Artificial Intelligence in Biobanking Ethical, Legal and Societal Challenges

Introduction    Peaking in the Blackbox of AI and Its Many Layers

Michaela Th. Mayrhofer, Santa Slokenberga, Signe Mežinska

Part 1: Legal Frameworks of AI

1 The Approach of EU Law to Tackling Statistical Bias in Medicine

Katharina Ó Cathaoir

2 Liability for Damages, AI, and Machine Learning for Digital Pathology as New Challenges for Biobanks

Dorota Krekora-Zając

Part 2: Between Risk and Trust

3 Unique  Design—the Need for Individualized Models of Trust in Biobanking AI

Anna Clareborn

4 A Possible Risk Governance Approach for AI in Health Research and Biobanking

Ilaria Colussi

 5 Artificial Intelligence, Sex, and Gender: Hypes, Hopes, and Potential Risks in Biobanking

Kaya Akyüz, Mónica Cano Abadía, Melanie Goisauf

Part 3: Communicating the Unknown

6 Fairness of an AI System in the Case of a Biobank of Images and Imaging Biomarkers

Valentina Colcelli

7 Artificial Intelligence and Communication with Research Participants in the Process of Biobanking Human Biological Material

Jarosław Sak, Jakub Pawlikowski

8 Tackling AI Transparency Concerns in Biomedical Research: Bringing a Communication-Participatory Approach to the Conversation

Leslie Salgado Arzuaga

Part 4: Embracing the Potentiality

9 Social Acceptance of Artificial Intelligence in Biobanking

Elodie Caboux, Patrick Courtney, Io Hong Cheong, Zisis Kozlakidis

10 Biobank-based Research Employing AI Techniques: Challenges for Research Ethics Committees

Signe Mežinska

11 Powerful AI: Between Accountability and Potentiality

Michaela Th. Mayrhofer

Conclusion

12 Learnings from Unboxing the Blackbox

Michaela Th. Mayrhofer, Santa Slokenberga, Signe Mežinska

Introduction                Peaking in the Blackbox of AI and Its Many Layers

by Michaela Th. Mayrhofer, Santa Slokenberga, Signe Mežinska

Part 1: Legal Frameworks of AI

Chapter One                The Approach of EU Law to Tackling Statistical Bias in Medicine

by Katharina Ó Cathaoir

Chapter Two               Liability for Damages, AI, and Machine Learning for Digital Pathology as New Challenges for Biobanks

by Dorota Krekora-Zając

Part 2: Between Risk and Trust

Chapter Three             Unique by Design—the Need for Individualized Models of Trust in Biobanking AI

by Anna Clareborn

Chapter Four               A Possible Risk Governance Approach for AI in Health Research and Biobanking

by Ilaria Colussi

Chapter Five               Artificial Intelligence, Sex, and Gender: Hypes, Hopes, and Potential Risks in Biobanking

by Kaya Akyüz, Mónica Cano Abadía, Melanie Goisauf

Part 3: Communicating the Unknown

Chapter Six                 Fairness of an AI System in the Case of a Biobank of Images and Imaging Biomarkers

by Valentina Colcelli

Chapter Seven             Artificial Intelligence and Communication with Research Participants in the Process of Biobanking Human Biological Material

by Jarosław Sak, Jakub Pawlikowski

Chapter Eight              Tackling AI Transparency Concerns in Biomedical Research: Bringing a Communication-Participatory Approach to the Conversation

by Leslie Salgado Arzuaga

Part 4: Embracing the Potentiality

Chapter Nine               Social Acceptance of Artificial Intelligence in Biobanking

by Elodie Caboux, Patrick Courtney, Io Hong Cheong, Zisis Kozlakidis

Chapter Ten                Biobank-based Research Employing AI Techniques: Challenges for Research Ethics Committees

by Signe Mežinska

Chapter Eleven           Powerful AI: Between Accountability and Potentiality

by Michaela Th. Mayrhofer

Conclusion

Chapter Twelve          Learnings from Unboxing the Blackbox

Michaela Th. Mayrhofer, Santa Slokenberga, Signe Mežinska

Biography

Michaela Th. Mayrhofer is a political scientist, historian, and sociologist specializing in the governance of life sciences. She is founder of Papillon Pathways e.U. and the lead of ELSI at the Medical University of Innsbruck, Institute of Human Genetics, both Austria. Michaela has served as Head of ELSI Services & Research Department (2019–2025) and Co-Interim Director General (2020) at BBMRI-ERIC, Austria. She is a review editor for Frontiers in Digital Health, as well as an independent ethics advisor to several consortia and organizations, and a research ethics expert for the European Commission.

Santa Slokenberga is an associate professor in medical law and a senior lecturer in administrative law at the Faculty of Law, Uppsala University, Sweden. She is a board member of the Nordic Permed Law Network and the European Association of Heath Law, as well as an independent ethics advisor to several consortia and organizations.

Signe Mežinska is a bioethicist and sociologist specializing in biomedical research ethics and medical ethics. She leads a research group at the University of Latvia, focusing on ethical challenges in the development and application of biotechnologies and the protection of patients' and research participants' rights. Signe has served as an ethics expert for international organizations, including UNESCO's International Bioethics Committee, WHO, and the European Commission.

"This impressive collection offers a fresh approach to the complex issues surrounding the use of AI in the field of biobanking. I highly recommend this book for the scope and quality of its contributions and the expertise of its authors. The authors are leaders in their field and offer insights that are useful not only for biobanking but also for other areas of biomedical research. This collection provides a clear, innovative and analytical presentation of these issues that no other book has done before."
— Jane Kaye, Professor of Health, Law and Policy & Director of the Centre for Health Law and Emerging Technologies, Faculty of Law, University of Oxford and Academic Convenor AI and Research, University of Melbourne

"Biobanks – collections of biological materials and data – have long been recognized for their potential in research on diseases, treatments and prevention methods, and in healthcare more generally. With recent developments in AI and big data analytics, an even greater potential is being unleashed. Yet at the same time, various pressing ethical, legal, and social issues arise. Michaela Th. Mayrhofer, Santa Slokenberga and Signe Mežinska have curated an excellent set of papers that tackle these crucial issues head on. A must-read for anybody interested in AI, big data, and biobanking!"
— Sven Nyholm, Professor of the Ethics of Artificial Intelligence, Ludwig-Maximilians-Universität München, Germany

"Artificial intelligence is like the Wild West right now, so books like Artificial Intelligence in Biobanking: Ethical, Legal and Societal Challenges are vital for understanding how to develop and deploy new technologies in a responsible, legal, ethical, and socially beneficial manner. The contributors address a range of important issues to do with the use of AI in biobanking, highlighting the importance of not treating AI as a mysterious black box we cannot shape in democratic and responsible ways."
— Kean Birch, Professor & Ontario Research Chair in Science Policy, York University, Cana