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Background: Clinical trials aim to improve health care by reducing treatment costs, enhancing quality, and advancing the discovery of safe treatments. Notably, limited knowledge among resident doctors may impact research quality. Aims and Objectives: The study seeks to evaluate awareness and knowledge of clinical trials among undergraduate, intern, and postgraduate medical students. Materials and Methods: It was an observational, cross-sectional study conducted on 300 medical students over 3 months after approval from the Institutional Ethics Committee (IEC). The pre-validated questionnaire containing 24 items was administered through email, WhatsApp, or in person. Data were analyzed using descriptive statistics. Results: In the study, 96.7% of participants believe the necessity of clinical trials. Notably, 72% of undergraduates and 76% of postgraduates express willingness to participate in a clinical trial. Furthermore, 93% of participants view trials as vital for innovative therapies, and 74.3% believe that they enhance health-care services. Knowledge gaps in clinical trials were evident: 56.3% of participants knew good clinical practice guidelines, 46.7% of participants were aware of them, and only 12.3% of participants knew the IEC role. However, 66.7% of participants recognized the Drug Controller General of India (DCGI) and IEC approvals as crucial for trials, and 53.7% of participants identified DCGI as the regulatory authority. 68.3% of participants could not define a placebo-controlled trial. However, 75% of participants were aware of the consequences of informed consent form non-compliance. Most knew about post-marketing surveillance (80.33%), but awareness of healthy volunteer involvement in Phase 1 was lower (48%). In addition, 62.33% of participants knew about marketing access after Phase 3, and 60% of participants were aware of adverse effects reporting procedures. Conclusion: The study reveals a concerning lack of awareness regarding clinical trials among undergraduate, intern, and postgraduate medical students, emphasizing the need for targeted educational interventions in medical curricula.

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The Research Ethics Committee (CEP) has become an essential mechanism for social control in Brazilian research involving human subjects, contributing to the development of studies guided by ethical standards and to the protection of research participants. This article analyzes the performance of CEP in Western Amazonian institution, its history, operating conditions, trends, and different aspects between 2018 to 2022. The theoretical framework addresses the history of research involving human subjects, the origins and evolution of bioethics in the international context, bioethics in Brazil, and regulations on the ethical analysis of research. The data were collected through the Brazil Platform and reports from the institution's CEP. The CEP evaluated 865 research protocols, most of which were from Health Sciences. Additionally, it was observed that during 2018 to 2022 the covid-19 pandemic had a negative impact on the number of projects submitted for evaluation to the CEP. The 57% drop in the number of projects registered during 2020/2022 reveals the negative impact of this event on the execution of projects with human participants.

El Comité de Ética en Investigación (CEP) se ha convertido en un mecanismo esencial para el control social en la investigación brasileña con seres humanos, contribuyendo al desarrollo de estudios guiados por normas éticas y a la protección de los participantes en la investigación. Este artículo analiza el desempeño del CEP en la institución amazónica occidental, su historia, condiciones de funcionamiento, tendencias y diferentes aspectos entre 2018 y 2022. El marco teórico aborda la historia de la investigación con seres humanos, los orígenes y la evolución de la bioética en el contexto internacional, la bioética en Brasil y la normativa sobre el análisis ético de la investigación. Los datos se recogieron a través de la Plataforma Brasil y de informes del CEP de la institución. El CEP evaluó 865 protocolos de investigación, la mayoría de los cuales eran de Ciencias de la Salud. Además, se observó que durante 2018 a 2022 la pandemia de covid-19 tuvo un impacto negativo en el número de proyectos presentados para evaluación al CEP. La caída del 57% en el número de proyectos registrados durante 2020/2022 revela el impacto negativo de este evento en la ejecución de proyectos con participantes humanos.

Os Comitês de Ética em Pesquisa (CEPs) tornaram-se um mecanismo essencial para o controle social em pesquisas brasileiras envolvendo sujeitos humanos, contribuindo para o desenvolvimento de estudos regido por padrões éticos e para a proteção de participantes de pesquisas. Esse artigo analisa o desempenho de CEP em instituição da Amazonia Ocidental, sua história, condições operativas, tendências e diferentes aspectos entre 2018 e 2022. O enquadre teórico visa a história da pesquisa envolvendo sujeitos humanos, as origens e evolução da bioética no contexto internacional, bioética no Brasil e regulamentos de análise ética de pesquisa. Os dados foram coletados através da Plataforma Brasil e relatórios do CEP da instituição. O CEP avaliou 865 protocolos de pesquisa, a maioria deles de Ciências da Saúde. Adicionalmente, foi observado que de 2018 a 2022 a pandemia da covid-19 teve um impacto negativo no número de projetos submetidos para avaliação do CEP. A queda de 57% no número de projetos registrados em 2020/2022 revela o impacto negativo desse evento na execução de projetos com participantes humanos.

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O assentimento infantil é uma exigência ética em pesquisas com crianças, porém sua comunicação eficaz tem sido um desafio. Neste relato, descrevemos a construção teórica e metodológica de um termo de assentimento infantil em formato de história em quadrinhos. A experiência foi realizada em uma escola municipal de Teresina, Piauí, com 32 crianças entre oito e dez anos. As etapas consistiram no estudo das questões éticas envolvidas, na construção da arte sequencial, na observação participante, em ajustes na história em quadrinhos e na aplicação e assinatura do termo de assentimento. A experiência resultou em um termo com legibilidade de Flesch de 91,81 sobre as questões éticas na pesquisa com crianças. O assentimento infantil em formato de história em quadrinhos apresentou linguagem acessível, lúdica e legibilidade adequada para comunicar pesquisa com crianças.

Child assent is an ethical requirement in research with children, however effective communication has been a challenge. In this report we describe the theoretical and methodological construction of a child assent term in comic book format. The experience was carried out in a municipal school of Teresina-Piaui with 32 children between eight and ten years old. The steps consisted of the study of ethical issues, the construction of sequential art, in participant observation, in adjustments to the comic strip and in the application and signature of the assent term. The experience resulted in a term with Flesch readability of 91.81 on ethical issues in research with kids. The childish nod in comic book format presented accessible, playful language and adequate legibility to communicate research with children.

El asentimiento infantil es una exigencia ética en investigaciones con niños. Sin embargo, la comunicación eficaz ha sido un desafío. En este relato describimos la construcción teórica y metodológica de un término de asentimiento infantil en formato de cómics. La experiencia ha sido realizada en una escuela municipal de Teresina, Piauí, con 32 niños entre ocho y diez años. Las etapas consistieron en el estudio de las cuestiones éticas, en la construcción del arte secuencial, en la observación participante, en ajustes en los cómics y en la aplicación y firma del término de asentimiento. La experiencia resultó en un término con legibilidad de Flesch de 91,81 sobre las cuestiones éticas en la investigación con niños. El asentimiento infantil en formato de cómics presentó lenguaje accesible, lúdica y legibilidad adecuada para comunicar investigación con niños.

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Based on the data of a national sampling survey, this paper described and analyzed the understanding, attitude, behavior, and their differences and influencing factors of Chinese medical researchers on ethical review of biomedical research involving human subject. The survey found that researchers with master’s degree or below, working in scientific research institutes or universities, no overseas experience, living in the central region and not serving as committee members have relatively poor acquaintance of "ethical review" ; researchers with the characteristics of male, the younger age, living in the western region, knowing less about "ethical review" , agree more with the view that "ethical review consumes too much time and energy" ; researchers who serve as members of the ethics committee are more likely to participate in scientific research projects that have not passed the ethical review process. Therefore, recommendations are put forward: comprehensively popularizing the training of ethical review, focusing on strengthening the vulnerable groups and regions, strictly implementing ethical review laws and regulations, and strengthening evaluation and supervision, so as to improve the service quality and efficiency of ethical review in multiple directions.

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In order to explore the ethical review experience of organ donation and transplantation after the death of citizens, and provide reference value for medical institutions to carry out corresponding ethical review. By using descriptive research, purpose sampling method and the principle of data saturation, 10 members and secretaries of ethics committee on clinical application of organ transplantation technology were finally selected as respondents for semi-structured interviews. The Colaizzi 7-step analysis method was adopted to analyze, summarize and refine the theme. The results showed that the ethical review experience of organ donation and transplantation after the death of citizens included four themes: the responsibilities of ethics committee, the key points of ethics review, the form of ethics review conference and its advantages and disadvantages, and the construction of the ethics committee of organ transplantation. Therefore, there are defects in the ethical review of organ donation and transplantation in medical institutions at present. These can be remedied by enriching elements of the ethical review following the four principles of medical ethics, refining the laws related to organ donation after citizens’ death, constructing a reasonable and efficient pattern of ethical review conference, and establishing a robust and appropriate operation mode of organ transplantation ethics committee.

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Under the premise that the relevant laws and regulations in China do not specify the review subject of compassionate drug use,it is controversial who should bear the responsibility for the review and approval.This paper summarized and elaborated on the characteristics of compassionate drug use,and discussed the responsibilities,professionalism,and necessity of review of the ethics committee.It is believed that the ethics committee should serve as the review subject of compassionate drug use,and focus on doctor qualifications,risk-benefit ratio,informed consent forms,and conflicts of interest.

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To analyze the main factors influencing the ethical review work of municipal hospitals in Shanxi Province by investigating the current situation of the construction and operation of ethics committees, and to put forward reasonable suggestions for improving the work of ethics committees. Questionnaire surveys and interviews were used to investigate the composition of ethics committees, systems and standard operating procedures, personnel training, review project methods, time limits, etc. of 24 hospitals at municipal levels in Shanxi Province. The establishment and system of ethics committees in tertiary hospitals at prefecture and city level were basically reasonable, and they could actively play the role of ethics committees. At present, most hospitals do not pay enough attention to the work of ethics committees, lack of full-time staff and systematic training, resulting in insufficient ethics review capabilities. The construction of the ethics committee of the second-level hospital is a mere formality, and no substantive work has been carried out. It is recommended to strengthen the supervision, increase the training of ethics committees and researchers, improve the information management of ethics committees, and establish regional ethics committees to further improve the ability and efficiency of ethics review.

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To ensure the rights and safety of the subjects and improve the quality of clinical trials, the author analyzed and discussed the deviation type and typical cases from 184 cases of protocol violation reviewed by the ethics committee in 56 clinical trials in a tertiary hospital in 2020. Among the 184 cases of violating the protocol, there were 29 major protocol violation cases and its proportion is 16%; 99 cases (54%) violated the GCP principle; 56 cases of other violations of the protocol that require to be reported, accounting for 30%. Through the case analysis of the researcher gave the wrong doses to subjects without following the protocol and drug administration did not conform to the rules, analyzed and discussed from the five perspectives of the research protocol design, the researcher, the clinical trial institution, the sponsor and the ethics committee, and put forward solutions and suggestions, so as to provide reference to improve the compliance of clinical trial protocol, reduce the risk of subjects and protect their rights and safety and ensure the successful progress of clinical trials.

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Significant advancements have been made in the establishment of ethics committees within medical institu-tions.However,in order to achieve a high-quality development it is imperative to focus on such critical points as distinguishment between biomedical research and the clinical application of medical technologies,steadfast adherence to the fundamental princi-ples of ethical review,establishment of an ethics committee with independent administrative authority,establishing independent ethics review committees in large medical institutions based on specialty,and strengthening of ethical training for medical person-nel and biomedical researchers.

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The Regulations on Donation and Transplantation of Human Organs were issued on December 14， 2023. It was interpreted in terms of improving the human organ donation system and clarifying the responsibilities of the Red Cross Society； adding a new system for the acquisition and distribution of human organs， emphasizing the independence of the organ acquisition department， and implementing the priority right of organ distribution； strengthening the management of human organ transplantation， strictly limiting the scope of recipients of living organ transplantation； and regulating the operation of the ethics committee for human organ transplantation and stepping up the crackdown on violations of the regulations. This paper then considered how to implement and improve incentives for human organ donation， including the implementation of the priority rights of organ donors and their close relatives， the improvement of the organ donation compensation system， and the establishment of a humanitarian assistance system； the implementation of a system for the acquisition and distribution of organ donation organization； the acceleration of the construction of the personnel team of the organ acquisition organization； the increase of efforts to advocate and mobilise； and the enhancement of the construction of the ethics committee for human organ transplantation. The Regulations on Donation and Transplantation of Human Organs help to give fuller play to the enthusiasm and creativity in the field of organ transplantation， and all departments should revise the systems and administrative rules relating to human organ donation and transplantation in time， so as to facilitate the work of donation and transplantation of human organ.

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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.

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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)

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Objective:To change the current situation of the relatively weak management of periodic follow-up review, and further to improve the continuous review capacity of the ethics committee.Methods:Through sorting out and analyzing the problems existing in the periodic follow-up review, corresponding solutions are taken: to detail management requirements; to strengthen daily supervision; special ethics training and communication to enhance the ethical awareness of researchers; to optimize the division of labor in the ethics office to improve work efficiency and the quality of committee review; the information review system helps strengthen tracking and reminding.Results:In one year′s practice, the omission of periodic follow-up has been significantly reduced, and the supervision ability of the Ethics Committee on periodic follow-up review has been improved.Conclusions:In periodic follow-up review, research institutions, ethics committees and researchers pay enough attention to fulfill their responsibilities and actively cooperate can effectively improve the quality of periodic follow-up review.

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Objective:To understand the cognition and attitude of medical staff towards medical ethics review, analyze possible influencing factors, to put forward relevant suggestions for strengthening ethical management in the future.Methods:From November 2021 to May 2022, a self-designed questionnaire and general data questionnaire on the cognition and attitude of medical staff to ethical issues in clinical research were used to investigate 408 medical staff from two first-class ternary hospitals in Hunan Province, data was analyzed to explore the respondents′ cognition and attitude, as well as related influence factors.Results:The average cognitive score of medical staff was 65.41, and the average attitude score was 91.83. Many possible influence actors regarding the cognition were identified, including degree, technical title, professional field, number of clinical research projects engaged as investigators, number of clinical research projects conducted as principle investigators, whether the hospital has established an ethics committee, and research ethics training experiences. While the influence factors of attitude were experiences of conducting and engaging in clinical research, the construction of hospital ethics committee and research ethics trainings.Conclusions:Medical staffs have the willingness to explore more research ethics knowledge, while their cognition of research ethics should be improved. Root-cause analysis should be conducted to identify influencing factors for improvement. The research management department should strengthen the publicity and training of clinical research ethics of medical staff, to improve their clinical research ethics knowledge literacy, and ensure the well-functioning of clinical research ethics review.

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Objective:Against the backdrop of the rapidly changing biomedical field and the expanding scope of ethical review, targeted acceleration of institutional ethics committee review efficiency is needed to alleviate the contradiction between innovative development and ethical speed limits.Methods:Through literature research and work practice, the main influencing factors on the efficiency of the current ethical review were analyzed, and suggestions and countermeasures were proposed.Results:The factors affecting the efficiency of institutional ethics committee review were mainly reflected in the imbalance of ethical review resources, incomplete ethical management system, insufficient management support of the ethics office, and inadequate attention paid by hospitals. To improve the efficiency of institutional ethics committee review, in combination with the recently released ″The Measures for Ethical Review of Life Sciences and Medical Research Involving Human Beings″ (hereinafter referred to as the ″New Measures″) and work practices, the hierarchical filing system was promoted, the top-level design of the organization was strengthened, the overall operational system of the committee was optimized, and measures such as integrating review resources, standardizing hierarchical management, exploring conditional consent, and innovating the operational mechanism of the Ethics Office were conducted to ensure the quality of review and improve the efficiency of ethical review.Conclusions:According to the new methods, targeted promotion of the hierarchical filing system, strengthening the top-level design of the institutions, integrating resource platforms, and optimizing the overall operational system of institutional committees, were conducive to improving the efficiency of institutional ethics committees based on the premise of reviewing quality, and promoting the innovative development of biomedicine.

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Objective:This study aims to explore the feasibility of ethical review and mutual recognition, focusing on the operational efficiency and review processes of the Ethics Committees in Tianjin′s third-level hospitals.Methods:A thorough online survey was conducted across tertiary hospitals in Tianjin, utilizing a detailed questionnaire. The survey primarily examined the operations and reviews of Ethics Committees from 2019 to 2022, evaluating the efficiency of ethical reviews, the effectiveness of clinical research administration, and the hospitals′ perspectives on mutual recognition of ethical reviews. From 29 collected responses, 28 were deemed suitable for in-depth statistical analysis.Results:In Tianjin′s 28 surveyed tertiary hospitals, 16 routinely hold ethics review meetings monthly. Nine hospitals have established pre-ethics review processes, and three have achieved mutual recognition of their ethical review outcomes. Additionally, five hospitals have integrated electronic information systems. From 2019 to 2021, there has been an increase in clinical trials and Investigator-Initiated Trials (IITs) under initial review, with a significant presence of multi-center clinical trials (90%) and multi-center IIT studies (75%). The timeframe for clinical research review opinions ranged from 18.84 to 20.69 days between 2019 and September 2022, while the duration for clinical research review approvals varied from 22.03 to 23.68 days. During the same period, clinical trial management efficiency spanned from 48.42 to 62.65 days, and IIT study management efficiency was between 25.54 to 28.17 days. Participants identified the main factors influencing management efficiency as stemming from research institutions and sponsors.The majority of hospitals expressed support for the advancement of mutual recognition of ethical reviews and the implementation of a unified submission checklist and template.Conclusions:The Ethics Committees in Tianjin′s third-level hospitals have progressively evolved towards standardization. There is a marked improvement in the efficiency of ethical reviews and overall management of clinical research, indicating a positive development towards more streamlined and effective ethical governance in clinical studies.

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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.

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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.

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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.

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Objective:By exploring the management of subject complaints by the ethics committee, to identify and correct the problems that damage the rights of subjects in clinical drug trials, in order to improve the ability of the ethics committee of protecting the rights and interests of the subjects.Methods:We conducted a retrospective analysis of 13 cases of subject complaints accepted by the Ethics Committee of Peking University People′s Hospital from January to December 2021, analyzed the causes of complaints, and proposed countermeasures and suggestions.Results:Problems exist in the subject complaints regarding the payment of compensation, investigators′ communication attitude and skills, subjects′ understanding bias, etc.Conclusions:The ethics committee should attach great importance to subject complaints, adopt a closed-loop management process, carry out hierarchical management, strict ethical review, improve the ability of continuous supervision, conduct targeted training for investigators, and provide counseling services for subjects, to improve the communication between investigators and subjects, effectively reduce and avoid the occurrence of complaints. Relevant functional departments of medical and health institutions should work together to protect the rights and interests of the subjects.