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Ethical and legal regulation of Big Data research - towards a sensible and efficient use of electronic health records and social media data [BigResearchEthics]

English title Ethical and legal regulation of Big Data research - towards a sensible and efficient use of electronic health records and social media data [BigResearchEthics]
Applicant Elger Bernice
Number 167211
Funding scheme NRP 75 Big Data
Research institution Institut für Bio- und Medizinethik (IBMB) Universität Basel
Institution of higher education University of Basel - BS
Main discipline Health Education
Start/End 01.02.2017 - 30.04.2021
Approved amount 430'322.00
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All Disciplines (6)

Discipline
Health Education
Public Health and Health Services
Legal sciences
Philosophy
Health
Sociology

Keywords (1)

Big Data, research ethics, law, EHR, social media

Lay Summary (German)

Lead
In diesem Projekt untersuchen wir die bestehenden Ethikrichtlinien und Gesetze bezüglich der Nutzung von Big Data in der medizinischen Forschung. Ausserdem befragen wir die Anspruchsgruppen - Forschende, Patientenvertreter und Vertreter der Öffentlichkeit - zu ihren praktischen Bedürfnissen.Das Projekt umfasst drei Phasen. Zunächst untersuchen wir mithilfe traditioneller Analyseverfahren die existierenden nationalen und internationalen Ethikrichtlinien und gesetzlichen Vorschriften für Forschungsvorhaben, die Big Data (u. a. elektronische Gesundheitsdaten und Daten aus sozialen Medien) nutzen. Dann befragen wir Forschende und Personen, deren Daten zu Forschungszwecken genutzt werden, zu ihrer Einstellung, ihren Bedürfnissen und ihren Bedenken. Schliesslich analysieren wir die in diesen Gesprächen vermittelten Probleme sorgfältig unter ethischen und juristischen Gesichtspunkten und führen eine unabhängige Prüfung der relevanten Ethikrichtlinien und Gesetzestexte durch.
Lay summary

Die auf Big Data gestützte Forschung kann einen Beitrag zu einer hochwertigen, bezahlbaren Gesundheitsversorgung leisten. Allerdings hinken die für die Forschung geltenden Regulierungen der technologischen Entwicklung hinterher, etwa bei Forschungsprojekten, die auf elektronischen Gesundheitsdaten oder Daten aus den sozialen Medien basieren. Diese Rechtsunsicherheit könnte allgemeine Befürchtungen vor dem Umgang mit vertraulichen personenbezogenen Daten schüren. Daher sollten Forschungsthemen, die Einwilligungserklärungen voraussetzen und Interessenkonflikte bergen können, unbedingt und sorgfältig nach ethischen und juristischen Kriterien geprüft werden.

Das Fehlen klarer Ethikrichtlinien könnte sich negativ auf den Datenaustausch auswirken und Forschungsprojekte verhindern, die sich auf Big Data stützen. Vorrangiges Ziel dieser Studie ist daher die sinnvolle und effiziente Nutzung von elektronischen Gesundheitsdaten und Daten aus sozialen Medien. Das Projektteam will ethische und regulatorische Unsicherheiten abbauen, indem es Forschenden und Forschungsinstitutionen ethische Leitlinien für die Erfassung, Archivierung und Analyse von umfangreichen elektronischen Gesundheitsdaten und anderen digitalen Daten an die Hand gibt.

Das Projekt leistet einen Beitrag zur Debatte über die ethischen und regulatorischen Aspekte der Nutzung von Big Data in der biomedizinischen Forschung. Es unterstützt Forschende mit praktischen Leitlinien und ermöglicht ein tieferes Verständnis der Ängste, die in der Öffentlichkeit über den Missbrauch von Daten bestehen. Im besten Fall wird es regulatorische Lösungen anregen, die den Schutz vertraulicher personenbezogener Daten regeln. Das Projekt schlägt vor, wie Einverständniserklärungen aussehen könnten, mit denen Personen ihre Daten zur Verfügung stellen können, und fördert den gesellschaftlichen Nutzen dieses wachsenden Forschungsgebiets.

Direct link to Lay Summary Last update: 26.07.2017

Lay Summary (French)

Lead
Ce projet entend analyser les règles éthiques et légales qui régissent la recherche qui utilise des mégadonnées. Il vise également à déterminer les besoins concrets des acteurs concernés, en interrogeant autant des chercheurs que des représentants des patients et du public.Le projet se divise en trois étapes. En utilisant des méthodes analytiques classiques, nous allons d’abord passer en revue les documents éthiques et légaux, à l’échelle nationale et internationale, ayant trait à la recherche impliquant des dossiers de santé électroniques et des données des médias sociaux. Nous étudierons ensuite les comportements, les besoins et les préoccupations des acteurs concernés en menant des interviews avec des chercheurs et des personnes dont on utilise les données. Enfin, nous allons effectuer une analyse approfondie des problèmes détectés lors de ces interviews ainsi qu’une évaluation indépendante des documents éthiques et légaux pertinents.
Lay summary

S’appuyant sur les mégadonnées, la recherche peut contribuer à un système de santé de qualité et accessible. Les réglementations qui régissent les activités scientifiques n’ont toutefois pas suivi le même rythme que l’évolution technologique. La recherche se basant sur des dossiers de santé électroniques et celle impliquant les médias sociaux sont deux exemples importants. Cette incertitude réglementaire pourrait alimenter les peurs du public en matière de protection de la sphère privée et de confidentialité. Les études impliquant un consentement éclairé ou des conflits d’intérêt nécessitent donc d’urgence une évaluation éthique et légale approfondie.

L’absence de directives éthiques pourrait entraîner une réduction du partage des données et gêner la science au point de pénaliser le bénéfice sociétal de la recherche se basant sur des mégadonnées. L’objectif principal de cette étude est donc de tendre vers une utilisation sensée et efficace des dossiers de santé électroniques et des données des médias sociaux. Le projet vise à diminuer l’incertitude éthique et réglementaire en fournissant des directives aux chercheurs et aux institutions de recherche en matière de collecte, de stockage et d’analyse d’importants jeux de données sanitaires électroniques et d’autres données numériques.

Le projet contribuera à la mise en place d’une réglementation locale et internationale ainsi qu’aux débats éthiques sur l’utilisation des mégadonnées dans la recherche biomédicale. Il fournira ainsi des directives pratiques aux chercheurs s’intéressera à mieux appréhender les peurs du public quant à l’utilisation abusive des données. Une application optimale serait la mise à disposition de solutions réglementaires respectant la sphère privée, la confidentialité et le consentement éclairé de ceux dont on utilise les données tout en maximisant les bénéfices sociétaux de cette recherche émergente.


Direct link to Lay Summary Last update: 26.07.2017

Lay Summary (English)

Lead
This project will analyse existing ethical and legal regulations on research using Big Data. It will also explore the practical needs of stakeholders by interviewing researchers and representatives of patients and the public.The project has three phases. First, we will review existing national and international ethical and legal documents related to Big Data research involving electronic health records and social media using classical analytical methods. Second, we will investigate the attitudes, needs and concerns of involved stakeholders by conducting interviews with researchers and those whose data are being used. Finally, we will conduct a thorough ethical and legal analysis of the issues identified during the interviews and an independent review of the relevant ethical literature and legal documents.
Lay summary

Research using Big Data has the potential to contribute to quality, affordable health care. But regulations governing research have not kept pace with technology. Research involving electronic health records or social media are but two prominent examples. This regulatory uncertainty could stoke public fears about privacy and confidentiality. Research issues related to informed consent and conflicts of interest thus urgently require careful ethical and legal assessment.

The absence of clear ethical guidance could lead to reduced sharing of data and hinder research in a way that affects the societal benefit of Big Data research. The primary goal of this study is thus to strive towards a sensible and efficient use of electronic health records and social media data. The project aims to reduce ethical and regulatory uncertainty by providing ethical guidance for individual researchers and research institutions concerning the collection, storage and analysis of large electronic health record data sets and other digital data.

This project will contribute to the local and international regulatory and ethical debate on the use of Big Data in biomedical research. In so doing, the project will help to provide practical guidance for researchers and lead to better understanding of public fears about misuse of data. An optimal outcome would be regulatory solutions that protect the privacy, confidentiality and informed consent of those whose data are being used while maximising the societal benefits of this emerging research trend.


Direct link to Lay Summary Last update: 26.07.2017

Responsible applicant and co-applicants

Employees

Project partner

Publications

Publication
Social Media Terms and Conditions and Informed Consent From Children: Ethical Analysis
Schneble Christophe Olivier, Favaretto Maddalena, Elger Bernice Simonne, Shaw David Martin (2021), Social Media Terms and Conditions and Informed Consent From Children: Ethical Analysis, in JMIR Pediatrics and Parenting, 4(2), e22281-e22281.
«Eigentum» an Patientendaten – Wer meint damit eigentlich was?
WidmerMichael, Schneble Christophe, EgliPhilipp, ElgerBernice (2021), «Eigentum» an Patientendaten – Wer meint damit eigentlich was?, in Pflegerecht. Pflege in Politik, Wissenschaft und Ökonomie, 1.
Social-Media und Social-Messaging im Spital
SchnebleChristophe, Martani Andrea, ShawDavid, Elger Bernice (2020), Social-Media und Social-Messaging im Spital, in Jusletter, 1.
First do no harm: An exploration of researchers’ ethics of conduct in Big Data behavioral studies
Favaretto Maddalena, De Clercq Eva, Gaab Jens, Elger Bernice Simone (2020), First do no harm: An exploration of researchers’ ethics of conduct in Big Data behavioral studies, in PLOS ONE, 15(11), e0241865-e0241865.
Working Through Ethics Review of Big Data Research Projects: An Investigation into the Experiences of Swiss and American Researchers
Favaretto Maddalena, De Clercq Eva, Briel Matthias, Elger Bernice Simone (2020), Working Through Ethics Review of Big Data Research Projects: An Investigation into the Experiences of Swiss and American Researchers, in Journal of Empirical Research on Human Research Ethics, 15(4), 339-354.
Data protection during the coronavirus crisis
Schneble Christophe Olivier, Elger Bernice Simone, Martin Shaw David (2020), Data protection during the coronavirus crisis, in EMBO reports, 21(9), 1.
All Our Data Will Be Health Data One Day: The Need for Universal Data Protection and Comprehensive Consent
Schneble Christophe Olivier, Elger Bernice Simone, Shaw David Martin (2020), All Our Data Will Be Health Data One Day: The Need for Universal Data Protection and Comprehensive Consent, in Journal of Medical Internet Research, 22(5), e16879-e16879.
Big Data and Digitalization in Dentistry: A Systematic Review of the Ethical Issues
Favaretto Maddalena, Shaw David, De Clercq Eva, Joda Tim, Elger Bernice Simone (2020), Big Data and Digitalization in Dentistry: A Systematic Review of the Ethical Issues, in International Journal of Environmental Research and Public Health, 17(7), 2495-2495.
Automated vehicles, big data and public health
Shaw David, Favrat Bernard, Elger Bernice (2020), Automated vehicles, big data and public health, in Medicine, Health Care and Philosophy, 23(1), 35-42.
Google's Project Nightingale highlights the necessity of data science ethics review
Schneble Christophe Olivier, Elger Bernice Simone, Shaw David Martin (2020), Google's Project Nightingale highlights the necessity of data science ethics review, in EMBO Molecular Medicine, 12(3), 1.
What is your definition of Big Data? Researchers’ understanding of the phenomenon of the decade
Favaretto Maddalena, De Clercq Eva, Schneble Christophe Olivier, Elger Bernice Simone (2020), What is your definition of Big Data? Researchers’ understanding of the phenomenon of the decade, in PLOS ONE, 15(2), e0228987-e0228987.
Big Data and discrimination: perils, promises and solutions. A systematic review
Favaretto Maddalena, De Clercq Eva, Elger Bernice Simone (2019), Big Data and discrimination: perils, promises and solutions. A systematic review, in Journal of Big Data, 6(1), 12-12.
Defining Data Donation After Death: Metadata, Families, Directives, Guardians and the Route to Big Consent
Shaw David M. (2019), Defining Data Donation After Death: Metadata, Families, Directives, Guardians and the Route to Big Consent, in Krutzinna Jenny (ed.), Springer International Publishing, Cham, 151-159.
The Cambridge Analytica affair and Internet‐mediated research
Schneble Christophe Olivier, Elger Bernice Simone, Shaw David (2018), The Cambridge Analytica affair and Internet‐mediated research, in EMBO reports, 19(8), e46579-e46579.

Collaboration

Group / person Country
Types of collaboration
Prof. Heiko Schuldt Switzerland (Europe)
- in-depth/constructive exchanges on approaches, methods or results
Prof. Arthur Caplan United States of America (North America)
- Publication
Prof. Mark Rothstein United States of America (North America)
- in-depth/constructive exchanges on approaches, methods or results
Jean-Daniel Zeller Switzerland (Europe)
- in-depth/constructive exchanges on approaches, methods or results
Prof. Henning Müller Switzerland (Europe)
- in-depth/constructive exchanges on approaches, methods or results

Scientific events

Active participation

Title Type of contribution Title of article or contribution Date Place Persons involved
14th World Congress Of Bioethics Poster Discriminative issues in Big Data analytics 05.12.2018 Bangalore, India Favaretto Maddalena;
EACME Amsterdam 2018 - Ethics in Action Talk given at a conference Big Data and Discrimination. Perils Promises and Solutions. A Systematic Review 06.07.2018 Amsterdam, Netherlands Favaretto Maddalena;


Self-organised

Title Date Place
Symposium: Ethical Issues in Big Data Research 29.11.2018 University of Basel , Switzerland
Contemporary Debates: Ethical and Legal Regulation of Big Data Research 18.09.2017 Basel, Switzerland

Abstract

Big Data research using electronic health records (EHR) and social media (SM) available through the internet are an effective and constantly improving means to generate quick and valuable knowledge about the functioning of human beings and society. They aid to answer important research questions related to health, well-being, functioning and behaviour of various populations and institutions. This type of readily available data is valuable for many disciplines including medicine, psychology, and sociology. It holds the potential to have a direct impact on quality and cost-efficiency of health care as validated by real time use of Big Data in smarter healthcare and cities projects.As research regulations have been originally conceived for clinical trials, researchers carrying out studies that use EHR and SM face considerable uncertainty. Recently, the public has reacted strongly to the perception that research involving data and biological samples (generating genetic data) is underregulated and therefore data abuse is becoming a high risk. Big Data research has opened previously unprecedented possibilities of data research and has increasingly highlighted public fears of abuse: predictive analysis of EHR is being developed for so-called smarter hospitals to help identify in real time patients at high risk for health deterrioration. Models based on algorithms are developed to predict and address healthcare and resource allocation in smarter hospitals. In medicine and psychology, routine data from EHR offer the potential to use data from millions of people to answer important research questions at much lower cost than clinical trials. Combination of information from SM, consumer data (e.g. data from the Migros Cumulus card) and EHR data could enable in finding objectivable results that were previously only available through more costly subjective tools such as patient or consumer questionnaires.This type of very promising Big Data research raises new technical and regulatory concerns due to its specific characteristics: the vast amount (variety, volume) of useful data generated at an unprecedented speed (velocity) encompassing not only medical information but also sociodemographic and financial data. It thus presents challenges on veracity at various levels of data flow, ranging from the extraction of information to data sharing and methods of data management and analysis. Among the most pressing ethical and regulatory concerns are issues of consent, privacy, confidentiality and conflicts of interest. Countries are struggeling individually and often differently with the regulatory void, and the varying domestic approaches lead to concerning barriers for international research. In Switzerland, it is at present not always clear which type of Big Data research is considered human subject research and must receive approval from cantonal research ethics committees (CRECs). Furthermore, CRECs lack capacities to treat all research from such grey zones, especially if they are done outside of medical faculties. Some researchers have sought to address this shortcoming by enacting their own department or faculty commissions to approve research. These commissions, in contrast to the CRECs, do not have a legal status and their competence and scope remain undefined. The past has shown that if research remains largely unregulated there is a risk of public “backfire”. Citizens’ fear of abuse and of research taking place “behind their backs” can create the feeling that regulations must be particularly strict. There are several recent historical examples to this effect. The present project fills the existing research gap of how to deal ethically with dsata while at the same time avoiding unnecessary barriers to otherwise beneficial Big Data research. Guidance for ethics committees worldwide, and also locally in Switzerland, is urgently needed. The objectives and methods of this project are the following:i.Review existing national and international ethical as well as legal guidance related to Big Data research involving EHR and SM using classical comparative analysis methods.ii.Understand the attitudes and local needs of researchers and barriers they fear: to this aim we will carry out qualitative interviews with (a) researchers and (b) with those whose data are used.iii.Use the results from the preceding parts (i. & ii.) and perform thourough ethical analysis, after review of the relevant ethico-legal literature, to influence the local and international regulatory and ethical debate and to propose and further a sensitive and efficient research ethics framework.
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