Carla Saenz’s research while affiliated with Organización Panamericana de la Salud and other places

What is this page?


This page lists works of an author who doesn't have a ResearchGate profile or hasn't added the works to their profile yet. It is automatically generated from public (personal) data to further our legitimate goal of comprehensive and accurate scientific recordkeeping. If you are this author and want this page removed, please let us know.

Publications (50)


The Revision of the Declaration of Helsinki Viewed From the Americas—Paving the Way to Better Research
  • Article

October 2024

·

6 Reads

·

2 Citations

JAMA The Journal of the American Medical Association

Carla Saenz

·

Sarah Carracedo

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.


Advancing collaborative research for health: why does collaboration matter?
  • Literature Review
  • Full-text available

September 2024

·

51 Reads

·

3 Citations

Carla Saenz

·

Timothy M Krahn

·

·

[...]

·

Ludovic Reveiz

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.

Download

Ethics Review Challenges

April 2024

·

70 Reads

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.




Preparing ethical review systems for emergencies: next steps

October 2023

·

107 Reads

·

3 Citations

BMC Medical Ethics

Ethical review systems need to build on their experiences of COVID-19 research to enhance their preparedness for future pandemics. Recommendations from representatives from over twenty countries include: improving relationships across the research ecosystem; demonstrating willingness to reform and adapt systems and processes; and making the case robustly for better resourcing.


Priority Tiers for Allocating Monkeypox Vaccines.
Equitable global allocation of monkeypox vaccines

July 2023

·

44 Reads

·

3 Citations

Vaccine

With the world grappling with continued spread of monkeypox internationally, vaccines play a crucial role in mitigating the harms from infection and preventing spread. However, countries with the greatest need - particularly historically endemic countries with the highest monkeypox case-fatality rates - are not able to acquire scarce vaccines. This is unjust, and requires rectification through equitable allocation of vaccines globally. We propose applying the Fair Priority Model for such allocation, which emphasizes three key principles: 1) preventing harm; 2) prioritizing the disadvantaged; and 3) treating people with equal moral concern. Post-exposure prophylaxis (PEPV) has the most potential to mitigate harm, and so ensuring countries have sufficient supply for PEPV should be the first priority. And historically endemic countries, which face disadvantages that compound potential harms from monkeypox, should be the first recipients of such vaccines. Once sufficient supply is allocated for countries to apply PEPV, global allocation could move on to pre-exposure prophylaxis (PrEP), again prioritizing historically endemic countries first before distribution to the rest of the global community, based on projected number of cases and vulnerability to harm.


Fair domestic allocation of monkeypox virus countermeasures

May 2023

·

18 Reads

·

4 Citations

The Lancet Public Health

Countermeasures for mpox (formerly known as monkeypox), primarily vaccines, have been in limited supply in many countries during outbreaks. Equitable allocation of scarce resources during public health emergencies is a complex challenge. Identifying the objectives and core values for the allocation of mpox countermeasures, using those values to provide guidance for priority groups and prioritisation tiers, and optimising allocation implementation are important. The fundamental values for the allocation of mpox countermeasures are: preventing death and illness; reducing the association between death or illness and unjust disparities; prioritising those who prevent harm or mitigate disparities; recognising contributions to combating an outbreak; and treating similar individuals similarly. Ethically and equitably marshalling available countermeasures requires articulating these fundamental objectives, identifying priority tiers, and recognising trade-offs between prioritising the people at the highest risk of infection and the people at the highest risk of harm if infected. These five values can provide guidance on preferable priority categories for a more ethically sound response and suggest methods for optimising allocation of countermeasures for mpox and other diseases for which countermeasures are in short supply. Properly marshalling available countermeasures will be crucial for future effective and equitable national responses to outbreaks.




Citations (36)


... Evidences show that collaborative research, especially in health, is often more efficient and impactful. To give an example during pandemic due to collaboration the process of vaccine development and delivery was expedited (Saenz et al., 2024). ...

Reference:

Bibliometric analysis of research in ethical concerns and dilemmas of digital mental health care in the last two decades
Advancing collaborative research for health: why does collaboration matter?

... Este debate involucra consideraciones fundamentales de equidad y justicia en la distribución de recursos y esfuerzos en salud pública. (30) La exigencia moral sugiere que los procedimientos realizados, como las investigaciones ejecutadas, deben estar estrechamente relacionados con los resultados obtenidos, de manera que estos se traduzcan en un mayor acceso a la atención sanitaria, sin embargo, esta relación puede verse comprometida cuando los beneficios públicos generados en las investigaciones que son financiadas con fondos públicos, se destinan al cuidado de la salud, que en países con menores recursos favorecen principalmente poblaciones más aventajadas, lo que se aleja del principio de justicia. (7) Lo mencionado, evidencia la inexistencia de una distribución justa de la carga de la investigación, que restringe a otros grupos poblacionales expuestos como la población latina, manteniéndolos en el anonimato e imposibilitando la opción de generar el conocimiento necesario para proteger y promover la salud de ellos. ...

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

Revista Panamericana de Salud Pública

... Different scholars have been reflecting on how to design, conduct and report research that addresses public health emergencies in a timely manner (Abeysinghe and Leppold, 2023;Ambrogi et al., 2023;London et al., 2018;Lysaght et al., 2022;O'Mathúna, 2015;O'Mathúna and Upadhaya, 2022), while being ethically, socially and scientifically sound (Canario Guzmán et al., 2017;Folayan et al., 2016;Saxena et al., 2021;Singh et al., 2022). Furthermore, different research and policy papers have looked at how research ethics committees (RECs) can carry out sound and meaningful reviews in emergency contexts (Alirol et al., 2017;Bain et al., 2018;Ekmekci et al., 2023;IJkema et al., 2021;Maketa et al., 2022;Palmero et al., 2021;Saxena et al., 2019;Schopper et al., 2017;Tansey et al., 2017), to ensure the protection of the research participants and of their communities, without delaying relevant research (Burgess et al., 2023;De Crop et al., 2016;Faust et al., 2021;Ramesh et al., 2022;Sisa et al., 2021;Wright et al., 2023). Our paper will focus on an element that seems to be recurrent in the literature on research ethics and research ethics review in (public health) emergencies, namely, the role of RECs in promoting meaningful engagement with the community. ...

Preparing ethical review systems for emergencies: next steps

BMC Medical Ethics

... This practice not only limits the availability of vaccines for lower-income nations but also reinforces inequities, as those countries cannot compete financially in the vaccine market. A more equitable approach would involve manufacturers setting aside a portion of their vaccine supply for global distribution, ensuring that all countries have access regardless of their economic status [55]. ...

Equitable global allocation of monkeypox vaccines

Vaccine

... In the 1970s, Japan developed a highly attenuated live vaccine, LC16m8, at the Chiba Serum Institute, aiming to replace first-generation vaccines such as Lister and Dryvax. The virus in LC16m8 is attenuated due to the lack of the B5R envelope protein gene, and its replication ability in vaccine recipients is limited (23). LC16m8 showed no severe adverse reactions in 100,000 infants and was proven to have the same immunogenicity as its parent strain. ...

Fair domestic allocation of monkeypox virus countermeasures
  • Citing Article
  • May 2023

The Lancet Public Health

... The Pan American Health Organization (PAHO) strategies emphasize resource allocation and capacity building for ethics committees. (5) The WDAD study highlighted the low participation of South American countries in delirium research, prompting questions about the means by which delirium awareness can be enhanced in the region. Implementing additional protocols, increasing knowledge on the disorder, and providing better tools for practice are urgently needed. ...

Research ethics systems in Latin America and the Caribbean: a systemic assessment using indicators

The Lancet Global Health

... Con 16 artículos publicados en ese año, el volumen de publicaciones casi cuadruplica el promedio general de la muestra (4.47 artículos por año). Aunque ninguno de los artículos de ese período aborda explícitamente el tema de la pandemia, es plausible pensar que el corpus analizado refleje una tendencia similar a la observada en otras áreas del conocimiento durante esos años: un aumento general en el volumen de publicaciones, posiblemente debido a una mayor disposición de tiempo para labores que requieren concentración y bajos niveles de interrupción (Chapman et al., 2023). ...

Mapeo de protocolos de investigación, publicaciones y colaboraciones sobre la COVID-19 en América Latina y el Caribe

Revista Panamericana de Salud Pública

... The WHO, in its aforementioned guidance, also mentions the need to have CHIM protocols reviewed by ethics committees with specific training, expertise and resources to conduct a rigorous and relevant review [2] and, where necessary, to call upon another independent ethics body (for pathogens carrying specific risks, for example). A speech at the recent workshop on ethical approval for Controlled Human Infectious Models (CHIM) clinical trial protocols in Brussels (30--31 May 2023) reported that in the United Kingdom, where a CHIM trial with SARS-COV 2 was authorised, the public authority considered that some ethics committees in the United Kingdom were already used to examining this type of protocol but that it was necessary to form a specific committee for the first trials with this new pathogen, given the public interest during a pandemic and the need to have a completely transparent process without any real or perceived conflict of interest [28]. ...

Ethics review of COVID-19 human challenge studies: a joint HRA/WHO workshop

Vaccine

... During the COVID-19 pandemic, the multinational pharmaceutical industries engaged in the production of vaccines only after having received the necessary state financial guarantees that ensured its future profitability. These guarantees included successive government subsidies and direct financial assistance, preorders of vaccines from national governments and international organizations, sufficient public funding for the research and development of new vaccines, and high vaccine prices per dose (Cross et al. 2021;Fortner 2022;Emanuel et al. 2021;Aksu Tanık 2022). Table 2 illustrates the guarantees and methods applied during the COVID-19 pandemic ensuring the profitability of the global pharmaceutical industry in its fight against COVID-19. ...

What are the obligations of pharmaceutical companies in a global health emergency?
  • Citing Article
  • August 2021

The Lancet

... At the same time, significant decreases were observed in El Salvador (-48%), Nicaragua (-29%), Colombia (-22%) and Peru (-6%). (2) The confirmatory test for the diagnosis of HIV, according to the World Health Organization (WHO), are the Immunoblot, Line Immunoassay (LIA) and Indirect Immunofluorescence (IFI) tests, within the screening tests are used 4th generation enzyme-linked immunosorbent assay (ELISA), the application of these diagnostic tests requires an optimal infrastructure, as well as appropriate equipment and reagents. (3) During the pandemic period, not only did COVID-19 disease generate a break in public health, but also various diseases such as HIV/AIDS that were not diagnosed, treated, or controlled. ...

El panorama de los ensayos clínicos sobre COVID-19 en América Latina y el Caribe: evaluación y desafíos

Revista Panamericana de Salud Pública