tem enfrentado desafios para equalizar a simetria decisória das diferentes unidades do sistema e entre as próprias unidades, principalmente na transposição do olhar ético das pesquisas biomédicas para as pesquisas das humanidades.

Objective / Background. Scientific research contributes to the well-being of socie-ty, but conducts of doubtful ethical character persist. When interests conflict, they promote uncertainties of researcher autonomy and care for the researched. This article aims to analyze aspects related to the evaluation of ethical aspects of research involving human beings in Brazil and the participation of Social Control in this process. Methodology / Approach. The article is developed from an inter and multidisciplinary qualitative analysis that analyzes asymmetries, limitations and progresses present within the normative system and executor of the ethical parameters for research with humans in Brazil and the participation of Social Control. Especially, it addresses conflicts of evaluative orientation of ethical aspects in human research. Results / Findings. Divergent evaluative conducts of ethical aspects in human research are not limited to the different ethics committees, they are present within the committees themselves and need to be pacified. The representative of the research participants becomes mandatory presence as a member of the committees and reflects the need for continued training to exercise the function. Discussion / Conclusions. In Brazil, the National Commission on Ethics in Research (CONEP) was created in 1996. With consultative, deliberative, normative, and educational functions, it seeks to implement norms and guidelines regula-ting research with humans in Brazil mediated by a systemic and decentralized network of ethics committees. CONEP has faced challenges to equalize the decision-making symmetry of the different units of the system and among the units themselves, especially in the transposition of the ethical view of biomedical research to humanities research.

Objetivo/Antecedentes. La investigación científica contribuye al bienestar de la sociedad, pero persisten conductas de dudoso carácter ético. Cuando los intereses entran en conflicto, promueven la incertidumbre sobre la autonomía del investigador y el cuidado del investigado. Este artículo tiene como objetivo analizar los aspectos relacionados con la evaluación de los aspectos éticos de la investigación con seres humanos en Brasil y la participación del Control Social en este proceso. Metodología/Enfoque. El artículo se desarrolla a partir de un análisis cualitativo inter y multidisciplinario que analiza las asimetrías, limitaciones y avances presentes en el sistema normativo y ejecutor de los parámetros éticos para la investigación con humanos en Brasil y la participación del Control Social. En especial, aborda los conflictos de la orientación evaluativa de los aspectos éticos en la investigación con seres humanos. Resultados/Hallazgos. Las conductas evaluativas divergentes de los aspectos éticos en la investigación con humanos no se limitan a los diferentes comités de ética, están presentes dentro de los propios comités y deben ser pacificadas. El representante de los participantes en la investigación se convierte en presencia obligatoria como miembro de los comités y refleja la necesidad de formación continua para el ejercicio de la función. Discusión/Conclusiones/Contribuciones. En Brasil se creó en 1996 la Comisión Nacional de Ética en la Investigación (CONEP). Con funciones consultivas, deliberativas, normativas y educativas, busca implementar normas y directrices que regulen la investigación con seres humanos en Brasil, mediadas por una red sistémica y descentralizada de comités de ética. El CONEP se ha enfrentado a retos para igualar la simetría de la toma de decisiones de las diferentes unidades del sistema y entre las propias unidades, especialmente en la transposición de la visión ética de la investigación biomédica a la investigación en humanidades.

Promoting the information management of hospital ethics review by establishing an information system / 中华医学科研管理杂志

Objective:Through the establishment of a tertiary hospital ethics review information system, the information management of ethics review is carried out, thereby improving the quality and efficiency of ethics review.Methods:Four steps that including status quo analysis and problem identifying, corrective action plan making, outcome monitoring, as well as experience analysis were conducted, according to which a full-chain ethical review information system was developed. This system has certain characteristics such as well-featured functions, reasonable structure and user friendly, which fulfilled the expectation of the information management of review work.Results:The updated ethics review information system provides much stronger support for ethics review management and also improves its efficiency.Conclusions:The information system makes the management of ethics review more efficient, standardized and well-organised.

Ethics review characteristics of clinical research of acupuncture and moxibustion / 中国针灸

The elements of ethical review related to clinical research of acupuncture and moxibustion is discussed to provide ideas for various institutions to carry out relevant ethical review. It is believed that the ethical review of clinical research of acupuncture and moxibustion needs to focus on the specificity of acupuncture and moxibustion. Starting from the basic theory of traditional Chinese medicine, the theory of meridians and acupoints and the theory of syndrome differentiation along meridians, the key contents of ethical review such as intervention methods, grouping design and placebo control should be considered, so as to standardize the clinical research of acupuncture and moxibustion and protect the health and rights and interests of participants.

Research in the time of COVID-19: Challenges of research ethics committees / Journal of the ASEAN Federation of Endocrine Societies

@#<p style="text-align: justify;">Compliance with ethics guidelines for research are even more critical in the time of emergency public health situations such as a pandemic. Underpinned by the principles laid out in the 1979 Belmont report, conduct of research at any time should focus on respect for persons, beneficence and justice. Certain Standard Operating Procedures (SOPs) in research ethics committees may be revised to provide a quicker turn-around and timely review. Key elements in effective review of studies include rigorousness, responsiveness and timeliness. It is crucial to recognize that ethics review committees share responsibility with researchers and its institutions, funding agencies and regulatory agencies for upholding ethical principles in research at all times.</p>

Investigation on the development and ethical review of experimental animals' welfare / 中华医学科研管理杂志

Objective Animal experiment is indispensible for the progress of medicine and medical research.Experimental animals deserve basic respect and care.This paper reviewed the history and status of the experimental animal welfare nationally and internationally to identify the ethical problems existed in animal experiments,and finally discuss the establishing of ethical review system of experimental animals.Methods According to literature review,as well as summarizing the operating practice in the affiliated hospital of Chengdu university of TCM,this study analyzed the problems in the field of experimental animal welfare protection.Results Many countries,such as Britain,Germany and the United States,have legislation on the welfare of experimental animals.There are no such laws in China while departmental regulations has formulated.At present,the weak cognition of bioethics among medical personnel,lack of corresponding certification system,lack of the ethical review system of laboratory animal are still unsolved problems.This paper summarizes the principles of ethical review,the documents of review and the elements of review.Conclusions The protection of experimental animals is a systematic project,and ethical review as the first link of animal experiments can play a good role in promoting animal experiment.

Improving the Level and Quality of Ethics Review in Chinese Medicine and Integrative Medicine / 中国结合医学杂志

Three features of ethics review in Chinese medicine (CM) and integrative medicine (IM) were put forward in this paper. It is consistent with the principles of ethical review in Western medicine; it has to be compliant with the laws of CM and IM; emphasis should be laid on the review of clinical practice facts and experience. Three problems were pointed out. The characteristics of CM and IM are not distinctive enough, operation procedures need to be refined and effectiveness remains to be improved. Based on the mentioned above, seven measures were proposed to improve the level and quality of ethics review in CM and IM, including better brand awareness, considerable tolerance, treatment based on disease differentiation and syndrome differentiation, scientific review and toxicity and side effects of CM, perfection of the ethics review system, reasonable procedures of ethics review and more specialized ethics review workers.

Comitês de ética em pesquisa no Brasil: estudo com coordenadores / Research ethics committees in Brazil: a study with coordinators / Comités de Ética de la Investigación en Brasil: un estudio con coordinadores

Resumo Este estudo buscou caracterizar perfil e operacionalização de Comitês de Ética em Pesquisa. Foi enviado questionário eletrônico aos 645 comitês existentes à época e respondido por 129 coordenadores. As respostas foram categorizadas por frequência e média e passaram por teste estatístico. Os resultados obtidos indicaram que a maioria dos coordenadores concluíra mestrado ou doutorado em Ciências Biológicas e da Saúde. Os comitês funcionavam há mais de nove anos em instituições de ensino superior com apoio institucional insuficiente. Os membros eram capacitados por meio da leitura das regulamentações e orientações do Comitê. A distribuição de protocolos era feita por afinidade temática, e a decisão grupal se dava por consenso ou votação. Conclui-se que os comitês estão consolidados e cumprem a regulamentação ética, mas necessitam dialogar mais com pesquisadores e a Comissão Nacional de Ética em Pesquisa.

Abstract This study aimed to characterize the Research Ethics Committees in their profile and operationalization. An electronic questionnaire was sent to the 645 existing committees at the time and answered by 129 coordinators. The answers were categorized by frequency and mean of the answers and passed by a statistical test. The results indicated that most of the coordinators had a degree in Biological and Health Sciences, at Masters and PhD levels. The committees had been operating for more than nine years in higher education institutions, with insufficient institutional support. Members were empowered by readings of the Committee';s regulations and guidelines. The distribution of protocols was done by subject affinity and the group decision was given by consensus or vote. It is concluded that the committees are consolidated, comply with ethical regulations, but they need to dialogue more with researchers and with the National Commission of Ethics in Research.

Resumen Este estudio tuvo como objetivo caracterizar el perfil y la operatividad de los Comités de Ética de la Investigación. Se les envió un cuestionario electrónico a los 645 comités existentes a la fecha y fue respondido por 129 coordinadores. Las respuestas se clasificaron por la frecuencia y el promedio y se sometieron a una prueba estadística. Los resultados obtenidos indicaron que la mayoría de los coordinadores finalizaron su magíster o doctorado en Ciencias Biológicas y de la Salud. Los comités funcionaban hace más de nueve años en instituciones de educación superior, con apoyo institucional insuficiente. Se capacitaba a los miembros por medio de la lectura de las normas y directrices del Comité. La distribución de los protocolos se realizó por afinidad temática y la decisión grupal se estableció por consenso o por votación. Se concluyó que los comités están consolidados y cumplen con las normas éticas, pero necesitan dialogar más con los investigadores y con la Comisión Nacional de Ética de la Investigación.

The synergistic mechanism of hospital scientific research management and ethical review / 中华医学科研管理杂志

Objective To explore the cooperative mechanism of hospital research management and ethics review.Methods Through the analysis of current ethical conditions,as well as the relationship between hospital research management and ethical review,study on how to integrate them during the management of scientific research project.Results Research management and ethical review have different emphasis from different perspectives,however,both of them serve for research projects which makes inseparable connections.Conclusions Hospital research management and ethical review can be synergistic,according to which the management of scientific research projects will be more reasonable and scientific.

Analysis of the Influential Factors of Medical Staff's Cognition on Medical Ethics Review / 中国医学伦理学

Objective:To analyze the influential factors of medical staff's cognition on medical ethics review in Wuhan municipal medical institutions,and thus to provide suggestions for strengthening the ethical construction.Methods:Aquestionnaire survey was conducted among medical staff.Chi-square test and Logistic regression method were performed to analyze the influential factors of medical staff's cognition on medical ethics review.Results:The results showed that medical staff's cognition on medical ethics review was affected by the technical tide,education background,whether had received ethical education,the cognition on ethics committees and whether the medical institution had established ethics committee.With higher technical titles,they thought more necessity to establish ethics committees and conduct ethical review of the clinical applications of new technology and new business.Those with higher technical titles and had read the ethical propaganda materials thought it more necessary to conduct ethical review of the clinical application of new technology and new business and the ethical review of biomedical research involved human beings.Conclusions:The medical institution should embody the establishment and standardization of ethical committees into the hospital assessment management system,as a necessary condition for the application of research projects and achievement awards.Also,it should conduct medical ethics training for all medical staff.Only those passed the examination can enter into the research and clinical operation with certificates,which can protect the medical ethics education into practice.It should strengthen the medical staff's cognition on ethical review,constantly innovate the operation rules and management system based on following the basic ethical review principles,and constantly improve the medical ethical review mechanism.

Ethics review on research of forensic medicine / 中国法医学杂志

Ethics review as the content of the research management of forensic medicine,is the research object of forensic medicine.Focusing on ethics review of the forensic medicine research,this paper discussed on the necessity of ethics review and guiding principles of ethics committee,and appealed for the construction of ethics review in forensic medicine research.

Discussion on the Overall Principle of Traditional Chinese Medicine Research Ethics Review-Study on the Characteristics of Traditional Chinese Medicine Research Ethics Review (Four) / 中国医学伦理学

In the traditional Chinese medicine research ethics review, the basis of strengthening the overall concept and adhering to the overall principle is that paying attention to the rights and interests of the subjects at the same time focusing on the study objective and the study design, which is the ethics committee′s responsibility. The overall concept is the essential characteristic of traditional Chinese medicine. Only when sticking to the overall prin-ciple, the safety of subjects can be ensured. The implementation of the overall principle should review all of the fol-lowings:whether the investigational drug is certificated, the integrity of the test drug prescriptions, the prevention of drug side effect, and strengthen the construction of ethics committee.