BACKGROUND:Institutional Review Boards (IRBs) play a vital role in safeguarding the rights and interests of both research participants and researchers. However, China initiated the establishment of its own IRB system relatively late in comparison to international standards. Despite commendable progress, there is a pressing need to strengthen the organizational capacity building of Chinese IRBs. Hence, this study aims to analyze the key factors driving the enhancement of organizational capacity within these committees.METHOD:The cross-sectional survey for this research was conducted from July 2020 to January 2022. Following the statistical grouping based on the "2020 China Health Statistical Yearbook", a systematic investigation of IRBs in various provinces of China was carried out. In-depth interviews and questionnaire surveys were conducted with the chairpersons and administrative executives (or secretaries) of highly cooperative IRBs. Subsequently, data were collected from 107 IRBs. Qualitative Comparative Analysis (QCA) was employed as the method to analyze the factors influencing the organizational capacity of medical ethics committees and explore the diverse combinations of these factors.RESULTS:Through a singular necessary condition analysis, the variable "protection of rights and interests" emerges as a critical factor contributing to the robust construction of Institutional Review Boards Institutional Review Boards (IRBs). Conversely, the variables of "lack of member ability, absence of review process, and deficiency in the supervision mechanism" collectively constitute a sufficient condition leading to weaker IRB construction. The state analysis uncovers three interpretation modes: member ability-oriented (M1), system process-oriented mode (M2), and resource system-oriented mode (M3).CONCLUSIONS:The results of this study are effectively explicable using the "Triangular Force" model proposed for the hypothesis of IRBs' organizational capacity, which provides a solid foundation for the development of organizational capabilities in IRBs. To enhance the organizational capacity of IRBs in China, it is imperative to elevate the competence of committee members and strengthen team development. This can be achieved by establishing a comprehensive regulatory framework and refining procedural protocols. Moreover, clarifying the organizational structure and optimizing resource allocation are essential steps in bolstering the overall organizational capabilities of these committees.

Objective:To understand the ethical misconduct of Chinese medical researchers and its influencing factors, so as to provide a reference for regulating such misconduct in clinical research.Methods:From September to November 2021, a stratified random sampling method was adopted to select medical researchers from the China Clinical Trial Registration Platform as interview objects, and semi-structured interviews were made on ethical misconduct and its influencing factors in clinical trials. The interview data were analyzed using NVivo11 software.Results:A total of 28 interviewees were included, 57%( n=16) of whom holding that medical researchers accept research ethics passively in most cases. The influencing factors of ethical misconduct of medical researchers are summarized into 7 secondary nodes and 43 tertiary nodes, including 248 reference points. The environmental factors included poor ethical supervision, great research pressure information asymmetry between subjects and researchers, and insufficient ethical atmosphere, including 54, 40, 38, and 29 reference points respectively. The self-factors included lack of ethical knowledge, weak ethical awareness, and individual characteristics of researchers, including 48, 21 and 18 reference points respectively. Conclusions:The attitude and behavior of clinical research ethics of Chinese medical researchers are generally in the transitional stage from passive acceptance to positive compliance, and there are many factors influencing ethical misconduct. In order to further standardize the ethical behavior of medical researchers, the authors suggest relevant authorities to improve ethical review and supervision, establish systematic ethical training, improve the scientific research environment, and actively carry out clinical trials and science popularization.

Abstract BackgroundCompared with international Institutional Review Board, China started late; however, in recent years, under the promotion of Chinese government departments, academic organizations, and experts and scholars at all levels, Chinese Institutional Review Board have made great achievements in the protection of rights and interests, systems, and procedures， Chinese Institutional Review Board are still weak in their organizational capacity building. The organizational capacity building of Institutional Review Board is a subject with complex causality, and it is difficult to offer a completely reasonable explanation for all aspects. MethodIn this article, we analyzed the influencing factors that affect the current status of the operation of Chinese Institutional Review Board, using literature analysis to refine the conditional variables and analyze the cases of 107 tertiary hospitals in China through crisp-set qualitative comparative analysis (csQCA) to explore the impact of medical ethics. Using the necessary conditions and combination of committee construction, combined with the “Yang Triangle” model of organizational capabilities, we designed a “Triangle force” model of the organizational capabilities of Institutional Review Board and proposed solutions from the perspective of organizational capabilities, reflecting on and analyzing the current management status of Chinese Institutional Review Board. ResultsWe found that the protection of rights and interests was a necessary condition for a medical ethics committee. A lack of member ability, lack of review process, and lack of a supervision mechanism were sufficient conditions for a poor construction of a medical ethics committee. ConclusionsWe analyzed seven interpretation paths for this organization to operate well and they can be summarized into three typical paths: member ability-oriented, institutional process-oriented, and resource system-oriented, which are consistent with the “Triangle force” model hypothesis of the medical ethics committee’s organizational capabilities as constructed in this article. The driving factors and supporting forces of an ethics committee provide a theoretical basis and policy suggestions for the organization of Chinese Institutional Review Board.

Objective:Given the indispensable role played by medical ethics committees in protecting the rights and interests of subjects and researchers, such committees in China are found with weak organizational capacity. This study was designed to analyze the driving factors to improve their organizational capacity.Methods:Form July to September 2020, a survey and interview of 71 tertiary A hospitals in eastern China were conducd, and a total 60 valid samples were obtained. Through crisp-se qualitative comparative analysis(csQCA), the medical ethics committees of 60 tertiary hospitals were analyzed, and the factors affecting the organizational capabilities of the medical ethics committees and their combinations were explored.Results:Protection of rights and interests was key to medical ethics committee′s organizational capacity, while incompetency of the members and the irregular review process were sufficient reasons for the weak organizational capacity. There were six combinations of sufficient conditions for the medical ethics committee to be strong in organizational capacities, which could be explained by the three models of member capacity-orientation, system-process-orientation, and resource-system-orientation.Conclusions:The medical ethics committees are recommended to enhance members capacity, enhance team building; complete rules and regulations, and process mechanism; clarify organization structure, and optimize resource matching, in an effort to enhance the organizational capacity of these committees in China.