Requirement for Ethics Committee after China Food and Drug Administration Join ICH-GCP / 中国医学伦理学

Objective:To summarize the opportunities,challenges and countermeasures that China Food and Drug Administration (CFDA) joining ICH-GCP will bring to the construction of ethics committee,so as to provide reference for the standardization construction and review ability of ethical committee in China.Methods:We reviewed and comprehensively analyzed the domestic literatures about the requirement for ethics committee after CF-DA join ICH-GCP.Results:CFDA joining ICH-GCP was conducive to speeding up the construction of Chinese ethics committee.Aiming at the challenge of the standardization construction of ethics committee,it could use the revised policy regulations and guidelines to integrate with ICH-GCP,establish ethics certification system in line with the national condition,clear the composition of members,standardize operational procedures,and establish regional ethics committee and leader the review of the unit system;to improve the review ability,it could strengthen reviewing requirement from the aspects of sponsor responsibilities,researchers qualification,research protocols,informed consent,researcher brochures and documents management.Conclusion:CFDA joining ICH-GCP brings a rapid development opportunity for the ethics committee as well as challenges.We can solve problems from standardization construction and the improvement of review ability,to speed up the construction of ethics committee that meets the requirements of ICH-GCP.

The Fourth Paradigm of clinical research: the innovation of clinical study management pattern in the era of biological big data / 中华医学科研管理杂志

Objective To explore the impact of biological big data on clinical study management.Methods To understand the changeof clinical study resulted from big data from the perspectiveof scientific study management.Results Bigdata Clinical Trial (BCT) based on massive clinical study data will turn out to be one of the most important parts of clinical study gradually.General rules target population will be obtained from clinical study model of the whole population.Reality fact will be more closely approached by the results of study on macro factors.Precise trend of dynamic changes can be demonstrated via data of full time linear tracking studies.Data collection will include those unordered data which are potentially inaccurate andregarded as useless in small data time.Conclusions Revolutionary changes will be presented in clinical study model in which data acquisition and info analysis are used as the primary approaches in big data era,and prediction of clinical study developmenttrend based on big data as well as innovation of management model for clinical study will make power ful support for better utilization of big data tools and accomplishment for big data realization and precision technology.

Discussion on Ethical Review Question of CRISPR/Cas9 Gene Editing Technology in Clinical Research / 中国医学伦理学

Objective:To explore the ethical review questions of CRISPR/Cas9 gene editing technology caused in clinical research,and thus to provide a reference for matters needing attention of the ethical review involved in this technology in clinical.Methods:This paper summarized the ethical problems of CRISPR/Cas9 gene editing technology at home and abroad,analyzed the reasons and put forward some suggestions for the application of new technology in line with China's national conditions.Results:It should allow CRISPR/Cas9 gene editing technology to be applied in somatic cell gene therapy,forbidden for genital gene therapy and not considered to enhance.Since CRISPR/Cas9 lack clear subject of responsibility ethics,it brings security,conflict of rights and social equality issues.The measures that need to be taken include the strengthening of cultural communication,the formation of ethic forms of gene editing technology,the establishment of independent ethical review body at national's level,the improvement of legal norms,the formulating of technical standards and ethical principles and the major support to gene editing research field at the national level.Conclusion:In view of the potential clinical application of CRISPR/Cas9,our country should progressively restrictively develop the embryonic gene editing techniques from the prohibition.The ethics committee is responsible for the ethical review and supervision of clinical research.Members of the ethics committee and ethical staff should strengthen the study of new knowledge,strictly docking policies and regulations from accepting the clinical research projects involving CRISPR / Cas9 to ethical review,and thus to ensure the effectively review the ethical problems of genetic editing technology project.

Natural science-social science multidisciplinary research in medical research and its research organization / 中华医学科研管理杂志

Medical research has entered the era of mega-science.The multidisciplinary collaboration has attracted great attention.besides studies on genes and the environment interaction,multidisciplinary research between natural sciences has received widespread recognition.However muhidisciplinary researches on the interaction between the gene and social factors or behavioral factors on health science deserve more emphasis.This article described development of multidisciplinary research and its features;analyzed importants of conducting multidisciplinary research between natural and social disciplines,and finally provided suggestions on research organization reform in order to promote the multidisciplinary research.

Challenges faced by public health research organization in the context of translational research / 中华预防医学杂志

Translational research in public health (TRPH) increasingly attracted attention. Focus of TRPH is not only patients, it also emphasizes to promote health for all society and whole population. Therefore, TRPH is more complicated, involves multi-disciplines and multi-sectors. This paper analyzed the conception, features of TRPH, and challenges faced by research organization of public health.

Health of peacekeepers protection with perspective of global health / 中华预防医学杂志

Global health arisen recently, but it developed rapidly and attracted great attention from global researchers and institutions. China, as a member of United Nation, actively participated in many international peacekeeping activities. Health of peacekeepers is global health and it is important to consider and dealt with health of peacekeepers with conception of global health. This article reviewed and analyzed health problems and risk factors faced by peacekeepers,and provided suggestions to strategies to protect health of peacekeepers.

Translational medicine and clinical nursing / 中华医学科研管理杂志

Nursing had a long history over thousands of years which developed from ancient saying better bid the cooks than the medicine,disease-centered and patient centered tohealth-centered clinical nursing.In order to promote quality of clinical nursing,it need innovation by introducing translational medicine into nursing.This paper analyzed how to integrate translational medicine into clinic nursing and explore nursing model based on translational medicine.

Expansion of foreign affairs functions to enhance the scientific and technological strength of the military medical university / 中华医学科研管理杂志

Starting from the transformation of the management models of foreign affairs,we introduced the achievements made through expanding the functions of foreign affairs at a military medical university in terms of academic exchanges,research collaboration,and training of young intellectuals,which resulted in the improvement of scientific and technological strength.Further expansion of foreign affair functions was then discussed in aspects of establishing institutional mechanisms,improving the service platform and building a team of qualified foreign affair administrators.

Prediction of Chinese Translational Research Organizations——Illuminations of Research Organization Comparison between American and China / 中华医学科研管理杂志

translational research highly depends on Translational research organizations.America is the leading country in science and technology. It is very important to learn from America successful experience in order to develop perfect translational research organization.This paper analyzed the needs of changing the current research organization,and provided some suggestions for Chinese translational research organization based on understanding the differences between America and Chinese present research organization.

Collaborative Innovation Promoting Translational Medicine development / 中华医学科研管理杂志

The nature of collaborative innovation is to share the resources for innovation through management,which would play great role in scientific policy change in China. Translational medicine actually is combine theory and daily practice,basic and clinic research,which need multidiscipline,collaboration between different areas.Collaborative innovation is the requirement of translational medicine.Therefore,establishing research organization with characteristic of collaborative innovation is the key for the development of translational medicine.

Establishment of index system for evaluating sustainable innovation ability of science and technology in large general hospital / 中华医学科研管理杂志

Objectives To establish an evaluation index system for general hospital's sustainable innovation ability of science and technoloby and determine the index weight. Methods Firstly, the theory of scientific and technological innovation was discussed based on the systematic analysis of the related facts from the documents. Secondly, a set of targets was drafted with methods of work breakdown structure (WBS), classification and combination from references to many other studies of science and technology evaluation, and then revised by experts who are familiar with the subject. Thirdly, the weight of each target was decided through Analytical Hierarchy Process (AHP) and questionnaires. Results A systematic and comprehensive evaluation system of the general hospital's sustainable innovation ability of science and technology, comprised 3 first-level indicators, 15 second-level indicators and 37 third-level indicators, which were proved reliable by consistency check. The weights of each indicator were also defined. Conclusions The evaluation system comprises both qualitative and quantitative indicators. The indicators not only reflect the performance of a period, but also reflect the sustainability of large general hospitals' scientific and technological innovation ability. By using the scientific consultation, analysis and statistics, the evaluation system is proved to be valid and reliable.

Comprehensive study of evaluation system for sustainable innovation ability of science and technology in large general hospitals / 中华医学科研管理杂志

Objective To evaluate the sustainable innovative ability of science and technology (S &T) of four large general hospitals from three different regions of China(Chongqing, Shaanxi and Hunan) with an evaluation system. Method The data collected were processed with normalization method. The evaluation models were established and varied in design to reflect either the dynamic trends or the levels of innovative abilities in different hospitals. Results Hospital A, B and D took on an ascending trend in sustainable S & T ability for innovation, while hospital C showed a descending trend in recent years. Overall, hospital A and D had a stronger sustainable S & T ability for innovation than hospital B and C. Conclusion The eval-uation system established is able to reflect the levels and trends of sustainable S & T innovative ability of the selected hospitals, which is in accordance with the actual situations, and is therefore scientific and feasible.It could provide reference for hospital S & T administrators to make decisions and is favorable to the sustainable development of hospital's S & T innovative ability.

New suspicious gene loci correlated with the generation and development of children 's retinoblastoma / 中国组织工程研究

BACKGROUND: Recent researches have indicated that the generation and development of retinoblastoma(RB) might also be related with other anti-oncogenes except the known Rb1 gene.OBJECTIVE: To explore the loci of other genes which possibly participated in RB generation and development and try to find and confirm the indicators for the loss of heterozygosity(LOH) with merits in surveillance and prognosis.DESIGN: A case analysis by employing RB patients as subjects SETTING: A center of gene diagnosis and therapy of a military medical university-affiliated hospitalPARTICIPANTS: The study was conducted in the center of gene diagnosis and therapy of Xinan Hospital affiliated to Third Military Medical University of Chinese PLA. Sixteen RB cases including 10 males and 6 females were the patients of the outpatient department of three-affiliated hospitals of the Third Military Medical University of Chinese PLA from May 1998 to October 2001.Inclusion criteria: in accordance with RB diagnostic criteria and younger than 3 years old; Exclusion criteria: family heredity history. Two eyes were involved in 12 cases and one eye was involved in 4 cases.METHODS: Fourteen micro-satellite DNA labels on the 13th chromosome in tumor or peripheral blood samples were separately amplified by polymerase chain reaction(PCR) to analyze the incidence of LOH of each locus. Simultaneously, the genetic source of loci loss was confirmed by genealogical analysis.MAIN OUTCOME MEASURES: Frequency of LOH incidence on the 13th chromosome.RESULTS: In 16 RB patients,LOH occurred in one or more than one locus on the 13th chromosome of 12 cases. Thereinto, the probability of LOH occurrence on three loci including D13S265,D13S263 and D13S153(in Rb1gene) was the highest. Ten loci of LOH in 12 LOH positive samples were confirmed from agnate chromosomes. The RB confirmation of LOH-positive group or LOH-negative group needed 504 days or 1086 days,which was significantly different(t=2. 357,P<0.05).CONCLUSION: RB confirmation was earlier in LOH-positive patients than LOH-negative patients. Except the confirmed Rb1 gene, LOH on two loci including D13S263(13q14.1-14.2) and D13S265 (13q31-32) also might have certain suggestive effect on early intervention and functional surveillance of RB patients.