Ethical issues in using ambient intelligence in health-care settings.

Ambient intelligence is increasingly finding applications in health-care settings, such as helping to ensure clinician and patient safety by monitoring staff compliance with clinical best practices or relieving staff of burdensome documentation tasks. Ambient intelligence involves using contactless sensors and contact-based wearable devices embedded in health-care settings to collect data (eg, imaging data of physical spaces, audio data, or body temperature), coupled with machine learning algorithms to efficiently and effectively interpret these data. Despite the promise of ambient intelligence to improve quality of care, the continuous collection of large amounts of sensor data in health-care settings presents ethical challenges, particularly in terms of privacy, data management, bias and fairness, and informed consent. Navigating these ethical issues is crucial not only for the success of individual uses, but for acceptance of the field as a whole.

Ensuring ethical data access: the Sierra Leone Ebola Database (SLED) model.

PURPOSE: Organizations responding to the 2014-2016 Ebola epidemic in Sierra Leone collected information from multiple sources and kept it in separate databases, including distinct data systems for Ebola hot line calls, patient information collected by field surveillance officers, laboratory testing results, clinical information from Ebola treatment and isolation facilities, and burial team records. METHODS: After the conclusion of the epidemic, the Sierra Leone Ministry of Health and Sanitation and the U.S. Centers for Disease Control and Prevention partnered to collect these disparate records and consolidate them in the Sierra Leone Ebola Database. RESULTS: The Sierra Leone Ebola Database data are providing a lasting resource for postepidemic data analysis and epidemiologic research, including identifying best strategies in outbreak response, and are used to help families locate the graves of family members who died during the epidemic. CONCLUSION: This report describes the Ministry of Health and Sanitation and Centers for Disease Control and Prevention processes to safeguard Ebola records while making the data available for public health research.

Participated without consent: Mandatory authorization of government database for secondary use.

Compared with data that is initially collected for research purposes, the mandatory authorization of a government database for secondary use deserves greater scrutiny because it consists of information that is collected initially for administrative purposes. Using the case of Taiwan's National Health Insurance (NHI) Database as an example, this paper analyzes the ethical issues that emerge when the research participants are "participated" in studies without their consent, according to the current policy. The proponents of secondary use for research purposes maintain that the authorized use of the NHI Database is necessary for public interests, while the opponents argue that the potential lack of democratic accountability and the infringement on people's rights to privacy and information autonomy is unwarranted. Drawing on the solidarity-based approach, this paper proposes a temporal solution as a possible reform direction for better ethical justification of the secondary use of the NHI Database.

[A New Paradigm in Health Research: FAIR Data (Findable, Accessible, Interoperable, Reusable)]. / Um Novo Paradigma em Investigação em Saúde: Dados FAIR (Localizáveis, Acessíveis, Interoperáveis, Reutilizáveis).

The digital era, that we are living nowadays, is transforming health, health care models and services, and the role of society in this new reality. We currently have a large amount of stored health data, including clinical, biometric, and scientific research data. Nonetheless, its potential is not being fully exploited. It is essential to foster the sharing and reuse of this data not only in research but also towards the development of health technologies in order to improve health care efficiency, as well as products, services or digital health apps, to promote preventive and individualized medicine and to empower citizens in health literacy and self-management. In this sense, the FAIR concept has emerged, which implies that health data is findable, accessible, shared and reusable, facilitating interoperability between systems, ensuring the protection of personal and sensitive data. In this paper we review the FAIR concept, 'FAIRification' process, FAIR data versus open access data, ethical issues and the general data protection regulation, and digital health and citizen science.

Vivemos uma nova era digital que está a transformar a saúde, os modelos de cuidados e serviços de saúde, e o próprio papel da sociedade nesta realidade. Atualmente dispomos de uma grande quantidade de dados de saúde armazenados, incluindo dados clínicos, biométricos e de investigação científica, cuja potencialidade não está a ser devidamente explorada. É essencial favorecer a partilha e reutilização destes dados não só na investigação, como também para o desenvolvimento de tecnologias para melhorar a eficiência dos cuidados de saúde, de produtos ou serviços de saúde digitais, promover uma medicina preventiva e individualizada, mas também o empoderamento da população em literacia em saúde e na gestão da doença. Recentemente, surgiu o conceito FAIR que implica que os dados de saúde sejam facilmente localizáveis, acessíveis, partilhados e reutilizáveis, facilitando desta forma a interoperacionalidade entre sistemas e assegurando a proteção de dados pessoais e sensíveis. Neste artigo é feita uma revisão do conceito FAIR, processo de 'FAIRificação', dados FAIR versus dados de acesso livre, questões de éticas e o regulamento geral de proteção de dados, e saúde digital e ciência cidadã.

Ética de la revisión por pares en publicaciones científicas / Ethics of peer reviewing in scientific publications

RESUMEN La revisión por pares garantiza que los materiales publicados sean válidos y confiables, tanto como sea posible. El objetivo fue reconocer la importancia del trabajo de los revisores en las publicaciones científicas médicas y de la observación de los aspectos éticos durante su desempeño. Las revisiones por pares pueden ser a ciegas, a doble ciegas o abiertas, cada una de ellas con ventajas y desventajas. Durante las publicaciones de resultados de investigaciones científicas pueden producirse sesgos por parte de los revisores. Entre los sesgos de los revisores relacionados con faltas éticas se encuentran: los incumplimientos en plazos de revisión, la superficialidad de las revisiones, el lenguaje ofensivo contra editores o autores, el "amiguismo cognitivo" y el "sesgo de ego" por propia voluntad, entre otros. No obstante, es posible implementar acciones para minimizar los sesgos relacionados con esas faltas éticas. El trabajo de los revisores es digno de reconocer, teniendo en cuenta que casi siempre es realizado durante el tiempo libre, de forma voluntaria y por personas de alto prestigio como investigadores. En el mundo actual esta labor ha sido amenazada con la proliferación de revistas predadoras, pero también destacan los intentos para su reivindicación y promoción, como el del sitio web Publons. En el trabajo de los revisores intervienen múltiples factores, a veces contradictorios: intereses, deberes, derechos; pero todos ellos deben ponderarse sobre la base de una sólida formación y desempeño éticos (AU).

ABSTRACT Peer reviews guarantee published materials be as valid and reliable as it be possible. Recognize reviewers' work importance on scientific medical publication as well as the ethics issues to be accomplished during their performance. Development: Peer reviews could be single blind, double blind or open, each one with its advantages and disadvantages. During scientific research results publications, peer reviewer biases could be occurred. Some peer reviewer biases are related to ethical mistakes: no fulfillment of time limits, superficial evaluations, offense languages against editors or authors, at will cognitive cronyism and "ego bias", among others. Nevertheless, measures' implementation to minimize biases related to ethical mistakes is possible. The reviewers' work is suitable to be recognized, taking into account it is done almost all the times on free time, without financial compensation and by researchers with recognized prestige. In the present word, even when this work has been threat by predatory journals spreads, some intent to do it justice and promotion are highlight, as do the website Publons. Multiple factors, contradictory sometime, are involved in the reviewers' work: interests, duties, rights; but all of them should be pondering over the base of a solid ethic education and behavior (AU).

[Are studies of claims databases reproducible? The hypothesis of an instituted ethical misconduct in public health]. / Les études portant sur les bases de données médico-administratives sont-elles reproductibles ? - L'hypothèse d'une inconduite éthique en santé publique.

Methodological reproducibility refers to the ability to reproduce exactly the same results by reproducing the same study protocol on the same data. The aim of this study was to assess the methodological reproducibility of studies published in the Revue d'Epidémiologie et de Santé Publique between 2008 and 2017 and using data from the national health data system. Our results suggest that only 49% of the studies could be replicated without the help of the authors. The results may reveal a lack of concern about the purpose of public health research. It is difficult to attribute responsibility for this default of reproducibility solely to researchers, so we hypothesize an instituted ethical misconduct.

TITLE: Les études portant sur les bases de données médico-administratives sont-elles reproductibles ? - L'hypothèse d'une inconduite éthique en santé publique. ABSTRACT: La reproductibilité méthodologique fait référence à la capacité à obtenir exactement les mêmes résultats, en reproduisant le même protocole d'étude sur les mêmes données. Nous avons voulu évaluer la reproductibilité méthodologique des études publiées entre 2008 et 2017 dans la Revue d'épidémiologie et de santé publique, qui font appel à des données issues du système national des données de santé. Nos résultats suggèrent que seules 49 % des études portant sur ce système national pourraient être reproduites sans le recours aux auteurs initiaux. L'absence de partage systématique des programmes peut révéler un manque de préoccupation quant à la finalité de la recherche en santé publique. Il est difficile d'attribuer la responsabilité de ce manque de reproductibilité aux seuls chercheurs, et nous faisons donc l'hypothèse d'une inconduite éthique instituée.

Checklist for gene/disease-specific variation database curators to enable ethical data management.

Databases with variant and phenotype information are essential for advancing research and improving the health and welfare of individuals. These resources require data to be collected, curated, and shared among relevant specialties to maximize impact. The increasing generation of data which must be shared both nationally and globally for maximal effect presents important ethical and privacy concerns. Database curators need to ensure that their work conform to acceptable ethical standards. A Working Group of the Human Variome Project had the task of updating and streamlining ethical guidelines for locus-specific/gene variant database curators. In this article, we present practical and achievable steps which should assist database curators in carrying out their responsibilities within acceptable ethical norms.

The role of data custodians in establishing and maintaining social licence for health research.

In this article we explore the role of data custodians in establishing and maintaining social licence for the use of personal information in health research. Personal information from population-level data collections can be used to make significant contributions to health and medical research, but this use is dependent on community acceptance or a social licence. We conducted semi-structured interviews with data custodians across Australia to better understand data custodians' views on their roles and responsibilities. This inductive, thematic analysis of the interview data focuses on three factors that contribute to social licence - reciprocity, non-exploitation and the public good. While the data custodians interviewed did not explicitly frame their role in the context of social licence, their descriptions of their roles and responsibilities clearly indicated that they did have some role to play in building and maintaining social licence.