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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
Ethics review of big data research: What should stay and what should be reformed?
Ferretti Agata, Ienca Marcello, Sheehan Mark, Blasimme Alessandro, Dove Edward S., Farsides Bobbie, Friesen Phoebe, Kahn Jeff, Karlen Walter, Kleist Peter, Liao S. Matthew, Nebeker Camille, Samuel Gabrielle, Shabani Mahsa, Rivas Velarde Minerva, Vayena Effy (2021), Ethics review of big data research: What should stay and what should be reformed?, in BMC Medical Ethics, 22(1), 51-51.
Ethical requirements for responsible research with hacked data
Ienca Marcello, Vayena Effy (2021), Ethical requirements for responsible research with hacked data, in Nature Machine Intelligence, 3(9), 744-748.
Mobile apps for travel medicine and ethical considerations: A systematic review
Ferretti Agata, Hedrich Nadja, Lovey Thibault, Vayena Effy, Schlagenhauf Patricia (2021), Mobile apps for travel medicine and ethical considerations: A systematic review, in Travel Medicine and Infectious Disease, 43, 102143-102143.
Digital Contact Tracing Against COVID-19 in Europe: Current Features and Ongoing Developments
Blasimme Alessandro, Ferretti Agata, Vayena Effy (2021), Digital Contact Tracing Against COVID-19 in Europe: Current Features and Ongoing Developments, in Frontiers in Digital Health, 3, 660823.
Ethics and Governance of Big Data in Health Research and Digital Health Applications
FerrettiAgata (2021), Ethics and Governance of Big Data in Health Research and Digital Health Applications, /, ETH Zurich.
Big Data, Biomedical Research, and Ethics Review: New Challenges for IRBs
Ferretti Agata, Ienca Marcello, Hurst Samia, Vayena Effy (2020), Big Data, Biomedical Research, and Ethics Review: New Challenges for IRBs, in Ethics & Human Research, 42(5), 17-28.
From principles to practice: benchmarking government guidance on health apps
Ferretti Agata, Ronchi Elettra, Vayena Effy (2019), From principles to practice: benchmarking government guidance on health apps, in The Lancet Digital Health, 1(2), e55-e57.
Dual use in the 21st century: emerging risks and global governance
Ienca Marcello, Vayena Effy (2018), Dual use in the 21st century: emerging risks and global governance, in Swiss Medical Weekly, w14688.
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
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
Swiss Academy of Medical Sciences Switzerland (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
EraPerMed on Personalised Medicine (04/2021) Talk given at a conference Ethical Implications of Big Data and Artificial Intelligence for Personalised Medicine 01.04.2021 online, Switzerland Ferretti Agata;
Online webinar, School of Medicine University of Zagreb Talk given at a conference Digital Health: Ethical, Legal and Social Perspective for a Sustainable Future 01.12.2020 Zagreb, Croatia Ienca Marcello;
Online Webinar, Centre for Biomedical Ethics (CBmE), National University of Singapore (11/2020) Talk given at a conference Conceptual issues impeding uses & sharing of big data in biomedicine 01.11.2020 online, Singapore Ferretti Agata;
Nexa Centre for Internet & Society, Polytechnic University of Turin Talk given at a conference Natural and Artificial Intelligence: Considerations between science and ethics 01.09.2020 Online, Italy Ienca Marcello;
i-Consent conference Talk given at a conference Rethinking Consent: Emerging Challenges in the Digital Era 01.03.2020 Online, Germany Ienca Marcello;
Oxford University Workshop Talk given at a conference Public engagement for data uses 01.01.2020 Oxford, Great Britain and Northern Ireland Vayena Effy (Eftychia);
CPDP 13th International Conference Talk given at a conference Panel discussion on Data Privacy and Artificial Intelligence 01.01.2020 Brussel, Belgium Vayena Effy (Eftychia);
Symposium University of Wisconsin Talk given at a conference Ethics of Artificial Intelligence in Medicine 01.10.2019 Madison, United States of America Ienca Marcello;
ASBH 21st Annual Meeting Talk given at a conference The ethics of using hacked data 01.10.2019 Online, United States of America Vayena Effy (Eftychia);
EACME conference 2019: rethinking ethics in 21st century Europe Talk given at a conference Health-related big data research: what are the implications and recommendations for Ethical Review Committees? 01.09.2019 Oxford, Great Britain and Northern Ireland Ferretti Agata;
European conference on philosophy of medicine and health care Talk given at a conference Shedding light on the black-box 01.08.2019 Lisbon, Portugal Ferretti Agata;
Oxford global health and bioethics international conference 2019 Talk given at a conference How can AI and Big Data support the achievement of SDG#3 in resource-poor settings? 01.07.2019 Oxford, Great Britain and Northern Ireland Ferretti Agata;
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);
Human enhancement – debating a social challenge (organizer; NEK, Zurich CH) Talk given at a conference Getting the better of me: being oneself in the age of big data 01.11.2018 Zurich, 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
Big Data Challenges for Ethics Review Committees (ERCs) 01.04.2020 online, Switzerland
Digital Health Ethics: What's next? 07.09.2018 ETH Zurich, Switzerland
Digital Health Ethics: What’s Next?” 01.09.2018 Zurich, Switzerland

Knowledge transfer events

Active participation

Title Type of contribution Date Place Persons involved
AI+X Summit (ETH Zurich) Poster 13.10.2021 ETH Zurich, Switzerland Ferretti Agata;
Swissethics – Swiss Cantonal RECs - “Health-related big data research: Implications and recommendations for Research Ethics Committees (RECs)” Talk 01.04.2021 Online, Switzerland Ferretti Agata;
Swiss Alliance for Data-Intensive Services - "BEHALF - An ethical framework for the use of health-related Big Data" Talk 02.11.2020 Online, Switzerland Ferretti Agata;
World Health Summit 2020 - “A Call to Action for Health Data Governance” Talk 01.10.2020 Online, Switzerland Vayena Effy (Eftychia);
Future Health 2020 - "Me, Myself and Algorithms" Talk 01.01.2020 Basel, Switzerland Ienca Marcello;
IBM Research - "Ethics of Deep Learning" Talk 01.09.2019 Zurich, Switzerland Ienca Marcello;
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 "We have to ask ourselves what to do with hacked data" ETH News German-speaking Switzerland International 2021
Talks/events/exhibitions “Data Privacy Day: Privacy and Neurorights”, International 2021
Talks/events/exhibitions “Technology, Ethics and the Future of Humanity” International 2021
Other activities BEHALF Webpage - Summary of the project International 2021
Talks/events/exhibitions Science afternoon: Health data and digital technology International 2021
New media (web, blogs, podcasts, news feeds etc.) “To trace or not to trace: Contact tracing and respecting privacy” ETH Podcast International 2020
Talks/events/exhibitions “Towards a patient-centered use of artificial intelligence” International 2020
Media relations: print media, online media «Les crises de cette ampleur tendent un miroir à nos sociétés» Le Temps Western Switzerland 2020
Talks/events/exhibitions 2nd Meeting of the Ad Hoc Committee on Artificial Intelligence (CAHAI), Council of Europe International 2020
Media relations: print media, online media The “black box” problem. The Globe & ETH Magazine International 2020
Talks/events/exhibitions Global Forum on AI for Humanity (in the presence of the President of the French Republic, Mr. Eman International 2019
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 German-speaking Switzerland Western 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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