Ética en investigación: desafíos durante la pandemia / Research ethics: challenges during the pandemic

Durante la pandemia de Covid-19 los hospitales pediatricos se vieron menos afectados, debido a la menor infección en niños, y sus recursos fueron reasignados en distintas tareas.. El Comité de Ética en Investigación del Hospital General de Niños Pedro de Elizalde presenta los distintos procedimientos implementados en esta emergencia, para sostener diferentes investigaciones, y que les permitió una rápida respuesta a esta situación.

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.

III. The role of the Research Ethics Committees in the regulation of Pharma-Sponsored studies

Participants of Pharma-sponsored research are exposed to risks, benefits, and uncertainties that do not occur in other forms of clinical studies. Ethics committees represent the subjects’ first line of protection. This responsibility begins with the study review and ends after all study subjects finish the intervention. The objective of this paper is to review the most common controversial issues found in Pharma-sponsored studies. Potential solutions are proposed to prevent or resolve the polemical aspects. However, different challenges will be faced in the near future (e.g., when new therapies reach their late stage of development). All parties involved in research should work together to guarantee the protection of participants, the paramount principle on which clinical investigation is based. Pharma-sponsored research is a crucial driver to develop and implement innovative approaches to improve the informed consent process and the execution of the studies.

Los comités de investigación en salud: su autoridad, responsabilidad fundamental y necesidad de que se sometan a auditorías periódicas / Health research committees: their authority, fundamental responsibility and the need for them to undergo periodic audits

Resumen La ética de la investigación debe incluir las dimensiones teórica y práctica. La primera la conforman regulaciones y directrices y la segunda alude a la forma cómo los comités de ética y ética de la investigación interpretan y aplican esas regulaciones y directrices. En este artículo se analiza la operación de los comités a nivel práctico. Dado que la evaluación y el dictamen de los protocolos de investigación es un proceso que requiere consciencia plena, la omisión de esta conlleva importantes implicaciones para la investigación en salud.

Abstract Research ethics must include theoretical and practical dimensions. The first one is structured by regulations and policies, and the second dimension refers to how the committee interprets and applies those regulations and policies. This article analyses the operation of the committees at a practical level. Given that the evaluation and judgement of research protocols is a process that requires full awareness, its omission entails important implications for health research.

I. The role of research ethics committees in observational studies: epidemiological registries, case reports, interviews, and retrospective studies

Abstract It is often unclear to the clinical investigator whether observational studies should be submitted to a research ethics committee (REC), mostly because, in general, no active or additional interventions are performed. Moreover, obtaining an informed consent under these circumstances may be challenging, either because these are very large epidemiological registries, or the subject may no longer be alive, is too ill to consent, or is impossible to contact after being discharged. Although observational studies do not involve interventions, they entail ethical concerns, including threats such as breaches in confidentiality and autonomy, and respect for basic rights of the research subjects according to the good clinical practices. In this context, in addition to their main function as evaluators from an ethical, methodological, and regulatory point of view, the RECs serve as mediators between the research subjects, looking after their basic rights, and the investigator or institution, safeguarding them from both legal and unethical perils that the investigation could engage, by ensuring that all procedures are performed following the international standards of care for research. The aim of this manuscript is to provide information on each type of study and its risks, along with actions to prevent such risks, and the function of RECs in each type of study.

A Rare Opportunity: Examining the Experience of a New Institutional Review Board.

The process of creating a new Institutional Review Board (IRB) or Research Ethics Committee (REC) presents many challenges; however, little has been published to describe this experience. Thus, many questions about creating a new IRB/REC and the challenges they face remain. The establishment of a new federal-wide single IRB provided a rare opportunity to describe these experience and outcomes. A census of the activity and outcomes of this new board is reported for its first 3 years of operation: The convened board approved 50 protocols, required an average of 93.24 days and 2.76 reviews for protocol approval, and issued an average of 31.82 stipulations per protocol. The census data helped to identify several issues that impacted the board's outcomes and it serves as a baseline for future comparisons. The overall dynamics, challenges, and outcomes of this new single IRB are discussed.

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)

Fair, just and compassionate: A pilot for making allocation decisions for patients requesting experimental drugs outside of clinical trials.

Patients have received experimental pharmaceuticals outside of clinical trials for decades. There are no industry-wide best practices, and many companies that have granted compassionate use, or 'preapproval', access to their investigational products have done so without fanfare and without divulging the process or grounds on which decisions were made. The number of compassionate use requests has increased over time. Driving the demand are new treatments for serious unmet medical needs; patient advocacy groups pressing for access to emerging treatments; internet platforms enabling broad awareness of compelling cases or novel drugs and a lack of trust among some that the pharmaceutical industry and/or the FDA have patients' best interests in mind. High-profile cases in the media have highlighted the gap between patient expectations for compassionate use and company utilisation of fair processes to adjudicate requests. With many pharmaceutical manufacturers, patient groups, healthcare providers and policy analysts unhappy with the inequities of the status quo, fairer and more ethical management of compassionate use requests was needed. This paper reports on a novel collaboration between a pharmaceutical company and an academic medical ethics department that led to the formation of the Compassionate Use Advisory Committee (CompAC). Comprising medical experts, bioethicists and patient representatives, CompAC established an ethical framework for the allocation of a scarce investigational oncology agent to single patients requesting non-trial access. This is the first account of how the committee was formed and how it built an ethical framework and put it into practice.

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

Inconsistencies and time delays in site-specific research approvals hinder collaborative clinical research in Australia.

BACKGROUND/AIM: The aim of this study was to describe the time and documentation needed to gain ethics and governance approvals in Australian states with and without a centralised ethical review system. METHODS: This is a prospective descriptive study undertaken between February 2012 and March 2015. Paediatric and adult hospitals (n = 67) in Australian states were approached to allow the review of their medical records. Participants included 15- to 24-year-olds diagnosed with cancer between 2008 and 2012. The main outcomes measures were time (weeks) to approval for ethics and governance and the number and type of documents submitted. RESULTS: Centralised ethics approval processes were used in five states, with approval taking between 2 and 18 weeks. One state did not use a centralised process, with ethics approval taking a median of 4.5 weeks (range: 0-15) per site. In four states using a centralised ethics process, 33 governance applications were submitted, with 20 requiring a site clinician listed as an investigator. Governance applications required the submission of 11 documents on average, including a Site-Specific Assessment form. Thirty-two governance applications required original signatures from a median of 3.5 (range: 1-10) non-research persons, which took a median of 5 weeks (range: 0-15) to obtain. Governance approval took a median of 6 weeks (range: 1-45). Twelve research study agreements were needed, each taking a median of 7.5 weeks (range: 1-20) to finalise. CONCLUSION: The benefits of centralised ethics review systems have not been realised due to duplicative, inflexible governance processes. A system that allowed the recognition of prior ethical approval and low-risk applications was more efficient than a central ethics and site-specific governance process.

Estructura y funcionamiento de los comités de ética en investigación de la Ciudad Autónoma de Buenos Aires y el Gran Buenos Aires / Structure and functioning of research ethics committees in the Autonomous City of Buenos Aires and Greater Buenos Aires

En función de los escasos estudios publicados sobre los comités de ética en investigación (CEI) de Argentina, este trabajo tiene como objetivo describir la estructura y funcionamiento de los CEI de instituciones de la Ciudad Autónoma de Buenos Aires y el Gran Buenos Aires. Con ese fin, se realizó un estudio descriptivo, cuali-cuantitativo, a partir de la aplicación de una encuesta entre marzo y julio de 2012. La muestra quedó conformada por 46 CEI. El 40% de sus miembros eran médicos y la distribución por sexo y edad se adecuaba a la normativa. Se encontraron falencias en la cantidad de metodólogos, representantes de la comunidad, abogados y miembros externos a las instituciones, falta de personal administrativo y de lugar fijo para las reuniones, presupuestos escasos para gastos y poco entrenamiento en ética de la investigación. Algunos de los encuestados reportaron problemas de relación con la institución y los investigadores, y con el tiempo disponible para realizar la tarea.

Given the few existing studies on research ethics committees (RECs) in Argentina, this paper aims to describe the structure and functioning of institutional RECs in the Autonomous City of Buenos Aires and Greater Buenos Aires. A descriptive, qualitative and quantitative research study was carried out using a survey conducted between March and July 2012. The sample was made up of 46 RECs. Forty percent of committee members were doctors and the age and sex distribution met standards. Inadequate numbers of methodologists, community representatives, lawyers and members external to the institution were identified, as well as shortcomings regarding administrative staff, fixed locations for meetings, budgets adequate to expenditures and training in research ethics. Some of those surveyed reported problems in their relationship with the institution and with researchers, in addition to difficulties regarding the time available to perform tasks.

Defining the research category in pediatric Phase I oncology trials.

Clinical research studies in children are classified by risk into three major categories. These are as follows: a) minimal risk studies, b) more than minimal risk studies but with benefit, and c) studies with minor increase over minimal risk but with no benefit. Pediatric Phase I oncology trials, which are conducted in a highly vulnerable population of severely ill children with cancer, are designed to establish safety and to determine the maximum tolerated dose (MTD), as well as establish dose limiting toxicity (DLT). These types of studies can be associated with significant risk. The research design of such high- risk studies, which comprise short-term treatments with varying doses, is generally not associated with any clinical benefit. Classification of the research category in these pediatric studies poses a special problem for the Institutional Review Board (IRB) with major implications for the consenting process. The challenges associated with the classification of such studies are discussed in this article.

Ethical, legal and practical issues of establishing an adipose stem cell bank for research.

Access to human tissue is critical to medical research, however the laws and regulations surrounding gaining ethical and legal access to tissue are often poorly understood. Recently, there has been a huge increase in the interest surrounding the therapeutic application of adipose tissue, and adipose-derived stem cells. To facilitate our own research interests and possibly assist our local colleagues and collaborators, we established a Research Tissue Bank (RTB) to collect, store and distribute human adipose tissue derived cells with all the appropriate ethical approval for subsequent downstream research. Here we examine the legal, ethical and practical issues relating to the banking of adipose tissue for research in the UK, and discuss relevant international guidelines and policies. We also share our experiences of establishing an RTB including the necessary infrastructure and the submission of an application to a Research Ethics Committee (REC).

Institutional review boards: what's old? What's new? What needs to change?

SUMMARY: Institutional review boards have come under fire for being burdened with work, causing delays in the progress of human subject research without improvements in the protection of human subjects. Over the years, there have been increases in the numbers of clinical trials, the use of multisite studies, and the amount of bureaucracy, but there have been no changes to the system to accommodate these advancements. Proposed changes include the use of a centralized institutional review board for multisite studies and harmonization of reporting requirements among agencies. The purposes of this article are to review the history, structure, and purpose of the institutional review board, to assess the criticisms of the current system, and to discuss solutions for improvement.

Investigators' successful strategies for working with Institutional Review Boards.

This study was designed to identify successful strategies used by investigators for working with their Institutional Review Boards (IRBs) in conducting human subjects research. Telephone interviews were conducted with 46 investigators representing nursing, medicine, and social work. Interview transcripts were analyzed using qualitative descriptive methods. Investigators emphasized the importance of intentionally cultivating positive relationships with IRB staff and members, and managing bureaucracy. A few used evasive measures to avoid conflict with IRBs. Few successful strategies were identified for working with multiple IRBs. Although most investigators developed successful methods for working with IRBs, further research is needed on how differences in IRB culture affect human subjects protection, and on best approaches for obtaining IRB approval of multi-site studies.

Collaborative Chronic Care Networks (C3Ns) to transform chronic illness care.

Despite significant gains by pediatric collaborative improvement networks, the overall US system of chronic illness care does not work well. A new paradigm is needed: a Collaborative Chronic Care Network (C3N). A C3N is a network-based production system that harnesses the collective intelligence of patients, clinicians, and researchers and distributes the production of knowledge, information, and know-how over large groups of people, dramatically accelerating the discovery process. A C3N is a platform of "operating systems" on which interconnected processes and interventions are designed, tested, and implemented. The social operating system is facilitated by community building, engaging all stakeholders and their expertise, and providing multiple ways to participate. Standard progress measures and a robust information technology infrastructure enable the technical operating system to reduce unwanted variation and adopt advances more rapidly. A structured approach to innovation design provides a scientific operating system or "laboratory" for what works and how to make it work. Data support testing and research on multiple levels: comparative effectiveness research for populations, evaluating care delivery processes at the care center level, and N-of-1 trials and other methods to select the best treatment of individual patient circumstances. Methods to reduce transactional costs to participate include a Federated IRB Model in which centers rely on a protocol approved at 1 central institutional review board and a "commons framework" for organizational copyright and intellectual property concerns. A fully realized C3N represents a discontinuous leap to a self-developing learning health system capable of producing a qualitatively different approach to improving health.