Ética en investigación: Nuevos desafíos, ¿viejos dilemas? / Research Ethics: New challenges, old dilemmas?

Memoria de las ponencias del 1er Congreso de Ética en Investigación, realizado en la Ciudad de Buenos Aires en septiembre de 2022, y organizado por el Comité Central de Ética en Investigación del Ministerio de Salud de esta ciudad. Los dos ejes del Congreso fueron: Desafíos éticos en la investigación durante la pandemia y post-pandemia; y Aporte de las nuevas tecnologías para los procesos de investigación. Se presentan las ponencias del congreso, organizadas en los capítulos: El trabajo de los Comités de Ética en Investigación durante la pandemia; El rol de las comunidades en la investigación; Aporte de las nuevas tecnologías para los procesos de investigación; y Desafíos modernos para la investigación en salud.

Gobernanza para la supervisión ética de la investigación sobre COVID-19 en América Latina: un estudio exploratorio / Governance for ethical oversight of COVID-19 research in Latin America: an exploratory study

Presentación de "Estudio Exploratorio de los Marcos de Gobernanza para la Revisión y Supervisión Ética de la Investigación de COVID-19 en América Latina", trabajo descriptivo para identificar si los países de América Latina adoptaron políticas para acelerar la evaluación ética de las investigaciones, a la vez de que aseguraban los estándares éticos para su realización, durante la pandemia.

COVID-19, ¿un conflicto ético? / COVID-19, an ethical conflict?

Exposición sobre posibles dilemas éticos ante la pandemia Covid-19 desde los comité de ética en investigación, en relación a la validación de resultados y distribución de diferentes vacunas, y a los criterios objetivos en la toma de decisiones con respecto a las conductas médicas aprobadas y permitidas durante la pandemia; de modo tal de crear un protocolo especial para la utilización de las futuras generaciones en contextos similares.

Investigación en Pandemia: intervenciones del Comité Provincial de Bioética de Santa Fe / Pandemic research: Santa Fe Provincial Committee of Bioethics interventions

Se presenta brevemente la evaluación ética de los protocolos presentados durante la pandemia de Covid-19 al Comité Provincial de Bioética de Santa Fe, organismo que regula las investigaciones con seres humanos en esta provincia, articulando esta tarea con los 24 comités de ética acreditados a nivel provincial. Se describen especialmente dos protocolos que fueron observados y en uno de los casos rechazado por el Comité en base a aspectos éticos.

A Qualitative Study on Experiences and Perspectives of Members of a Dutch Medical Research Ethics Committee.

The aim of this research was to gain insight into the experiences and perspectives of individual members of a Medical Research Ethics Committee (MREC) regarding their individual roles and possible tensions within and between these roles. We conducted a qualitative interview study among members of a large MREC, supplemented by a focus group meeting. Respondents distinguish five roles: protector, facilitator, educator, advisor and assessor. Central to the role of protector is securing valid informed consent and a proper risk-benefit analysis. The role of facilitator implies that respondents want to think along with and assist researchers in order to help medical science progress. As educators, the respondents want to raise ethical and methodological awareness of researchers. The role of advisor implies that respondents bring in their own expertise. The role of assessor points to contributing to the overall evaluation of the research proposal. Various tensions were identified within and between roles. Within the role of protector, a tension is experienced between paternalism and autonomy. Between the role of protector and facilitator tensions occur when the value of a study is questioned while risks and burdens for the subjects are negligible. Within the role of assessor, a tension is felt between the implicit nature of judgments and the need for more explicit formulations. Awareness of various roles and responsibilities may prevent one-sided views on MREC work, not only by members themselves, but also by researchers. Tensions within and between the roles require reflection by MREC members.

Ethics committees and research in Italy: seeking new regulatory frameworks (with a look at the past). Commentary.

The legislation of Italy and the European Union requires a shift in terms of the organisation and national regulation of ethics committees and clinical trials. More generally, this affects the entire sphere of biomedical research. The first part of this contribution provides a brief review of the history of ethics committees in Italy. We then discuss the current situation and formulate proposals. There is a vital need for rules that promote efficiency of ethics committees, to guarantee that Italy's position remains competitive and attractive within the European Union.

Salud pública, innovaciones en investigación y perspectivas éticas: Segundo Encuentro de Comités de Ética en Investigación / Public health, research innovations and ethic perspectives: Second Meeting of Ethics Committees in Researching

El 25 de octubre de 2018 se realizó el Segundo Encuentro de Comités de Ética en Investigación 2018 "Salud Pública, Innovaciones en Investigación y Perspectivas Éticas", en la sede del Ministerio de Salud del Gobierno de la Ciudad de Buenos Aires. Los objetivos propuestos fueron coordinar acciones para la conformación de redes de conocimiento en investigación traslacional en un marco ético, brindar una actualización en aspectos éticos de nuevos diseños en investigación, traslacional, gestión de datos y muestras biológicas en salud y proponer un espacio de encuentro y diálogo entre los diferentes actores ligados a la investigación en salud. (AU)

Are the Italian ethics committees ready for Europe? Commentary.

The Law of 3 January 2018 established in Italy the "National Centre for the Coordination of Regional Ethics Committees for Clinical Trials of Medicines and Medical Devices for Human Use" and reduced the number of ethics committees in the country to 40. This Act should, amongst other things, facilitate Italy's compliance with the provisions set forth in European Regulation (EU) 536/2014. Hopefully, in addition to the provisions set forth in the Law, the National Centre will strive to foster the harmonisation of ethics committee procedures, in order to reform Italian legislation on the evaluation of clinical trials and, more generally, biomedical studies.

Why Public Comments Matter: The Case of the National Institutes of Health Policy on Single Institutional Review Board Review of Multicenter Studies.

PURPOSE: In 2014, the National Institutes of Health (NIH) requested public comments on a draft policy requiring NIH-funded, U.S.-based investigators to use a single institutional review board (sIRB) for ethical review of multicenter studies. The authors conducted a directed content analysis and qualitative summary of the comments and discuss how they shaped the final policy. METHOD: Two reviewers independently assessed support for the policy from a review of comments on the draft policy in 2016. A reviewer conducted an open text review to identify prespecified and additional comment themes. A second researcher reviewed 20% of comments; discrepancies were resolved through discussion. RESULTS: The NIH received 167 comments: 65% (108/167) supportive of the policy, 23% (38/167) not supportive, and 12% (21/167) not indicating support. Clarifications or changes to the policy were suggested in 102/167 comments (61%). Criteria for selecting sIRBs were addressed in 32/102 comments (31%). Also addressed were institutional review board (IRB) responsibilities (39/102; 38%), cost (27/102; 26%), the role of local IRBs (14/102; 14%), and allowable policy exceptions (19/102; 19%). The NIH further clarified or provided guidance for selection criteria, IRB responsibilities, and cost in the final policy (June 2016). Local IRB reviews and exemptions guidance were unchanged. CONCLUSIONS: In this case study, public comments were effective in shaping policy as the NIH modified provisions or planned supplemental guidance in response to comments. Yet critical knowledge gaps remain, and empirical data are necessary. The NIH is considering mechanisms to support the establishment of best practices for sIRB implementation.

Primer Encuentro de Comités de Ética en Investigación: Resumen Ejecutivo: Vínculos entre la comunidad y la investigación en y para la salud / First Meeting of Research Ethics Committees: Executive Summary: Links between the community and research in and for health

El 9 de mayo de 2018 se realizó el Primer Encuentro de Comités de Ética en Investigación 2018 "Vínculos entre la Comunidad y la Investigación en y para la Salud", en la sede central del Ministerio de Salud de la Ciudad de Buenos Aires. Los objetivos propuestos fueron los de visibilizar problemáticas asociadas al rol del representante de la comunidad en el Comité de Ética en Investigación, identificando barreras y oportunidades para el desempeño de sus funciones; generar un espacio de encuentro entre diferentes actores ligados a la salud de la comunidad y los Comités de Ética en Investigación, para fortalecer el conocimiento interinstitucional y el trabajo mancomunado; y exponer las nuevas pautas CIOMS con énfasis en el rol de representantes de la comunidad en los CEIs. (AU)

Resumen Ejecutivo: Encuentro de Investigación: Investigación traslacional para los objetos de desarrollo sostenible: 18 de diciembre 2018 / Executive Summary: Research Meeting: Translational Research for Sustainable Development Objects: 18 December 2018

Encuentro de investigación realizado en la sede del Ministerio de Salud de la Ciudad de Buenos Aires, basado en tres ejes principales: Políticas públicas de investigación: oportunidades para avanzar en la construcción de una red de conocimiento para la salud; Estrategias para consolidar la gestión del conocimiento en salud en el ámbito público; y Acreditación y supervisión de comités de ética en investigación públicos y privados: oportunidades para el fortalecimiento de la formación en investigación

Research ethics committee approval as reported for abstracts submitted to the annual Euroanaesthesia meeting.

BACKGROUND: The annual congress of the European Society of Anaesthesiology (ESA) is one of the largest anaesthesia congresses in the world and exhibits more than 1200 abstracts annually. OBJECTIVES: The aims of this study were to quantify the frequency of inadequate evidence of ethical approval for abstracts submitted to the ESA congress and to examine whether abstracts without appropriate ethical approval were subsequently accepted. DESIGN AND SETTING: All abstracts submitted in 2015 were adjudicated according to European ethical criteria. MAIN OUTCOME MEASURE: The proportion of submitted abstracts that lacked evidence of appropriate ethics committee approval. Secondary outcomes included the proportion of accepted abstract that lacked evidence of appropriate ethical approval; the proportion of correctly identified case reports; the proportion of accepted abstracts that lacked evidence of appropriate ethics committee approvals corresponding to location (within/outside Europe); and the proportion of accepted abstracts that lacked evidence of appropriate ethics committee approvals corresponding to a specific area of research. RESULTS: In total, 1792 abstracts were reviewed and 1572 (87.7%) involved humans. In 527 (29.4%), the authors failed to demonstrate adequate ethical approval with higher rates in abstracts submitted from Europe (32.1%) than the rest of the world (23.5%), P < 0.001. Appropriate approvals were reported in 80% of animal studies, 74.6% of case reports and 57.6% of human research studies. The proportion with evidence of adequate ethical approvals was lowest in obstetric anaesthesia and emergency medicine. Case reports were identified correctly 98.6% (347/352) of the time, but 14 research abstracts were assigned wrongly to this category. Most abstracts (68.5%, 361/527) lacking evidence of ethical approval were still accepted for presentation. CONCLUSION: Research abstracts lacking evidence of appropriate ethical approval are common worldwide. Societies shoulder the responsibility for ensuring that only ethically sound abstracts are presented at meetings. Abstract submission systems must include mechanisms to ensure that publications are accepted and judged not just on scientific merit but also on adherence to best ethical practice.

A Proposed Process for Reliably Updating the Common Rule.

The recent Common Rule revision process took almost a decade and the resulting changes are fairly modest, particularly when compared to the ambitious ideas proposed in the advance notice of proposed rulemaking (ANPRM) and notice of proposed rulemaking (NPRM). Furthermore, the revision process did not even attempt to tackle any of the Common Rule subparts pertaining to vulnerable populations (i.e., pregnant women and fetuses, prisoners, children) where commentators think the rules unduly restrict important research. We believe that this was a missed opportunity to make desirable changes, and that given the usual process the next opportunity to revisit the Common Rule is unacceptably remote. In this article, we argue that the Common Rule should be regularly reassessed, with a mechanism for making substantive (and expeditious) changes. Drawing on lessons learned from the recent revision process, we make recommendations about ways to structure future attempts to maximize the ability to make timely and necessary changes.

Ethical standards for medical research in the Israeli military - review of the changes in the last decade.

BACKGROUND: The Israel Defense Forces Medical Corps (IDF MC) institutional review board (IRB) is one of approximately 50 IRBs active in Israel. In addition to routine IRB considerations it must also address in its deliberations specific safeguards in place in the IDF to protect research volunteers in the military environment. In this report, we present the characteristics of the IDF IRB, including the unique circumstances that led to a 2008 change in the pre-IRB advisory and preparatory process (APP). We also present quantitative data on the IRB's throughput and outcomes, in order to provide a benchmark for other IRBs. METHODS: We reviewed all relevant IDF regulations, both historical and current, pertaining to the structure, activity and oversight of the IRB and of medical research conducted in the IDF. Additionally, we analyzed the ethical review process for all research proposals submitted to the IDF APP between January 1, 2013 and December 31, 2015. RESULTS: In 2008 the IDF implemented several major changes which have had a substantial impact on the ethical regulation of military medical research. The period following these changes has seen a rise in the number of research proposals submitted to the IDF IRB annually. During the years 2013-2015, 377 research proposals entered the APP, of which 329 were deemed appropriate for IRB deliberation. Eight study protocols were granted waivers, 19 were rejected, and the remaining 302 were authorized. Overall, 345 of the 377 research proposals submitted (92 %) were ultimately cleared for execution; 310 of 329 proposals (94 %) deliberated by the IRB were authorized. The IRB required protocol revisions for 47 % of the research proposals, one-third of which were revisions directly associated with military-specific ethical precautions. CONCLUSIONS: Guided by the principles of protecting personal autonomy in the complex military setting, the IDF has implemented several unique measures aimed at maintaining the highest ethical standards in medical research. By sharing research approval process data similar to those presented here, medical institutions can help build and support a peer-based benchmarking process through which individual IRBs can appraise their own processes and approval rates.

Towards a balanced approach to identifying conflicts of interest faced by institutional review boards.

The welfare and protection of human subjects is critical to the integrity of clinical investigation and research. Institutional review boards (IRBs) were thus set up to be impartial reviewers of research protocols in clinical research. Their main role is to stand between the investigator and her human subjects in order to ensure that the welfare of human subjects are protected. While there is much literature on the conflicts of interest (CIs) faced by investigators and researchers in clinical investigations, an area that is less explored is CIs that may affect members of IRBs during the institutional ethics review of clinical investigations. This article examines the notion of CIs in clinical research and attempts to develop a framework for a clearer and more balanced approach to identifying CIs that may influence members of IRBs and impede their independence. It will also apply the proposed framework to demonstrate how IRBs possess, or at least may appear to possess, forms of financial CIs and non-financial CIs. The proper identification and management of these CIs is critical to preserving the integrity of clinical investigations and achieving the primary aim of human subjects protection.