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 page The BEHALF project 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 page p3.snf.ch/Project-167223

Project Partner:
external page Swiss National Science Foundation

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 page potential in the field of health and medicine. However, the literature also reports about the external page technical and methodological challenges 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 page black box” 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 page dual use) or by digital tools that lack clear external page safety and efficacy evidences.

Our research findings show that external page privacy 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 page overlooking other ethical concerns (e.g., research accountability, fair distribution of risks and benefits, individual autonomy and empowerment, and group-level harm mitigation).

The external page fragmented ethical and regulatory guidance 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 page weak oversight mechanisms, which are challenged by the novelties of big data. In the field of research, for instance, RECs must be external page reformed at various levels (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 page Samia Hurst
Professor of Bioethics at the Institute for Ethics, History, Humanities, University of Geneva

external page Milo Puhan
Professor of Epidemiology and Public Health at the University of Zurich

external page Christian Lovis
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 page Minerva Rivas Velarde
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 page Edward S. Dove
Lecturer at the School of Law, University of Edinburgh

external page Susanne Driessen
President of Swissethics

external page Bobbie Farsides
Professor of Clinical and Biomedical Ethics at the Brighton and Sussex Medical School

external page Phoebe Friesen
Assistant Professor at the Biomedical Ethics Unit, McGill University

external page Nadja Hedrich
PhD Candidate at University of Zurich

external page Jeff Kahn
Professor Bioethics and Public Policy at the Johns Hopkins University Berman Institute of Bioethics

external page Walter Karlen
Professor of Biomedical Engineering at Ulm University

Peter Kleist
Managing Director of the Research Ethics Committee, Canton Zurich

external page S. Matthew Liao
Professor of Bioethics at the New York University School of Global Public Health

external page Thibault Paul Lovey
PhD Candidate at University of Zurich

external page Camille Nebeker
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 page Gabrielle Samuel
Research Fellow at the Department of Global Health and Social Medicine, King’s College London

external page Mahsa Shabani
Assistant Professor at the Faculty of Law and Criminology, Ghent University

external page Mark Sheehan
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 page Patricia Schlagenhauf
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 page https://doi.org/10.1016/j.tmaid.2021.102143

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 page https://doi.org/10.1177/15562646211053538

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 page https://doi.org/10.3389/fdgth.2021.660823

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 page https://doi.org/10.1186/s12910-021-00616-4

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 page https://doi.org/10.1002/eahr.500065

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 page https://doi.org/10.1016/S2589-7500(19)30027-5

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 page https://doi.org/10.1371/journal.pone.0204937

Ienca, M., & Vayena, E. (2018). Dual use in the 21st century: emerging risks and global governance. Swiss medical weekly, 148, w14688. external page https://doi.org/10.4414/smw.2018.14688

Vayena E., & Ienca, M. (2018). Digital Medicine and Ethics: Rooting for Evidence. The American Journal of Bioethics, 18(9), 49-51. external page http://dx.doi.org/10.1080/15265161.2018.1498955

Ferretti, A., Schneider, M., & Blasimme, A. (2018). Machine Learning in Medicine. European Data Protection Law Review, 4(3), 320-332.
external page https://doi.org/10.21552/edpl/2018/3/10

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 page https://doi.org/10.3389/fmed.2018.00013

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 page collaborative position paper.

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 page Swissethics – 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 page further use of data (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 page beyond data protection and privacy preserving approaches
Translate scattered and general ethical guidance into external page actionable and streamlined practices
Establish external page minimum international standards for ethically aligned data uses
Introduce external page regulatory, procedural, and complementary reforms 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)

Self assessment tool (flowchart)

Enlarged view: Self Assessment Tool — This self assessment tool was designed to help RECs, both in Switzerland and abroad, assess their preparedness and address their weaknesses in the big data research context. Using the flowchart, committees can identify shortcomings and take actions to overcome them. As well, this tool highlights certain big data projects that currently fall outside ethical review. By doing so, the tool draws RECs’ attention to those areas in research ethics that may need regulatory revisions.

Ethical assessment tool (checklist)

Enlarged view: Ethical Assessment Tool — RECs can use this ethical assessment tool when reviewing big data projects. Adoption of this tool across committees would help increase the consistency and transparency of their review approach. Researchers too can use this tool to ethically assess their research with big data, and identify how well their project meets RECs’ standards. Thus this tool helps researchers reflect on and address ethical issues that might emerge in their research. Ultimately, this tool promotes ethical data uses also outside academia. Private sector developers and researchers can also use this tool to recognize ethical issues which could cause reputational harm if left unaddressed. As well, private sector use of this tool would promote collaboration with academic research partners.