Biobanks, defined as "structured collections of biological materials and associated data, stored for purposes of present and future scientific research" [see inside this book for more definitions, in particular in chapter 2], have become an essential tool in in life science research. The use of biobanks poses technological, ethical, but also legal problems (think data protection, intellectual property and administrative law), especially so in a cross-institutional and cross-border context.
"Global Genes, Local Concerns" is the fruit of a cross-faculty research project funded by the Excellence Programme for Interdisciplinary Research of the University of Copenhagen. The 14 chapters, divided in four main topics, cover many of the various legal, as well as some non-legal questions, posed by biobanks and provide practical insights. Most contributions are based on (positive and negative) experiences with existing biobanks, which makes this book a valuable tool not only for researchers and policymakers, but also to legal practitioners.
Part I is dedicated to "big data and modes of collaboration". Chapter 1 (K. Hoeyer, A. Tupasela, M. Bogehus Rasmussen) explores policy pitfalls of cross-national collaboration and the standards and rules developed in relation to data sharing. The authors also point out moral and social implications of the international use of biobanks, such as, for example, building relationships with tissue donors.
Chapter 2 (M.J. Madison) considers biobanks as a case of knowledge commons. The author considers biobanks as more than just a collection of physical specimens and focuses on the information and data that come with the specimens. The chapter sets forth empirical and systematical aspects of biobank governance, emphasizing that this implies more than just regulatory and contractual aspects.
Part II is dedicated to "translational medicine and tech transfer" aspects. Chapter 3 (W. N. Price) explores big data implications of biobanks. It considers biobanks as a potentially essential innovation infrastructure for translational medicine, but it also flags the fragmentation of data, which reduces the opportunities for innovation. The author calls for more opening of data silos to ease biobanks' role in innovation.
Chapter 4 (B. J. Clark, T. Bossow) puts the accent on good governance principles related to the use of human biosamples. It explores the practical aspects of controlling the lawful obtention and the responsible use of human biosamples. As well, it draws attention to the importance of internal processes to this effect.
Part III relates to the interface between biobanks, human rights and patient involvement. Chapter 5 (P. K. Yu) explores the operation of biobanks against the background of the rights of the tissue donors. It also examines intellectual property issues related to scientific productions that are based on the use of biological materials.
Chapter 6 (A. Hellstadius, J. Schovsbo) provides an overview related to free and informed consent in European patent law, based on the Biotech Directive and the EPC. It gives examples of implementation in national, EU and EPO law. It also explores the implementation of the requirement to provide free and informed consent from the perspective of fundamental rights and health regulatory law.
Chapter 7 (J. Kaye, M. Prictor) deals with the concept of dynamic consent in the context of biobanking. In the context of biobanks, the use of samples and data is often unspecific or unforeseen at the time of collection. The authors propose, based on real-life examples, that instead of a one-off unspecific and broad consent given at collection, online platforms of "dynamic consent" be used to provide updated information to participants and researchers and enable the withdrawal or modification of consent to specific uses.
Chapter 8 (E. van Zimmeren) explores whether the use of dynamic consent can overcome trust challenges in biobanking. It underscores the link between interpersonal and organizational trust, the latter being critical in the context of biobanks.
Chapter 9 (N. Kongsholm) suggests that efforts to harmonize informed consent requirements risks overlooking local factors. The author provides practical examples of psychological and cultural factors that are not often taken sufficiently into account.
Chapter 10 (T. Caulfield, B. Murdoch) equally underscores the “consent problem” and advocates a conceptually coherent consent policy. The authors call for policymakers and politicians to step in and create clearer frameworks.
Part IV is dedicated to “biobanks, guidelines and good governance”. Chapter 11 (H. Yu) makes the case for more responsible research and innovation, in particular through more publicly funded research.
Chapter 12 (F. Vogl, K. Sargsyan) describes biobanks’ difficulties to access long-term funding. One of the possible ways to increase funding is to use collected samples for many different studies. This begs the question of whether – and how – the usage of biospecimens could and should be limited in time.
Chapter 13 (E. Ortega-Paino, A. Tupasela) focuses on networks of biobanks. Such networks can facilitate the sharing of both samples and information. In practice, biobank networks can contribute to the creation of governance structures. Such soft law influences how society perceives new practices related to collection, distribution and use of samples.
Chapter 14 (K. Liddell, J. Liddicoat, M. Jordan) takes a critical view on IP policies for large bioresources. The authors examine how “openness” is understood by different actors and what a commitment of organizations to “openness” means in practical terms. At the same time, the authors also reckon that harmonization of access policies is both desirable and feasible. They also outline how future research can improve (and harmonize) openness.
Publisher: Edward Elgar Publishing Limited (UK)
ISBN 978 1 78811 618 3 (cased)
ISBN 978 1 78811 619 0 (eBook)
GBP 85.50 (hardcover, available here)
Book Review: Global Genes, Local Concerns Reviewed by Peter Ling on Tuesday, October 29, 2019 Rating: