Corrigendum Research priority-setting is an ethics exercise: lessons from the Global Forum on Bioethics in Research for the Region of the Americas / Corrigendum La priorización de la investigación es un ejercicio ético: lecciones del Foro Global de Bioética en la Investigación para la Región de las Américas / Corrigendum à Priorização da pesquisa é um exercício ético: lições do Fórum Global de Bioética em Pesquisa para a Região das Américas

The Pan American Journal of Public Health draws readers' attention to an error in the following article, pointed out by the authors: Saenz C, Carracedo S, Caballero C, Hurtado C, Leite Ribeiro A, Luna F, et al. Research priority-setting is an ethics exercise: lessons from the Global Forum on Bioethics in Research for the Region of the Americas. Rev Panam Salud Publica. 2024;48:e32. https://doi.org/10.26633/RPSP.2024.32 In article published on March 2024, reference 2 appears as follows: Global Forum on Bioethics in Research. GFBR 2023 Key- note presentation [Internet video]. Youtube. 2024 Feb 01 [cited 2024 Feb 13]. Available from: https://www.youtube.com/ watch?v=HlPgN6n6i8M The correct way to reference 2 is: Millum J. Ethics of health research priority setting [video]. Uploaded by Global Forum on Bioethics in Research, 1 February 2024. [Accessed on 13 February 2024] Available from: https://www.youtube.com/ watch?v=HlPgN6n6i8M.

Corrigendum La priorización de la investigación es un ejercicio ético: lecciones del Foro Global de Bioética en la Investigación para la Región de las Américas / Corrigendum Research priority-setting is an ethics exercise: lessons from the Global Forum on Bioethics in Research for the Region of the Americas / Corrigendum à Priorização da pesquisa é um exercício ético: lições do Fórum Global de Bioética em Pesquisa para a Região das Américas

La Revista Panamericana de Salud Pública llama la atención de los lectores sobre un error en el siguiente artículo, señalado por los autores: Saenz C, Carracedo S, Caballero C, Hurtado C, Leite Ribeiro A, Luna F, et al. La priorización de la investigación es un ejercicio ético: lecciones del Foro Global de Bioética en la Investigación para la Región de las Américas. Rev Panam Salud Publica. 2024;48:e26. https://doi.org/10.26633/RPSP.2024.26 En el artículo publicado en marzo 2024, la referencia 2 aparece de la siguiente manera: Global Forum on Bioethics in Research. GFBR 2023 Keynote presentation [video en internet]. Youtube. 1 de febrero de 2024 [citado 13 de febrero de 2024]. Disponible en: https://www.youtube.com/watch?v=HlPgN6n6i8M La forma correcta para la referencia 2 debe ser: Millum J. Ethics of health research priority setting [video]. Subido por Global Forum on Bioethics in Research, 1 de febrero de 2024. [citado 13 de febrero de 2024] Disponible en: https://www.youtube.com/ watch?v=HlPgN6n6i8M

Salud digital en América Latina: legislación actual y aspectos éticos / Digital health in Latin America: current legislation and ethical aspects / Saúde digital na América Latina: legislação atual e aspectos éticos

[RESUMEN]. Objetivo. Describir la legislación vigente respecto a historia clínica electrónica (HCE) y telesalud de los países latinoamericanos y analizar el tratamiento de la confidencialidad y el secreto profesional. Métodos. Entre marzo y septiembre de 2022, se realizó un relevamiento de la reglamentación vigente en los 21 países latinoamericanos en estudio, en dos niveles: i) la existencia de legislación respecto a la HCE y la telesalud, y ii) el tratamiento de la confidencialidad y el secreto profesional en la HCE y la telesalud. Se con- feccionó una ficha de extracción de datos por país. Se recolectaron datos a partir de fuentes on-line oficiales. Se analizó cualitativamente la información y se sintetizó en forma de tablas cuando fue posible. Resultados. El uso de la HCE está reglamentado legalmente en 16 países. Para el caso de telesalud, son 19 países los que cuentan con legislación en referencia a esta herramienta. Todos los países analizados resguardan la confidencialidad y el secreto profesional a través de reglamentaciones. Sin embargo, en el contexto de telesalud se mencionan en 11 países, en tanto en el contexto de la HCE, solo en 9 países. Conclusiones. Desde el inicio del segundo milenio América Latina ha avanzado respecto a la legislación de herramientas digitales en la atención en salud como la HCE y la telesalud. Se observa a su vez un interés por las cuestiones éticas relacionadas con el uso de la HCE y la telesalud, en particular de la confidencialidad y secreto profesional, aunque dichos aspectos deben ser fortalecidos en la salud digital.

[ABSTRACT]. Objectives. Describe the current legislation on electronic medical records (EMR) and telehealth in Latin Ame- rican countries and analyze the treatment of confidentiality and professional secrecy. Methods. Between March and September 2022, a survey of the regulations in force in 21 Latin American countries was conducted at two levels: the existence of legislation on EMR and telehealth, and the treatment of confidentiality and professional secrecy in EMR and telehealth. A data extraction form was prepared for each country. Data were collected from official on-line sources. The information was analyzed qualitatively and synthesized in tables when possible. Results. The use of EMR is legally regulated in 16 countries. Nineteen countries have legislation on telehealth. All the countries analyzed safeguard confidentiality and professional secrecy through regulations. However, confidentiality and professional secrecy are mentioned in 11 countries in the context of telehealth, and in only nine countries in the context of EMR. Conclusions. Since the start of this century, Latin America has made progress in the legislation of digital tools for health care, such as EMR and telehealth. There is also interest in ethical issues related to the use of EMR and telehealth, particularly confidentiality and professional secrecy, aspects that should be strengthened in digital health.

[RESUMO]. Objetivo. Descrever a legislação vigente sobre prontuários eletrônicos e telessaúde nos países da América Latina e analisar o tratamento da confidencialidade e do sigilo profissional. Métodos. Entre março e setembro de 2022, realizou-se um levantamento sobre a regulamentação vigente nos 21 países latino-americanos incluídos no estudo, em dois níveis: i) existência de legislação sobre prontuários eletrônicos e telessaúde; e ii) tratamento da confidencialidade e do sigilo profissional em prontuários eletrônicos e telessaúde. Uma planilha para extração de dados foi elaborada para cada país. Os dados foram coletados de fontes oficiais disponíveis on-line. Foi realizada uma análise qualitativa das informações, que foram resumidas em tabelas, quando possível. Resultados. O uso dos prontuários eletrônicos é legalmente regulamentado em 16 países. Quanto à telessaúde, 19 países têm legislação sobre essa ferramenta. Todos os países analisados protegem a confidencialidade e o sigilo profissional por meio de regulamentação. No entanto, no contexto da telessaúde, eles são mencionados em 11 países; já no contexto dos prontuários eletrônicos, em apenas 9 países. Conclusões. Desde o início dos anos 2000, a América Latina vem avançando em relação à legislação sobre ferramentas digitais na atenção à saúde, como prontuários eletrônicos e telessaúde. Há também interesse nas questões éticas relacionadas ao uso de prontuários eletrônicos e telessaúde, especialmente em relação à confidencialidade e ao sigilo profissional, embora esses aspectos precisem ser reforçados na saúde digital.

Research priority-setting is an ethics exercise: lessons from the Global Forum on Bioethics in Research for the Region of the Americas

Following the 2023 meeting of the Global Forum on Bioethics in Research (GFBR), this letter to the editor makes a call to consider health research priority-setting as an ethical exercise in Latin America and the Caribbean. This implies that research priority-setting processes are not limited to a matter of procedures, but rather include an explicit discussion of the substantive ethical criteria that guide prioritization.

La priorización de la investigación es un ejercicio ético: lecciones del Foro Global de Bioética en la Investigación para la Región de las Américas

A raíz de la reunión del 2023 del Foro Global de Bioética en la Investigación (GFBR por su sigla en inglés), esta carta al editor hace un llamado a considerar la priorización de la investigación en salud como un ejercicio ético en América Latina y el Caribe. Ello implica que los procesos de priorización de la investigación no se limiten a cuestiones procedimentales, sino que incluyan una discusión explícita sobre los criterios éticos sustantivos que guían la priorización.

Ethical research when abortion access is legally restricted.

Risks and benefits of some clinical research may be altered.

Charity or empowerment? The role of COVAX for low and middle-income countries.

What has the past reaction to the COVID-19 pandemic taught us? We have seen that many low and middle-income countries (LMICs) still lack access to vaccines, and it seems little progress has been made in the last few months and year. This article discusses whether the current strategies, most notably, vaccine donations by the international community and the COVID-19 global access facility COVAX, offer meaningful solutions to tackle the problem. At the centre of our analysis, we compare the concepts of "donations" and "charity" with "vaccine equity" and the "empowerment" of poorer countries. We suggest that the achievement of fair global vaccine production requires that our global approach is supportive of the idea of empowerment. We, therefore, need structural reforms, which would most importantly include capacity building, to positively impact this goal and to take the interests of the global poor seriously.

Vulnerability in practice: Peeling back the layers, avoiding triggers, and preventing cascading effects.

The concept of vulnerability is widely used in bioethics, particularly in research ethics and public health ethics. The traditional approach construes vulnerability as inherent in individuals or the groups to which they belong and views vulnerability as requiring special protections. Florencia Luna and other bioethicists continue to challenge traditional ways of conceptualizing and applying the term. Luna began proposing a layered approach to this concept and recently extended this proposal to offer two new concepts to analyze the concept of vulnerability, namely understanding external conditions that trigger vulnerability and layers of vulnerability with cascading effects. Luna's conception of vulnerability is useful, which we demonstrate by applying her layered view and the new analyses in multiple contexts. We begin by outlining Luna's view and we use vignettes from healthcare involving transgender patients, the care of patients in psychiatric contexts, and research involving prisoners to illustrate how each part of Luna's concept elucidates important moral issues.

On the Ethics of Vaccine Nationalism: The Case for the Fair Priority for Residents Framework.

COVID-19 vaccines are likely to be scarce for years to come. Many countries, from India to the U.K., have demonstrated vaccine nationalism. What are the ethical limits to this vaccine nationalism? Neither extreme nationalism nor extreme cosmopolitanism is ethically justifiable. Instead, we propose the fair priority for residents (FPR) framework, in which governments can retain COVID-19 vaccine doses for their residents only to the extent that they are needed to maintain a noncrisis level of mortality while they are implementing reasonable public health interventions. Practically, a noncrisis level of mortality is that experienced during a bad influenza season, which society considers an acceptable background risk. Governments take action to limit mortality from influenza, but there is no emergency that includes severe lockdowns. This "flu-risk standard" is a nonarbitrary and generally accepted heuristic. Mortality above the flu-risk standard justifies greater governmental interventions, including retaining vaccines for a country's own citizens over global need. The precise level of vaccination needed to meet the flu-risk standard will depend upon empirical factors related to the pandemic. This links the ethical principles to the scientific data emerging from the emergency. Thus, the FPR framework recognizes that governments should prioritize procuring vaccines for their country when doing so is necessary to reduce mortality to noncrisis flu-like levels. But after that, a government is obligated to do its part to share vaccines to reduce risks of mortality for people in other countries. We consider and reject objections to the FPR framework based on a country: (1) having developed a vaccine, (2) raising taxes to pay for vaccine research and purchase, (3) wanting to eliminate economic and social burdens, and (4) being ineffective in combating COVID-19 through public health interventions.

Brief communication International cooperation in a non-ideal world: the example of COVAX.

The world witnessed one of the fasted responses in history to a new disease in terms of drug and vaccine development. However, despite the fact that safe and effective vaccines for COVID-19 were developed at a remarkable pace, international cooperation seems to have failed regarding the global equitable allocation of vaccines. This article explores challenges to international cooperation in global health and specifically to the fair allocation of vaccines at a global scale. We will present major obstacles to cooperative efforts and an interesting answer such as the COVAX facility, a cooperative redistribution scheme that has recently been launched by WHO, CEPI and Gavi. Considering COVAX a laudable and necessary first step to improve international cooperation in health, we nevertheless argue that the facility needs to identify key areas of potential improvement.

O mundo foi testemunha de uma das respostas mais rápidas da história a uma nova doença em termos de desenvolvimento de medicamentos e vacinas. No entanto, apesar do facto de que as vacinas seguras e eficazes para COVID-19 foram desenvolvidas a um ritmo notável, a cooperação internacional parece ter falhado no que diz respeito à distribuição global equitativa de vacinas. Este artigo explora os desafios para a cooperação internacional em matéria de saúde global e, especificamente, para a distribuição justa de vacinas à escala global. Apresentaremos os principais obstáculos aos esforços cooperativos e uma resposta interessante, como o mecanismo COVAX, um esquema de redistribuição cooperativa que foi lançado recentemente pela OMS, CEPI e Gavi. Considerando o COVAX como um primeiro passo louvável e necessário para melhorar a cooperação internacional em saúde, argumentamos que o mecanismo precisa de identificar as áreas de potencial melhoria.

El mundo ha sido testigo de una de las respuestas más rápidas a una nueva enfermedad, en términos de desarrollo de drogas y vacunas. Sin embargo, pese al hecho de que se han desarrollado vacunas seguras y efectivas para el COVID-19 a un paso impresionante; la cooperación internacional en relación al acceso equitativo a las vacunas parece haber fallado. Este artículo explora los desafíos a la cooperación internacional que se plantean en relación a la salud global y, específicamente, a la distribución justa de vacunas a escala global. Presentaremos algunos obstáculos a los esfuerzos cooperativos, así como también una respuesta interesante como lo es la del mecanismo COVAX, un sistema cooperativo de redistribución que ha sido recientemente introducido por la OMS, CEPI y GAVI. Aunque consideramos a COVAX un primer paso meritorio y necesario para mejorar la cooperación internacional en salud; argumentamos que el mecanismo necesita identificar áreas de mejora.

International cooperation in a non-ideal world: the example of COVAX / Cooperação internacional num mundo não ideal: o exemplo do COVAX / Cooperación internacional en un mundo no ideal: el ejemplo de COVAX

The world witnessed one of the fasted responses in history to a new disease in terms of drug and vaccine development. However, despite the fact that safe and effective vaccines for COVID-19 were developed at a remarkable pace, international cooperation seems to have failed regarding the global equitable allocation of vaccines. This article explores challenges to international cooperation in global health and specifically to the fair allocation of vaccines at a global scale. We will present major obstacles to cooperative efforts and an interesting answer such as the COVAX facility, a cooperative redistribution scheme that has recently been launched by WHO, CEPI and Gavi. Considering COVAX a laudable and necessary first step to improve international cooperation in health, we nevertheless argue that the facility needs to identify key areas of potential improvement.

O mundo foi testemunha de uma das respostas mais rápidas da história a uma nova doença em termos de desenvolvimento de medicamentos e vacinas. No entanto, apesar do facto de que as vacinas seguras e eficazes para COVID-19 foram desenvolvidas a um ritmo notável, a cooperação internacional parece ter falhado no que diz respeito à distribuição global equitativa de vacinas. Este artigo explora os desafios para a cooperação internacional em matéria de saúde global e, especificamente, para a distribuição justa de vacinas à escala global. Apresentaremos os principais obstáculos aos esforços cooperativos e uma resposta interessante, como o mecanismo COVAX, um esquema de redistribuição cooperativa que foi lançado recentemente pela OMS, CEPI e Gavi. Considerando o COVAX como um primeiro passo louvável e necessário para melhorar a cooperação internacional em saúde, argumentamos que o mecanismo precisa de identificar as áreas de potencial melhoria

El mundo ha sido testigo de una de las respuestas más rápidas a una nueva enfermedad, en términos de desarrollo de drogas y vacunas. Sin embargo, pese al hecho de que se han desarrollado vacunas seguras y efectivas para el COVID-19 a un pasoimpresionante; la cooperación internacional en relación alacceso equitativo a las vacunas parece haber fallado. Este artículo explora los desafíos a la cooperación internacional que se plantean en relación ala salud global y, específicamente, a la distribución justa de vacunas a escala global. Presentaremos algunos obstáculos a los esfuerzos cooperativos,así como también una respuesta interesante como lo es la del mecanismo COVAX, un sistema cooperativo de redistribución que ha sido recientemente introducido por la OMS, CEPI y GAVI. Aunque consideramos a COVAX un primer paso meritorio y necesario para mejorar la cooperación internacional en salud; argumentamos que el mecanismo necesita identificar áreas de mejora.

HIV prevention research and COVID-19: putting ethics guidance to the test.

BACKGROUND: Critical public health measures implemented to mitigate the spread of the novel coronavirus disease (COVID-19) pandemic have disrupted health research worldwide, including HIV prevention research. While general guidance has been issued for the responsible conduct of research in these challenging circumstances, the contours of the dueling COVID-19 and HIV/AIDS pandemics raise some critical ethical issues for HIV prevention research. In this paper, we use the recently updated HIV Prevention Trials Network (HPTN) Ethics Guidance Document (EGD) to situate and analyze key ethical challenges related to the conduct of HIV prevention research during the COVID-19 pandemic as well as identify potential areas for refinement of the guidance document based on this unprecedented state of affairs. MAIN BODY: Necessary actions taken for HIV prevention research studies due to the COVID-19 pandemic involve an array of ethical issues including those related to: (1) risk mitigation; (2) behavior change; (3) compounding vulnerability; (4) community engagement; (5) trial reopening; and 6) shifting research priorities. CONCLUSIONS: In the context of the dueling HIV and COVID-19 global pandemics, research teams and sponsors must be nimble in responding to the rapidly changing environment by being sensitive to the associated ethical issues. The HTPN EGD provides a rich set of tools to help identify, analyze and address many of these issues. At the same time, future refinements of the HPTN EGD and other research ethics guidance could be strengthened by providing explicit advice regarding the ethical issues associated with disrupted research and the reopening of studies. In addition, additional consideration should be given to appropriately balancing domains of risk (e.g., physical versus social), addressing the vulnerability of research staff and community partners, and responding to un-anticipatable ancillary care needs of participants and communities. Appropriately addressing these issues will necessitate conceptual work, which would benefit from the careful documentation of the actual ethical issues encountered in research, the strategies implemented to overcome them, and their success in doing so. Throughout all of these efforts, it is critical to remember that the HIV pandemic not be forgotten in the rush to deal with the COVID-19 pandemic.