Legal Aspects of Biobanking as Key Issues for Personalized Medicine and Translational Exploitation

Timo Minssen; Jens Schovsbo

Disclosures

Personalized Medicine. 2014;11(5):497-508. 

In This Article

The Dynamics & Complexities of Biobanking: Different Types of Biobanks, Stakeholders & Policy Objectives

When one considers the dynamic and complex settings in which biobanks operate, it becomes evident that it will not be an easy task to improve the regulatory and legal framework. It is a basic challenge to any legal or regulatory discussions that they have to deal with the fact that biobanks have very different designs curtailed to meet a wide variety of scientific goals. This diversity obviously is challenging as seen from a legal and organizational perspective and requires a careful determination of the characteristics of the biobank in question. Biobanks of human samples, which are at the focus of this paper, can be distinguished by various categories depending on purpose and design. They include among other things population-based biobanks, disease-oriented biobanks, case control biobanks, tissue biobanks and biobanks within the context of clinical trials. These very basic categories could be further divided into more specific subgroups, such as stem cell biobanks, tumor biobanks or cord-blood banks.[2]

Just to mention two examples, the main research objective of population-based biobanks is generally to discover biomarkers for disease susceptibility within a specific population through prospective molecular epidemiology research strategies. These types of biobanks typically recruit healthy donors who are representative of a region, country or specific ethnic group.[2] In contrast to population-based biobanking initiatives, disease-oriented biobanks store a much more heterogeneous collection of biological materials and may include tumor banks as well as collections of blood and other samples from a variety of diseases together with normal controls.[24,25] Biological materials found in such biobanks are usually collected from patients within the context of clinical care, and can lead to eventual re-sampling at follow-up visits in the course of their disease treatment.[2]

All of these biobank types are used for different kinds of biomarker research.[8,26] They are also complementary, because individual research projects may require the support of more than one biobank type.[8,27] For this and other reasons, it is hoped that the ongoing establishment of heterogeneous biobank networks, such as the Biobanking and Biomolecular Resources Research Infrastructure network in Europe, will enhance research efficacy.[28]

Apart from the different designs and scientific purposes, a biobank can also be distinguished by different basic models, submodels and hybrid concepts of financing them as research infrastructures. Herbert Gottweis and Georg Lauss, for example, distinguish between "three different types of ordering in this domain: the entrepreneurial biobank model that is often carried out in a public private partnership (PPP) between a commercially oriented entity and different state institutions; the biosocial model in which patient activist groups promote, fund and facilitate the creation and operation of a biobank; and the public biobank model in which biobank networks are supported mostly through taxpayers money and nonprofit research funding organizations".[29]

Publicly funded biobanks, which often involve universities and university hospitals, are typically constructed to operate for several decennia and to be used by numerous research projects. Thus, they are mostly referred to as research infrastructures rather than research projects. These could potentially be used by a great variety of different actors with different objectives, including private companies, university researchers, biohackers, research foundations and governmental bodies or 'hybrid' consortia within the framework of PPPs, among others. Since turning basic research into commercially useful knowledge and marketable products often requires the involvement of industry, universities may also be engaged in such hybrid forms of biobanking.

Considering the great variety of biobank types, the various modes of financing them, as well as the necessity of international and interdisciplinary cooperation to meet different scientific goals, it becomes evident that biobanking involves an enormous number and variety of different stakeholders with different understandings of how biobanks should be defined, governed and what they should achieve in terms of scientific and commercial outcomes. This is also backed up by empirical studies, which have demonstrated that while "there is a general consensus regarding the key criteria of biological samples, data, and their use for research", various stakeholders have very "divergent views on the importance of size, sharing and diversity of samples".[6]

Achieving clearer definitions of various biobank models, identifying applicable biospecimen standards, developing transparent governance and user guidelines for each type of biobank, as well as identifying and educating the relevant biobank stakeholders appear necessary for regulating biomedical research to facilitate future biobank development and sharing.[6] Ideally this would also entail a more prominent role of thoroughly conducted stakeholder analysis[30] and the development of a sound economic policy in the early stage of a planned research biobank.

Considerations for the investment in the formation of a biobank "require more than a comprehensive understanding of the drivers and stakeholders behind the science of this industry".[31] First of all, a deep economic analysis of the market and pricing dynamics, business requirements and funding models is indispensable to ensure not only the establishment, but also the sustainability of this essential resource.[31] Second, and representing a partial response to the 'sustainability issue', there is a 'commercialization issue' about how to deal with the voluntary, altruistic relationship between biobanks and their participants, on the one hand, and the potential commercial relationships that a biobank may form with researchers/companies using biospecimen on the other.[32] A particularly crucial question that needs to be addressed in the context of governing public biobanks is whether the current ethical and legal framework can ensure that benefits will optimally accrue to the public who have funded and contributed samples to the resource.[33] Also and in the same vein, some authors have pointed out that in order to fully capture the value of information kept in biobanks the institutional and legal framework should promote openness, research collaboration and data sharing.[34,35] From a legal perspective, the pursuit of these values may create tensions vis-à-vis the rules and norms that underpin consent obligations, privacy and IPR, and for this reason careful planning and a balancing of interests are needed.

One factor that may further complicate such interdisciplinary endeavors is that the primary goals and fundamental principles on which a biobank is based might change over time, for example, due to technological and/or commercial possibilities and needs. For the case of university-based biobanks, Gottweis and Lauss have pointed out that: "Biorepositories of universities might collect disease tissue over long periods of time mainly for internal purposes and might not be in need of substantial outside funding nor be under pressure to develop extensive exchanges with different social stakeholders. But this situation might change quickly when the goals change and the mentioned biorepository begins to develop cooperation with industry or with international research partners. Likewise, public sensibilities towards topics of medical research and development change over time and are different from country to country. Business models that work well in certain periods of time are doomed in others".[29] All of these issues must therefore be carefully considered in their complexity, interactivity, relatedness and dynamism when discussing legal aspects related to the governance and translational utilization of biobanks. An effective use of biobank collections and sound policies to govern their use will require a thorough understanding of the enormous diversity found in organizational characteristics, including the very different history and dynamic goals that many biobanks may have.[36] Only then can the potential of biobank research be translated into the creation of value for research, health and industrial applications in the medical field.[29]

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