Reporting of conflict of interests, source of funding, and ethics committee approval in randomized trials of three clinical specialties published in Spanish language

Background: Confidence in the results reported by randomized clinical trials (RCTs) depends mainly on the internal validity of the trial and its conduct, but also on other aspects related to health research such as the complete reporting of conflicts of interest (COI), funding sources and approval by ethics committees. Bias in the study results may arise from any one of these elements. Prior studies have explored the reporting of these items in the medical literature, but there are no reports on RCTs published in Spanish and Latin American journals. This study aimed to evaluate the reporting of COIs, funding sources, and approval by ethics committees of RCTs published in Spanish and Latin American journals in dentistry, geriatrics and neurology. Methods: We did a systematic retrospective survey of all RCTs published from 1990 to 2018 in dentistry, neurology, and geriatrics journals published in Spain and Latin America and included in the BADERI database (Iberoamerican journals and trials database by its initials in Spanish). We completed with hand searching. We included RCTs with a recoverable full text published between 1990 and 2018. We extracted data on sources of funding, COI statements, and ethics reviews. The extraction of these items in the RCTs included was done independently by two pairs of reviewers and in parallel for each article, with a third independent reviewer resolving discrepancies. We analysed compliance for each item. Results: We identified RCTs in 69 journals from Spain and Latin American countries. Dentistry accounted for 75% (n = 52) of the journals, neurology 20.6% (n = 14), and geriatrics 4.4% (n = 3). Of the total number of RCTs included in this study (n = 392), only 102 (26%) reported the presence or absence of a COI, 103 (26%) studies reported funding, and 43 (36%) included the ethics committee approval. Conclusions: RCTs published in the Spanish language in dentistry, neurology, and geriatrics had poor compliance with the reporting of a COI, source of funding, and ethics committee approval. Future research should evaluate the accuracy and completeness of COI statements and their relationship to the funding source and direction of the results.

Política de medicamentos de alto costo en un hospital público pediátrico: Análisis de utilización y costos / High-cost medication policy at a public pediatric hospital: utilization and cost analysis

Objetivos. Analizar el circuito de utilización de los medicamentos de alto costo (MAC) y los resultados clínicos obtenidos en un hospital de pediatría público de alta complejidad de Argentina y presentar una estrategia de selección replicable para otras instituciones de similares características de la región. Métodos: Estudio prospectivo, descriptivo, aleatorizado, conducido en el Hospital de Pediatría Juan P. Garrahan de la Ciudad Autónoma de Buenos Aires en el período entre el 1 de setiembre de 2018 y el 31 de marzo de 2019. Se evaluaron dos unidades de estudio, la unidad paciente y la unidad MAC. Resultados: Los MAC consumen 7.921.200 dólares estadounidenses (USD) anuales y representan el 41% del costo de los medicamentos del hospital de alta complejidad. El 50% del costo de los MAC estuvo representado por la gammaglobulina (medicamento utilizado en diferentes enfermedades). Los pacientes proceden de toda la Argentina y otros países y un 44% tiene cobertura de salud. Los diagnósticos para los que se prescribieron MAC con mayor frecuencia fueron los relacionados con patología oncológica (leucemia linfoide aguda, leucemia mieloblástica aguda). El 54% de los pacientes presentó mejoría atribuible directamente a la administración de los MAC, 39% no presentó cambios y el 7% empeoró. Conclusiones: La efectividad en los resultados clínicos y el análisis de los circuitos de aprobación indican que, además de la aprobación por las entidades nacional e internacionales, la evaluación responsable por parte de las instituciones efectoras, mediante la discusión interdisciplinaria basada en la mejor evidencia, contribuye a optimizar la utilización de los MAC y la seguridad de los pacientes (AU)

Objectives. To analyze the utilization circuit of high-cost medications (HCM) and the clinical results obtained in a tertiarycare public pediatric hospital in Argentina and to present a selection strategy that may be disseminated to other institutions of similar characteristics in the region. Methods: A prospective, descriptive, randomized study was conducted at Hospital de Pediatría Juan P. Garrahan in Buenos Aires between September 1, 2018 and March 31, 2019. Two study units were evaluated, the patient and the HCM. Results: HCMs account for 7,921,200 US dollars (USD) per year and represent 41% of the cost of drugs in this tertiary-care hospital. Gamma globulin (a drug used for different diseases) accounted for 50% of the cost of HCMs. Patients came from Argentina and other countries and 44% had a health insurance. Cancer (acute lymphoid leukemia, acute myeloblastic leukemia) was the diagnosis for which HCMs were most frequently prescribed. Fifty-four percent of patients showed improvement directly attributable to the administration of HCMs, 39% showed no change, and 7% worsened. Conclusions: The effectiveness in clinical outcomes and the analysis of approval circuits show that, in addition to approval by national and international entities, responsible evaluation by the effector institutions through interdisciplinary discussion based on the best evidence contributes to optimizing the use of HCMs and patient safety (AU)

La batalla decisiva contra la fiebre tifoidea en Santiago de Chile en el siglo XX

Hasta 1983, cuando alcanzaba la increíble tasa de 118 casos por 100.000 habitantes, la fiebre tifoidea era la peor amenaza infecciosa en Santiago, Chile, ciudad que figuraba junto a Ciudad de México, El Cairo y Bombay, como una de las con mayor endemia en el mundo. El Ministerio de Salud respondió formando el Comité de Tifoidea de Chile, con participación de expertos nacionales y del grupo de Myron Levine, de la Universidad de Maryland, que llevó a cabo ingeniosas investigaciones, culpando al río Mapocho, cuyas aguas contaminadas con Salmonella typhi regaban los predios agrícolas vecinos, conformando así un ciclo largo de infección. Las vacunas antitíficas ensayadas (oral Ty21a atenuada y polisacárido capsular Vi inyectable) no mostraron eficacia, los portadores crónicos no se trataron, pero una campaña sanitaria a través de la televisión contribuyó decisivamente a mejorar los hábitos higiénicos de la población, fortalecida por el pánico que causó la llegada del cólera en 1991, y la fiebre tifoidea prácticamente desapareció del escenario.

Until 1983, when reached the incredible frequency of 118 cases for 100.000 habitants, typhoid fever was the worst infectious threat in Santiago, Chile, city that appeared next to Mexico City, Cairo and Bombay, as one of the most endemic in the world. The Ministry of Health responded with the creation of The Chilean Typhoid Committee, with the participation of national experts and Myron Levine's group, which carried out ingenious investigations blaming the Mapocho River, whose waters contaminated with Salmonella typhi irrigated the neighboring farms, thus conforming a long cycle of infection. Typhoid vaccines tested (strain Ty 21a oral and Vi capsular polysaccharide) did not show efficacy, chronic carriers were not treated, but a health campaign on television made a decisive contribution to improving hygiene habits of the population, strengthened by the panic caused by the arrival of cholera in 1991, and typhoid fever practically disappeared from the stage.

Characterization and Comparison Analysis of WHO Monographs on Selected Medicinal Plants and ISO Standards of Chinese Materia Medica / 中国结合医学杂志

Medicinal plants or Chinese materia medica (CMM) are now attracting worldwide attention as they have increasingly prominent advantages over chemical drugs in disease treatment and healthcare. Since the 1990s, World Health Organization (WHO) and International Organization for Standardization established the Technical Committee of Traditional Chinese Medicine (ISO/TC 249) have carried out the development of quality standards on medicinal plants or CMMs respectively, and a considerable number of monographs and international standards have been published. Since the two international organizations adhere to different principles, the standards they develop naturally have different emphasis. Driven by market demand and international trade, ISO mainly takes quality, efficacy and safety into consideration when developing standards, while WHO pays more attention to clinical practice, quality control and medication guidance. Up to now, there is a lack of comparative analysis on the records, background, principles, basic content, and main requirements of quality standards on medicinal plants or CMMs respectively published by WHO and ISO. Therefore, based on international standards of CMM developed by ISO/TC 249 platform and WHO Monographs on Selected Medicinal Plants, this paper systematically compares the purposes, selected principles, standard-developing process, basic content, and main quality requirements to summarize their similarities and differences, and find their merits, aiming to serve as a reference to the development of international standards for CMMs that helps them go global.

Análise das solicitações de medicamentos não padronizados de um hospital universitário terciário / Analysis of requests for non-standard medicines from a tertiary university hospital

Introdução: O uso extensivo de medicamentos não padronizados causa aumento de custos em saúde, além de potencial redução de segurança e uso racional de medicamentos. A Comissão de Farmácia e Terapêutica orienta a prescrição de medicamentos, por meio da avaliação e seleção de medicamentos a serem incluídos no formulário de medicamentos padronizados, com base nas melhores evidências científicas disponíveis e no perfil dos pacientes locais, promovendo o uso racional de medicamentos. O objetivo deste trabalho foi analisar as solicitações de fornecimento de medicamentos não padronizados na instituição. Métodos: Trata-se de um estudo observacional e descritivo onde foram analisadas as solicitações de medicamentos não padronizados realizadas entre fevereiro de 2016 e dezembro de 2021, identificando os medicamentos envolvidos e seus respectivos custos. Resultados: Foram realizadas 203 solicitações no período, sendo 174 incluídas no estudo. Os medicamentos que tiveram mais solicitações foram o rituximabe (41), a imunoglobulina humana (31), o sucralfato (23), a nitazoxanida (12) e o eltrombopague (7). As solicitações com maior custo foram as de imunoglobulina humana (US$ 799,702.38), rituximabe (US$ 717,320.26), eltrombopague (US$ 281,062.50), ruxolitinibe (US$ 167,867.46) e bortezomibe (US$ 149,033.52). As principais clínicas que solicitaram medicamentos não padronizado foram a neurologia (47), a hematologia (30), as moléstias infecciosas e parasitárias (17), e a anestesiologia (12). As solicitações de maior custo foram realizadas pela neurologia (US$ 145,519.08), hematologia (US$ 120,980.25), transplante de medula óssea (US$ 51,635.11) e dermatologia (US$ 44,813.40). Conclusão: O estudo demonstrou que há um fluxo estruturado de solicitação de medicamentos não padronizados na instituição, sendo uma importante ferramenta de gerenciamento dessas solicitações, evitando a aquisição desnecessária de itens que não compõem o elenco terapêutico do hospital.

Introduction: Widespread use of non-formulary drugs (NFD) increases cost and may reduce safety and rational use of medicines. The Pharmacy and Therapeutics Committee provides guidance on drug prescription by evaluating and selecting medications to be included in a hospital's formulary based on best scientific evidence available and local patients' profile, promoting rational use of medicines. The objective of this study was to assess non-formulary drugs prescriptions at a tertiary hospital. Methods: This was a retrospective study. NFD prescribed and its associated costs were assessed through NFD request forms received from February 2016 to December 2021. Results: A total of 203 NFD request forms were received, from which 174 were included in this study. The most frequently prescribed NFD included rituximab (n = 41), immunoglobulin (31), sucralfate (23), nitazoxanide (12), and eltrombopag (7), with the highest costs being with immunoglobulin (US$ 799,702.38), rituximab (US$ 717,320.26), eltrombopag (US$ 281,062.50), ruxolitinib (US$ 167,867.46), and bortezomib (US$ 149,033.52). The most frequent requesting specialties were neurology (n = 47), hematology (30), infectious disease (17) and anesthesiology (12), and highest costs requests were from neurology (US$ 145,519.08), hematology (US$ 120,980.25), bone marrow transplant unit (US$ 51,635.11), and dermatology (US$ 44,813.40). Conclusion: This study showed that a structured request flow for NFD prescription is a critical procedure in order to better manage drug prescription within the hospital, promoting rational use of medicines and preventing unnecessary spending with drugs for which the clinical indication may be covered by a drug already in the hospital's formulary.

Long-Term Care medicines formularies: any reasons for pharmacists' concern?

Abstract This study aimed to characterize and compare medicines formularies (MFs) used in Long-Term Care (LTC) facilities in Portugal, and to identify the prevalence of Potentially Inappropriate Medicines (PIMs). A systematic contact with LTC facilities was undertaken in December 2021. MFs were systematized according to the Anatomical Therapeutical Chemical classification system (ATC), followed by descriptive content analysis. A structured comparison between MFs developed by public organizations and private LTC facilities was performed. After duplicate removal and exclusion of medicines not for systemic use, two explicit criteria - the Algorithm of medication review in frail older people and the EU(7)-PIM list - were employed for PIMs identification. Five MFs were obtained and assessed. The three MFs developed by private institutions covered 23% of the national LTC facilities and approximately 34% of the national total of beds. Heterogeneity was particularly high for the Alimentary tract and metabolism, Blood and blood-forming organs, Musculoskeletal system, and Respiratory system ATC groups. A PIM prevalence of 29,4% was identified. Medicines distribution between the MFs suggests the need to develop national guidelines towards harmonizing medicines usage in LTC. The prevalence of PIMs found highlights the importance of a particular optimized use of this health technology in aged sub-populations

Construction of Evaluation Index System of the Interest Conflict for Medical Institution Ethics Committee / 中国医学伦理学

【Objective:】 To preliminary construct a scientific, systematic and applicable evaluation index system of the interest conflict for medical institutions ethics committee. 【Methods:】 Literature retrieval, interpretation of laws and regulations, expert group discussion and Delphi expert letter inquiry were used to screen indicators and determine the evaluation index system of interest conflict and the weight of various indicators. 【Results:】 The response rates of the two rounds of correspondence questionnaire were both 100%, the authority coefficient Cr values of the two rounds were 0.855 and 0.865, and the coordination coefficient W values of the two rounds were 0.817 and 0.826, which were statistically significant (P<0.05). The final formed system included 3 first-level indicators, 10 second-level indicators and 25 third-level indicators. 【Conclusion:】 The evaluation index system of interest conflict for medical institution ethics committee is scientific and reliable.

Guidelines for Ethical Review Entrustment Contract of Life Science and Medical Research Involving Humans / 中国医学伦理学

The passing of ethical review is a necessary conditions and prerequisite for the development of life science and medical research involving humans. At present, some medical and health institutions have no or insufficient ethical review capabilities. The lack of ethical review ability has become a bottleneck restricting the development of life science and medical research involving humans. According to documents such as Opinions on Deepening the Reform of the Review and Approval System and Encouraging the Innovation of Pharmaceutical and Medical Devices, Opinions on Strengthening the Ethical Governance of Science and Technology, institutions can entrust competent institutional ethics review committees or regional ethics review committees in writing to conduct ethical review. Entrustment ethical review provides a viable solution for institutions that need to carry out life science and medical research involving humans but do not have an ethics (review) committee or the ethics (review) committee is not competent to review. To conduct the entrustment ethical review, the entrustment between the principal and the trustee is required. According to The Measures for Ethical Review of Life Sciences and Medical Research Involving Humans, if medical and health institutions and their ethical review committees do not accept the formal entrustment to provide the ethical review opinions for other institutions, the local health authorities at or above the county level will impose administrative penalties and sanctions on the relevant institutions and personnel in accordance with the law. Signing the entrustment ethical review contract, implementing legal compliance entrusted ethical review to protect the rights and interests of the trustee and the principal, and protect the research participants.

Thinking from the Perspective of Medical Institutions on Measures for Ethical Review of Life Science and Medical Research Involving Humans / 中国医学伦理学

From the perspective of medical institutions, this paper sorted out the background of the promulgation and important changes of Measures for Ethical Review of Life Science and Medical Research Involving Humans, and summarized the changes that may significantly affect the ethical review of medical institutions. It involved terminology changes and expansion of the scope of ethic review, clarification of the responsibilities and independence of the ethics committee, the refinement of the ethical review process, the emphasis on the protection of personal information and the rights and interests of subjects, and first proposal to exempt from ethical review. In addition, based on the concept of strengthening the ethical governance of science and technology in the new version of regulations, this paper shared the consideration on the governance of ethical review within medical institutions, including safeguarding the dignity and rights of subject, clarifying the role and position of ethical review, exempting the implementation of ethical review, and managing entrusted ethical review. With a view to providing a certain reference for the ethics practitioners and researchers in various medical institutions.

Interpretation and Reflection on Measures for Ethical Review of Life Science and Medical Research Involving Humans / 中国医学伦理学

With the progress of life sciences and medicine and the improvement of laws, regulations and rules, to meet the objective needs and further standardize the ethical review of life sciences and medical research involving humans, it is necessary to refer to international ethical standards to integrate with international standards. On February 18, 2023, the National Health Commission, together with the Ministry of Education, the Ministry of Science and Technology, and the National Administration of Traditional Chinese Medicine, issued the Measures for the Ethical Review of Life Sciences and Medical Research Involving Humans. The scope of this revision is large, the content is more detailed, and many details and specific requirements are added. It expanded the extent of jurisdiction to include colleges and universities, scientific research institutes and other institutions; the scope of review included the field of life sciences; the ethical review and supervision efficiency problems caused by the requirement of multiple departments coordinated supervision required the cooperation of the National Health Commission, the Ministry of Education, the Ministry of Science and Technology, and the National Administration of Traditional Chinese Medicine to strengthen communication and implement supervision. It emphasized the management of conflict of interest, strengthened the protection of privacy and data management, clarified the application of summary procedure review, as well as added the ethical review exemption and the submission of initial review materials, key review content, approval criteria and informed consent content, which improved the operability. It proposed solutions or directions for urgent needs and issues of close concern, allowed commissioned review, strengthened follow-up review, registration and filing, and explored three-level supervision, ethical review collaboration mechanisms, and the construction of regional ethics committees. By continuously improving ethical review and supervision to ensure the safety and rights of research participants, promote the quality of life science and medical research in China, and enhance the international competitiveness of life science and medical research involving humans in China.

Challenges and Countermeasures of Science and Technology Ethics Governance Faced by Research-oriented Hospitals / 中国医学伦理学

Research-oriented hospitals are the currently development direction of large hospitals, and their research ethics management has played an important role in China’s scientific and technological innovation and clinical research development through years of practice. However, at present, China’s overall scientific and technology ethics governance framework system is still incomplete, governance authority is insufficient, ethics committee members lack ethical professional technical training, and the awareness and understanding of science and technology ethics among medical staff still need to be improved, which indicates that the level of technology ethics governance in research-oriented hospitals needs to be improved. It is suggested to improve from the aspects of regulatory system, governance responsibilities, training of ethical practitioners, supervision and punishment measures, and ethical education of scientific and technological research talents, so as to better protect subjects and promote the construction of scientific and technological ethics in the research-oriented hospitals.

New Requirements and Improvement Suggestion for the Protection of Vulnerable Groups in Ethical Review Measures for Life Science and Medical Research Involving Humans / 中国医学伦理学

In February 2023, the National Health Commission, together with the Ministry of Science and Technology, the Ministry of Education, and the State Administration of Traditional Chinese Medicine issued the Ethical Review Measures for Life Science and Medical Research Involving Humans, which emphasizes that research participants involving vulnerable groups such as children, intellectual disabilities, and mental disabilities should be given special protection. This paper expounded the current situation of protecting vulnerable groups from six aspects: inadequate protection of vulnerable groups by relevant laws and regulations, unclear definition of vulnerable groups, insufficient supervision by relevant departments, insufficient review ability of ethics committee to satisfy the protection of vulnerable groups, difficulty in fair inclusion of vulnerable groups, and the need to improve the ethical awareness of researchers and vulnerable groups. This paper also analyzed the new requirements for the protection of vulnerable groups in the Ethical Review Measures for Life Science and Medical Research Involving Humans from the following three aspects: expanding attention to potentially vulnerable research participants, paying more attention to the consent of research participants without or with limited capacity for civil conduct, and re-informed consent after the improvement of civil capacity level. Finally, suggestions on strengthening the protection of vulnerable groups were put forward from six aspects: improving the relevant legal system, clarifying the category of vulnerable groups, strengthening the implementation by regulatory departments, establishing a research participant protection system by research institutions, improving the ethical review capacity of ethics committees, formulating review guidelines by industry associations, and strengthening the education and training of all parties, so as to minimize the risk of vulnerable groups participating in clinical research and boost the quality and speed of clinical research in China.

Supervision of Electronic Informed Consent in International Clinical Research and Its Implications for China / 中国医学伦理学

At present, China is still in the exploratory stage in the field of electronic informed consent (eIC), and relevant policies, regulations and application guidelines have not yet been established and improved. While the traditional informed consent supervision system is difficult to meet the needs of the innovative development of eIC, such as subject privacy and data security. Through sorting out and analyzing the legal norms and construction system of eIC supervision in Europe and the United States, combined with the current development status, problems, and challenges of eIC in China, this paper targeted proposed the path to construct the supervision of eIC in clinical research in China from the aspects of restricting the signing form and process of eIC, adjusting the ethical review paradigm of eIC, enhancing the strength of eIC ethical review, improving the construction of eIC legal system, and strengthening the training of relevant researchers.

Further Discussion on Legal Points in Ethical Review of Research Participants’ Informed Consent / 中国医学伦理学

The protection of research participants’ rights and interests is mainly guaranteed through the informed consent system and the ethical review of the Ethics Committee. In practice, some sponsors or researchers misused or mixed legal terms when writing the informed consent forms. More importantly, during the implementation of informed consent by researchers, the phenomenon that insufficient and incomplete notification, and derogation of research participants’ specific rights and interests occurred. This not only affected the scientific nature of the research, but also violated the original intention of clinical trials or medical researchers, and did not fully respect the human dignity and value of research participants. It was urgent for the ethics committee to correct it during the ethical review, and urge the researchers or sponsors to correct and improve it in a timely manner.

The Role and Positioning of Clinical Trial Ethics Review under Pharmaceutical Innovation Strategy / 中国医学伦理学

Ethical review runs through the whole process of drug clinical trials, and is a critical step to ensure the rights and interests of subjects. This paper analyzed and discussed the role and positioning of ethical review in new drug clinical trials, cleared the principles of ethical review, identified the responsibilities of ethical review, and clarified the authority of ethical review approval documents. The ethical review should primarily focus on the ethics of the clinical trials, not replace other professional institutions to review the clinical trials’ legality and scientific nature. Ethical approval is only one of the necessary conditions for conducting clinical trials, not the only factor. It is recommended to strengthen the publicity and popularization of scientific and technological ethics awareness, improve the clinical trial approval mechanism, and optimize the phrasing of ethical review approval documents. It is warranted to further optimize the quality of ethical review, improve the construction of ethical review system, ultimately achieve the unity of promoting innovation and preventing risks, so as to effectively realize the benign interaction between high-quality development of scientific and technological innovation and high-level safety.

Problems and Proposal of Ethical Review on Clinical Application of Medical Technology / 中国医学伦理学

With the change of medical technology from "access management" to "filing management" in China, it is necessary for medical institutions, as the main responsibility, to pass standardized ethical review and supervision. However, there are many problems at present, such as the absence of regulations and guidelines for ethical review of clinical application of medical technology, the lack law of medical technology ethical review standard operating procedures, the insufficient review capacity, the lack of standardization in the choice of ethical review methods, the elements of informed consent and its examination need to be discussed, the lack of appropriate continuing review mode, as well as the confirmation of technical team members and department qualifications is not clearly defined. In order to safeguard the safety and rights of patients, it is important to take the following measures, including carrying out the whole-process supervision of medical institutions, clarifying the supervision process, improving the multi-departmental communication and cooperation mechanism, establishing a management committee for clinical application of medical technology, standardizing the review system of the medical technology ethics committee, clarifying submit the list of materials for ethical review, implementing classified ethical review and supervision to improve efficiency, exploring the tracking review mode, ensuring the whole-process supervision, and carrying out popular and professional ethics training. In the review of ethics committee, more attention should be paid to the main points of review, such as technical scheme, informed consent, qualifications of technical team members and departments, management system, risk assessment and emergency plan, patient compensation and other materials. While ensuring the safety and rights of patients, it also helps to accelerate the healthy development of medical technology.

Work Progress and Outlook of Rare Skin Diseases Team / 罕见病研究

There are many kinds of rare skin diseases, but the research into the diagnosis and treatment of rare skin diseases is relatively scarce. In recent years, the rare skin diseases team has made a series of accomplishments, including establishing the professional committee of Rare Skin Disease Committee of China Alliance for Rare Diseases, establishing China's first Medical Care Alliance for Rare Skin Diseases, launching two national collaborative projects, promoting the project of improving the diagnosis and treatment of rare diseases supported by the Central Special Lottery public welfare Fund, exploring the multidisciplinary diagnosis and treatment model of skin rare diseases, holding academic conferences, and compiling professional books on rare skin diseases. In the future, we will further improve the remote consultation model of rare skin diseases, develop artificial intelligence assisted diagnosis system of rare skin diseases, carry out high-quality clinical research, and improve the overall diagnosis and treatment level of rare skin diseases in China, for the sake of benefiting more patients.

Exploration on standardized management of ethical review of organ donation after citizen’s death / 器官移植

Objective To explore the standardized management mode of the Ethics Committee for organ donation after citizen’s death in hospitals. Methods The situations of ethical review before and after the standardized adjustment of the Ethics Committee of human organ donation in the First Affiliated Hospital of Chongqing Medical University were retrospectively analyzed. Baseline data of donors before and after standardized adjustment of the Ethics Committee of human organ donation were compared. The influence of standardized adjustment of the Ethics Committee on the attendance rate of committee members and duration of ethical review were analyzed. Results No significant differences were observed in donors' ethical review data, such as gender, age and death determination, before and after standardized adjustment of Ethics Committee structure (all P>0.05). Significant difference was noted regarding the cause of death in ethical review (P<0.05). Univariate analysis showed that there were significant differences in the impact of Ethics Committee standardization adjustment and cause of death on the attendance rate of committee members (both P<0.05). Multivariate analysis revealed that gender, cause of death and standardized adjustment of the Ethics Committee were the influencing factors of the attendance rate of committee members, and the attendance rate of committee members after standardized adjustment was higher than that before adjustment (P<0.05). Univariate analysis showed that there were statistically significant differences in the effects of Ethics Committee standardized adjustment, attendance rate of committee members and cause of death on the duration of ethical review (all P<0.05). Multivariate analysis indicated that standardized adjustment of the ethics committee was the influencing factor of the duration of ethical review, and the duration of ethics review after standardized adjustment was shorter than that before adjustment (P<0.05). Conclusions Appropriate arrangement of the total number of ethics committee members and standardizing the review process may improve the efficiency of ethical review. Scientific evaluation mechanism for ethical committee members should be established by dynamically adjusting the ethical committee members, clarifying the responsibilities and tasks of members and secretaries, aiming to further improve standardized management level of ethical review for organ donation after citizen’s death.

Ethical construction of recipients’ rights and interests protection in organ transplantation from expanded criteria donors / 器官移植

Under the background of severe shortage of donor organs and organ donation after citizen's death becoming the main source of donor organs in China, expanded criteria donor (ECD) has been widely applied in clinical practice. However, ECD has the disadvantages of basic diseases, old age, trauma, shock or infection, which will affect the quality of donor organs to varying degrees and become one of critical factors affecting clinical efficacy of organ transplantation. The recipients of ECD organ transplantation will also bear the additional risk and uncertainty of efficacy brought by ECD organs. Hence, it is necessary to pay attention to the protection of the recipients’ rights and interests. In this article, ethical issues faced by ECD organ transplantation in recipient protection and the shortcomings in the ethical review of organ ethics committee were reviewed, and suggestions on the ethical review institution and system construction of the rights and interests of organ transplantation recipients were elucidated, aiming to provide reference for promoting the advancement of ECD organ transplantation.

Analysis of the current situation of the construction of ethics committees in China / 中华医院管理杂志

Objective:To analyze the current development of ethics committees in China, for reference in promoting their progress to catch up with the current social development in China.Methods:From July to August 2022, a self-designed questionnaire was used to survey the status of ethics committees in secondary and above hospitals, the disease prevention and control centers and infectious disease hospitals nationwide, using multi-stage stratified sampling method for sampling. A descriptive analysis of questionnaire data was made on the data so collected. In 2022, 22 ethics committees were selected through stratified sampling based on the eastern, central, and western economic zones, and in-depth interviews were conducted with their secretaries. The interviews covered such factors as issues encountered in ethics review, specific suggestions for medical ethics training work, and the necessity of establishing an independent third-party social evaluation institution for ethics committees. The grounded theory was used to encode the interview data in three levels, and NVivo 11.0 software was used for coverage, emotion recognition and word frequency analysis.Results:107 questionnaires were effectively collected, covering 23 provincial-level administrative regions. Among them, 63 ethics committees operated as an independent office; 49 of the committees had one ethics expert as their member, and 80 institutional administrators served as the committee chairpersons at the same time; 107 institutions had developed their articles of association and ethical review regulations; 21 had not yet established a tracking and review mechanism; 33 institutions had not conducted education and training activities for the public, and only 25 institutions had passed the certification of relevant ethical certification systems at home and abroad. The results of the grounded theory analysis showed the following three problems in the construction of ethics committees: efficiency and quality of ethical review, ethical training, and multi-institution construction. Among the secondary nodes, the reference points focused on member capacity ( 24), work operation ( 24) and training activities ( 17) .Conclusions:At present, the ethics committees in China were steadily developing and were not yet perfect in terms of infrastructure, membership composition, review and supervision, education and training, and evaluation and accreditation. It is necessary to further optimize the allocation of resources, improve the membership structure and the proportion of experts from different specialties participating in ethical review, and strengthen the construction of regional ethic committees.