题目：Analysis of factors influencing the organizational capacity of Institutional Review Boards In China: a crisp-set Qualitative Comparative Analysis based on 107 cases

作者：Lu Lu1,Shuwen Shi，Bojing Liu and Chanjuan Liu

期刊《BMC Medical Ethics》

摘要：

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 combina-tions 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 super-vision 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 organiza-tional capabilities in IRBs. To enhance the organizational capacity of IRBs in China, it is imperative to elevate the com-petence of committee members and strengthen team development. This can be achieved by establishing a com-prehensive 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.