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BEHALF - Bigdata-Ethics-HeaLth Framework

English title BEHALF - Bigdata-Ethics-HeaLth Framework
Applicant Vayena Effy (Eftychia)
Number 167223
Funding scheme NRP 75 Big Data
Research institution Departement Gesundheitswissenschaften und Technologie (D-HEST) ETH Zürich
Institution of higher education ETH Zurich - ETHZ
Main discipline Public Health and Health Services
Start/End 01.09.2017 - 31.08.2021
Approved amount 628'988.00
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All Disciplines (3)

Discipline
Public Health and Health Services
Health Education
Genetics

Keywords (9)

Accountability ; Human Rights; Research Participation; Research Ethics; Digital privacy ; Informed consent; Big Data; Big Data Health Research ; Privacy

Lay Summary (German)

Lead
Ein interdisziplinäres Team erforscht komplexe ethische Fragen, die die Big-Data-Revolution in der Medizin aufwirft. Wie sollen Einverständniserklärungen aussehen, mit denen Personen ihre Gesundheitsdaten der Forschung zur Verfügung stellen können - und wie lässt sich der Schutz ihrer Privatsphäre gewährleisten?
Lay summary

Die Nutzung von Big Data in der medizinischen Forschung erfordert die umfangreiche Erfassung, Verbreitung und Auswertung grosser Mengen persönlicher und vertraulicher Informationen. Dies birgt Risiken, welche sorgfältig evaluiert werden müssen. Zu diesem Zweck konzentriert sich unser interdisziplinäres Expertenteam auf vier Säulen:

  1. Wir möchten neuartige ethische Herausforderungen im Gesundheitsbereich verstehen.
  2. Wir entwickeln Leitlinien für die ethische Bewertung von Big Data-Projekten.
  3. Wir schaffen eine benutzerfreundliche Plattform, welche Patienten und gesunden Personen eine direkte Forschungsteilnahme ermöglicht.
  4. Wir schlagen Regeln vor, welche die verantwortungsvolle Entwicklung der Gesundheitsforschung im Bereich Big Data gewährleisten.

Immer mehr Aspekte der menschlichen Gesundheit werden in Daten umgewandelt, die sowohl klinisch als auch wissenschaftlich ausgewertet werden können. Solche Daten können nicht nur von medizinischem Fachpersonal sondern auch von jeder Person (etwa mit dem Smartphone) selbst gesammelt werden. Die derzeitigen bioethischen Richtlinien und Vorschriften reichen nicht aus, um diesen rasanten Entwicklungen in der Gesundheitsversorgung Genüge zu tun.

Dieses Projekt geht die bestehenden Mängel bezüglich der ethischen Nutzung von Big Data in der medizinischen Forschung an. Unseren Schwerpunkt setzen wir auf Themen wie Risiko-Nutzen-Analyse, Einverständniserklärung, Privatsphärenschutz wie auch Beaufsichtigungsmechanismen, mit dem Doppelziel:

  1. Effiziente Instrumente für die ethische Bewertung und Handhabung von Big Data im Gesundheitsbereich zu schaffen
  2. Empfehlungen zur Überwindung von derzeitigen medizinischen Forschungshindernissen in der Schweiz abzugeben.

Direct link to Lay Summary Last update: 27.07.2017

Lay Summary (French)

Lead
Une équipe interdisciplinaire étudie les questions éthiques complexes que la révolution du Big Data soulève dans le domaine de la médecine. Comment formuler les déclarations de consentement éclairé lorsque des personnes mettent leurs données sanitaires à disposition de la recherche et comment garantir la protection de leur sphère privée?
Lay summary

L’utilisation du Big Data dans la recherche médicale exige la saisie, la diffusion et l’évaluation à large échelle de grandes quantités de données personnelles et confidentielles. Cela implique des risques qui doivent être évalués avec soin. A cette fin, notre équipe d’experts interdisciplinaire se concentre sur quatre piliers:

  1. comprendre les nouveaux défis éthiques qui se posent dans le domaine de la santé;
  2. développer des lignes directrices pour l’évaluation éthique de projets Big Data;
  3. créer une plateforme conviviale permettant aux patients et aux personnes en bonne santé de participer directement à la recherche;
  4. proposer des règles garantissant un développement responsable de la recherche médicale dans le domaine du Big Data.

De plus en plus d’aspects de la médecine humaine sont transformés en données exploitables aussi bien au niveau clinique que scientifique. La récolte de ces données ne se limite plus aux professionnels, car tout un chacun peut le faire par le biais d’un smartphone. Les directives éthiques actuelles ne sont pas suffisantes pour répondre à cette évolution rapide du monde de la santé.

Ce projet aborde les lacunes actuelles concernant l’utilisation éthique des mégadonnées dans la recherche médicale. Nous mettons l’accent sur des thèmes comme l’analyse bénéfices-risques, le consentement éclairé, la protection de la sphère privée ainsi que les mécanismes de contrôle, avec le double objectif de:

  1. créer des instruments efficaces pour l’évaluation éthique et le traitement des mégadonnées dans le domaine de la santé;
  2. émettre des recommandations pour surmonter les obstacles qui entravent actuellement la recherche médicale en Suisse.

Direct link to Lay Summary Last update: 27.07.2017

Lay Summary (English)

Lead
An interdisciplinary team is investigating complex ethical questions raised by the Big Data revolution in medicine. What form should declarations of consent take in cases where individuals are making their health data available to researchers - and how can protection of their privacy be guaranteed?
Lay summary

The use of Big Data in medical research calls for the widespread collection, dissemination and evaluation of large quantities of personal and confidential information. This entails risks which need to be carefully assessed. To this end, our interdisciplinary team of experts is focusing on four main areas:

  1. We wish to understand the new types of ethical challenges facing the healthcare industry.
  2. We will develop guidelines for the ethical evaluation of Big Data projects.
  3. We will create a user-friendly platform that gives patients and healthy individuals an opportunity to participate directly in research.
  4. We will propose rules designed to ensure the responsible development of health research in the Big Data domain.

Ever more aspects of human health are being converted into data that can be evaluated both clinically and scientifically. This data can be collected not only by medical specialists but by anyone (with a smartphone, for instance). Current bioethical guidelines and provisions have fallen behind these rapid developments in the healthcare sector.

The present project addresses existing shortcomings in the ethical use of Big Data in medical research. We will focus on topics such as risk-benefit analysis, declaration of consent, protection of privacy and control mechanisms, with the dual objective of:

  1. creating efficient tools for the ethical evaluation and handling of Big Data in the healthcare sector, and
  2. making recommendations on overcoming the current obstacles to medical research in Switzerland.

Direct link to Lay Summary Last update: 27.07.2017

Responsible applicant and co-applicants

Employees

Publications

Publication
Considerations for ethics review of big data health research: A scoping review
Ienca Marcello, Ferretti Agata, Hurst Samia, Puhan Milo, Lovis Christian, Vayena Effy (2018), Considerations for ethics review of big data health research: A scoping review, in PLOS ONE, 13(10), e0204937-e0204937.
Digital Medicine and Ethics: Rooting for Evidence
Vayena Effy, Ienca Marcello (2018), Digital Medicine and Ethics: Rooting for Evidence, in The American Journal of Bioethics, 18(9), 49-51.
Big data and dementia: charting the route ahead for research, ethics and policy.
Ienca Marcello, Vayena Effy, Blasimme Alessandro (2018), Big data and dementia: charting the route ahead for research, ethics and policy., in Frontiers in Medicine, 5(13), 00.
Machine Learning in Medicine.
Ferretti Agata, Schneider Manuel, Blasimme Alessandro (2018), Machine Learning in Medicine., in European Data Protection Law Review, 4(3), 320-332.

Collaboration

Group / person Country
Types of collaboration
Berkman Center for Internet & Society, Harvard Law School, Harvard University United States of America (North America)
- in-depth/constructive exchanges on approaches, methods or results
- Publication
- Exchange of personnel
Swiss Academy of Medical Sciences Switzerland (Europe)
- in-depth/constructive exchanges on approaches, methods or results
- Publication
The Salathe Group, School of Life Sciences, School of Computer and Communication Sciences EPFL Switzerland (Europe)
- in-depth/constructive exchanges on approaches, methods or results
- Publication
Oxford Internet Institute, University of Oxford Great Britain and Northern Ireland (Europe)
- in-depth/constructive exchanges on approaches, methods or results
- Publication

Scientific events

Active participation

Title Type of contribution Title of article or contribution Date Place Persons involved
Patient Advocacy in a Digital World Talk given at a conference Big data ethics for patient advocates 19.11.2018 Brussels, Belgium Ienca Marcello;
Sharing medical images for Big Data Talk given at a conference Adaptive governance for medical imaging 15.11.2018 Brocher Foundation, Switzerland Ienca Marcello;
The World Innovation Summit for Health (WISH) 2018 Talk given at a conference Ethical challenges in medical data sharing 13.11.2018 Doha, Qatar Vayena Effy (Eftychia);
Human Enhancement. Debating a Social Challenge Talk given at a conference Getting the better of me: being oneself in the age of big data 08.11.2018 Zürich, Switzerland Vayena Effy (Eftychia);
Third Workshop on Monitoring Dementia – New Insights from Health Claims Data and Electronic Medical Records Talk given at a conference Big data and dementia: scientific and ethical challenges 17.10.2018 Deutsches Zentrum für Neurodegenerative Erkrankungen, Germany Ienca Marcello;
Growing and Shaping the Internet of Things Wellness and Care Ecosystem Talk given at a conference Privacy and data protection non-medical Apps for Health and Wellness : review of OECD countries good practice 04.10.2018 New York, United States of America Vayena Effy (Eftychia);
Minding Neurotechnology: delivering responsible innovation for health and well-being” Talk given at a conference Big Data and the Brain 06.09.2018 Shanghai, China Ienca Marcello;
Postgraduate Bioethics Conference 2018 Talk given at a conference Big data trends in biomedical research: implications for ethics review boards 23.07.2018 Lisbon, Portugal Ferretti Agata;
Data Driven Life Workshop Talk given at a conference Data Driven Research 12.07.2018 Bruxelles, Belgium Vayena Effy (Eftychia);
Women in Big Data Poster Health-related big data: challenges and implications for ethics review committees 14.06.2018 Zürich, Switzerland Ferretti Agata;
Schweizerische Gesellschaft für Allgemeine Innere Medizin (SGAIM) Talk given at a conference Key ethical issues in data driven medicine 01.06.2018 Basel, Switzerland Vayena Effy (Eftychia);
The Cognitive Revolution Symposium Talk given at a conference Artificial Intelligence and Big brain data 17.05.2018 San Francisco , United States of America Ienca Marcello;
Workshop at Fondation Botnar Talk given at a conference Big data governance in the health sector: policy implications and ethical issues 23.03.2018 Fondation Botnar, Basel, Switzerland, Switzerland Vayena Effy (Eftychia);
'Changes' Talk given at a conference Ethishche Herausforderungen im Zeitalter von Big-Data und Digitalisierung 22.03.2018 Spital Emmental, 3400 Burgdorf, Switzerland Ienca Marcello;
Seminar “Better medicine thanks to data?” Talk given at a conference Ethical challenges in data sharing 21.03.2018 Swiss Academy of Medical Sciences, Zurich, Switzerland, Switzerland Vayena Effy (Eftychia);
Biannual Meeting of the European Network of Life Sciences Law Firms Talk given at a conference Big Brain Data: Do we Need Neurorights? 09.03.2018 Milan, Italy, Italy Ienca Marcello;
Lost in the Maze? Navigating Evidence and Ethics in Translational Neuroscience Talk given at a conference From Big Data to Smart Data: Accelerating the Translation of Digital Solutions for Dementia 14.02.2018 Hanover, Germany, Germany Ienca Marcello;
Médecine prédictive: faut-il rêver ou avoir peur? Talk given at a conference Aspects éthiques de la médecine personalisée, dans Médecine prédictive: faut-il rêver ou avoir peur? 08.02.2018 Lausanne, Switzerland Hurst-Majno Samia;
“Big data, big problems” Talk given at a conference “Challenges and opportunities in the context of data ownership, privacy and protection” 24.01.2018 The Delegation of the European Union to the UN and other international organisations in Geneva, Gene, Switzerland Vayena Effy (Eftychia);
Les futur-e-s professionnel-le-s de la santé se forment ensemble Talk given at a conference Ethique et Big Data dans Big Data et Santé 12.01.2018 Genève, Switzerland Hurst-Majno Samia;


Self-organised

Title Date Place
Digital Health Ethics: What's next? 07.09.2018 ETH Zurich, Switzerland

Knowledge transfer events

Active participation

Title Type of contribution Date Place Persons involved
AI for Good Global Summit 2018 Performances, exhibitions (e.g. for education institutions) 15.05.2018 Geneva, Switzerland Vayena Effy (Eftychia);


Communication with the public

Communication Title Media Place Year
Media relations: print media, online media Cambridge Analytica and Online Manipulation Scientific American International 2018
Media relations: print media, online media Online-Manipulation: Es geht nicht nur um Datenschutz German-speaking Switzerland 2018
Media relations: print media, online media Übertriebene Datenphobie schadet der Gesundheit NZZ Western Switzerland German-speaking Switzerland 2018

Associated projects

Number Title Start Funding scheme
187356 Digital Health Innovation: a Governance Roadmap for Switzerland (D-GOVmap) 01.04.2020 NRP 77 Digital Transformation

Abstract

This research project aims to develop an ethical framework for big data uses in health research. The framework will fill a current policy gap in how to ethically use a variety of data sets, that extend beyond the typical biomedical data, to conduct health research. Through a robust methodology we will develop: a typology of the ethical issues when big data are used in health; a set of ethical norms that address the ethical issues; and finally tools that can be used by researchers and ethics review committees to develop and review big data health research. BEHALF is the kind of innovative approach that is urgently needed in order for big data health research to fulfill its potential in Switzerland and globally.
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