Dear Colleagues, 

The COVID-19 pandemic has foregrounded many new and emerging ethical issues that international research architecture could not have anticipated.  In any public health emergency, research into novel diagnostics, therapies and vaccines is critical, and timely access to biological samples and health data is an essential facilitator of this work. The urgency of such research in the context of COVID-19 has necessitated the development of new mechanisms for data and sample sharing, often supported by ad-hoc guidelines and based on limited empirical evidence.  As a consequence, legal and ethical questions have arisen, many of which challenge long-established ethical frameworks for research. Exceptional procedures have been justified based on solidarity, the public interest, and the need to share our biological samples and personal health data for the common good. The question we must now ask ourselves is whether we are moving toward a “new normal” in research practices regarding the use of samples and data, and how we can adapt these practices to ensure they are more elastic and responsive in future.  This question takes on additional complexity when considered against the backdrop of data protection legislation, which is being passed in many countries, as well as the vast electronic and web-based infrastructure for data transfer that has emerged with cloud computing.

A second, and related, issue is that the wealth of biological samples and health data collected for clinical purposes during COVID-19 will be of immense value for future research as part of pandemic preparedness. Many of these samples and data are held by industry, and it is unclear whether there would be a willingness to share these samples and data for the common good, and under what conditions this would be permissible. Equally, it is unclear whether industry will use these samples and data for purposes other than responding to a public health emergency, and whether such uses can be legally and ethically justified.

This Special Issue will explore new and emerging ethical issues in the use of biological samples and health data for research during and after public health emergencies like COVID-19.  It will challenge the philosophical basis on which research participants are encouraged to share their data and unpack the meaning of the “public interest” and “public good”. We also wish to deepen our understanding of the use of the solidarity framework and its attendant implications in the research sphere.

We welcome papers on that reflect on the ethical and legal issues related to the use of biological samples and data for research in public health emergencies. Topics may include:

• Consent frameworks for data/sample collection and research, or consent waivers for research in these situations;
• Data protection and exceptions to the data-processing requirements for research in a public health emergency;
• Data and sample sharing and the protection of participants; especially considering the sharing of data internationally and cross-jurisdictional issues;
• Solidarity and research in a public health emergency; the ‘public interest’ and ‘public good’ justification, and its limitations;
• Use of samples and data after the public health emergency, and in pandemic preparedness for the future;
• Data- and sample-sharing, collective benefit sharing, representation and the North–South divide in research;
• Issues unique to sample and data collection in developing country settings during a pandemic, such as funding, post-trial access to effective therapies and genetic studies;
• Ethical implications in the research cycle, from the collection to the final product;
• Access to new therapies;
• The role of regulators, legislators, ethics committees and data protection officers in public health emergencies.

Prof. Dr. Deborah Mascalzoni
Dr. Harriet Etheredge
Dr. Ciara Staunton
Guest Editors

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• research in public health emergencies
• data-intense research
• medical ethics
• legal implications of data and sample collection in the pandemics