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)

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.

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.

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.

Analysis and discussion on the subject complaint in clinical drug trials / 中华医学科研管理杂志

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.

Aspectos éticos y recomendaciones para investigación en seres humanos en la era genómica

Este artículo revisa los principales desafíos éticos que plantea la investigación vinculada al genoma humano a la luz de la bibliografía internacional y entrega recomendaciones sobre su abordaje basada en nuestra experiencia en el Comité de Ética para la Investigación en Seres Humanos de la Facultad de Medicina, Universidad de Chile, incluyendo las regulaciones legales nacionales. Los estándares éticos de la investigación en seres humanos deben extremarse para proteger adecuadamente a los participantes en estudios involucrados con la genómica. Especialmente relevantes en este contexto son: la protección de la confidencialidad y anonimato; la política de entrega de resultados y la posibilidad de retirarse del estudio. Compartir datos resultantes de investigaciones genéticas permite optimizar recursos, otorga mayor transparencia y replicabilidad de los análisis y permite descubrir alteraciones genéticas responsables de enfermedades raras y genes involucrados en enfermedades hereditarias multifactoriales, además de contribuir al diseño de medicina de precisión y de nuevas estrategias terapéuticas. Sin embargo, plantea grandes desafíos: proteger la privacidad y evitar la re-identificación de los voluntarios, la entrega de resultados con asesoría pre y post estudio. Estos aspectos requieren la elaboración de un cuidadoso proceso de consentimiento informado para investigaciones genómicas cuyos componentes principales se analizan en este artículo.

This article reviews the main ethical challenges posed by human genome research in the light of the international literature and provides recommendations on how to approach them based on our experience in the Ethics Committee for Research on Human Subjects of the Faculty of Medicine, University of Chile, including national legal regulations. Ethical standards in human research must be extreme, in order to adequately protect participants in studies involving genomics. Particularly relevant in this context are the protection of confidentiality and anonymity; the policy of delivery of results and the possibility of withdrawing from the study. Sharing data resulting from genetic research optimizes resources, provides greater transparency, and replicability of the analyses and makes it possible to discover genetic alterations responsible for rare diseases and genes involved in multi-factorial hereditary diseases, as well as contributing to the design of precision medicine and new therapeutic strategies. However, it poses great challenges: protecting privacy and avoiding re-identification of volunteers, delivery of results with pre- and post-study counseling. These aspects require the elaboration of a careful informed consent process for genomic research, the main components of which are discussed in this article.

Challenges faced by ethics committee members in India during COVID-19 pandemic: A mixed-methods exploration

Background & objectives: The COVID-19 pandemic had a distinct impact on scientific research and Ethics Committees (ECs). We conducted a mixed-methods investigation to understand the issues faced and solutions identified by ECs during this pandemic in India. Methods: A quantitative online survey form (30 members) and qualitative in-depth interviews (10 members) from various ECs were conducted. Thematic content analysis for qualitative and proportion analysis for quantitative data was carried out. Results: During the online survey, an average difficulty score, which was measured using the Visual Analogue Scale, was 5.3 (SD 2.1). Pressure for expedited approvals was felt by EC members with a drastic increase in the number of submission of research projects. The scarcity of information on investigational products (IPs) and requisite consent process posed major hurdles. Ongoing non-COVID studies and post-graduate dissertations were badly hit due to the shift in attention towards COVID-related research. Non-familiarity with virtual technology and lack of face-to-face interactions were highlighted as demerits. However, a few of the EC members welcomed newer methods, being time-saving, convenient and reducing travel hassles. Site monitoring and severe adverse event-related analyses were also negatively impacted upon. Solutions included the alternate methods of consenting (virtual, abbreviated), a detailed explanation of the protocol and IPs and benefits versus risk assessment. Interpretation & conclusions: Despite various challenges posed by the COVID-19 pandemic, the ECs in India steered well through the hurdles. Moreover, adapting a hybrid mode, technical training and updating guidelines were perceived as urgent by EC members

Operation of research ethics committees in Colombia, Costa Rica, Guatemala, and Mexico: Mesoamerican Project / Funcionamiento de los comités de ética en investigación en Colombia, Costa Rica, Guatemala y México: Proyecto Mesoamericano

Abstract: Objective: To attain a better understanding of the structure and processes of Research Ethics Committees (REC) in the low-and middle-income countries of the Mesoamerican region. The objectives are knowing the operational practices of the RECs regarding project evaluation, training needs, and infrastructure. Materials and methods: The REC training and needs assessment involved an online survey of all the RECs (n=55) identified in Colombia (n=11), Costa Rica (n=5), Guatemala (n=5), and Mexico (n=34). Results: Participants reported inadequate infrastructure for its proper operation (only 49.1 %, or 27/55, have an exclusive office to safeguard files); insufficient administrative staff (47.3%, 26/55), or financial resources to conduct active site monitoring (85.6%, 47/55) to ensure the protection of rights and welfare of study participants. Conclusions: Investments in REC member training and infrastructure are needed to ensure compliance of REC evaluations with the standards for ethical conduct of research.

Resumen: Objetivo: Comprender la estructura y procesos de los Comités de Ética en Investigación (CEI) en países mesoamericanos de ingresos bajos y medios. Conocer las prácticas operativas en evaluación de proyectos, necesidades de capacitación e infraestructura. Material y métodos: Encuesta en línea para evaluar necesidades de capacitación de los CEI (n=55) identificados en Colombia (n=11), Costa Rica (n=5), Guatemala (n=5) y México (n=34). Resultados: Los participantes reportaron una infraestructura inadecuada para su correcto funcionamiento (oficina exclusiva para archivos 49.1%, 27/55); personal administrativo insuficiente (47.3%, 26/55), recursos financieros insuficientes para monitoreo del sitio (85.6%, 47/55), para garantizar protección de derechos y bienestar de los participantes. Conclusiones: Se necesita invertir en capacitación de los miembros e infraestructura del CEI, para garantizar la conducción ética de la investigación.

Jornadas de Bioética de Arica y Parinacota: siete años de crecimiento / Bioethics Conference in Arica and Parinacota: seven years of growth

Desde el año 2015 se realizan anualmente las Jornadas de Bioética de Arica y Parinacota, en la ciudad más extremo norte de Chile. Esta actividad ha permitido el conocimiento y desarrollo de la bioética en el ámbito hospitalario y académico en la XV región, y ha sido promotora de la creación del Comité Ético Científico de la Universidad de Tarapacá (CEC UTA) y de la revista Journal of Health and Medical Sciences (JOHMASC). Durante siete años han participado en forma activa, e ininterrumpida, exponentes locales y destacados invitados nacionales, quienes han contribuido a la enseñanza y difusión de esta interdisciplina en la ciudad de Arica, incluyendo la realización de las Jornadas Nacionales de la Sociedad Chilena de Bioética el año 2018.

Since 2015, the Arica and Parinacota Bioethics Sessions have been held annually, in the northernmost city of Chile. This activity has allowed the knowledge and development of bioethics in the hospital and academic field in the XV region, and has promoted the creation of the Scientific Ethics Committee of the University of Tarapacá (CEC UTA) and the Journal of Health and Medical Sciences (JOHMASC). For seven years, local exponents and prominent national guests have participated actively and uninterruptedly, contributing to the teaching and dissemination of this interdiscipline in the city of Arica, including holding the National Conference of the Chilean Society of Bioethics on year 2018.

Research ethics committees in Manila Schools: Exploring the reasons for its non-existence

Objectives@#This study aimed to explore the reasons behind the “resistance” of higher education institutions (HEIs) located in the south Manila area in creating research ethics committees (RECs). It also examined the proportion of researches in these HEIs with human participation. @*Methods@#Research directors underwent key informant interviews while faculty researchers participated in focus group discussions. Universal sampling was employed on all researches in the schools to determine the proportion with human participants and to know if they are ethically “high risk“ or “low risk” in terms of the participants’ involvement. @*Results@#We included ten higher education institutions in this study. Research directors and faculty researchers agreed that their school should have a REC and that studies should undergo ethical evaluation before commencement of data collection. Half of all researches were found to have human participant involvement and, after developing a tool to determine the risk level to participants, this study found that ethically high risk researches are found to represent 10% as a proportion of the total researches done in the schools. @*Conclusion@#Almost all respondents in this study agreed that RECs should be created; however, there are financial challenges that schools face in establishing RECs.

Marco ético y jurídico en la investigación científica en chile: acreditación de comités ético científicos / Ethical and legal framework in scientific research from Chile: functioning of accredited scientific ethics committees

RESUMEN: La investigación científica en seres humanos es fundamental para el desarrollo y avance en la ciencia de la salud y para el bienestar de la sociedad. La necesidad de contar con principios éticos explícitos y un marco regulatorio, permitió en el año 2001 la aprobación de la Norma sobre Regulación de Ensayos Clínicos en Seres Humanos. La ley 20.120 (2006), norma la investigación científica en el ser humano, describe aspectos centrales para el desarrollo de la investigación, dando sustento legal a la creación de los Comités Éticos Científicos (CEC), entidades colegiadas que tienen por objeto velar por la protección de la vulneración de derechos y libertades de los participantes, pudiendo aprobar o rechazar los protocolos de los proyectos. En Chile al año 2021 se registran 62 CEC acreditados. La región Metropolitana concentra el 58,2 %, la zona Norte un 11,2 % y en el sur del país un 30,6 %, de ellos solo el 12,9 % están acreditados para evaluar ensayos clínicos aleatorizados (ECA). Los criterios éticos internacionales más utilizados son la Declaración de Helsinki, pautas éticas sobre la salud, bienestar y los derechos de los pacientes; El Consejo Internacional de Ciencias Médicas (CIOMS) que protege en entornos vulnerables de escasos recursos; y el Informe Belmont en la protección de los sujetos de investigación. Se concluye que las guías éticas nacionales e internacionales son pautas que guardan relación con la adecuada protección jurídica de los participantes, velando por el respeto a la autonomía, la justicia y la selección justa de los participantes, a través del consentimiento informado voluntario. El desarrollo de una cultura de conducta ética en la investigación se debe basar en tres dimensiones generales; el ambiente humano, ambiente político y mecanismos de la sociedad civil.

SUMMARY: Scientific research in human beings is essential for the development and advancement of health science and for the well-being of society. The need to have explicit ethical principles and a regulatory framework allowed in 2001 the approval of the Standard on the Regulation of Clinical Trials in Human Beings. Law 20,120 (2006), regulates scientific research in human beings and describes central aspects for the development of research, giving legal support to the creation of Scientific Ethics Committees (SEC), collegiate entities whose purpose is to ensure the protection of the vulnerability of rights and freedoms of the participants, being able to approve or reject the protocols of the projects. In Chile by 2021, 62 accredited CECs are registered. The Metropolitan region concentrates 58.2 %, the North zone 11.2 % and in the south of the country 30.6 %, of which only 12.9 % are accredited to evaluate randomized clinical trials (RCTs). The most widely used international ethical criteria are the Helsinki Declaration, ethical guidelines on health, well-being and the rights of patients; The International Council of Medical Sciences (CIOMS) that protects in vulnerability low-resource settings; and the Belmont Report on the protection of research subjects. It is concluded that the national and international ethical guidelines are appropriate legal ethical guidelines and risk-benefit ratio that protect the participants, ensuring respect for the autonomy, justice and fair selection of the participants, through voluntary informed consent. The development of a culture of ethical conduct in research must be based on three general dimensions; the human environment, political environment and mechanisms of civil society.