This paper deeply studied the definition and characteristics of clinical research programs. On such basis, the researchers utilized theoretical and comparative studies in combination of practical studies, to probe deeply into both the operating procedures and management documents of the clinical research management council.These efforts contributed to constructing a systematic, overall and feasible management system,for reference of building such a council by medical institutions.

Objective:To explore the status quo and influencing factors of scientific research ethics cognition of medical staff in 3A-grade hospitals in Fuzhou, and to put forward suggestions for strengthening the construction of scientific research ethics in hospitals.Methods:A questionnaire survey was conducted using a self-designed questionnaire, and the data were statistically analyzed using SPSS 25.0 software.Results:Among the 478 respondents, 184 (38.49%) did not participate in ethics training, 123 (25.73%) were not aware of the organization of their hospital ethics committee, and 47 (9.83%) thought that carrying out ethics review was beneficial to patients but not to scientific research. Respondents with higher education, previous experience with ethics application review, who would consider relevant research ethics issues during clinical study protocol design and development, and who believed that ethical review of medical research would benefit both patients and research had a better overall cognition of research ethics ( P<0.05). Conclusions:Medical staff's cognition of various aspects of scientific research ethics is relatively weak. Hospitals should take multiple initiatives to improve the efficiency of ethical training, optimize the ethical review mechanism, and strengthen the construction of scientific research ethics.

Objective:To construct a follow-up evaluation index system for "Diagnosis of Brucellosis" (WS 269-2019), and provide a reference basis for the next revision and improvement of the standard.Methods:The evaluation index system for "Diagnosis of Brucellosis" (WS 269-2019) was preliminarily established by consulting relevant references and materials. The experts in the field of diagnosis, treatment, prevention and control of brucellosis were selected, and two rounds of expert consultation were carried out in the form of questionnaires using the Delphi method. The necessity and availability of evaluation indicators were scored, and suggestions for modifying and adding indicators were put forward. Based on this, a standard follow-up evaluation index system was established. At the same time, a judgment matrix was constructed combined with the Saaty scale, and the analytic hierarchy process was used to calculate the weight of each index in the system.Results:After 2 rounds of expert ( n = 10) consultation, a standard follow-up evaluation index system for "Diagnosis of Brucellosis" (WS 269-2019) was constructed with 3 first-level indexes, 8 second-level indexes and 21 third-level indexes. The positive coefficients of experts in 2 rounds of questionnaires were both 100%; the coefficient of authority of experts was 0.82; the Kendall's coefficients of concordance of first-level, second-level and third-level indexes were 0.722, 0.260, and 0.181, respectively, with P < 0.05. Among the first-level indexes, the weight of standard quality evaluation was the highest (0.364), and the weight of standard implementation status was the lowest (0.278); among the second-level indexes, the combined weight of social benefits was the highest (0.186), and the combined weight of advanced nature was the lowest (0.043); among the third-level indexes, the combined weight of timely diagnosis rate was the highest (0.096), and the combined weight of consistency with technical data was the lowest (0.009). Conclusions:The constructed follow-up evaluation index system for "Diagnosis of Brucellosis" (WS 269-2019) is scientific and reliable, which evaluated qualitatively and quantitatively, reduces the defects of a single evaluation, and provides a basis for subsequent revision and improvement of the standard.