To develop a patient-reported outcome instrument for chronic gastrointestinal diseases and to select items by analyzing the data from clinical investigation.

Clinical evaluation proceedings from patient-reported outcomes (PRO) are being concerned increasingly. Based on the concept of PRO, the report discusses the findings in the research recently made at home and abroad. PRO from apoplexy patients with spastic paralysis was taken as an example in the exploration of how to evaluate the curative effects in clinical practice on the basis of PRO.

This paper specifically elaborated the ethics committee of China and the United States review meet-ing in the project report , project FAQ, ethical discussion , voting and so on each link , analyzes the ethical review mode difference between the two countries , and according to the mode of ethical review meeting in China and the United States are compared , and the model helps to find their own ethical review meeting , improve their efficiency of ethical review committee meeting .

Most of apoplexy patients have suffered limb spastic-paralysis for a long time,which impacts their activity and emotion seriously.However,the instruments of evaluating apoplexy spastic-paralysis used come from abroad mostly.These instruments are not special for apoplexy spastic-paralysis patients,and that there is a lack of patients' experience.Therefore,it is urgent to develop a Patient Reported Outcomes(PRO)instrument specially for apoplexy spastic-paralysis patients.

According to the common standard of ethic review for clinical research , it is equal to each kind of research program whether western medicine or Traditional Chinese Medicine .It should be reviewed the ethic and scientific issues in the same time .However, on account of the two majority characteristics of Traditional Chinese Medicine , it would be concerned more evidence , such as the safety data before clinic , the syndrome differentiation and treatment of target disease , drug combination , dosage and course of treatment , the methods of outcome meas-urement, admixture of the drug, the selection of control drug including placebo and so on .

Chronic lung diseases, including bronchial asthma, chronic obstructive pulmonary disease (COPD), chronic bronchitis, allergic rhinitis and repeated respiratory tract infection (RRTL) in infants, exacerbate frequently in winter because of respiratory viral infections and low temperature. Summer acupoint application therapy (SAAT) is thought to be effective in reducing exacerbation frequency of chronic lung diseases in winter. It is a kind of therapy using a herbal mixture for external application on special acupoints during summer. The herbal mixture basically contains Semen Sinapis Albae, Herba Asari, Radix Euphorbiae Kansui and Rhizoma Corydalis. The acupoints include Feishu (BL13), Dazhui (GV14) and Danzhong (CV17). Through a large-scale multicenter trial based on three years of clinical observation, and retrospective and prospective analyses, this study aims to explore the efficacy of SAAT.

Objective:This thesis aims to construct the evaluation index system ethics management in Beijing medical institutions for application research.Method:The author applied the evaluation system which was agreed and adjusted by expert groups in four medical and health institutions.Result:After three rounds of expert groups have reached the agreement,the Evaluation Index System on Human Research Ethics Management in Beijing Medi-cal Institutions is established,which contains 6 first-class indicators,16 second-class indicators and 39 third-class indicators.The application on four medical and health institutions show that the evaluation index system is practical,operable and is of high degree of distinction.Conclusion:The evaluation index system is scientific,rea-sonable,practical and is of high degree of validity,credibility and distinction.

Clinical research differs from routine diagnosis and treatment,and the clinicians and clinical investi-gators differ due to their different responsibilities.From the aspects of personnel qualification requirements,activity implementation process and role conflict balance in clinical research and routine diagnosis and treatment work,this paper compared and analyzed the roles of clinicians and clinical investigators and differences,deepening clini-cians'understanding and grasping on the connotation of their different roles,enhancing the sense of responsibility of clinicians as clinical investigators and improving the quality of clinical research.

Scientific research is an important part of hospital work,the driving force of hospital construction and development,and the key to the hospital's comprehensive competitiveness and future development potential.Scientific research misconduct,which seriously deviates from the recognized norms of the scientific community,and will cause great harm to groups,society,and the public.It may also lead to the spread of false knowledge,resulting in misconceptions among peers and causing losses.By analyzing the scientific research integrity relationship between clinical doctors and clinical researchers,as well as looking at integrity standards from multiple dimensions,this paper found out the similarities and differences in the extension of integrity between them.Exploring measures to further promote the construction of scientific integrity and ethics,especially increasing the supervisory role of discipline inspection and supervision,which is conducive to the promotion of scientific research in the medical field in China.

Objective:With the rapid increase in the number of real world studies, especially the use of health data in medical institutions, ethical issues such as the use of patient health data and the protection of patient′s privacy rights and the right to know have been gradually exposed. To strike a good balance between promoting data sharing and maintaining subjects′ personal privacy, the mode of informed consent appears to be crucial. This paper provided guidance for the selection of informed consent models for real world research health data utilization.Methods:The authors extensively studied the relevant laws and regulations of health data utilization worldwide, conducted extensive searches in Chinese and English databases, sorted out and analyzed various alternative informed consent models, and summarized their characteristics and applications.Results:At present, five alternative informed consent models were used to conduct real world research based on health data utilization. Researchers can choose informed consent models according to the research purpose, research design, research risk, operability of informed consent, and vulnerable groups.Conclusions:Different alternative informed consent models have varied characteristics. Researchers need to choose informed consent models based on the above factors to ensure the maximum protection of patients' privacy rights while using health data.