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Article ; Online: Consideraciones bioéticas sobre la relación médico-paciente para el uso del cannabis medicinal en Perú.

Carracedo, Sarah

Revista peruana de medicina experimental y salud publica

2019 Volume 36, Issue 2, Page(s) 334–340

Abstract: In November 2017, medical use of cannabis was decriminalized in Peru. The challenges are diverse and this article focuses on those challenges related to the doctor-patient relationship. Given the status quo of medicinal cannabis, the medical treatment ... ...

Title translation	Bioethical considerations in the physician-patient relationship for the use of medicinal cannabis in Peru.
Abstract	In November 2017, medical use of cannabis was decriminalized in Peru. The challenges are diverse and this article focuses on those challenges related to the doctor-patient relationship. Given the status quo of medicinal cannabis, the medical treatment protocol to be developed by the Ministry of Health must formulate clear conditions to guide the physicians' decision to prescribe cannabis without affecting their ethical obligations to promote good and cause no harm to their patients. This article develops three important considerations for prescribing medicinal cannabis. First, it recommends the registration and education of physicians who decide to prescribe medicinal cannabis. Secondly, it proposes general criteria specifying the cases in which the use of medicinal cannabis is appropriate and, finally, it establishes the need for a bona-fide doctor-patient relationship for the prescription of medicinal cannabis.
MeSH term(s)	Bioethical Issues ; Decision Making/ethics ; Humans ; Medical Marijuana/administration & dosage ; Peru ; Physician-Patient Relations/ethics ; Practice Patterns, Physicians'/ethics
Chemical Substances	Medical Marijuana
Language	Spanish
Publishing date	2019-08-22
Publishing country	Peru
Document type	Journal Article
ZDB-ID	2120092-0
ISSN	1726-4642 ; 1726-4634
ISSN (online)	1726-4642
ISSN	1726-4634
DOI	10.17843/rpmesp.2019.362.3293
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Consideraciones bioéticas sobre la relación médico-paciente para el uso del cannabis medicinal en Perú

Sarah Carracedo

Revista Peruana de Medicina Experimental y Salud Pública, Vol 36, Iss 2, Pp 334-

2019 Volume 40

Abstract: En noviembre de 2017 se despenalizó en el Perú el uso medicinal del cannabis. Los desafíos que ello plantea son diversos y el presente artículo se centra en los relativos a la relación médico-paciente. Dado el status quo del cannabis medicinal, es ... ...

Abstract	En noviembre de 2017 se despenalizó en el Perú el uso medicinal del cannabis. Los desafíos que ello plantea son diversos y el presente artículo se centra en los relativos a la relación médico-paciente. Dado el status quo del cannabis medicinal, es necesario que el protocolo de tratamiento médico que el Ministerio de Salud debe elaborar, formule condiciones claras que guíen la decisión de los médicos de prescribir cannabis sin que ello afecte sus obligaciones éticas de promover el bien y de no causar daño a sus pacientes. Este artículo desarrolla tres consideraciones importantes para la prescripción de cannabis medicinal. En primer lugar, recomienda el registro y educación de los médicos que deciden prescribir cannabis medicinal. En segundo lugar, propone criterios generales que indican los casos en los que el uso del cannabis medicinal es apropiado, y finalmente, establece la necesidad de que exista una relación médico-paciente bona-fide para la prescripción del cannabis medicinal.
Keywords	marihuana medicinal ; cannabis ; relaciones médico-paciente ; bioética ; Medicine ; R ; Medicine (General) ; R5-920
Language	Spanish
Publishing date	2019-06-01T00:00:00Z
Publisher	Instituto Nacional de Salud
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Research ethics systems in Latin America and the Caribbean: a systemic assessment using indicators.

Aguilera, Bernardo / Carracedo, Sarah / Saenz, Carla

The Lancet. Global health

2022 Volume 10, Issue 8, Page(s) e1204–e1208

Abstract: 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 ... ...

Abstract	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.
MeSH term(s)	Caribbean Region ; Ethics, Research ; Humans ; Latin America ; Pan American Health Organization
Language	English
Publishing date	2022-06-15
Publishing country	England
Document type	Journal Article ; Review ; Research Support, Non-U.S. Gov't ; Research Support, N.I.H., Intramural
ZDB-ID	2723488-5
ISSN	2214-109X ; 2214-109X
ISSN (online)	2214-109X
ISSN	2214-109X
DOI	10.1016/S2214-109X(22)00128-0
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Article ; Online: La regulación de los ensayos clínicos para la COVID-19 en el Perú.

Lope, Paula Cahuina / Carracedo, Sarah / Romani, Franco

Revista peruana de medicina experimental y salud publica

2021 Volume 38, Issue 1, Page(s) 171–177

Abstract: COVID-19 has affected the conduct of clinical trials worldwide. Once the health emergency began in Peru, the national government took measures to guarantee the conduct of COVID-19 clinical trials. A national research ethics committee was exclusively ... ...

Title translation	The regulation of COVID-19 clinical trials in Peru.
Abstract	COVID-19 has affected the conduct of clinical trials worldwide. Once the health emergency began in Peru, the national government took measures to guarantee the conduct of COVID-19 clinical trials. A national research ethics committee was exclusively established for COVID-19 clinical trials; and a regulatory framework was implemented to ensure the ethical and timely conduct of these studies. To december 31, 2020, the Peruvian National Health Institute authorized 29 clinical trials, of which 4 test vaccines. The mean and standard deviation of time authorization were 19.3 and 10.5 days, respectively. 58.6% (n= 17) were phase II clinical trials and 34.5% (n= 10) were phase III; 31.0% (n= 9) were sponsored by a Peruvian institution. The aim of the actions implemented was to promote COVID-19 research while responding to the health emergency needs without affecting the protection of participants or the rigor of the studies.
MeSH term(s)	COVID-19 ; Ethics Committees, Research ; Humans ; Peru ; SARS-CoV-2
Language	Spanish
Publishing date	2021-06-25
Publishing country	Peru
Document type	Journal Article
ZDB-ID	2120092-0
ISSN	1726-4642 ; 1726-4634
ISSN (online)	1726-4642
ISSN	1726-4634
DOI	10.17843/rpmesp.2021.381.6627
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Article ; Online: Governance frameworks for COVID-19 research ethics review and oversight in Latin America: an exploratory study.

Palmero, Ana / Carracedo, Sarah / Cabrera, Noelia / Bianchini, Alahí

BMC medical ethics

2021 Volume 22, Issue 1, Page(s) 147

Abstract: 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 ... ...

Abstract	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.
MeSH term(s)	COVID-19 ; Ethics Committees, Research ; Ethics, Research ; Humans ; Latin America ; Pandemics ; SARS-CoV-2
Language	English
Publishing date	2021-11-06
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2041552-7
ISSN	1472-6939 ; 1472-6939
ISSN (online)	1472-6939
ISSN	1472-6939
DOI	10.1186/s12910-021-00715-2
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Article ; Online: [No title information]

Saenz, Carla / Carracedo, Sarah / Caballero, Cristina / Hurtado, Cinthia / Leite Ribeiro, Andréa / Luna, Florencia / Ortiz, Zulma / Palmero, Ana / Peralta, Guímel / Ponce Testino, Ramón / Reveiz, Ludovic / Sisa, Iván

Revista panamericana de salud publica = Pan American journal of public health

2024 Volume 48, Page(s) e26

Title translation	La priorización de la investigación es un ejercicio ético: lecciones del Foro Global de Bioética en la Investigación para la Región de las Américas.
Language	Spanish
Publishing date	2024-03-08
Publishing country	United States
Document type	Journal Article
ZDB-ID	1376934-0
ISSN	1680-5348 ; 1020-4989
ISSN (online)	1680-5348
ISSN	1020-4989
DOI	10.26633/RPSP.2024.26
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Article ; Online: 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 publica = Pan American journal of public health

2024 Volume 48, Page(s) e32

Language	English
Publishing date	2024-03-08
Publishing country	United States
Document type	Journal Article
ZDB-ID	1376934-0
ISSN	1680-5348 ; 1020-4989
ISSN (online)	1680-5348
ISSN	1020-4989
DOI	10.26633/RPSP.2024.32
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Article ; Online: The regulation of COVID-19 clinical trials in Peru

Paula Cahuina Lope / Sarah Carracedo / Franco Romani

Revista Peruana de Medicina Experimental y Salud Pública, Vol 38, Iss 1, Pp 171-

2021 Volume 7

Abstract	COVID-19 has affected the conduct of clinical trials worldwide. Once the health emergency began in Peru, the national government took measures to guarantee the conduct of COVID-19 clinical trials. A national research ethics committee was exclusively established for COVID-19 clinical trials; and a regulatory framework was implemented to ensure the ethical and timely conduct of these studies. To december 31, 2020, the Peruvian National Health Institute authorized 29 clinical trials, of which 4 test vaccines. The mean and standard deviation of time authorization were 19.3 and 10.5 days, respectively. 58.6% (n= 17) were phase II clinical trials and 34.5% (n= 10) were phase III; 31.0% (n= 9) were sponsored by a Peruvian institution. The aim of the actions implemented was to promote COVID-19 research while responding to the health emergency needs without affecting the protection of participants or the rigor of the studies.
Keywords	covid-19 ; ensayos clínicos como asunto ; infecciones por coronavirus ; perú ; regulación gubernamental ; Medicine ; R ; Medicine (General) ; R5-920
Subject code	610
Language	Spanish
Publishing date	2021-03-01T00:00:00Z
Publisher	Instituto Nacional de Salud
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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

Carracedo, Sarah / Palmero, Ana / Neil, Marcie / Hasan-Granier, Anisa / Saenz, Carla / Reveiz, Ludovic

Revista panamericana de salud publica = Pan American journal of public health

2021 Volume 45, Page(s) e33

Abstract: A considerable number of clinical trials is being conducted globally in response to the COVID-19 pandemic, including in low- and middle-income countries such as those in the Latin America and Caribbean region (LAC). Yet, an abundance of studies does not ... ...

Title translation	The landscape of COVID-19 clinical trials in Latin America and the Caribbean: assessment and challenges.
Abstract	A considerable number of clinical trials is being conducted globally in response to the COVID-19 pandemic, including in low- and middle-income countries such as those in the Latin America and Caribbean region (LAC). Yet, an abundance of studies does not necessarily shorten the path to find safe and efficacious interventions for COVID-19. We analyze the trials for COVID-19 treatment and prevention that are registered from LAC countries in the International Clinical Trials Registry Platform, and identify a trend towards small repetitive non-rigorous studies that duplicate efforts and drain limited resources without producing meaningful conclusions on the safety and efficacy of the interventions being tested. We further assess the challenges to conducting scientifically sound and socially valuable research in the LAC region in order to inform recommendations to encourage clinical trials that are most likely to produce robust evidence during the pandemic.
Language	Spanish
Publishing date	2021-03-08
Publishing country	United States
Document type	English Abstract ; Journal Article
ZDB-ID	1376934-0
ISSN	1680-5348 ; 1020-4989
ISSN (online)	1680-5348
ISSN	1020-4989
DOI	10.26633/RPSP.2021.33
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Article ; Online: El panorama de los ensayos clínicos sobre COVID-19 en América Latina y el Caribe

Sarah Carracedo / Ana Palmero / Marcie Neil / Anisa Hasan-Granier / Carla Saenz / Ludovic Reveiz

Revista Panamericana de Salud Pública, Vol 45, Iss 33, Pp 1-

evaluación y desafíos

2021 Volume 5

Abstract: Se está llevando a cabo un número considerable de ensayos clínicos en todo el mundo en respuesta a la pandemia de COVID-19, incluso en países de ingresos bajos y medios como los de América Latina y el Caribe. Sin embargo, la abundancia de estudios no ... ...

Abstract	Se está llevando a cabo un número considerable de ensayos clínicos en todo el mundo en respuesta a la pandemia de COVID-19, incluso en países de ingresos bajos y medios como los de América Latina y el Caribe. Sin embargo, la abundancia de estudios no necesariamente acorta el camino para encontrar intervenciones seguras y eficaces frente a la COVID-19. Se analizaron los ensayos para el tratamiento y la prevención de la COVID-19 de los países de América Latina y el Caribe que están registrados en la Plataforma de Registros Internacionales de Ensayos Clínicos de la Organización Mundial de la Salud, y se identificó una tendencia hacia la realización de estudios pequeños, repetitivos y no rigurosos que duplican los esfuerzos y merman recursos limitados sin producir conclusiones significativas sobre la seguridad y la eficacia de las intervenciones evaluadas. Se evaluaron asimismo los desafíos que plantea la realización de investigaciones científicamente sólidas y socialmente valiosas en América Latina y el Caribe a fin de brindar recomendaciones que alienten la realización de ensayos clínicos que tengan más probabilidades de producir evidencia sólida durante la pandemia.
Keywords	infecciones por coronavirus ; ensayo clínico ; ética en investigación ; políticas públicas de salud ; américa latina ; región del caribe ; Medicine ; R ; Arctic medicine. Tropical medicine ; RC955-962 ; Public aspects of medicine ; RA1-1270
Language	English
Publishing date	2021-03-01T00:00:00Z
Publisher	Pan American Health Organization
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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