Bigdata-Ethics-HeALth Framework - BEHALF
BEHALF was a four-year project funded by the Swiss National Science Foundation, within the NRP 75 Programme on Big Data. This research project aimed to develop an ethical framework for big data uses in health research. The framework guides the evaluation of ethical questions that were unanswered, such as: How to ensure responsible big data research in health and beyond given the evolving big data ecosystem? Are the existing ethical standards sufficient to adequately assess big data and artificial intelligence (AI) driven projects? Are the current ethical oversight mechanisms effective fulfilling their role given the emerging challenges in the big data context?
Through a robust methodology we developed:
- a typology of ethical challenges to watch for when big data are used in health research, and digital health more broadly;
- a set of ethical norms and policy recommendations that address these challenges;
- a tool for Research Ethics Committees (RECs) to assess their readiness in big data health research;
- a tool for both researchers and ethical oversight mechanisms to ensure responsible big data health research and digital health development.
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.
History of the project
external pageThe BEHALF projectcall_made ran from September 2017 to August 2021. This project led by Prof. Effy Vayena aimed to answer interrogatives such as: how should researchers ethically use data sets that extend beyond the typical biomedical data to conduct health research? Do we need new global research ethics standards considering current technological advancements (e.g., big data, AI-enabled tools, increased computational power, etc.)? Are RECs (in Switzerland and abroad) adequately equipped to deal with new challenges? Are other mechanisms necessary to improve oversight of big data uses in research and digital health applications?
Project Link:
external pagep3.snf.ch/Project-167223call_made
Project Partner:
external pageSwiss National Science Foundationcall_made
Project Team:
Effy Vayena
Marcello Ienca
Agata Ferretti
- Over the past 10 years the research community became increasingly aware of the big data and AI-enabled technologies external pagepotentialcall_made in the field of health and medicine. However, the literature also reports about the external pagetechnical and methodological challengescall_made that emerge at various stages of the data lifecycle, and their ethical implications.
- Among the technical implications of big data research and AI-enabled technologies for health and medicine, the “external pageblack boxcall_made” issue in AI systems and the risk of biased datasets are increasingly debated. Authors have also expressed concerns about the potential harm caused by misplaced health technologies (i.e., external pagedual usecall_made) or by digital tools that lack clear external pagesafety and efficacycall_made evidences.
- Our research findings show that external pageprivacycall_made is the most debated ethical concern of big data and AI-enabled technologies. In fact, researchers and app developers seem to understand the ethical use of big data mainly as compliance with existing data protection regulations. However, to consider data protection as ethical panacea might translate in external pageoverlooking other ethical concernscall_made (e.g., research accountability, fair distribution of risks and benefits, individual autonomy and empowerment, and group-level harm mitigation).
- The external pagefragmented ethical and regulatory guidancecall_made about how to use big data and AI-enabled technology in health research increases uncertainty among a variety of stakeholders. For instance, technology developers and researchers need to orient themselves in a jungle of scattered norms and unclear standards, potentially leaving emerging harms unaddressed.
- This ambiguity within the ethical frameworks is amplified by external pageweak oversight mechanismscall_made, which are challenged by the novelties of big data. In the field of research, for instance, RECs must be external pagereformed at various levelscall_made (i.e., regulatory, procedural, complementary) to effectively fulfill their role of key oversight mechanism.
- Empirical results collected in the Swiss context expose RECs’ lack of expertise in big data science as well as their uncertainty about how to account for big data research risks. To address some of their limitations, RECs expressed the need for more specific training in the technical matters of big data research, the willingness to refine their ethical assessment tools, and a positive disposition towards introducing complementary forms of oversight.
The BEHALF project was led by a team of researchers from the Health Ethics and Policy Lab, ETH Zurich in collaboration with colleagues from the University of Geneva and the University of Zurich.
Leading Principal Investigator
Effy Vayena
Professor of Bioethics at the Health Ethics and Policy Lab, ETH Zurich
Co - Principal Investigators
external pageSamia Hurstcall_made
Professor of Bioethics at the Institute for Ethics, History, Humanities, University of Geneva
external pageMilo Puhancall_made
Professor of Epidemiology and Public Health at the University of Zurich
external pageChristian Loviscall_made
Professor of Clinical Informatics at the University of Geneva
Project Team
Marcello Ienca
Senior Research Fellow at the Health Ethics and Policy Lab, ETH Zurich
Agata Ferretti
Postdoctoral Researcher at the Health Ethics and Policy Lab, ETH Zurich
external pageMinerva Rivas Velardecall_made
Research Fellow at the Department of Radiology and Medical Informatics, University of Geneva
Collaborators:
Alessandro Blasimme
Senior Scientist at the Health Ethics and Policy Lab, ETH Zurich
external pageEdward S. Dovecall_made
Lecturer at the School of Law, University of Edinburgh
external pageSusanne Driessencall_made
President of Swissethics
external pageBobbie Farsidescall_made
Professor of Clinical and Biomedical Ethics at the Brighton and Sussex Medical School
external pagePhoebe Friesencall_made
Assistant Professor at the Biomedical Ethics Unit, McGill University
external pageNadja Hedrichcall_made
PhD Candidate at University of Zurich
external pageJeff Kahncall_made
Professor Bioethics and Public Policy at the Johns Hopkins University Berman Institute of Bioethics
external pageWalter Karlencall_made
Professor of Biomedical Engineering at Ulm University
Peter Kleist
Managing Director of the Research Ethics Committee, Canton Zurich
external pageS. Matthew Liaocall_made
Professor of Bioethics at the New York University School of Global Public Health
external pageThibault Paul Loveycall_made
PhD Candidate at University of Zurich
external pageCamille Nebekercall_made
Associate Professor in the School of Medicine at the University of California, San Diego
Elettra Ronchi
Senior Policy Analyst at the Organization for Economic Co-operation and Development (OECD)
external pageGabrielle Samuelcall_made
Research Fellow at the Department of Global Health and Social Medicine, King’s College London
external pageMahsa Shabanicall_made
Assistant Professor at the Faculty of Law and Criminology, Ghent University
external pageMark Sheehancall_made
Research Fellow at the Ethox Centre, University of Oxford
Klaas Enno Stephan
Professor of of Translational Neuromodeling & Computational Psychiatry at the University of Zurich & ETH Zurich
Diana Zandi
Technical Officer at the World Health Organization (WHO)
external pagePatricia Schlagenhaufcall_made
Professor of Travel Medicine and Malaria at University of Zurich
Peer-reviewed publications
The BEHALF project produced numerous peer-reviewed publications published in international outlets.
Ienca, M. & Vayena, E. (2021) Ethical requirements for responsible research with hacked data. Nature Machine Intelligence. https://doi.org/10.1038/s42256-021-00389-w to the behalf webpage https://bioethics.ethz.ch/research/BEHALF.html
Ferretti, A., Hedrich, N., Lovey, T., Vayena, E., Schlagenhauf, P. (2021) Mobile apps for travel medicine and ethical considerations: a systematic review. Travel Medicine and Infectious Disease. external pagehttps://doi.org/10.1016/j.tmaid.2021.102143call_made
Ferretti, A., Ienca, M., Rivas Velarde, M., Hurst, S., Vayena, E. (2021). The Challenges of Big Data for Research Ethics Committees: A Qualitative Swiss study. Journal of Empirical Research in Human Research Ethics, doi: external pagehttps://doi.org/10.1177/15562646211053538call_made
Blasimme, A., Ferretti, A., & Vayena, E. (2021). Digital contact tracing against COVID-19 in Europe: current features and ongoing developments. Frontiers in Digital Health, 3, 61. external pagehttps://doi.org/10.3389/fdgth.2021.660823call_made
Ferretti, A., Ienca, M., Sheehan, M., Blasimme, A., Dove, E. S., Farsides, B., ... & Vayena, E. (2021). Ethics review of big data research: What should stay and what should be reformed?. BMC Medical Ethics, 22(1), 1-13. external pagehttps://doi.org/10.1186/s12910-021-00616-4call_made
Ferretti, A., Ienca, M., Hurst, S., & Vayena, E. (2020). Big Data, Biomedical Research, and Ethics Review: New Challenges for IRBs. Ethics & human research, 42(5), 17-28. external pagehttps://doi.org/10.1002/eahr.500065call_made
Ferretti, A., Ronchi, E., & Vayena, E. (2019). From principles to practice: benchmarking government guidance on health apps. The Lancet Digital Health, 1(2), e55-e57. external pagehttps://doi.org/10.1016/S2589-7500(19)30027-5call_made
Ienca, M., Ferretti, A., Hurst, S., Puhan, M., Lovis, C., & Vayena, E. (2018). Considerations for ethics review of big data health research: A scoping review. Plos One, 13(10). external pagehttps://doi.org/10.1371/journal.pone.0204937call_made
Ienca, M., & Vayena, E. (2018). Dual use in the 21st century: emerging risks and global governance. Swiss medical weekly, 148, w14688. external pagehttps://doi.org/10.4414/smw.2018.14688call_made
Vayena E., & Ienca, M. (2018). Digital Medicine and Ethics: Rooting for Evidence. The American Journal of Bioethics, 18(9), 49-51. external pagehttp://dx.doi.org/10.1080/15265161.2018.1498955call_made
Ferretti, A., Schneider, M., & Blasimme, A. (2018). Machine Learning in Medicine. European Data Protection Law Review, 4(3), 320-332.
external pagehttps://doi.org/10.21552/edpl/2018/3/10call_made
Ienca, M., Vayena, E., & Blasimme, A. (2018). Big Data and Dementia: Charting the Route Ahead for Research, Ethics, and Policy. Frontiers in Medicine, 5(13). external pagehttps://doi.org/10.3389/fmed.2018.00013call_made
Doctorate Thesis
Agata Ferretti began as a SNSF funded doctoral candidate on the BEHALF project, and since then transitioned to a Postdoctoral position. Agata’s work on the BEHALF project was included in her cumulative PhD dissertation titled “Ethics and Governance of Big Data in Health Research and Digital Health Applications”.
Scientific events
Experts Online Workshop: “Big Data Challenges for Ethics Review Committees (ERCs)” (April 2020)
The online workshop allowed experts in the field of data governance, research ethics and big data to reflect on how the ethical, legal and social implications (ELSI) of big data impact current research oversight mechanisms, and set the basis for an international ethical framework for the ethics review of big data in health research. This event provided the opportunity to foster collaborations between international academic experts working in this domain of research, and resulted in a external pagecollaborative position papercall_made.
International Symposium: “Digital Health Ethics: What’s Next?” (September 2018)
At the international symposium the participants discussed the blurry lines between medical and non-medical data, given the proliferation of new computational technologies and the possibility to generate, process, and analyse an increasing amount of data. A report of the event is available as: Jobin, A. & Ferretti, A. (2019 – in press). The future of digital health ethics. Bioethica Forum (ISSN 1662-601X).
Revisions of the Swissethics templates for researchers
As a result of the findings of this project, external pageSwissethicscall_made – the umbrella organisation of the Swiss Cantonal Ethics Committees – modified and expanded their templates used by researchers for project submissions. Specificially, regarding projects that involve the external pagefurther use of datacall_made (with and without consent). Some template sections were expanded, while others were introduced anew, such as sections about biases in the datasets, transparent data processing, strategies to store data securely, risk-benefit assessment, scientific validity of the research, and findings dissemination. The findings of BEHALF also informed the revision of those checklist used by Cantonal RECs to assess whether a research protocol is ethically aligned or not.
International call to reform the ethics oversight mechanism and big data governance in health research and digital health
This project highlights gaps in the current regulatory and oversight landscape of big data uses for health research and digital health. The following policy recommendations may help filling these gaps and streamline the processes that govern ethical data uses:
- Revise and expand the existing ethical standards going external pagebeyond data protection and privacy preserving approachescall_made
- Translate scattered and general ethical guidance into external pageactionable and streamlined practicescall_made
- Establish external pageminimum international standardscall_made for ethically aligned data uses
- Introduce external pageregulatory, procedural, and complementary reformscall_made to strengthen the role of the existing oversight mechanisms and improve the review process
To know more about these policy recommendations, please see Agata Ferretti’s doctorate thesis (CHAPTER 10, p. 214)
Ethics Toolkit
This project resulted in an ethics toolkit designed to help RECs and researchers reflect on and assess ethical uses of big data. As well, this toolkit provides a means for REC's and researchers to practically implement high-level recommendations and international governance. The toolkit, consisting of two parts as shown below, was developed by Agata Ferretti and Marcello Ienca under the supervision of Effy Vayena.
To know more about this toolkit, please see Agata Ferretti’s doctorate thesis (CHAPTER 10, p. 216)