Overview #
The COVID-19 pandemic presented an unparalleled public health challenge, compelling governments, health agencies, and institutions worldwide to make swift decisions in order to develop effective diagnostics, treatments, and vaccines.
During a pandemic, the timely collection, analysis, and sharing of samples and data become crucial to advance global research efforts, along with the use of digital technologies, including automated data processing, location data, and contact tracing applications. Biobanks therefore emerge as vital infrastructures, providing access to high-quality samples and data necessary for research.
However, beyond the technical and logistical aspects of responding to a global pandemic, the ethical, legal and societal issues associated with biobanking gain heightened importance. The need to protect public health requires measures that may infringe on individual freedoms, such as quarantine and mandatory testing. It is crucial to ensure that individual rights and balanced with public good, and that measures introduced are ethically justified, proportionate and maintain public trust.
Key ethical, legal and societal implications #
Data Protection and privacy #
Whilst collecting and sharing data quickly and widely can accelerate research, it does raise concerns about privacy, data ownership, intellectual property, as well as the potential for misuse. This includes the use of digital tools for surveillance, such as contact tracing apps adopted in a pandemic, which can also have long-term impacts on privacy and fundamental rights. Establishing clear guidelines and oversight mechanisms is crucial. It is also essential to ensure that data is securely stored, anonymised where possible, and only used for legitimate public health purposes is essential. Only the data necessary to achieve public health objectives should be used.
Whilst international collaboration needs to be facilitated during a pandemic, it would still be necessary to ensure that data-sharing agreements respect the national regulatory and ethical frameworks.
Informed consent #
Informed consent during a pandemic can be challenging, particularly when time is of the essence or when individuals are incapacitated. The urgency of research often necessitates rapid sample collection, which sometimes challenges traditional informed consent processes. There may be a need for biobanks and researchers to adapt consent procedures to ensure that participants are fully informed and that their autonomy is respected, even under time constraints. It would also be important to ensure that vulnerable populations are not disproportionately burdened or exploited in research or public health interventions.
Public Trust #
The success of biobanking and biomedical research during a pandemic can depend heavily on public trust. Biobanks therefore need to be transparent about their practices, including how samples are collected, stored, and used. Clearly communicating the benefits and risks associated with participation during a pandemic remains crucial.
Legal and ethical EU sources #
- General Data Protection Regulation (GDPR): The GDPR provides a regulatory framework for lawfully processing personal data. While not explicitly about COVID-19 or other global health emergencies, the GDPR would apply.
- EDPB, Statement on the processing of personal data in the context of the COVID-19 outbreak (European Data Protection Board, 2020): several considerations should be considered to guarantee the lawful processing of personal data and in all cases, it should be recalled that any measure taken in this context must respect the general principles of law and must not be irreversible
- European Commission, Guidance on the management of clinical trials during the Covid-19 pandemic, 2022: it should be noted that the simplification measures proposed in this document will only last during the current public health crisis until the revocation of this Guidance, when there is a consensus that the period of the COVID-19 outbreak in the EU/EEA, has passed.
BBMRI-ERIC resources #
The below resources have been developed by those included in the BBMRI network:
Webinars #
- COVID-19 and Ethical, Legal and Societal Issues – This webinar explores the ethical issues encountered and addressed during the COVID-19 outbreak in relation to biobanking, looking at cases from Italy and Germany. Additionally, it addresses legal and societal aspects of the pandemic, touching on the intersection between clinical routine and research.
Publications #
- Oldoni E, van Gool A, García Bermejo L, Scherer A, Mayrhofer MT, Florindi F, Demotes J, Kubiak C, Fauvel AC, Bietrix F, Ussi A, Andreu AL.. Biomarker Research and Development for Coronavirus Disease 2019 (COVID-19): European Medical Research Infrastructures Call for Global Coordination. Clin Infect Dis. 2021 May 18;72(10):1838-1842. doi: 10.1093/cid/ciaa1250. PMID: 33091118; PMCID: PMC7665366.
- Catchpoole DR, Florindi F, Ahern C, Garcia DL, Mullins P, Van Enckevort E, Zaayenga A, Mayrhofer MT, Holub P.. Expanding the BBMRI-ERIC Directory into a Global Catalogue of COVID-19-Ready Collections: A Joint Initiative of BBMRI-ERIC and ISBER. Biopreserv Biobank. 2020. https://doi.org/10.1089/bio.2020.29075.drc
- Holub P, Kozera L, Florindi F, van Enckevort E, Swertz M, Reihs R, Wutte A, Valík D, Mayrhofer MT; BBMRI-ERIC community.. BBMRI-ERIC’s contributions to research and knowledge exchange on COVID-19. Eur J Hum Genet. 2020. https://doi.org/10.1038/s41431-020-0634-8
- Jahns R, Lavitrano M, Chassang G, Mayrhofer MT, Goisauf M, Adeniran A, Akyüz K, Cano Abadía M, Casati S. BBMRI-ERIC ELSI Services & Research Q&A on COVID-19 & ELSI (Version V1). https://zenodo.org/records/3839273
Q&A and Templates #
- BBMRI-ERIC ELSI Services & Research Q&A on COVID-19 & ELSI by Jahns, R., Lavitrano, M., Chassang, G., et al : This document addresses questions posed during the ELSI Dialogues Webinar, exploring the topics in more detail. It also showcases two examples from Germany and Italy, as well as a detailed commentary on contact-tracing-apps from a legal perspective.
- Informed Consent to the Collection, Storage and Use of Biological Materials for COVID-19 Research: This is an informed consent template for biobanking practices for COVID-19 research.
External resources #
The below resources have been developed outside of the BBMRI network:
- Statement on the processing of personal data in the context of the COVID-19 outbreak by the European Data Protection Board (Adopted on 19 March 2020). This Statement gives an overview of various considerations to guarantee the lawful processing of personal data. The need to respect the general principles of law are highlighted.
- European Solidarity and the Protection of Fundamental Rights in the COVID-19 Pandemic by the European Group on Ethics in Science and Technology. This statement issued by the European Group on Ethics in Science and New Technologies calls for vigilance with regards to the necessity, evidence, proportionality of any policy and technological intervention that suspends fundamental rights, even if temporarily.
- Responsibility of Research Ethics Committees during the COVID-19 Pandemic by the European Network of Research Ethics Committees (EUREC). The position of EUREC outlines 7 rules that should be followed to ensure responsible research.
- Maximising the accessibility of COVID-19 research results by the European Commission. The European Commission launched a manifesto to maximise the accessibility of research results in the fight against COVID-19.
Relevant literature #
- COVID-19 pandemics: Ethical, legal and social issues by Dov Greenbaum, David Gurwitz, Yann Joly (eds), 2022, Frontiers in Genetics – Special Issue: Lausanne: Frontiers Media SA. doi: 10.3389/978-2-83251-035-3
- “The Ethical, Legal and Social Issues of Pandemics. An Analysis from the EU Perspective” by Iñigo de Miguel Beriain, 2022, Springer
- Ethical and Legal Issues in COVID-19 Case Investigation and Contact Tracing: A Case Study of A Large Academic Public Health Partnership by Lexy C. White, Laura G. Meyer, Meghan Jehn, Journal of Law, Medicine & Ethics. 2024;52(2):422-428. doi:10.1017/jme.2024.98
- COVID-19 ethics: unique aspects and a review as of early 2024 by Wayne X. Shandera, Monash Bioeth. Rev. 42, 55–86 (2024). https://doi.org/10.1007/s40592-024-00199-x
- Blurring Boundaries: A Proposed Research Agenda for Ethical, Legal, Social, and Historical Studies at the Intersection of Infectious and Genetic Disease by Sheethal Jose, Juli Bollinger, Gail Geller, Jeremy Greene, Leslie Meltzer Henry, Brian Hutler, Eric Thomas Juengst, Jeffrey Kahn, Anna C. Mastroianni, Graham Mooney, Alexandre White, Rebecca Wilbanks, Debra J. H. Mathews, Journal of Law, Medicine & Ethics. 2024;52(2):443-455. doi:10.1017/jme.2024.116
- Ethical implications of COVID-19: vulnerabilities in a global perspective by Els Maeckelberghe , European Journal of Public Health, Volume 31, Issue Supplement_4, November 2021, Pages iv50–iv53, https://doi.org/10.1093/eurpub/ckab158
- ELSIhub Collection: “Ethical, Legal, and Social Implications at the Intersection of Genomics and Infectious Disease” by Debra JH Mathews, Sheethal Jose, 2021, https://doi.org/10.25936/v85x-5c22
Acknowledgements #
The work done stems from research conducted in the context of the project Beyond COVID (BY-COVID) project, which has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement ID: 101046203. The project started on 1 October 2021 and ended on 30 September 2024.
