Ignacio Mastroleo

National Scientific and Technical Research Council | conicet · IICSAL - Instituto de Investigaciones Sociales de América Latina FLACSO Argentina

The general aim of this article is to give a critical interpretation of post-trial obligations towards individual research participants in the Declaration of Helsinki 2013. Transitioning research participants to the appropriate health care when a research study ends is a global problem. The publication of a new version of the Declaration of Helsink...

In an insightful article, Jacob Earl (2019) outlines the concept of innovative practice, addresses ethical problems and presents a permissive oversight proposal to deal with the ethical concerns identified. We agree to a large extent with Earl's approach and, therefore, decided to develop his comprehensive analysis further. In particular, we want t...

Emergency use of unproven clinical interventions outside clinical trials – including “off-label” interventions – has surged during the COVID-19 pandemic, with unjustified, unconstrained use of unproven interventions, which raises serious ethical concerns. This document is intended to provide a reminder and an updated version of the ethical framewor...

Recent ethics guidelines from the World Health Organization (WHO) on monitored emergency use (MEURI) state that, during a public health emergency, prospective ethical review and oversight of the use of unproven interventions outside of the context of research is an ethical principle or criterion for its permissible use. In this chapter, we argue th...

A significant part of the literature on innovative practice in medicine relates to seizing opportunities and curbing harms for patients in desperate situations. Unfortunately, the term innovation has multiple meanings and a rich rhetorical flourish that adds confusion and misunderstanding to an already difficult debate. This paper aims to enhance t...

Integridad se dice de muchas maneras. En este trabajo, reconstruiremos tres sentidos de integridad en la investigación científica (reglas, virtudes y valores) que se encuentran en la literatura reciente. Al respecto, partiremos de la hipótesis de que contar con un concepto claro de integridad y buena conducta en investigación puede fomentar su uso...

The public release of version 3.5 of the ChatGPT conversational algorithm in November 2022 marked a turning point in the ongoing process of technological change. Although the technology itself is not novel, its ability to generate human-like responses has led to two prevailing attitudes in the public debate about artificial intelligence (AI). On th...

Cancer detection and classification from gigapixel whole slide images of stained tissue specimens has recently experienced enormous progress in computational histopathology. The limitation of available pixel-wise annotated scans shifted the focus from tumor localization to global slide-level classification on the basis of (weakly-supervised) multip...

Resumen La bibliografía especializada ha presentado objeciones éticas a la exclusión de las mujeres embarazadas en los ensayos clínicos y ha llamado a cambiar de paradigma. Aunque indudablemente se trata de una causa justa, esta iniciativa está vertebrada por una compren- sión cisnormativa del género y, por consiguiente, reproduce sus problemas. En...

Recent ethics guidelines from the World Health Organization's (WHO) on monitored emergency use (MEURI) state that, during a public health emergency, prospective ethical review and oversight of the use of unproven interventions outside of the context of research is an ethical principle or criterion for its permissible use. In this chapter, we argue...

Given the unknown therapeutic value of targeting Alzheimer's disease pathology and the discovery of robust risk factors for dementia, non-pharmacological risk reduction (RR) is increasingly offered as an alternative to targeting Alzheimer's disease pathology. While RR will surely be a useful tool to make public health gains, we propose solutions to...

Background: To reopen society, various countries are planning or have implemented differential public health and social measures (PHSMs) for COVID-19-vaccinated individuals, by exempting these individuals from some of the measures. Aims: To examine the ethical considerations raised by differential PHSMs by differrnt countries based on individual...

Two potential disease-modifying approaches for dementia are being vigorously tested: the early targeting of the neuropathology of Alzheimer's disease (AD) and multi-domain lifestyle interventions to promote resilience to neuropathology. We apply the "web of information" model of clinical translation to both approaches to argue firstly that tests of...

As the world reflects upon one year since the first cases of coronavirus disease 2019 (COVID-19) and prepare for and experience surges in cases, it is important to identify the most crucial ethical issues that might lie ahead so that countries are able to plan accordingly. Some ethical issues are rather obvious to predict, such as the ethical issue...

Medical practice is ideally based on robust, relevant research. However, the lack of disease-modifying treatments for Alzheimer's disease has motivated "innovative practice" to improve patients' well-being despite insufficient evidence for the regular use of such interventions in health systems treating millions of patients. Innovative or new non-v...

This document offers a proposal for the elaboration of a triage guideline in the context of the COVID-19 pandemic. This proposal includes recommendations on the procedural norms and substantive norms that should govern the allocation and reallocation of therapeutic resources in conditions of extreme scarcity. Copyright © 2020 Eduardo Rivera López,...

A significant part of the literature on innovative practice in medicine relates to seizing opportunities and curbing harms for patients in desperate situations. Unfortunately, the term innovation has multiple meanings and a rich rhetorical flourish that adds confusion and misunderstanding to an already difficult debate. This paper aims to enhance t...

E l 30 de enero la Organización Mundial de la Sa-lud declaró oficialmente que el brote del nuevo coronavirus SARS-CoV-2, causa de la enferme-dad Covid-19, constituía una emergencia sani-taria de preocupación internacional; el 11 de marzo anunció que el mundo enfrentaba la primera pan-demia de la historia provocada por un coronavirus. ¿Qué problemas...

Este documento ofrece una propuesta desde la perspectiva de la bioética para la elaboración de un protocolo de triaje en el contexto de la pandemia de COVID-19. Dicha propuesta incluye recomendaciones sobre las normas procedimentales y normas sustantivas que deben regir la asignación y reasignación de recursos terapéuticos en condiciones de escasez...

Este documento ofrece una propuesta desde la perspectiva de la bioética para la elaboración de un protocolo de triaje en el contexto de la pandemia de COVID-19. Dicha propuesta incluye recomendaciones sobre las normas procedimentales y normas sustantivas que deben regir la asignación y reasignación de recursos terapéuticos en condiciones de escasez...

Traducción en progreso no oficial de las guías éticas de uso monitoreado de emergencia de intervenciones experimentales fuera de investigación (MEURI) desarrolladas por la Organización Mundial de la Salud. Palabras clave: MEURI, ética médica, práctica no validada, COVID-19, uso compasivo, hidroxicloroquina, plasma, BCG, uso fuera de prospecto ,...

he ideal exercise of Castellanos et al. asks IRB members to accept or deny a researchers’ request for disclosing genes associated with breast-ovarian cancer, a potential clinically significant finding (CSF), to a subgroup of 1500 research participants of a research database of 300,000 subjects. Here, we defend that researchers are under a rational...

A significant part of the literature on innovative practice in medicine relates to seizing opportunities and curbing harms for patients in desperate situations. Unfortunately, the term innovation has multiple meanings and a rich rhetorical flourish that adds confusion and misunderstanding to an already difficult debate. This paper aims to enhance t...

Integridad se dice de muchas maneras. En este trabajo, reconstruiremos tres sentidos de integridad en la investigación científica (reglas, virtudes y valores) que se encuentran en la literatura reciente. Al respecto, partiremos de la hipótesis de que contar con un concepto claro de integridad y buena conducta en investigación puede fomentar su uso...

Innovative practice usually relates to seizing opportunities and curbing harms for patients in desperate situations and the ethical dilemmas around it. Sadly, the term innovation has multiple meanings, adding confusion and misunderstanding to an already difficult debate. This presentation aims to enhance the definition of innovative practice in two...

The term “innovation” or “innovative care” has recently gained attention in the context of the use of novel and not yet fully validated medical interventions and technologies. Most notably, there have been various incidences of medical activities insufficiently validated for its regular use in healthcare that fall into this category, such as stem c...

The term "innovation" or "innovative care" has recently gained attention in the context of the use of novel and not yet fully validated medical interventions and technologies. Most notably, there have been various incidences of medical activities insufficiently validated for its regular use in healthcare that fall into this category, such as stem c...

This chapter analyses and develops the concept as well as the ethics of "clinical innovation" in the context of the emerging field of individualized approaches in medicine. We argue for clinical innovation as an alternative approach to clinical research in the context of the application of new and yet untested interventions. Even though clinical in...

The activity of innovative practice relates to seizing opportunities now for patients in desperate situations and the ethical dilemmas around it. Sadly, the term innovation has multiple meanings, adding confusion and misunderstanding to an already difficult debate. This paper aims to enhance the definition of innovative practice in two ways. Fist,...

In “An International Study of Research Misconduct Policies”, Resnik et al. inquire about national policies on misconduct. As the authors initially argue, research misconduct is an international concern. Therefore, it is very important to know the policies that countries have in relation to misconduct. Is there a classification of what constitutes m...

This chapter analyzes and develops the concept and ethics of "clinical innovation" in the context of the emerging field of individualized approaches in medicine. We argue for clinical innovation as an alternative approach to clinical research in the context of the application of new and yet untested interventions. Even though clinical innovation ap...

El Foro Global de Bioética en Investigación (GFBR por sus siglas en inglés) se reunió el 3 y 4 de noviembre en Buenos Aires, Argentina, con el objetivo de discutir la ética de la investigación con mujeres embarazadas. El GFBR es una plataforma mundial que congrega a actores clave con el objetivo de promover la investigación realizada de manera étic...

El Foro Global de Bioética en Investigación (GFBR por sus siglas en inglés) se reunió el 3 y 4 de noviembre en Buenos Aires, Argentina, con el objetivo de discutir la ética de la investigación con mujeres embarazadas. El GFBR es una plataforma mundial que congrega a actores clave con el objetivo de promover la investigación realizada de manera étic...

A commentary on “Models of Consent to Return of Incidental Findings in Genomic Research,” by Paul S. Appelbaum, Erik Parens, Cameron R. Waldman, Robert Klitzman, Abby Fyer, Josue Martinez, W. Nicholson Price II, and Wendy K. Chung, in the July-August 2014 issue.

The problem of transitioning research participants when the study is concluded to the appropriate health care is a global problem. The publication of a new version of the Declaration of Helsinki and its public discussion is a great opportunity to rethink this problem. According to my interpretation, the Declaration of Helsinki 2013 identifies two d...

Este trabajo revisa críticamente el modelo de evaluación de las investigaciones científicas para las sociedades democráticas defendido por Philip Kitcher. El "enfoque de las verdades significativas" propone una alternativa viable a dos imágenes clásicas de la ciencia: la de los "detractores" que creen que la ciencia siempre sirve a los intereses de...