Research On Evaluation Of Hospital Ethics Committees In Shanghai

[BACKGROUND]In recent years, some regions and countries begin to explore and develop the methods to evaluate the operational quality of institutional review boards (IRBs) or ethics committees. The United States accredits their IRBs or ethics committees through Associtation for the Accreditation of Human Research Protection Program (AAHRPP), an non-governmental organization. The Forum for Ethical Review Committees in the Asian and Western Pacific Region (FERCAP) also carries out the accreditation of the Ethics Committees in order to foster an improved understanding and better implementation of ethical review of behavioral and biomedical researches in the region. Although the construction of hospital ethics committees in China has been enhanced, there is no systemetic assessment measures to evaluate the hospital ethics committees in China. Therefore, we have studied on the evaluation of hospital ethics committees in Shanghai.[OBJECTIVEIThe objectives of our research include:①to form the measures for the evaluation of hospital ethics committees, including indicators, weights, and criteria of the assessment;③to evaluate13hospital ethics committees in Shanghai according to the formed assessment measures;③to provide an effective way and bases for strengthening the standardized administration of hospital ethics committees in Shanghai.[CONTENT]The main research contents include:①to analyse of current status on the function and management of hospital ethics committees in Shanghai These included the genenral status of hospitals, organization, routine management, review tasks, training of hospital ethics committees, and the recognition and evaluation of principal investigators.②to research on the indicator framework for the assesment of hospital ethics committees in Shanghai We preliminarily designed the assessment indicators and evaluation methods from three dimensions, which are organization, management and performance.③to form the weights, criteria, and assessment methods of the indicators According to the objectives and principles of the evaluation and after2rounds of expert consultations, we formed the weights, criteria, and assessment methods of the indicators.④to apply the evaluation measures We analyzed the effectiveness of the formed evaluation measures through empirical study and also analyzed the consistency in the assessment scores among the experts’evaluation, hospitals’self-evaluation and principal investigators’evaluation.[METHOD]①Literature review We collected and read the international and domestic reference on the evaluation of hospital ethics committees in order to form the preliminary measures for the assessment of hospital ethics committees, including the indicators, criteria and assessment methods.②Expert consultation11experts were invited to attend2rounds of consultations to form the evaluation measures of hospital ethics committees in Shanghai, including indicators, weights, evaluation elements and assessment methods.③Questionaire survey3general hospitals and4specialist hospitals affiliated to Chinese ministry of health or Shanghai municipal government, and3general hospitals and3specialist hospitals affiliated to district governments were chosen from the public hospitals that had hospital ethics committees in Shanghai. The surveys of these hospitals and their principal investigators and the field review of the experts were made.④Group discussion7secretaries of the selected hospital ethics committees were invited to review the draft of the research report and to make suggestions for revise the report and the assessment measures.⑤Data analysis We used Epidata3.1and Excel2010to input the data. SAS9.1was used to make statistic analysis. Quantitative analysis included descriptive statistics, chi-square test. The interview data were analysed by qualitative description. We also analysed the consistency of the assessment scores among experts, hospitals and principal investigators by Kappa. [RESULT]The evaluation measures of hospital ethics committees in Shanghai was formed, consisting of3first-level indicators (organization, management and quality),14second-level indicators and49third-level indicators. The empirical analysis showed that the average total scores of13hospital ethics committees in Shanghai was70.87; that the average scores for organization, management and quality were82.56,70.63and70.82respectively; but, the average total score in the general hospitals affiliated to Chinese ministry of health or Shanghai municipal government was the highest (84.01), while that the specialist hospitals affiliated to district governments was the lowest (39.51).Analysis on the current fuction and management status of hospital ethics committees in Shanghai showed that the13surveyed hospital ethics committees were aligned with international and domestic bioethical principles, guidelines, and the regulations related to bioethics review. The study showed that hospital ethics committees in Shanghai had explicit statutes, working regulations and/or standard operating procedures, had the members that met the basic requirements and got certain training, and strictly followed the relevant national rugulations and guidelines when they made ethics review. Most of the hospital ethics committees had relatively comprehensive and well organized records of bioethic reviews. But there were some deficiencies in continuing review, including inadequate input of human resources, financing and equipment and facilities.[RECOMMENDATION]Based on the results of this study, we recommended to strengthen the systemetic evaluation of hospital ethics committees, to establish regional hospital ethics committees based on a core hospital in the region; to further improve the organization, management and quality of hospital ethics committees in Shanghai.