Sarah Carracedo’s research while affiliated with Organización Panamericana de la Salud and other places

RESUMEN Los estándares éticos internacionales para la investigación con personas que tienen disminuida su capacidad para tomar decisiones permiten delegar la decisión sobre la participación en una investigación en un representante que puede actuar como un sustituto. Esto, sin embargo, ha sido cuestionado por la Convención sobre los derechos de las personas con discapacidad (CDPD), que establece que toda persona con discapacidad, cualquiera sea su condición mental y neurológica, siempre tiene capacidad jurídica universal para tomar sus decisiones. La incompatibilidad entre los estándares éticos y la CDPD es evidente e impacta en la realización de investigaciones con personas con discapacidad mental, tan necesaria para la mejora de su salud y bienestar. El presente artículo plantea una propuesta que buscar conciliar la CDPD con los estándares éticos para la investigación en lo que respecta a los procesos de consentimiento informado y provee recomendaciones prácticas, sobre todo para los países de América Latina que aún tienen el desafío de implementar la CDPD en el ámbito de la investigación.

This Viewpoint explores the 2024 update to the Declaration of Helsinki from the perspective of the Americas and how countries in this region can implement the Declaration’s guidance to ethically govern scientific health research.

The calls for health research to be collaborative are ubiquitous—even as part of a recent World Health Assembly resolution on clinical trials—yet the arguments in support of collaborative research have been taken for granted and are absent in the literature. This article provides three arguments to justify why health research ought to be collaborative and discusses trade-offs to be considered among the ethical values guiding each argument.

In the context of a public health emergency it is imperative to conduct research studies that will produce evidence rapidly while upholding ethical standards. The Ebola and Zika outbreaks highlighted the importance of devising agile processes for ethics review in emergencies, and international research ethics guidelines stress the duty to depart from standard processes for ethics review in emergency circumstances. However, before the COVID-19 pandemic it was not entirely clear what emergency procedures should look like. An additional challenge is that while the same substantive ethical standards apply in emergency and non-emergency settings, deciding what these standards entail in the specific circumstances of a pandemic may be difficult. During the COVID-19 pandemic, challenges included identifying thresholds of social and scientific value, along with duties towards research participants, given the absence of therapeutic options; assessing continually changing risk–benefit profiles of studies, given rapidly emerging new evidence; developing appropriate informed consent processes, given lockdown scenarios; and even addressing the ethics of offering unproven interventions outside research settings. Additional issues raised during epidemics include devising feasible and meaningful community engagement strategies, mechanisms to ensure fairness in the distribution of the benefits that may result from research, and equitable and effective data-sharing plans that will inform pandemic response. Learning from these procedural and substantive challenges encountered in the ethics review of COVID-19 research is important for enhancing ethics preparedness for future emergencies. It can also potentially contribute to improving the ethics review of research in non-emergency circumstances. The seven cases in this chapter highlight ethical issues associated with ethics approval of multi-centre studies in pandemics, the need for careful consideration of the social and scientific value of research and challenges encountered when interventions are being transitioned from research to rollout, and issues that can arise when existing regulations and policies may limit capacities to appropriately adapt research to pandemic contexts.

En esta mesa redonda propuesta por el Comité Nacional de Bioética de la Investigación (CNBI) de Panamá, se contó con la participación de las siguientes expertas nacionales e internacionales, Sarah Carracedo quien se enfocó en las Pautas éticas internacionales para el uso ético de muestras y datos en investigación, Ana Palmero quien habló sobre Repositorios y Biobancos de muestras biológicas en investigación, en tanto que Jesica Candanedo abordó los aspectos regulatorios de la recolección y uso de muestras y datos en la investigación para la salud y Dora Sánchez- Pothá desarrolló los aspectos relativos a la confidencialidad y la protección de datos de fuentes secundaria en investigación.La recolección y uso ético de muestras y datos para investigaciones futuras, es un tema que requiere ser analizado y regulado, a fin de que se respeten los derechos de los participantes , sin ir en detrimento de las necesidades de investigación, el uso racional de los recursos y la validez científica de la investigación futura. La reutilización de muestras o datos de una investigación previa, representa para los investigadores una ventaja desde el punto de vista económico y de tiempo, condición ante la cual los comités de bioética tienen la responsabilidad de la revisión del proceso de consentimiento informado para preservar los derechos humanos de los participantes y su dignidad, en una investigación futura cuyo objetivo es diferentes al previsto originalmente. Para garantizar que los riesgos que esta práctica conlleva sean mínimos en Panamá, en todos los estudios que así lo consideren necesario, se ha considerado incorporar en el proceso de consentimiento informado una autorización anticipada por parte de los participantes para el uso de sus muestras o datos, en futuros estudios con previa aprobación de un comité de bioética de la investigación acreditado. Este tema en el contexto nacional e internacional incluye también investigaciones que usen datos recolectados con una finalidad distinta a la de investigación, como por ejemplo, los datos de los expedientes clínicos o los de salud pública.

To strengthen research ethics systemically, the Pan American Health Organization (PAHO) devised a strategy that includes objectives and indicators to address core components of research ethics systems. We assessed 22 countries in Latin America and the Caribbean using these indicators. Most countries have adopted legal instruments to govern research with human participants and have implemented national bodies tasked with the oversight of research ethics committees. However, performance with regard to ethics training policies and clinical trial registration was less advanced, and efforts to adopt policies on responsible conduct of research and accelerated ethics review of emergency research did not meet the PAHO objectives in most countries. We discuss the pending challenges and provide recommendations aimed at helping countries from Latin America and the Caribbean to achieve the indicators, and, more generally, to strengthen research ethics with a systemic approach.

Background Research has been an essential part of the COVID-19 pandemic response, including in Latin American (LA) countries. However, implementing research in emergency settings poses the challenge of producing valuable knowledge rapidly while upholding research ethical standards. Research ethics committees (RECs) therefore must conduct timely and rigorous ethics reviews and oversight of COVID-19 research. In the LA region, there is limited knowledge on how countries have responded to this need. To address this gap, the objective of our project is to explore if LA countries developed policies to streamline ethics review and oversight of research in response to the pandemic while ensuring its adherence to ethical standards, and to analyze to what extent these governance frameworks are in accordance with international guidance. Methods We conducted a descriptive and exploratory study assessing the COVID-19 research ethics governance frameworks of 19 LA countries, considering 4 dimensions based on international COVID-19 ethics guidance documents: (i) ethics review organizational model adopted, (ii) measures to coordinate between RECs and other research stakeholders, (iii) operational guidance for RECs, and (iv) key ethical issues for review and oversight of COVID-19 research. Results 10 out of 19 LA countries have some policy to streamline ethics review of COVID-19 research. Of these countries only 6 issued comprehensive documents following international guidance that contemplate strategies with recommendations for concrete actions for a timely and rigorous review. Conclusion LA countries adopted partial strategies and operational guidance that may demonstrate a lack of a comprehensive view of research ethics for the review and oversight of COVID-19 research. Continuing efforts should be directed to strengthen LA countries' research capacity to respond timely and ethically to future health emergencies. Past lessons and the ones from this pandemic should be the basis to develop international standards and operational guidelines for ethics review and oversight of any research for public health emergencies.

Background Research has been an essential part of the COVID-19 pandemic response, including in Latin American (LA) countries. However, implementing research in emergency settings poses the challenge of producing valuable knowledge rapidly while upholding research ethical standards. Research ethics committees (RECs) therefore must conduct timely and rigorous ethics reviews and oversight of COVID-19 research. In the LA region, there is limited knowledge on how countries have responded to this need. To address this gap, the objective of our project is to explore if LA countries developed policies to streamline ethics review and oversight of research in response to the pandemic while ensuring its adherence to ethical standards, and to analyze to what extent these governance frameworks are in accordance with international guidance. Methods We conducted a descriptive and exploratory study assessing the COVID-19 research ethics governance frameworks of 19 LA countries, considering 4 dimensions based on international COVID-19 ethics guidance documents: (i) ethics review organizational model adopted, (ii) measures to coordinate between RECs and other research stakeholders, (iii) operational guidance for RECs, and (iv) key ethical issues for review and oversight of COVID-19 research. Results 10 out of 19 LA countries have some policy to streamline ethics review of COVID-19 research. Of these countries only 6 issued comprehensive documents following international guidance that contemplated strategies with recommendations for concrete actions for a timely and rigorous review. Conclusion LA countries adopted partial strategies and operational guidance that may demonstrate a lack of a comprehensive view of research ethics for the review and oversight of COVID-19 research. Continuing efforts should be directed to strengthen LA countries' research capacity to respond timely and ethically to future health emergencies. Past lessons and the ones from this pandemic should be the basis to develop international standards and operational guidelines for ethics review and oversight of any research for public health emergencies of international concern.