Untangling the ethical intersection of epidemiology, human subjects research, and public health.

PURPOSE: Members of the American College of Epidemiology (ACE) Ethics Committee identified current ethics and epidemiology topic areas to consider for further discussion, consultation, teaching opportunities, and conference presentation. This article reflects on the activities of the Committee at the ACE Annual Meeting in New Orleans, Louisiana, September 24-26, 2017. METHODS: The overall aim for the Ethics Committee was to engage members of the College and other audiences and highlight the evolution of ethics and epidemiology since the inception of the original Ethics Guidelines published by the ACE Ethics and Standards of Practice Committee in 2000. The Ethics Committee organized a symposium session at the 2017 Annual Meeting of ACE on the ethics of human subjects research as it relates to specialized areas of epidemiology and the intersecting role of public health. This article presents a summary and further discussion of that symposium session. RESULTS: Three topic areas were presented: an overview of ethics and epidemiology (E.S.P.), very high biomarker levels in environmental epidemiology research (S.M.P.), and the interface of epidemiology, human subjects research, and public health interventions (S.M.). This article begins by reviewing the foundations of epidemiology and public health and the well-known ethical principles of human subjects research. Then, it considers the ethical considerations in the use of population registry data in epidemiological research, environmental epidemiology, and epidemic surveillance and response. This article may form the basis of teaching of ethics principles related to epidemiology and public health and may serve as a companion piece to the original ACE Ethics Guidelines. CONCLUSIONS: Researchers are increasingly faced with ethical considerations in diverse, nontraditional, and specialized areas of epidemiology and public health. This article illustrates these challenges with real-world examples of clinical and population registry data, the study of environmental biomarkers, and Zika virus epidemic; it also reviews relevant ethical principles underpinning these examples and identifies where gaps in knowledge may exist.

The virtuous epidemiologist.

This article addresses the scholarly gap in the ethics of epidemiology by exploring what virtue ethics, one of the oldest ethical traditions in moral philosophy, has to say about 'the virtuous epidemiologist'. It expounds comparatively the content and merits of a virtue ethics approach against more popular contemporary schools of thought such as consequentialism and deontology. Without necessarily dismissing the value of principles and standards, it presents a vision that a virtuous epidemiologist should cultivate wisdom in making prudential judgments in conditions of uncertainty; fortitude in dealing with powerful politicians and administrators which does not sacrifice truth; temperance and self-restraint in keeping one's ideological views from compromising one's scientific credibility; and justice in giving due weight to individual rights and the public interest when doing research and giving advice on public health interventions.

Ethics and Epistemology of Big Data.

In this Symposium on the Ethics and Epistemology of Big Data, we present four perspectives on the ways in which the rapid growth in size of research databanks-i.e. their shift into the realm of "big data"-has changed their moral, socio-political, and epistemic status. While there is clearly something different about "big data" databanks, we encourage readers to place the arguments presented in this Symposium in the context of longstanding debates about the ethics, politics, and epistemology of biobank, database, genetic, and epidemiological research.

Ethics, big data and computing in epidemiology and public health.

PURPOSE: This article reflects on the activities of the Ethics Committee of the American College of Epidemiology (ACE). Members of the Ethics Committee identified an opportunity to elaborate on knowledge gained since the inception of the original Ethics Guidelines published by the ACE Ethics and Standards of Practice Committee in 2000. METHODS: The ACE Ethics Committee presented a symposium session at the 2016 Epidemiology Congress of the Americas in Miami on the evolving complexities of ethics and epidemiology as it pertains to "big data." This article presents a summary and further discussion of that symposium session. RESULTS: Three topic areas were presented: the policy implications of big data and computing, the fallacy of "secondary" data sources, and the duty of citizens to contribute to big data. A balanced perspective is needed that provides safeguards for individuals but also furthers research to improve population health. Our in-depth review offers next steps for teaching of ethics and epidemiology, as well as for epidemiological research, public health practice, and health policy. CONCLUSIONS: To address contemporary topics in the area of ethics and epidemiology, the Ethics Committee hosted a symposium session on the timely topic of big data. Technological advancements in clinical medicine and genetic epidemiology research coupled with rapid advancements in data networks, storage, and computation at a lower cost are resulting in the growth of huge data repositories. Big data increases concerns about data integrity; informed consent; protection of individual privacy, confidentiality, and harm; data reidentification; and the reporting of faulty inferences.

What Do Ethical Guidelines for Epidemiology Say About an Ethics Review? A Qualitative Systematic Review.

Epidemiological research is subject to an ethics review. The aim of this qualitative review is to compare existing ethical guidelines in English for epidemiological research and public health practice in regard to the scope and matter of an ethics review. Authors systematically searched PubMed, Google Scholar and Google Search for ethical guidelines. Qualitative analysis (constant comparative method) was applied to categorize important aspects of the an ethics review process. Eight ethical guidelines in English for epidemiological research were retrieved. Five main categories that are relevant to the review of epidemiological research by Institutional Review Boards/Research Ethics Committees were distinguished. Within the scope of main categories, fifty-nine subcategories were analyzed. There are important differences between the guidelines in terms of the scope and matter of an ethics review. Not all guidelines encompass all identified ethically important issues, and some do not define precisely the scope and matter of an ethics review, leaving much to the ethics of the individual researchers and the discretion of IRBs/RECs.

Emergency response in a global health crisis: epidemiology, ethics, and Ebola application.

PURPOSE: The link between ethics and epidemiology can go unnoticed in contemporary gatherings of professional epidemiologists or trainees at conferences and workshops, as well as in teaching. Our goal is to provide readers with information about the activities of the College and to provide a broad perspective on a recent major issue in epidemiology. METHODS: The Ethics Committee of the American College of Epidemiology (ACE) presented a plenary session at the 2015 Annual Meeting in Atlanta, GA, on the complexities of ethics and epidemiology in the context of the 2014-2015 Ebola virus disease outbreak and response in West Africa. This article presents a summary and further discussion of that plenary session. RESULTS: Three main topic areas were presented: clinical trials and ethics in public health emergencies, public health practice, and collaborative work. A number of key ethical concepts were highlighted and discussed in relation to Ebola and the ACE Ethics Guidelines. CONCLUSIONS: The Ebola virus disease outbreak is an example of a public health humanitarian crisis from which we hope to better understand the role of professional epidemiologists in public health practice and research and recognize ethical challenges epidemiologists faced.

Cultural conundrums: the ethics of epidemiology and the problems of population in implementing pre-exposure prophylaxis.

The impending implementation of pre-exposure prophylaxis (PrEP) has prompted complicated bioethical and public health ethics concerns regarding the moral distribution of antiretroviral medications (ARVs) to ostensibly healthy populations as a form of HIV prevention when millions of HIV-positive people still lack access to ARVs globally. This manuscript argues that these questions are, in part, concerns over the ethics of the knowledge production practices of epidemiology. Questions of distribution, and their attendant cost-benefit calculations, will rely on a number of presupposed, and therefore, normatively cultural assumptions within the science of epidemiology specifically regarding the ability of epidemiologic surveillance to produce accurate maps of HIV throughout national populations. Specifically, ethical questions around PrEP will focus on who should receive ARVs given the fact that global demand will far exceed supply. Given that sexual transmission is one of the main modes of HIV transmission, these questions of 'who' are inextricably linked to knowledge about sexual personhood. As a result, the ethics of epidemiology, and how the epidemiology of HIV in particular conceives, classifies and constructs sexual populations will become a critical point of reflection and contestation for bioethicists, health activists, physicians, nurses, and researchers in the multi-disciplinary field of global health. This paper examines how cultural conundrums within the fields of bioethics and public health ethics are directly implicated within the ethics of PrEP, by analyzing the problems of population inaugurated by the construction of the men who have sex with men (MSM) epidemiologic category in the specific national context of South Africa.

A dimensão da ética de um inquérito populacional em saúde / The ethical dimension of a population health survey

A epidemiologia dá sustentação às práticas coletivas em saúde. Por isso, vários dos seus recursos podem ser utilizados para identificar as necessidades coletivas em saúde. Os inquéritos populacionais são um deles. A Pesquisa Nacional de Saúde Bucal (SBBrasil 2010) foi o quarto inquérito de abrangência nacional realizado nessa área, cujas equipes de campo foram compostas por profissionais do próprio Sistema Único de Saúde (SUS). Esta pesquisa teve como objetivo geral analisar como a dimensão da ética se expressa no SBBrasil 2010, a partir da percepção de gestores desse inquérito populacional epidemiológico. Realizou-se estudo descritivo, qualitativo, na modalidade estudo de caso. Foram entrevistados, individualmente, mediante roteiro semiestruturado, informantes-chave (n=14), no Distrito Federal e em 11 estados. Os participantes desta pesquisa integraram o Grupo Gestor ou o Comitê Técnico Assessor do Ministério da Saúde, incumbidos do planejamento e execução do SBBrasil 2010, e dois coordenadores, um estadual, outro municipal. Os resultados estão expressos como Discurso do Sujeito Coletivo. Informação complementar sobre conteúdos de entrevistas para esclarecer menções e compreender fatos e contextos foi obtida dos participantes. As ideias centrais (IC) referentes às dificuldades de cunho ético inerentes a um inquérito como o SBBrasil 2010 abordaram: autorização dos gestores locais para participação dos profissionais, diferenças político-partidárias, desagregação de dados para o município, perfil dos ocupantes de cargos de gestão, valor atribuído aos inquéritos pelos trabalhadores do SUS e violência. No tocante às situações vivenciadas no SBBrasil 2010 que, na concepção dos entrevistados, envolveram aspectos éticos, foram identificadas IC sobre: fabricação de dados, não adesão ao protocolo de campo, treinamento e calibração, benefícios da pesquisa, devolução de documentos, seleção de profissionais, vulnerabilidade social, recusa de municípios e consulta pública. Na apuração dos dados do SBBrasil 2010 verificou-se que uma capital apresentava o índice de cárie aos 12 anos com média muito acima da expectativa para o local. A decomposição do banco de dados permitiu detectar indícios sólidos de erro de registro para dois examinadores, indicando que houve falha na etapa de treinamento e calibração, ou fabricação de dados, ou ambos. Quanto às contribuições, as IC revelaram que os inquéritos devem gerar ação, conhecimento e memória, estimular políticas públicas equânimes, promover integração academia-serviços e qualificar a prática profissional. De cinco IC, três indicaram desacordo com a crítica de que há necessidade de adequação das resoluções éticas nacionais às pesquisas de base populacional. As IC restantes abordaram duas necessidades: de maior flexibilidade na obtenção do consentimento e de consideração às especificidades do SBBrasil 2010, visto que a realização de inquéritos é atribuição do SUS. Os depoimentos dos entrevistados revelam que em um inquérito, a ética não está presente somente na aprovação do projeto pelo Sistema CEP/CONEP (Comitê de Ética em Pesquisa/Comissão Nacional de Ética em Pesquisa), mas em todo o trajeto de elaboração e execução. Da decisão pela realização até a publicação dos dados, todas as etapas têm, indubitavelmente, uma dimensão que é ética. O SBBrasil 2010 agrega três características que a tornam ainda mais evidente: é nacional, de base domiciliar e feito pelo SUS

Invited commentary: consequential(ist) epidemiology: let's seize the day.

Now is the time for the science of epidemiology to embrace its pragmatic roots. The article by Galea in this issue of the Journal (Am J Epidemiol. 2013;178(8):1185-1191) calls for us to become more "consequentialist." The Affordable Care Act allows us to access population-level databases from which we can examine how to deliver care more efficiently and cost-effectively. Asking the questions "so what" and "how much" will increase our relevance over the next decade.

An argument for a consequentialist epidemiology.

Epidemiology is the study of the causes and distributions of diseases in human populations so that we may identify ways to prevent and control disease. Although this definition broadly serves us well, I suggest that in recent decades, our discipline's robust interest in identifying causes has come at the expense of a more rigorous engagement with the second part of our vision for ourselves-the intent for us to intervene-and that this approach threatens to diminish our field's relevance. I argue here for a consequentialist epidemiology, a formalization and recalibration of the philosophical foundations of our discipline. I discuss how epidemiology is, at its core, more comfortably a consequentialist, as opposed to a deontological, discipline. A more consequentialist approach to epidemiology has several implications. It clarifies our research priorities, offers a perspective on the place of novel epidemiologic approaches and a metric to evaluate the utility of new methods, elevates the importance of global health and considerations about equity to the discipline, brings into sharp focus our engagement in implementation and translational science, and has implications for how we teach our students. I intend this article to be a provocation that can help clarify our disciplinary intentions.

El silencio epidemiológico y la ética de la Salud Pública cubana / Epidemiological silence and the ethics of the Cuban public health

Se realiza un recorrido histórico que aborda el desarrollo de la salud pública cubana y la necesidad del conocimiento a profundidad de la riqueza de su pensamiento, acción y ética. Se destaca la presencia del mosquito Aedes aegypti y el dengue en la región de Las Américas y en Cuba y se realiza una descripción de las acciones emprendidas para enfrentar y controlar la epidemia de dengue hemorrágico en el año 1981. Se plantea que existen hechos científicos exitosos en Cuba y en otros países que ponen de manifiesto los procederes para enfrentar epidemias, y se resalta que cuando los informes oficiales no existen o no son tan frecuentes como cabría desear, surgen numerosos rumores extraoficiales. Se hace hincapié en el hecho de que cuando el silencio epidemiológico no se corresponde con la realidad, no contribuye ni a la disminución de los casos sospechosos y enfermos ni a una percepción real del riesgo de la potencial gravedad del dengue como enfermedad y de la necesidad de la eliminación de su principal agente transmisor. El legado ético de los sanitaristas cubanos que a lo largo de cientos de años han forjado la salud pública en Cuba constituyen una riqueza y una referencia de un alto valor en las actuales circunstancias nacionales y mundiales donde la ética se ha convertido en un aspecto clave y una necesidad imperiosa e impostergable para el enfrentamiento y solución de los problemas de salud que nos afectan(AU)

This article presented a historical account of the Cuban public health development and the need for in-depth understanding of the wealth of thought, action and ethics in this field. It highlighted the presence of Aedes aegypti mosquitoes and dengue in the Americas and in Cuba and described the actions taken to face and control the dengue hemorrhagic fever epidemics in 1981. It was argued that there is positive scientific evidence in Cuba and other countries that shows the procedures to face epidemics, and it also stressed that when the official reports are inexistent or not as frequent as they should be, then numerous unofficial rumours circulate. Emphasis was made on the fact that when the epidemiological silence does not match the realities, then it does not support either the reduction of the suspected or confirmed cases or the real risk perception of the potential severity of dengue and of the urgent need for eliminating its main disease-borne agent. The rich ethical legacy of Cuban health specialists that over hundreds of years have shaped the public health in our country represents a valuable reference in the present national and global settings, where ethics has become a key element and a compelling and urgent need to face and to solve health problems that affect us(AU)

El silencio epidemiológico y la ética de la Salud Pública cubana / Epidemiological silence and the ethics of the Cuban public health

Se realiza un recorrido histórico que aborda el desarrollo de la salud pública cubana y la necesidad del conocimiento a profundidad de la riqueza de su pensamiento, acción y ética. Se destaca la presencia del mosquito Aedes aegypti y el dengue en la región de Las Américas y en Cuba y se realiza una descripción de las acciones emprendidas para enfrentar y controlar la epidemia de dengue hemorrágico en el año 1981. Se plantea que existen hechos científicos exitosos en Cuba y en otros países que ponen de manifiesto los procederes para enfrentar epidemias, y se resalta que cuando los informes oficiales no existen o no son tan frecuentes como cabría desear, surgen numerosos rumores extraoficiales. Se hace hincapié en el hecho de que cuando el silencio epidemiológico no se corresponde con la realidad, no contribuye ni a la disminución de los casos sospechosos y enfermos ni a una percepción real del riesgo de la potencial gravedad del dengue como enfermedad y de la necesidad de la eliminación de su principal agente transmisor. El legado ético de los sanitaristas cubanos que a lo largo de cientos de años han forjado la salud pública en Cuba constituyen una riqueza y una referencia de un alto valor en las actuales circunstancias nacionales y mundiales donde la ética se ha convertido en un aspecto clave y una necesidad imperiosa e impostergable para el enfrentamiento y solución de los problemas de salud que nos afectan

This article presented a historical account of the Cuban public health development and the need for in-depth understanding of the wealth of thought, action and ethics in this field. It highlighted the presence of Aedes aegypti mosquitoes and dengue in the Americas and in Cuba and described the actions taken to face and control the dengue hemorrhagic fever epidemics in 1981. It was argued that there is positive scientific evidence in Cuba and other countries that shows the procedures to face epidemics, and it also stressed that when the official reports are inexistent or not as frequent as they should be, then numerous unofficial rumours circulate. Emphasis was made on the fact that when the epidemiological silence does not match the realities, then it does not support either the reduction of the suspected or confirmed cases or the real risk perception of the potential severity of dengue and of the urgent need for eliminating its main disease-borne agent. The rich ethical legacy of Cuban health specialists that over hundreds of years have shaped the public health in our country represents a valuable reference in the present national and global settings, where ethics has become a key element and a compelling and urgent need to face and to solve health problems that affect us

[Reflections on qualitative research. Interview of Luisa Saiani with Luigina Mortari]. / Alcune riflessioni sulla ricerca qualitativa. Intervista di Luisa Saiani a Luigina Mortari.

Reflections on qualitative research. Interview of Luisa Saiani to Luigina Mortari. Luigina Mortari, an internationally known expert of epistemology and qualitative research, was interviewed to explore her thoughts on issues relevant for qualitative research: when a research question can be considered relevant; key methodological elements; ethical issues.

Children as means and ends in large-scale medical research.

This paper considers the often-expressed fear that medical research may use children merely as means, and not respect them as ends in themselves - especially insofar as they are deemed less able to consent than adults. The main focus is on large-scale genetic, socio-medical and epidemiological research. The theoretical starting point of the paper is that to be treated as an end in oneself is to be regarded as - and to act as - a participant in cooperative endeavours. This participatory status is certainly connected with individual authority to consent and dissent; and there is no doubt that consent plays an important role when adults participate in many research projects. However, insofar as consent is located within structures of human cooperation, the authority to consent is not a straightforward privilege. Rather, consent is bound up with responsibility for one's choices and commitment to shared terms of cooperation. Given this understanding, it is argued that consent should not be our principal concern when we involve children in research. This is not because of children's (possible) incompetence to consent as such, but rather because children are still learning how to respect and assess the cooperative terms involved in our institutional lives. Instead, our leading concern should be with the terms regulating their involvement in research. Given suitable safeguards, research is one way in which children may learn what it is to bear responsibilities and to act as an end in oneself - that is, to cooperate with others on reasonable terms and for worthy ends.

Identificación y selección de enfermedad de posible origen laboral atendida por el sistema público de salud / Identification and selection of diseases of possible occupational origin managed through the National Health System

ObjetivoIdentificar y seleccionar la patología posiblemente laboral que es atendida en el sistema público de salud.DiseñoEstudio transversal.EmplazamientoCataluña (España).ParticipantesPersona mayor de 15 años que registra una primera visita en atención primaria o un ingreso en un hospital o un episodio de incapacidad por contingencia común en 2008 en Cataluña o que ha fallecido en esta misma comunidad en 2007.Mediciones principalesA partir de la conversión de la lista europea de enfermedades profesionales en 407 entidades de la CIE-10, se identificaron 34 entidades que fueron valoradas por un grupo de expertos.ResultadosEstas entidades posiblemente laborales suponían el 6,7% de las primeras visitas, el 13,8% de las incapacidades laborales, el 13,6% de los contactos con los hospitales agudos y el 15,8% de las defunciones. El asma fue una patología de posible origen laboral identificada en las 4 bases de datos. Después de la selección de los expertos, las 26 entidades representan el 3,3% de las primeras visitas, el 8,9% de las incapacidades y el 2,7% de los contactos con hospitales de agudos.ConclusionesLa implantación de un sistema de alerta en la historia clínica electrónica, cada vez que una de estas 26 enfermedades es registrada, puede ayudar a mejorar la comunicación de trastornos profesionales(AU)

ObjectiveTo identify and select common diseases of possible occupational origin, managed through the Spanish National Health System.DesignCross-sectional study.SettingCatalonia (Spain).ParticipantsData were collected on people over 15 years of age who were seen for the first time in a primary care clinic or were admitted to a hospital or had an episode of non-occupational sickness absence in catalonia in 2008 or died in this region in 2007.Main measurementsA total of 407 diagnostic codes for possible occupationally-related diseases were selected from a modified version of the european union ICD-10 list of diagnostic codes, from which 34 were selected and assessed by an expert panel.ResultsThe initial 34 diagnoses represented 6.7% of all new outpatient visits, 13.8% of the sickness absence episodes, 13.6% of acute admissions and 15.8% of all annual deaths. Asthma appeared prominently in all four databases. The list was pared down to a final list of 26 four-digit icd-10 codes, that accounted for 3.3% of the first visits, 8.9% of lost work time episodes and 2.7% of acute admissions.ConclusionsThe implementation of a “red flag” into the electronic medical record each time one of these 26 diagnostic codes is entered, could help to improve the reporting of occupational diseases(AU)