RESUMO
To combat malnutrition in all its forms, actions must be integrated from society as a whole. The main interest of the actors involved in these actions should be health. However, there are actors with conflict of interest that interfere in the design, planning, implementation and monitoring of public health nutrition policies. In order to mitigate the adverse effect that result from these conflicts, from evidence generation to the design and implementation of policies, this Code is proposed. It invites the nutrition and health community to adopt it, promote it and subscribe it, and to favor the advancement of actions and policies without industry interference to address the problem of malnutrition.
Para combatir la mala nutrición en todas sus formas es necesario integrar acciones desde la sociedad en su conjunto. El interés superior de los actores involucrados en generar estas acciones debe ser la salud. No obstante, existen actores con conflictos de interés que interfieren en el diseño, planeación, implementación y monitoreo de las políticas derivadas de dichas acciones. A fin de mitigar el efecto adverso que generan estos conflictos desde la etapa de generación de evidencia hasta el diseño e implementación de las políticas, se propone este código. Se invita a la comunidad de nutrición y salud a adoptarlo, promoverlo y sumarse al mismo, para favorecer el avance de las acciones y políticas necesarias sin interferencia de la industria y resolver el problema de la mala nutrición.
Assuntos
Academias e Institutos/ética , Conflito de Interesses , Indústria Alimentícia/ética , Desnutrição/prevenção & controle , Política Nutricional , Humanos , México , Obesidade/prevenção & controle , Formulação de PolíticasRESUMO
Resumen: Para combatir la mala nutrición en todas sus formas es necesario integrar acciones desde la sociedad en su conjunto. El interés superior de los actores involucrados en generar estas acciones debe ser la salud. No obstante, existen actores con conflictos de interés que interfieren en el diseño, planeación, implementación y monitoreo de las políticas derivadas de dichas acciones. A fin de mitigar el efecto adverso que generan estos conflictos desde la etapa de generación de evidencia hasta el diseño e implementación de las políticas, se propone este código. Se invita a la comunidad de nutrición y salud a adoptarlo, promoverlo y sumarse al mismo, para favorecer el avance de las acciones y políticas necesarias sin interferencia de la industria y resolver el problema de la mala nutrición.
Abstract: To combat malnutrition in all its forms, actions must be integrated from society as a whole. The main interest of the actors involved in these actions should be health. However, there are actors with conflict of interest that interfere in the design, planning, implementation and monitoring of public health nutrition policies. In order to mitigate the adverse effect that result from these conflicts, from evidence generation to the design and implementation of policies, this Code is proposed. It invites the nutrition and health community to adopt it, promote it and subscribe it, and to favor the advancement of actions and policies without industry interference to address the problem of malnutrition.
Assuntos
Humanos , Indústria Alimentícia/ética , Conflito de Interesses , Política Nutricional , Desnutrição/prevenção & controle , Academias e Institutos/ética , Formulação de Políticas , México , Obesidade/prevenção & controleRESUMO
BACKGROUND: Coronavirus (CoV) disease (COVID)-19 poses difficult situations in which the ethical course of action is not clear, or choices are made between equally unacceptable responses. METHODS: A web search was performed using the terms "bioethics; COVID-19; ethics; severe acute respiratory syndrome CoV-2; emergent care; pandemic; and public health emergencies." RESULTS: Protection from COVID-19 has resulted in the cancellation of necessary medical interventions, lengthened suffering, and potential non-COVID-19 deaths. Prolonged lockdown reduced well-being, triggering or aggravating mental illnesses and violence, and escalated medical risks. Collateral damage includes restrictions on visitations to hospitals, alienation from the deceased relative, or lack of warm caring of patients. Finally, in a public health crisis, public health interest overrides individual rights if it results in severe harm to the community. CONCLUSION: Balancing ethical dilemmas are one more challenge in the COVID-19 pandemic.
Assuntos
COVID-19/epidemiologia , Alocação de Recursos para a Atenção à Saúde/ética , Política de Saúde , Pandemias/ética , Saúde Pública , SARS-CoV-2 , COVID-19/prevenção & controle , COVID-19/psicologia , Efeitos Psicossociais da Doença , Ética em Pesquisa , Acessibilidade aos Serviços de Saúde , Humanos , Relações Interpessoais , Transtornos Mentais/epidemiologia , Transtornos Mentais/etiologia , Pandemias/prevenção & controle , Relações Profissional-Paciente , Qualidade de Vida , Quarentena , Isolamento Social , TelemedicinaRESUMO
Participants of Pharma-sponsored research are exposed to risks, benefits, and uncertainties that do not occur in other forms of clinical studies. Ethics committees represent the subjects' first line of protection. This responsibility begins with the study review and ends after all study subjects finish the intervention. The objective of this paper is to review the most common controversial issues found in Pharma-sponsored studies. Potential solutions are proposed to prevent or resolve the polemical aspects. However, different challenges will be faced in the near future (e.g., when new therapies reach their late stage of development). All parties involved in research should work together to guarantee the protection of participants, the paramount principle on which clinical investigation is based. Pharma-sponsored research is a crucial driver to develop and implement innovative approaches to improve the informed consent process and the execution of the studies.
Assuntos
Ensaios Clínicos como Assunto/métodos , Indústria Farmacêutica/economia , Comitês de Ética em Pesquisa/organização & administração , Ensaios Clínicos como Assunto/economia , Ensaios Clínicos como Assunto/ética , Humanos , Consentimento Livre e Esclarecido , Apoio à Pesquisa como Assunto/economiaRESUMO
Participants of Pharma-sponsored research are exposed to risks, benefits, and uncertainties that do not occur in other forms of clinical studies. Ethics committees represent the subjects first line of protection. This responsibility begins with the study review and ends after all study subjects finish the intervention. The objective of this paper is to review the most common controversial issues found in Pharma-sponsored studies. Potential solutions are proposed to prevent or resolve the polemical aspects. However, different challenges will be faced in the near future (e.g., when new therapies reach their late stage of development). All parties involved in research should work together to guarantee the protection of participants, the paramount principle on which clinical investigation is based. Pharma-sponsored research is a crucial driver to develop and implement innovative approaches to improve the informed consent process and the execution of the studies.
Assuntos
Humanos , Ensaios Clínicos como Assunto/métodos , Comitês de Ética em Pesquisa/organização & administração , Indústria Farmacêutica/economia , Apoio à Pesquisa como Assunto/economia , Ensaios Clínicos como Assunto/economia , Ensaios Clínicos como Assunto/ética , Consentimento Livre e EsclarecidoRESUMO
It is often unclear to the clinical investigator whether observational studies should be submitted to a research ethics committee (REC), mostly because, in general, no active or additional interventions are performed. Moreover, obtaining an informed consent under these circumstances may be challenging, either because these are very large epidemiological registries, or the subject may no longer be alive, is too ill to consent, or is impossible to contact after being discharged. Although observational studies do not involve interventions, they entail ethical concerns, including threats such as breaches in confidentiality and autonomy, and respect for basic rights of the research subjects according to the good clinical practices. In this context, in addition to their main function as evaluators from an ethical, methodological, and regulatory point of view, the RECs serve as mediators between the research subjects, looking after their basic rights, and the investigator or institution, safeguarding them from both legal and unethical perils that the investigation could engage, by ensuring that all procedures are performed following the international standards of care for research. The aim of this manuscript is to provide information on each type of study and its risks, along with actions to prevent such risks, and the function of RECs in each type of study.
Assuntos
Comitês de Ética em Pesquisa/organização & administração , Estudos Observacionais como Assunto/ética , Projetos de Pesquisa , Humanos , Consentimento Livre e Esclarecido/ética , Entrevistas como Assunto/métodos , Sistema de Registros/ética , Pesquisadores/organização & administração , Estudos RetrospectivosRESUMO
Abstract It is often unclear to the clinical investigator whether observational studies should be submitted to a research ethics committee (REC), mostly because, in general, no active or additional interventions are performed. Moreover, obtaining an informed consent under these circumstances may be challenging, either because these are very large epidemiological registries, or the subject may no longer be alive, is too ill to consent, or is impossible to contact after being discharged. Although observational studies do not involve interventions, they entail ethical concerns, including threats such as breaches in confidentiality and autonomy, and respect for basic rights of the research subjects according to the good clinical practices. In this context, in addition to their main function as evaluators from an ethical, methodological, and regulatory point of view, the RECs serve as mediators between the research subjects, looking after their basic rights, and the investigator or institution, safeguarding them from both legal and unethical perils that the investigation could engage, by ensuring that all procedures are performed following the international standards of care for research. The aim of this manuscript is to provide information on each type of study and its risks, along with actions to prevent such risks, and the function of RECs in each type of study.
Assuntos
Humanos , Projetos de Pesquisa , Comitês de Ética em Pesquisa/organização & administração , Estudos Observacionais como Assunto/ética , Pesquisadores/organização & administração , Sistema de Registros/ética , Entrevistas como Assunto/métodos , Estudos Retrospectivos , Consentimento Livre e Esclarecido/éticaRESUMO
According to the World Health Organization Expert Consultation, current body mass index (BMI) cut-offs should be retained as an international classification. However, there are ethnic differences in BMI-associated health risks that may be caused by differences in body fat or skeletal muscle mass and these may affect the interpretation of phase angle and bioelectrical impedance vector analysis (BIVA). Therefore, the aim of this study was to compare body composition measured by bioelectrical impedance analysis among 1048 German, 1026 Mexican, and 995 Japanese adults encompassing a wide range of ages and BMIs (18-78 years; BMI, 13.9-44.3 kg/m2). Regression analyses between body composition parameters and BMI were used to predict ethnic-specific reference values at the standard BMI cut-offs of 18.5, 25, and 30 kg/m2. German men and women had a higher fat-free mass per fat mass compared with Mexicans. Normal-weight Japanese were similar to Mexicans but approached the German phenotype with increasing BMI. The skeletal muscle index (SMI, kg/m2) was highest in Germans, whereas in BIVA, the Mexican group had the longest vector, and the Japanese group had the lowest phase angle and the highest extracellular/total body water ratio. Ethnic differences in regional partitioning of fat and muscle mass at the trunk and the extremities contribute to differences in BIVA and phase angle. In conclusion, not only the relationship between BMI and adiposity is ethnic specific; in addition, fat distribution, SMI, and muscle mass distribution vary at the same BMI. These results emphasize the need for ethnic-specific normal values in the diagnosis of obesity and sarcopenia.
Assuntos
Composição Corporal , Índice de Massa Corporal , Impedância Elétrica , Etnicidade , Tecido Adiposo/fisiologia , Adolescente , Adulto , Idoso , Antropometria , Estudos Transversais , Feminino , Alemanha/etnologia , Humanos , Japão/etnologia , Masculino , México/etnologia , Pessoa de Meia-Idade , Músculo Esquelético/fisiologia , Valores de Referência , Análise de Regressão , Adulto JovemRESUMO
Objective. To estimate the association between perceived body mass index (BMI) and socioeconomic variables in adults in Mexico. Materials and methods. We studied 32052 adults from the Mexican National Health and Nutrition Survey of 2006. We estimated BMI misperception by comparing the respondent's weight perception (as categories of BMI) with the corresponding category according to measured weight and height. Misperception was defined as respondent's perception of a BMI category different from their actual category. Socioeconomic status was assessed using household assets. Logistic and multinomial regression models by gender and BMI category were estimated. Results. Adult women and men highly underestimate their BMI category. We found that the probability of a correct classification was lower than the probability of getting a correct result by chance alone. Better educated and more affluent individuals are more likely to have a correct perception of their weight status, particularly among overweight adults. Conclusions. Given that a correct perception of weight has been associated with an increased search of weight control and that our results show that the studied population underestimated their BMI, interventions providing definitions and consequences of overweight and obesity and encouraging the population to monitor their weight could be beneficial.
Objetivo. Estimar la asociación entre la percepción del índice de masa corporal (IMC) y las variables socioeconómicas en adultos de México. Material y métodos. Se estudiaron 32052 adultos que participaron en la Encuesta Nacional de Salud y Nutrición 2006. Se estimó la percepción incorrecta del IMC clasificando la percepción del entrevistado sobre su peso en categorías de IMC y comparándola con la que le correspondía de acuerdo con la medición real de su peso y estatura. El nivel socioeconómico se evaluó mediante los activos en los hogares. Se estimaron modelos de regresión logística y multinomial por género y categoría de IMC. Resultados. Las mujeres y hombres adultos subestiman su categoría de IMC. La probabilidad de tener una percepción correcta es menor que la probabilidad de obtener un resultado correcto sólo por azar. Los individuos con mayor nivel de escolaridad y socioeconómico tienen mayor probabilidad de percibir correctamente su IMC, particularmente en personas con sobrepeso. Conclusiones. Dado que una correcta percepción del peso se ha asociado con mayor búsqueda de su control y que nuestros resultados muestran que la población estudiada subestima su IMC, las intervenciones que provean información sobre definiciones y consecuencias del sobrepeso y la obesidad y que promuevan el monitoreo del peso corporal pueden ser benéficas.
Assuntos
Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Índice de Massa Corporal , Autoimagem , Estudos Transversais , México , Classe SocialRESUMO
OBJECTIVES: We assessed the association between birthplace, residence, or years in the United States and actual weight (body mass index), perceived weight accuracy, or provider screens for overweight or obesity among Mexican immigrant women. METHODS: We used linked data from Health and Nutrition Examination Survey waves 2001-2006 and 2006 National Mexican Health and Nutrition Survey to compare 513 immigrants with 9527 women in Mexico and 342 US-born Mexican American women. RESULTS: Immigrants were more likely than women in Mexico to be obese and to perceive themselves as overweight or obese after adjustment for confounders. Recent immigrants had similar weight-related outcomes as women in Mexico. Immigrants were less likely to be obese than were US-born Mexican Americans. Within the overweight or obese population, reported provider screens were higher among immigrants than among women in Mexico, but lower than among US-born Mexican Americans. US residency of at least 5 years but less than 20 years and reporting insufficient provider screens elevated obesity risk. CONCLUSIONS: Mexican-origin women in the United States and Mexico are at risk for overweight and obesity. We found no evidence of a "healthy immigrant" effect.