Topic: COVID-19 Research

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 Issues 

Ethical, legal, and societal considerations include: 

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.   

Relevant EU Legislation  

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.  

BBMRI Resources 

The below resources have been developed by those included in the BBMRI network: 

ELSI Dialogues Webinar: 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.  

BBMRI-ERIC ELSI Services & Research Q&A on COVID-19 & ELSI 

by Jahns, R., Lavitrano, M., Chassang, G., et al  

This document address 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 the 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 Statements 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. 

Last Updated: August 2024