We first extracted the conditional variables that affect the construction of Institutional Review Board through the combination of policies and regulations and literature analysis, and constructed the “Triangle force” hypothetical model of medical ethics committee’s organizational capabilities from the perspective of organizational capability. The “Triangle force” model is a reflection and exploration of the management method of a medical ethics committee, which is centered on the core value of a medical ethics committee (protecting the rights and interests of subjects and experimenters) to create the “Triangle force”, that is, the organizational support of the medical ethics committee (office resources and supervision mechanism), medical ethics committee management expertise (review process and rules and regulations), and medical ethics committee member ability.
Through the crisp-set qualitative comparative analysis (csQCA) method, 107 Institutional Review Board were empirically analyzed, and we found single condition variables and condition configurations that affected the differences in the construction of Institutional Review Board, from the perspective of single condition variables.
The variable of “protection of rights and interests” is a single necessary condition that leads to a better construction of Institutional Review Board, while the variable of “lack of member ability, lack of review process, and lack of supervision mechanism” is a single sufficient condition that leads to poor construction of Institutional Review Board. From the perspective of state analysis, three interpretation modes are summarized: the member ability-oriented (M1), system process-oriented mode (M2), and resource system-oriented mode (M3), and the organizational capabilities of the medical ethics committee are constructed in this article. The hypothesis of the “Triangle force” model is consistent. The “Triangle force model” of the medical ethics committee’s organizational capacity provides a reference for the organization of Institutional Review Board and provides a reference for the management of Institutional Review Board. Therefore, the following revelations are drawn:
Focus on the Shaping of Member Capabilities
The working ability of the ethics committee members is the basic ability of the hospital ethics committee to perform its functions; however, the abilities of the ethics committees of each hospital are not the same. In the actual operation of the hospital, the review standards of the ethics committee of each hospital are often different. In the same report, it is not uncommon for a hospital to pass the review without modification but not pass the review in other hospitals. This shows that the review capabilities of the ethics committees of each hospital are different.
The fundamental reason lies in the ethics of the ethics committee members. There is a gap between quality and ethical review ability. Insufficient ethics knowledge training and education come from different professional hospital ethics committee members with special skills. The necessary knowledge of medical ethics, the ability to understand and execute ethical principles and related laws and regulations, and the degree of understanding and mastery of new medical technologies may be different. However, as a member of the ethics committee, the imperfection of ethical knowledge will seriously affect the effective use of the ethical review role of the hospital ethics committee.
The role of the ethics committee members is not balanced. The members of the committee have different professional backgrounds and understandings of ethical principles and laws. The grasp of laws and regulations, the understanding and grasp of experimental schemes are different, and there are huge differences in the angle and authority of review. The members of the ethics committee perform the functions of the ethics committee and are closely related to their own interests and even have conflicts. Most of the members of the hospital ethics committee are employees of the hospital. The interest and emotional relevance of the unit may affect the objectivity and fairness of the ethics review (Liu, 2018).
Stakeholders of hospital ethics committee members participate in ethical review, which will lead to conflicts between their obligations to perform their duties and their pursuit of their own professional development and other self-interests. The urgent need for the construction of hospital ethics committees at this stage is prominently reflected in the hospital ethics committee’s skill building. This is the fundamental requirement for improving the efficiency and level of the hospital ethics committee and giving full support to the role and function of the hospital ethics committee.
Optimize the Improvement of the System Process
The establishment of a sound system process can better ensure the independence of ethical organizations and also truly reflects the connotation of independence. Independence not only includes the requirements of independent places and supporting facilities, but more importantly, the rules and regulations of ethical organizations, and particularly the standards of ethical organizations. In the implementation of procedures, the institutional process-oriented model (M2) in the above-mentioned research and any medical ethics organization must standardize its operation, where the primary task is to continuously improve the construction of a series of rules and regulations with the goal of standardization, institutionalization, and proceduralization.
The rules and regulations of medical ethics organizations mainly include related systems in the construction and operation of hospital ethics organizations, which include: an ethics office management system, ethics organization work charter, member generation and replacement system, education and training system, conflict of interest declaration and avoidance system, financial management system, ethics committee year-end summary system, etc.
Relevant systems in ethics organization consulting review include a meeting review and emergency meeting review system, rapid review system; follow-up review management system after ethics review; management system for ethics consulting, review, and complaint acceptance; standard operating procedures; and a meeting management system. The file management system includes file creation, preservation, inspection and copying, etc. Hospital ethics organizations must strictly abide by various rules and regulations. For ethics organizations and their persons in charge who do not strictly abide by the rules, necessary punishments and the disqualification of evaluation qualifications must be carried out to ensure the standard operation of ethics organizations.
Attention Regarding the Construction of Resource Systems
The prerequisite for the medical ethics committee to have full power in its role is that it has sufficient organizational support—that is, the resource system-oriented model (M3) in the above-mentioned research. The current system of medical ethics committee management in China is mainly reflected in the unclear organizational structure, and they are often affiliated with unused departments, insufficient authorization of Institutional Review Board, a lack of internal self-monitoring and supporting information platforms, etc.
The reason is that the lack of resources (facilities, funds, technology, etc.) of the medical ethics committee is mainly reflected in the institution’s lack of in-depth understanding regarding Institutional Review Board, a lack of scientific planning, and because it is not an independent department, a difficulty in obtaining organizational resources. Therefore, it is indispensable to match the necessary resources related to the work and to enhance the organizational support of the medical ethics committee. Organizational funding is one of the basic conditions for maintaining the normal operation of ethics organizations.
The 2016 “Measures for the Ethical Review of Biomedical Research Involving People” also mentioned that the department or institution that establishes the institutional ethics committee should be granted based on the work of the ethics committee members. Appropriate remuneration and training requires funding. However, a considerable number of ethics organizations in China still lack the basic funds to maintain their normal operations. In most cases, in the hospitals where they are allocated certain funds or project review fees, there are potential risks that affect the independence, objectivity, and fairness of the review results.
The reason is that the interests and reputation of medical institutions may exceed the safety of patients or subjects. The state can establish a reasonable funding mechanism, and provide appropriate special projects based on scientific budgets and funding management systems formulated by various ethical organizations, including funds to support the construction and operation of hospital ethics organizations and the scientific research related to them. The appropriate administrative intervention of the organization’s organization is conducive to improving the construction of Institutional Review Board.
Therefore, it is advisable for the administrative department to be responsible for the supervision of the ethical organization’s work; however, for the supervisory body, its specific responsibilities should be further clarified and specific. This should be mainly from two aspects: internal and external. Regarding the internal need for institutional ethics committee self-management, the institution should have special departments and personnel for internal quality supervision; regular self-assessment, and the development of quality improvement plans. Ethics committees should have improvement measures for problems found in self-examination, and should evaluate, train, and assess the chairman, committee members, office director, secretary, and staff. External supervision needs to be disclosed to the public through the official website, including the contact information of the committee, the list of members, occupations, affiliated units, articles of association and guidelines, etc., and they should accept industry supervision in accordance with the industry’s regulatory requirements of the institution.
Shortcoming And Prospects
Finally, although many new discoveries and understandings were formed in this research, the current research on this issue is mostly qualitative analysis or single-case study, and there is a lack of systematic research on multi-case quantitative methods. This article used quantitative methods to study this problem for the first time. This was a tentative exploration, and it is inevitable that there are deficiencies. Judging from the existing literature, on the one hand, this work was limited by the literature and method framework, and there is still room for optimization of the conditional variables. Although the case selection of this study strictly followed scientific steps, limitations are unavoidable.
The influence of subjective factors may have strong subjectivity. Future research should increase the diversity of the influencing factors of the medical ethics committee and select multiple factors from different perspectives to further enhance the explanatory power. In addition, with the continuous increase of public information and the continuous deepening of research in related fields, the author will continue to work hard to solve the problems that still exist in this research, and further enhance the scientificity and effectiveness of this research.
Generally speaking, the Chinese medical ethics committee started late, has just finished the rapid development stage, and now in the transitional period of focusing on quality. In fact, the Chinese medical ethics committee has fully learned from the experience of other countries in its development process. And now, we try to summarize the findings of the survey in China into the experience that can be used by other countries.