DOTTORATO DI RICERCA IN
DOTTORATO DI RICERCA IN
LAW, SCIENCE AND TECHNOLOGY
Ciclo XXXVI
Settore Concorsuale: 12/H3 – FILOSOFIA DEL DIRITTO
Settore Scientifico Disciplinare: IUS/20 – FILOSOFIA DEL DIRITTO
COLLECTION OF HUMAN BIOLOGICAL SAMPLES AND PERSONAL DATA FOR BIOBANKING PURPOSES: A LEGAL STUDY FOR A TRUSTWORTHY BIOBANK GOVERNANCE
Presentata da: Xxxxx Conditi
Coordinatore Dottorato Supervisore
Prof.ssa Xxxxxx Xxxxxxxxx Prof.ssa Xxxxxx Xxxxxxxxx
Co – supervisore Prof.ssa Xxxxx Xxxxxx Xxxxxxx
Esame finale anno 2024
ABSTRACT
Research biobanks are collections of human biological samples and personal data on a long-term basis for future scientific research purposes and, therefore, fundamental infrastructure for the conduction of scientific research and the advancement of society, especially in the medical field. However, the matter is not specifically regulated, either at the supranational or the national level, and therefore the applicable provisions should be found in the sectorial regulations that govern biobanking activities. Among the various controversial issues that arise in this field, that of the models for the collection of human biological samples and the personal data to be stored in the biobank is particularly controversial. The aim of this study is, therefore, to provide a comprehensive analysis of these models from a regulatory perspective, at both the supranational and national level. After having provided general definitions of the main concepts used in biobanking and an overview of the hard and soft law instruments applicable to the field, the study is devoted to describing the available lawful methods for collecting biological samples and personal data first as a primary and then as a secondary use. In order to choose the appropriate method, the biobank should evaluate its impact on the participant’s right to data protection in its actual conceptualisation, and strike a balance between the latter and the interest of society in the advancement of scientific research. Moreover, the study proposes a subsidiary test to conduct to this end, i.e. a trust test to evaluate the impact of the choice on participant’s trust in biobanking. Finally, an overview of the issue of anonymity in the context of biobanking is provided, usually referred to as the technical measure to solve data protection issues, but which is rendered increasingly more challenging to achieve by technological advancements.
TABLE OF CONTENTS
INTRODUCTION
CHAPTER I – DEFINITIONS, LEGAL FRAMEWORK AND STRUCTURE OF THE WORK
2.1.1 An Umbrella Term – Identifying Its Core Elements 19
2.1.2 Research Biobanks and Their Classification 22
2.1.3 The Content of Research Biobanks 25
2.1.3.1 Human Biological Samples (HBSs) 27
2.1.3.2 Data for Biobanks - Their Importance for Precision Medicine 30
2.2 A Categorisation of the Different Practical Scenarios for the Collection and Use of the Content of Research Biobanks 34
2.3 Other Important Terminologies 37
3 The Applicable Legal Framework 38
3.1.1.1 The Declaration of Helsinki and the Declaration of Taipei 41
3.1.1.2 The CIOMS International Ethical Guidelines 43
3.1.1.3 The OECD Recommendations 44
3.1.1.4 The Unesco Declarations 45
3.1.1.5 The Recommendation R(2016)6 46
3.1.3 The Oviedo Convention 52
3.2 (Binding and Non-Binding) Instruments at the National Level 54
CHAPTER II - TRUST IN BIOBANKING
2 The Importance of Trust in Biobanking – (A) Practical Examples 66
2.1 ... (B) Theoretical Analysis: (B1) Hard and Soft Law Instruments 68
3 Trust as a Dynamic Concept – Relevant Factors for the Biobank Governance 74
CHAPTER III - PROPOSED MODELS FOR THE COLLECTION OF HUMAN BIOLOGICAL SAMPLES AND BIOBANK DATA
PART A - HUMAN BIOLOGICAL SAMPLES
2 Relevant Conceptual Distinctions and Scope of the Analysis 90
3 The Framework Applicable to the Collection of HBSs for Biobanking Purposes – Consent at the Supranational Level 94
3.1 ...and the National Level 102
4 The Dual Nature of HBSs – (A) The Material Nature, or Human Biological Samples as Detached Parts of the Human Body 104
4.1 (B) The Informational Nature, or Human Biological Samples as Sources
of Personal Data and Parts of the Identity of the Person 112
5 Developing a Framework for HBSs – On the Unitarian Consideration of Their Dual Nature 115
5.1 The Prevalence of the Informational Nature – The Relational-Control Model 116
5.2 Assessing the Applicability of the Relational-Control Model to the Unitarian Consideration of HBSs 119
6 Conclusion 124
PART B - BIOBANK DATA
1 Introduction 126
2 Types of Biobank Data 129
3 Preliminary Considerations – (A) The Actor Classification System Applied to Biobanking 132
3.1 ... (B) Biobanking Purposes V. Scientific Research Purposes 138
4 Collecting Biobank Data – (I) The Legal Framework at the Supranational Level 146
4.1 Consent-Based Model 150
4.1.1 Withdrawal of Consent 153
4.2 …and the Necessity-Based Model 155
4.2.1 The Legal Bases of Art. 6(1) GDPR 157
4.2.2 The Exemptions of Art. 9(2) GDPR 162
4.2.2.1 Art. 9(2)(I) Public Interest in the Area of Public Heath 163
4.2.2.2 Art. 9(2)(J) Scientific Research 165
4.2.3 Possible Consequences of the Necessity-Based Model 167
4.2.3.1 (A) Derogations Derived From Provisions of the GDPR 167
4.2.3.2 (B) Derogations Derived From Enacted Union or Member State Law 169 5 ... (II) The Legal Framework at the National Level 170
6 The Secondary Use of Personal Data in Biobanking 175
6.1 The Supranational Level – Art. 5(1)(B) and 6(4) GDPR 176
6.2 The National Level – Art. 110 and 110-Bis Italian Privacy Code and the General Authorisations 181
6.3 The Duty to Provide Information According to Art. 14(4) GDPR in Case of the Further Processing of Personal Data 184
7 Assessing the Framework for the Biobank Choice 186
7.1 The Participants’ Right to Data Protection 187
7.2 The Choice at the Supranational Level – Between the Necessity-Based Model and the Consent-Based Model 193
7.3 The Choice at the National Level - Alternative Models for Collecting Informational Consent 199
7.3.1 Broad Consent Model 204
7.3.2 Dynamic Consent Model 209
7.3.3 Choosing an Alternative Model for Collecting Informational Consent for Biobanking 212
7.3.4 An Alternative Solution – Specific Informational Consent for Biobanking
...............................................................................................................216 8 The DGA and the EHDS.......................................................................218
8.1 Data Governance Act 218
8.1.1 Specificities of the DGA System for Data Altruism 221
8.1.2 Applying the DGA’s Data Altruism Mechanism to Biobanks 223
8.2 The European Health Data Space 225
8.2.1 Applying the EHDS to Biobanks 229
8.2.2 The Proposed Amendments to the EHDS Proposal 231
CHAPTER IV - ANONYMITY
1 Introduction 234
2 Anonymity of HBSs 235
3 Anonymity of Biobank Data 237
4 The Anonymisation Process According to the GDPR 241
4.1 The Approach of the Article 29 Working Party – The Zero-Risk Test 242
4.2 The CJEU Approach – The Risk-Based and Dynamic Approach 244
4.3 The Evaluation to Be Conducted for Considering Data Anonymous 248
5 Anonymisation in the EHDS and the DGA 250
6 Legal and Practical Issues of Anonymity 252
6.1 Possible Concrete Strategies to Be Adopted 259
CONCLUSION 265
INTRODUCTION
In the last decades, biobanks have acquired an increasingly important role in the conduction and advancement of scientific research, especially in the medical field. In their simplest definition, biobanks are collections of human biological samples and personal data, mostly genetic and health-related data, stored in order to be processed for future scientific research projects. Therefore, because of their existence, researchers might have (relatively) easy access to large quantities of data.
Their importance for society was particularly evident during the COVID-19 pandemic, because of their fundamental role in ensuring the availability of biological samples and personal data for scientific research aimed at discovering possible strategies for treating and curing the disease and making the stored samples and data available transnationally through cooperation.1
Because of the importance of scientific research for changes and advancements in society,2 biobanks might be said to play an essential public function,3 because they represent fundamental infrastructures for scientific research.4. In order to adequately fulfil such function, they need to adopt a governance system in which all the emerging issues are solved via a careful balancing exercise among the various rights and interests possibly affected and involved in their activities. In particular, biobanks shall ensure the protection of the privacy and fundamental rights of the participants, while at the same time guaranteeing fair access to the stored resources for public good purposes and the advancement of society in the medical field.5
Varied are the issues that arise in biobanking, among which are worth mentioning those of “consent, especially for secondary research purposes; feedback to participants; benefit sharing the public interest; participation in decision making; protecting privacy; access;
1 Xxxxxxxxxx, Xxxxx, et al. “Basic Principles of Biobanking: from Biological Samples to Precision Medicine for Patients”; Xxxxxxxxxx, Xxxxxx, et al. “The COVID-19 Pandemic Reveals the Wide-ranging Role of Biobanks.” Frontiers in Public Health, vol. 11, 2023, pp. 1-7.
2 Guarda, Xxxxx, Il Regime Giuridico dei Dati della Ricerca Scientifica, Editoriale scientifica, 2021.
3 Xxxxxxxxx, Xxxxxx “Brevi Note xxxxx Xxxxxxx Giuridico del Materiale Biologico Umano.” Europa e Diritto Privato, vol. 2, 2017, pp. 625-666.
5 Pacia, Romana “Xxxxxxxx Biologico e Consenso Informato nella Ricerca Genetica: il Possibile Ruolo delle Biobanche.” Jus Civile, vol. 3, 2014, pp. 65-10.
ownership and intellectual property rights”.6 Among these, the following study intends to study the possible methods available for the collection of human biological samples and personal data for biobanking purposes, with the aim of suggesting for biobank governance purposes a solution that not only is the result of a fair balance between the various interests at stake but also adequately preserves and enhances participants’ trust in the biobanking activities.
In particular, the biobanking field is highly heterogenous and, in the lack of a common and harmonised legal framework, requires a careful analysis of its various aspects in order to evaluate which specific sectorial legislation is applicable, as well as soft-law instruments and more generally ethical guidelines, and how to concretely apply the provisions established thereby. Therefore, problems for the interpreter arise at the very beginning of the discussion, both in the attempt to define its object and in collecting the pieces of the regulatory patchwork applicable to biobanks. The coexistence of hard and soft law instruments at various levels of enforceability hinders harmonisation on the matter, and that of supranational and national norms renders any attempt at collaborating among biobanks in different Member States extremely difficult. To the analysis of this complicated framework is devoted Chapter I of this work, where I provide a description of the main characteristics of research biobank, which will be the focus of the entire analysis, and an overview of the hard and soft law instruments applicable to the various elements of the biobanking implementation, and in particular to the collection of the human biological samples and personal data to be subsequently used for research purposes.
Indeed, precisely on the ability to collect and retain personal data and making these available for future specific scientific research projects depends the very existence of the biobank. Therefore, in general, this work will be devoted to presenting the possible lawful scenarios according to the regulations applicable to the processing of personal (and sensitive) data available for biobanks at both the supranational and national levels.
The decision in this regard has direct consequences on the level of participants’ trust in the biobank and its activities, which, as I will extensively discuss in Chapter II, is of fundamental importance for existence and appropriate functioning of the collection. To
6 Xxxx, Xxxx “Do We Need a Uniform Regulatory System for Biobank across Europe?”, European Journal of Human Genetics, vol. 15, 2005, pp. 245-248.
emphasise such importance and attempt at protecting and enhancing trust throughout the biobank lifecycle, but particularly at the moment of the collection of its content, I will provide an example of trust test that may be conducted when choosing the method for collecting samples and data to be implemented in the biobank governance. In this regard, I believe that after having established which are the possible lawful methods available to adopt in a concrete situation and having carefully balanced the various contrasting rights and interests at stake (namely those of the participants and of society at large in the advancement of research), it may be beneficial for the biobank to address the issue of trust and to finally choose the option that better protects it.
Chapter III is then devoted to the detailed analysis of the alternative models for the collection of the content of the biobank, namely biological samples and personal data. On the one hand, in Part A I will analyse the issues related to human biological samples, which in particular are connected to and derived from their dual nature, i.e. their existence as material samples and at the same time sources of important genetic data on the person. This characteristic of the samples, as well as their intrinsic and ontological link with the human body, complicates their legal qualification. The issue in this regard relates to the possibility of considering them as objects possibly transferable from the patient to the biobank for scientific research purposes by simply providing consent (rectius, interventional biobank consent, as I will be referring to) or as equivalent to personal data. As I will attempt to demonstrate, I believe that the last solution should be preferred, given that the value of the samples for research nowadays mainly derives from their informational nature.
Part B is then dedicated to the study of the possible alternative models for the collection of personal data, both “ordinary” and sensitive data, at the supranational and national level. As it will become apparent throughout the discussion, the GDPR provides for various alternative models, both for the primary use of the personal data and their further processing. In particular, the data controller (rectius, the biobank in my analysis) is left with a choice to be made (usually from the outset) between a regime that directly involves the data subject, considered as factual controller of the use of her data (consent-based model), and using the provisions available for maximising the processing of the personal data by reducing the concrete involvement of the data subject in the decision-making
process with the aim of fostering the conduction and development of scientific research (necessity-based model).
At the national level, the Italian legislator opted for asking for the informed consent of the data subject (which I will refer to as informational consent) in almost the totality of the cases, thus both for the processing of the personal data for biobanking or for scientific research purposes, and as a primary or secondary purpose.
The last part of Chapter III is therefore dedicated to providing biobanks with a method for choosing between the various alternatives at her disposal. Indeed, as mentioned, I believe that any choice related to the choice of the biobank governance should be first of all made according to the balance of the various rights and interests at stake. In this regard, one of the rights possibly affected by the biobanking activities is the participant’s fundamental right to data protection, which should therefore be carefully analysed for its significance, content and value. Subsequently, the result of such a balance is evaluated in terms of impact on participant’s trust by conducting the trust test, whose core elements were identified in Chapter II. The same test is applied in case none of the contrasting interests should concretely prevail.
Finally, I will evaluate the applicability of two newly introduced regulations, the Data Governance Act and the Proposal for a European Health Data Space, to biobanking and their impact on the decision-making process previously highlighted.
The final Chapter IV is then devoted to the study of anonymisation. Indeed, the latter is frequently suggested as the technical solution to the data protection issues posed by the processing of personal data for scientific research purposes, but rendered increasingly difficult by the collection of large amounts of data and by the very activity conducted by the biobank.
Overall, in its various parts the analysis is devoted to demonstrating that under a regulatory point of view and because of the absence of a comprehensive and specific regulation, biobanking does not entail the mere application of fixed norms but is frequently the result of a balancing exercise between various contrasting interests all worth of (constitutional) protection. In this regard, assuming the role of intermediate impartial entity might help making the mentioned choice, while at the same time preserving participants’ trust in the biobanking activities and, more generally, society at large.
CHAPTER I – DEFINITIONS, LEGAL FRAMEWORK AND STRUCTURE OF THE WORK
Summary: 1 Introduction; 2 Definitions; 2.1 Biobank; 2.1.1 An umbrella term – Identifying its core elements; 2.1.2 Research biobanks and their classification; 2.1.3 The content of research biobanks; 2.1.3.1 Human biological samples; 2.1.3.2 Data for biobanks – Their importance for precision medicine; 2.1.3 Research purposes and precision medicine; 2.2 A categorisation of the different purposes of the collection and use of biological samples and data; 2.3 Other important terminologies; 3 The applicable legal framework; 3.1 The supranational Level; 3.1.1 Soft law instruments; 3.1.1.1 The Declaration of Helsinki and the Declaration of Taipei; 3.1.1.2 The CIOMS International Ethical Guidelines; 3.1.1.3 The OECD Recommendations; 3.1.1.4 The UNESCO Declarations; 3.1.1.6 The Recommendation R(2016)6; 3.1.2 Hard law instruments; 3.1.3 The Oviedo Convention; 3.2 (binding and non-binding) instruments at the national level; 4 Structure of the work
The field of biobanking is governed by highly heterogeneous norms from various disciplines, established by hard and soft instruments enacted at all levels of enforceability and at the interception among law, ethics and technology. Therefore, reconstructing the applicable framework is a complex theoretical and practical task because of the difficulties that the interpreter encounters in finding the applicable norms of this “fragmented landscape”7 and harmonising them in order to have a viable framework.
Consequently, it is first of all important to define the perimeter of the discussion and the fundamental terms to be used, especially because of the absence of sector-specific definitions. Setting the foundations8 of the specific analysis is paramount to avoid possible confusion and differences in interpretations.
7 Tzortatou, Xxxx, et al. “Biobanking Across Europe Post-GDPR: A Deliberately Fragmented Landscape.”
GDPR and Biobanking, edited by Xxxxxxxxxxx, Santa, Springer, 2021, pp. 397-420.
8 Slokenberga, Santa “Setting the Foundations: Individual Rights, Public Interest, Scientific Research and Biobanking.” GDPR and biobanking, edited by Xxxxxxxxxxx, Santa, Springer, 2021, pp. 11-30.
As a consequence, in the following paragraphs, I will first of all provide the definitions of the fundamental concepts to be used throughout the whole discussion, while other terms more specific to other Parts or Chapters of this work will be defined or identified later on. I will then provide an overview of the legal “fragmented landscape”9 applicable to biobanks. Indeed, in the absence of a universal, European or national general regulation of the matter, systematising the constellation of sectorial regulations and norms, soft law instruments and guidelines relevant to the biobanking fields would help navigate the matter. To this end, the discussion will be divided between the supranational and the national level, taking into consideration both soft law and hard law documents. Indeed, the field of biobanking is primarily regulated via non-binding instruments, mainly because of its high heterogeneity, while the binding ones deal primarily with topics (such as data protection, for instance) that are not specific to biobanking but are nonetheless applicable to it.
Finally, I will provide a general overview of the structure of the work of the following chapters.
First and foremost, it is necessary to define the general concepts further used in the discussion. Indeed, given the absence of a specific unique regulation applicable to biobanking, any analysis of the issues on the matter usually lacks anchor points10, and setting the boundaries of the concepts used is of paramount importance.
Indeed, it has been pointed out that providing definitions would help increase uniformity and ease communication among the different stakeholders involved,11 as well as their (translational) collaborations, and is also valuable to anchor the following discussion to concepts with a definite meaning and specifically designed for the biobanking field.
Moreover, the multifaceted nature of biobanking brings along a wide variety of ethical and legal issues and defining the concepts to be used will also help delimit the horizon of the discussion in the following pages.
9 Tzortatou, Xxxx, et al. “Biobanking Across Europe Post-GDPR: A Deliberately Fragmented Landscape.” 10 Macilotti, Xxxxxx, Le biobanche di ricerca, Studio xxxxxxxxx sulla “zona grigia” tra privacy e proprietà, Università di Trento, 2013.
11 Xxxx, Xxxxx X., et al. “Social and Behavioral Research in Genomic Sequencing: Approaches from the Clinical Sequencing Exploratory Research Consortium Outcomes and Measures Working Group.” Genetics in medicine: official journal of the American College of Medical Genetics, vol. 16, n. 10, 2014, pp. 727-35.
There are multiple definitions of the term biobank, both at the national and supranational level, given the absence of a universally agreed one12 and because such a concept usually applies to a wide variety of organisations and facilities.13
Indeed, also because of the lack of a precise definition, the term “biobank” is sometimes confused or interchanged with others, such as “biorepositories” or “biological resource centres”, and drawing the exact dividing line among these concepts is not always easy.14 It derives from this difficulty, for instance, the decision taken in the Declaration of Taipei to provide the same principles for both biobanks and health databases because they “both give rise to similar concerns about dignity, autonomy, privacy, confidentiality and discrimination”.15
As notorious, the term biobank first appeared in 199616 and was initially used to describe human population-based biobanks.17 Indeed, an example of this initial approach is provided in 2006 by the Organisation for Economic Co-operation and Development (OECD) in the report entitled “Creation and Governance of Human Genetic Research Databases” where biobanks were defined as “a collection of biological material and the associated data and information stored in an organised system, for a population or a large subset of a population.” Later on, in 2009, in its Recommendation on Human Biobanks and Genetic Research Database, the OECD described biobanks in general as “structured resources that can be used for genetic research and which include: (a) human biological material and information generated from the analysis of the same; and (b) extensive
12 Slokenberga, Santa “Setting the Foundations: Individual Rights, Public Interest, Scientific Research and Biobanking”; Xxxxxx, Xxxxxx, and Xxxxx, Xxxxxx “Defining Biobank.” Biopreservation and Biobanking, vol. 11, n. 5, 2013, pp. 309-315; Xxxxxxx, Xxxxxxxxx “La Circolazione dei Dati Genetici e delle Biobanche: Limiti e Prospettive de iure condendo.” xxxxxxxxxxx.xx, vol. 5, 2021, pp. 129-173.
13 For a comprehensive analysis of the topic, see Xxxxxx, Xxxxxx, and Xxxxx, Xxxxxx “Defining Biobank.” 14 Xxxxxxxxxxx, Santa “Setting the Foundations: Individual Rights, Public Interest, Scientific Research and Biobanking.”
15 Preamble paragraph 4). On the topic, Xxxxxxxx, Xxxxxxxx, and Xxxxxxxxxx, Real-Sebbag “Research Biobanks and Health Databases: The WMA Declaration of Taipei, Added Value to European Legislation (Soft and Hard Law).” European Journal of Health Law, vol. 25, n. 5, 2018, pp. 501-516.
16 European, Middle Eastern and African Society for Biopreservation and Biobanking, Aix-en-Provence, France.
17 Xxxxxx, Xxxxxx, and Xxxxx, Xxxxxx “Defining Biobank.”
associated information”.18 The latter definition clearly moved away from defining population-based biobanks exclusively to adopt a more comprehensive approach.19
At the European level, an official definition can be extrapolated by the provisions of Recommendation R(1994)1, where biobanks are qualified as “non-profit-making institutions which are officially licensed by national health administrations, or recognised by the competent authorities”20 responsible for the collection, storage and distribution of human tissues. However, Recommendation R(1994)1 is not decisive on the matter, because it substantially builds upon the norms for such licensing or recognition and therefore upon the definitions included therein, transferring to national legislators the task of defining, and the responsibilities that come with it.
Moreover, on the specific topic of population-based biobanks, Recommendation R(2006)4 gives the following definition: “a collection of biological materials that (…) i. has a population basis; ii. it is established, or has been converted, to supply biological materials or data derived therefrom for multiple future research projects; iii. it contains biological materials and associated personal data, which may include or be linked to genealogical, medical and lifestyle data and which may be regularly updated; iv. it receives and supplies materials in an organised manner”.21
Definitions at the national level vary considerably among Member States as well. For instance, the Spanish regulation on the matter establishes that a biobank is “a public or private, non-profit establishment that houses a collection of biological samples conceived for diagnostic or biomedical research purposes and organised as a technical unit with criteria of quality, order and destination”22 with a strong focus on its non-profitable character and its organised structure.
Somewhat differently and more generally, the new Swedish Biobank Act of 2023 defined biobanks very broadly as “one or more sample collections held by one and the same
18 Organisation for Economic Co-Operation and Development, Recommendation on Human Biobanks and Genetic Research Database, 2009.
19 Slokenberga, Santa “Setting the Foundations: Individual Rights, Public Interest, Scientific Research and Biobanking.”
20 Council of Europe, Recommendation R(1994)1 of the Committee of Ministers to Member States on Human Xxxxxx Xxxxx, 1994.
21 Council of Europe, Recommendation R(2006)4 of the Committee of Ministers to Member States on Research on Biological Materials of Human Origin, 2006.
22 Act on Biomedical Research—Ley de Investigación Biomédica, LIB-, Article 3 (d).
principal”, that in turn is the “legal entity responsible for a biobank” and that established it.23
In Italy, given the absence of a specific national regulation on biobanks and on biobanking research, definitions can be found in various documents, such as non-legislative acts adopted by administrative authorities or other soft law documents, but never in officially binding laws on biobanking. Indeed, as a matter of example, in the agreement between the Italian government and the Italian regions signed in 2009 biobanks are defined as service units without a direct profitable character built within public or private healthcare facilities, whose aim is to collect, process, store and distribute human biological samples for diagnosis, research or therapeutical purposes.24 Moreover, the Guidelines for certification of biobanks drawn up by the National Committee for Biosecurity and Biotechnologies in 2006 defines biobanks as “service units, not for direct profit, aimed at collecting and preserving human biological material used for diagnosis, biodiversity studies and research”.25
It appears thus clear that there is no general supranational consensus on a definition for biobank, nor can it be inferred from the national provisions. However, this high terminology heterogeneity may cause a problem of nomenclature, but more importantly, is an obstacle to harmonisation and transnational cooperation among biobanks,26 and may cause regulatory uncertainty because of possible doubts that may emerge on whether a certain repository should be qualified as a biobank, with the related consequences in terms of specific national or supranational rules to be complied with.27
23 Biobank Sweden’s translation of the Biobank Act (2023:38), Chapter 1 Section 2.
24 The original version is the following “unità di servizio situate all’interno di strutture sanitarie pubbliche o private, senza fini di lucro diretto, finalizzare alla raccolta, alla lavorazione, alla conservazione, allo stoccaggio e alla distribuzione di materiale biologico umano, a scopo di indagine diagnostica, ricerca e uso terapeutico.” Accordo tra il Governo, le Regioni e le Province autonome di Trento e Bolzano sulle linee progettuali per l’utilizzo da parte delle Regioni delle risorse vincolate, ai sensi dell’articolo 1, commi 34 e 34bis, xxxxx xxxxx 23 dicembre 1996, n. 662, per la realizzazione degli obiettivi di carattere prioritario e di rilievo nazionale per l’anno 2009, stipulato in sede di Conferenza permanente per i rapporti tra lo Stato, le Regioni e le Province autonome di Trento e Bolzano, in data 25 marzo 2009.
25 Comitato Nazionale per la Biosicurezza e le Biotecnologie, Linee Guida per la certificazione delle biobanche, Rapporto del gruppo di lavoro, 2006.
26 Xxxxx, Xxxxxxxxx, and Xxxxxxxxx, Xxxx “Biobanking Strategies and Regulative Approaches in the Eu: Recent Perspectives.” Journal of Biorepository Science for Applied Medicine, vol. 3, 2015, pp. 69-81; Xxxx, Xxxxx X et al. “What is a biobank? Differing definitions among biobank stakeholders.” Clinical genetics vol. 85, n. 3, 2014, pp. 223-227.
27 On the topic, see Xxxx, Xxxxx X et al. “What is a biobank? Differing Definitions among Biobank Stakeholders”; Xxxx, Xxxx and Xxxxx M. C., Xxxxxxx “Mapping the Regulatory Space for Genetic Databases and Biobanks in England and Wales.” Medical Law International, vol. 9, 2008, pp. 111-130.
Indeed, it has been pointed out that a comprehensive definition of the term biobank is difficult to reach because of its nature as “umbrella term” used to describe a wide variety of collections of samples and data devoted to supporting scientific research at large.28 Moreover, precisely because of the high heterogeneity and dynamic nature of biobanks,29 strongly intertwined with, and somehow dependent on the advancement of technology and science, finding a static definition might not be the ideal solution.30
Instead, Xxxxxx proposed identifying only the core characteristics of what constitutes a biobank,31 and along the same line of reasoning I will now try to identify the general and common traits of a collection that qualifies as a biobank.
2.1.1 AN UMBRELLA TERM – IDENTIFYING ITS CORE ELEMENTS
Acknowledging the difficulty in providing an omnicomprehensive and clear definition of the term biobank, Xxxxxx et al. proposed the following general definition “A biobank is a facility for the collection, preservation, storage and supply of biological samples and associated data, which follows standardised operating procedures and provides material for scientific and clinical use”, and at the same time underlined the importance of linking the term with additional specifications, such as population-based, disease-oriented, hospital-integrated, etc., in order to circumscribe the focus of every analysis or discussion.32
In line with these approaches, the German National Ethics Council already in 2010 set a list of criteria to help assess whether a collection of samples and data should be considered a biobank. Starting from the assumption that biobanks have a dual nature because they
28 Xxxxxxxx, Xxxx Protecting Genetic Privacy in Biobanking through Data Protection Law, OUP Oxford, 2021; Xxxxxx, Xxxxxx, and Xxxxx, Xxxxxx “Defining Biobank.”
29 Xxxxxxxxx Xxxxxx, Xxxxxxx Xxxxx “Regolare le Biobanche tra Interessi Pubblici e Xxxxxxx: il Nodo dei Campioni Biologici.” xxxxxxxxxxx.xx, vol. 12, 2023, pp. 231-249; Xxxxxxx, Xxxx Biobanche di Ricerca e Xxxxxx xxxxx Persona, PhD Thesis, Università degli Studi di Napoli Xxxxxxxx XX, Anno Accademico 2013- 2014; Xxxxx, Xxxxxx La Donazione dei Materiali Biologici Umani ai Xxxx xxxxx Ricerca Biomedica xxxx’Ambito del Diritto Internazionale e del Diritto dell’Unione Europea, PhD thesis, Università degli Studi di Cagliari - Universidad xx Xxxxxxx, Anno Accademico 2018-2019; Xxxxxxxxx, Xxxxxx X. “Property Rights in Blood Genes and Data: Naturally Yours?” Nijhoff Law Specials, 2005.
30 Guerra, Xxxx, et al. “Orientamenti per ‘linee guida’ in materia di biobanche.” Biobanche. Aspetti Scientifici ed Xxxxx-Xxxxxxxxx, edited by Xxxxxx, Xxxxxxx, Xxxx x Xxxxxxxx, 2014.
31 Xxxx, Xxxx “Embedding Biobanks in a Changing Context.” Governing Biobanks. Understanding the Interplay between Law and Practice, edited by Xxxx, Xxxx, et al. Bloomsbury, 2012, pp. 30-51. On the importance of focusing on the characteristics of the collection, instead of providing a static definition, also Xxxxxxx, Xxxx, and Xxxx Xxxxxxxx “Legal Aspects of Biobanking as Key Issues for Personalised Medicine and Translational Exploitation.” Personalised medicine, vol. 11, n. 5, 2014, pp. 497-508.
32 Xxxxxx, Xxxxxx, and Xxxxx, Xxxxxx “Defining Biobank.”
are collections of both human samples and data, the Council listed the three following criteria:
1 A biobank shall contain genetic material of human origin and related data;
2 Samples shall be electronically linked to personal information and other further information, in particular, related to health;
3 Those samples and data are collected, preserved or used for scientific research purposes.33
Subsequently, these criteria have been further elaborated by the European Commission in the Report “Biobanks for Europe: A Challenge for Governance”, where it is suggested that biobanks:
a. “collect and store biological materials that are annotated not only with medical but also epidemiological data (e.g. environmental exposures, lifestyle/occupational information);
b. are not static “projects” since biological materials and data are usually collected on a continuous or long-term basis;
c. are associated with current (defined) and future (not yet specified) research projects at the time of biospecimen collection;
d. apply coding or anonymisation to assure donor privacy but have, under specific conditions, provisions that participants remain re-identifiable to provide clinically relevant information back to the donor; and
e. include established governance structures (e.g. ethics review committees) and procedures (e.g. consent) that serve to protect donors’ rights and stakeholder interests”.34
It is worth noticing that both the mentioned documents include the purpose of the collection among the elements to be focused on in order to identify a collection that constitutes a biobank.
However, I agree with those scholars who consider the purpose more a classification element than a substantial one.35 As a consequence, I suggest not including it among the
33 German National Ethics Council, Human biobanks for research – Opinion. 2010.
34 Expert Group on Dealing with Ethical and Regulatory Challenges of International Biobank Research, Biobanks for Europe. a challenge for governance, 2012.
35 Xxxxxxx, Xxxx Biobanche di Ricerca e Xxxxxx xxxxx Persona. the author divides among research biobanks, disease biobanks, forensic biobanks, etc.
general defining elements, and I will consider it for classifying biobanks in the following paragraph.36 I therefore propose limiting the notion of biobanks to collections meeting the following criteria related to:
● the content – samples of human origin and data, also linked to one another and stored respecting the donors’ rights, collected on a continuous basis.37 According to the new Declaration of Taipei, the dual nature of the content (samples and data) is what distinguishes biobanks from health databases.38 Indeed, according to the Declaration the latter are collections of data only, without any biological sample being included;
● the structure/organisation – a specific governance system is in place to collect samples and data for a given purpose, for providing access to the content, etc.39
Finally, I also propose not to include the non-profitable character as a determinant factor for identifying what constitutes a research biobank. Indeed, some legislative acts include it, such as for example the Spanish legislation, in order to establish a more relaxed regulatory regime for the collections that meet specific requirements, usually related to pursue public interests rather than private individual ones. As a consequence, the exclusion of the element of profit from the definition is most of the time the result of a balancing operation already conducted by the legislator between private and public
36 On the contrary, on the importance of including the research purpose among the criteria used to identify when a collection is a biobank, see Xxxx, Xxxxx X., et al. “Social and Behavioral Research in Genomic Sequencing: Approaches from the Clinical Sequencing Exploratory Research Consortium Outcomes and Measures Working Group.”
37 On the importance of the content aspect of biobanks, see Xxxxxxxxxx, Xxxxx, et al. “Basic Principles of Biobanking: from Biological Samples to Precision Medicine for Patients.”.
38 Xxxxxxx, Xxxxxxxxx “La Circolazione dei Dati Genetici e delle Biobanche: Limiti e Prospettive de iure condendo”; Xxxxxxx, Xxxxxxxx, and Xxxxxx Xxxxxxxxxxx, “I Campioni Biologici.” Trattato di Biodiritto. Il governo del corpo Tomo I, edited by Xxxxxxxxxx, Xxxxxxx, et al. Xxxxxxx, 2011, pp. 1027-1062; Xxxxxxxxx, Xxxxxx “Le Biobanche: Disciplina e Diritti della Persona.” Il Governo del Corpo Tomo I, edited by Xxxxxxxxxx, Xxxxxxx et al. Xxxxxxx, 2011, pp. 1195-1215; Xxxxxx, Xxxxxxx “Database Genetici, Biobanche e “Health Information Technologies” Il Diritto dell’Era Digitale, edited by Xxxxxxxx, Xxxxxxxx, Il Mulino, 2016, pp. 305-320.
39 On the importance of the organisational aspect, Xxxxxxxxx, Xxxxxx, Le biobanche di ricerca, Studio xxxxxxxxx sulla “zona grigia” tra privacy e proprietà, and also the guidelines on recognition and accreditation of biobanks by the Comitato Nazionale per la Biosicurezza e le Biotecnologie e le Scienze xxxxx Xxxx - Linee Guida per il riconoscimento/accreditamento delle Biobanche, 2008. Moreover, on the same topic, Xxxxxxxx, Xxxxxxx, and Xxxx, Xxxxxxxx Biobanks Governance in Comparative Perspective, Routledge, Xxxxxx & Xxxxxxx Group, 2008; Xxxxxx, Xxxxx, et al. “Biobanks for Life Sciences and Personalized Medicine: Importance of Standardization, Biosafety, Biosecurity, and Data Management.” Current Opinion in Biotechnology, vol. 65, 2020, pp. 45-51.
interests.40 Therefore, the elements used to abstractly identify a research biobank for the purposes of this analysis do not include the hypothetical profit that the collection may make out of the use of the samples and data stored therein.
2.1.2 RESEARCH BIOBANKS AND THEIR CLASSIFICATION
As previously mentioned, different types of biobanks exist,41 as well as different classification methods.42 As for the latter, classifications are based on tissue type, purpose, ownership, group of participants, or size.43
In particular, as far as the purpose is concerned, some of the documents mentioned in the previous paragraph provide a list of characteristics that are fundamental for the identification of a biobank and include conducting research among them (i.e. the purpose of the biobank). However, the term biobank may also be used for collections of samples and data for other purposes, such as in a clinical context (clinical biobanks) or for forensic purposes (forensic biobanks),44 and therefore, as mentioned, I suggested not to include conducting scientific research among the identifying elements, but to consider it as a classifying element and in particular to distinguish among research biobanks, clinical biobanks, forensic biobanks, etc.
Xxxxxxxx from the belief that any legal evaluation shall be context-dependent, I chose to focus this work only on research biobanks, i.e. biobanks established for the purposes of providing human biological samples and data for research projects. This choice originates from the belief that research biobanks have a peculiar impact on individuals and society at large, different from those of other biobanks with different purposes, while at the same time they are tools to pursue public health and the public good more generally. Indeed,
40 Moreover, the non-profitable character is usually more an obligation to be complied with than an actual defining element.
41 Xxxxx, Xxxxxxxxx X., et al. “Biobanks and Personalized Medicine.” Clinical Genetics vol. 86, n. 1, 2014, pp. 50-55.
42 Xxxxxxxxxx, Xxxxx, et al. “Basic Principles of Biobanking: from Biological Samples to Precision Medicine for Patients”; Xxxxxxxxx, Judita “Biobanks in the Era of Personalized Medicine: Objectives, Challenges, and Innovation: Overview.” the EPMA Journal, vol. 7, n. 4, 2016, pp. 1-9; Xxxxxxxx, Xxxxxxx, and Xxxx, Xxxxxxxxx “Biobank Governance: Trends and Perspectives.” Pathobiology, vol. 74, n. 4, 2007, pp. 206–211; Xxxxxxx, Xxxxx, et al. “Biobanking in the year 2007.” Transfusion Medicine and Hemotherapy, vol. 34, 2007, pp. 286–92.
43 Xxxxxxxxxx, Xxxxxxxx, et al. “A Classification and Comparative Study of European Biobanks: an Analysis of Biobanking Activity and its Contribution to Scientific Progress.” Archives of Medicine, vol. 8, n. 3, 2016, pp. 1-10; Xxxxx, Xxxxxx La Donazione dei Materiali Biologici Umani ai Xxxx xxxxx Ricerca Biomedica xxxx’Ambito del Diritto Internazionale e del Diritto dell’Unione Europea.
44 Xxxxx, Xxxxxx La Donazione dei Materiali Biologici Umani ai Xxxx xxxxx Ricerca Biomedica xxxx’Ambito del Diritto Internazionale e del Diritto dell’Unione Europea.
the structure, governance and balance between the different interests at stake for building a research biobank are drastically different from those considered for biobanks with other purposes.45
In this regard, two specifications are of particular importance, a practical and a conceptual one.
On the one hand, as it stems also from the definition of the term provided above, biobanks are collections of samples and data on a long-term basis. Therefore, when their purpose is conducting scientific research, their aim is to provide samples and data for a possible undefined or unlimited number of scientific research projects, provided that the applicable ethical, legal and governance principles are complied with. This specific aspect of biobanks has peculiar consequences on the way human biological samples and data are collected, because of the impossibility of providing in advance to the participant a clear and detailed overview of every scientific project for which the collected material will be used.
On the other hand, as stated by BBMRI research biobanks are expected to act as an “intermediary” between donors/participants, scientists, patients, hospitals, etc.46 Consequently, research biobanks are not research projects per se, but are ontologically built to provide human biological samples and data for research.47 In this regard, in the vast majority of cases, biobanks provide a service for researchers in the sense that they collect the samples and data, store them in a manner suitable for preserving their quality,
45 Xxxxxx, Xxxxx “Il Modello Italiano di Regolamentazione Giuridica delle Biobanche: alla Ricerca di una Sintesi per una Materia Poliedrica.” Biobanche: importanza, implicazioni e opportunità per la società. Risvolti scientifici, xxxxx-xxxxxxxxx e sociologici, edited by Xxxxxxxx, Xxxxxxx, xxxxxxxxxxxxxxxxxxxxx.xx, 2010, pp. 21-48; Xxxxxxxx, Xxxxxxx, and Xxxxxxxxx, Xxxxxx “Il trattamento dei dati genetici e biometrici.” Il Nuovo Codice in Materia di Protezione Dei Dati Personali: La Normativa Italiana Dopo il D. Lgs. 101/2018, edited by Xxxxxx, Xxxxx, et al. Xxxxxxxxxxxx, n. 2, 2019, pp. 113-131.
46 Xxxxxx-Portal, Xxxxxxx, and Xxxxxx Xxxxxxxx “The Reconfiguration of Biobanks in Europe under the BBMRI-XXXX Framework: towards Global Sharing Nodes?” Life Sciences, Society and Policy, vol. 16, n. 1, 2020, pp. 1-15; Xxxxxx, Xxxxx, et al. “The Evolution of Withdrawal: Negotiating Research Relationships in Biobanking.” Life Sciences, Society and Policy, vol. 10, n. 16, 2014, pp. 1-13; Xxxxxxxx, Xxxxxxxx, and Xxxxxxxxxx, Real-Sebbag “Research Biobanks and Health Databases: The WMA Declaration of Taipei, Added Value to European Legislation (Soft and Hard Law).”
47 Xxxxxx, Xxxxx, et al. “The Evolution of Withdrawal: Negotiating Research Relationships in Biobanking”; Xxxxx, Xxxxxx La Donazione dei Materiali Biologici Umani ai Xxxx xxxxx Ricerca Biomedica xxxx’Ambito del Diritto Internazionale e del Diritto dell’Unione Europea; Macilotti, Xxxxxx “Le Biobanche: Disciplina e Diritti della Persona.”
grant the researchers’ requests to access the content for their own research projects, and so on.48
To reach their purpose, research biobanks can be implemented in various settings and environments, in particular hospitals (hospital-based biobanks which receive samples and data from the organisation they are built-in), research centers (for instance as part of clinical trials or case-control biobanks), pharmaceutical companies and patient advocacy organisations.49
At the same time, different classifications of research biobanks exist,50 which include for instance population-based biobanks, disease-oriented biobanks, case-control biobanks, tissue biobanks and biobanks within the context of clinical trials.51 A general classification of research biobanks identifies population-based biobanks on the one hand and disease-oriented biobanks on the other.52
In the first case, as previously mentioned, the biobank collects samples and data from a vast group of people or a large percentage of a given population and aims at studying common and complex diseases53 by linking data with environmental factors and other information related to a patient’s health status and lifestyle.54 Therefore, data and samples
48 In a limited number of instances, the biobank may also be the entity which collects and stores the biological samples and data, while at the same time conducting some or all the research projects. While I will make reference to this scenario whenever relevant, it will not be specifically addressed in the present work, because of the substantially different characteristics and issues of the eventuality in which the biobank is open to external researchers or not.
49 Xxxxxxxxxx, Xxxxx, et al. “Basic Principles of Biobanking: from Biological Samples to Precision Medicine for Patients”; Xxxxxx, Xxxxxxx Xx Xxxxxxx Giuridico della Bioinformazione tra Biobanche di Ricerca e Fascicolo Sanitario Elettronico, PhD Thesis, University of Trento, Anno Accademico 2012- 2013.
50 Xxxxxxx, Xxxxxxxxx “La Circolazione dei Dati Genetici e delle Biobanche: Limiti e Prospettive de iure condendo”; Paris, Xxxxxx “Biobanche di Ricerca e Banca Dati Nazionale del DNA: un Difficile Bilanciamento tra Interessi Contrapposti.” BioLaw Journal, vol. 1, 2022, pp. 83-107.
51 Xxxxxxx, Xxxx, and Xxxx Xxxxxxxx “Legal Aspects of Biobanking as Key Issues for Personalised Medicine and Translational Exploitation.”
52 On the topic, among others, Xxxxxxxxx, Xxxxxx, Le biobanche di ricerca, Studio xxxxxxxxx sulla “zona grigia” tra privacy e proprietà; Guerra, Xxxx, et al. “Orientamenti per ‘linee guida’ in materia di biobanche”; Xxxxxxx, Xxxxxxxxx “La Circolazione dei Dati Genetici e delle Biobanche: Limiti e Prospettive de iure condendo.”
53 Xxxxxxxxx, Xxxxxx “Biobanks in the Era of Personalized Medicine: Objectives, Challenges, and Innovation: Overview”; Xxxxxxx, Xxxxx, et al. “Biobanking in Health Care: Evolution and Future Directions.” Journal of Translational Medicine, vol. 17, n. 172, 2018, pp. 1-18; Xxxxxx, Xxxxxxx Xx Xxxxxxx Giuridico della Bioinformazione tra Biobanche di Ricerca e Fascicolo Sanitario Elettronico; Xxxxxxxx, Xxxxxxxx “Aspetti Giuridici delle Biobanche.” Biobanche: importanza, implicazioni e opportunità per la società. Risvolti scientifici, xxxxx-xxxxxxxxx e sociologici, edited by Xxxxxxxx, Xxxxxxx, xxxxxxxxxxxxxxxxxxxxx.xx, 2010.
54 Xxxxxxx, Xxxxxxxxx “La Circolazione dei Dati Genetici e delle Biobanche: Limiti e Prospettive de iure condendo.”
to be stored in this kind of biobank are usually collected from healthy representative donors for a given region, country or specific ethnic group.55 A popular example of this kind of biobank is the UK Biobank.
On the contrary, a disease-oriented biobank focuses on storing (and conducting scientific research on) samples and data related to a specific condition to identify possible therapeutic strategies.56 Riegman further divides disease-oriented biobanks into disease- oriented biobanks for epidemiology, where samples from both healthy and diseased subjects are stored, and disease-oriented general biobanks, where the samples and data stored are collected from patients with a specific disease throughout the life-cycle of disease progression and treatment.57 For disease-oriented biobanks, biological materials are usually collected in the context of clinical care.58
2.1.3 THE CONTENT OF RESEARCH BIOBANKS
As previously mentioned, the dual nature of research biobanks derives from the fact that their content comprises both human biological samples and related data of participants, collected from various sources which are possibly of a different nature.
Therefore, one of the most important aspects to consider when developing and building a research biobank is the standardisation of the processes for the collection, storage and quality control of human biological samples and data.59 Indeed, standardised processes would help not only to ensure high quality of the biobank content, but also improve exchanges and cooperation between different biobanks and various researchers. In this regard, the ISO 20387:2020 was released in 2020,60 concerning the general requirements for the competence, impartiality and consistent operation of biobanks for research and development (thus excluding clinical and therapeutic diagnostic biobanks), including
55 Xxxxxxx, Xxxx, and Xxxx, Schovsbo “Legal Aspects of Biobanking as Key Issues for Personalised Medicine and Translational Exploitation.”
56 Xxxxxxx, Xxxxx, et al. “Biobanking in Health Care: Evolution and Future Directions”; Xxxxxx, Xxxxxxx Xx Xxxxxxx Giuridico della Bioinformazione tra Biobanche di Ricerca e Fascicolo Sanitario Elettronico. 57 Xxxxxxx, Xxxxx X. X., et al. “Biobanking for Better Healthcare.” Molecular Oncology vol. 2, n. 3, 2008, pp. 213-222. On the topic, see also Xxxxxxxx, Xxxxxxxx “Aspetti Giuridici delle Biobanche”; Xxxxxxx, Xxxxxxxxx “La Circolazione dei Dati Genetici e delle Biobanche: Limiti e Prospettive de iure condendo.” Further on classifying biobanks, see Xxxxxxxxxx, Xxxxx, et al. “Basic Principles of Biobanking: from Biological Samples to Precision Medicine for Patients.”
58 Xxxxxxx, Xxxx, and Xxxx, Schovsbo “Legal Aspects of Biobanking as Key Issues for Personalised Medicine and Translational Exploitation.”
59 Xxxxxxxxxx, Xxxxx, et al. “Basic Principles of Biobanking: from Biological Samples to Precision Medicine for Patients.”
60 As an update of the previous version ISO 20387:2018.
quality control requirements for their content. However, more broadly than the focus of this work, ISO 20387 is applicable to biobanks that store biological material derived from humans, but also animals, plants, microorganisms or multicellular organisms.61 Moreover, biobanks shall include in their governance also processes to ensure the traceability of their content, as well as procedures for their destruction (i.e. destruction of the human biological samples and deletion of the data), should it be necessary or required. All the mentioned aspects shall be addressed in the biobank governance, to ensure transparency and consistency in their application.
In this context, Xxxxxxx and Xxxxxxx identified three governance models that biobanks may adopt to provide samples and related data for research purposes: the tissue procurement model, the classic biobanking model and the population based/epidemiological bioresource.62
In the first model, biological samples and data are collected to meet the specific requirements of individual researchers or individual research projects and to this end the samples are distributed soon after collection.63
According to the classic biobanking model, the biobank decides autonomously what samples and data to collect and according to which criteria and procedures. This model is particularly useful for studies that require an extensive number of clinical data and samples.64
Finally, as for the third model, the content of a biobank is collected to address a specific healthy population or subpopulation or from patients with a specific disease.65
For the purposes of our analysis, what can be inferred from this categorisation is a confirmation of the above-mentioned idea that biobanks provide a service for research and cannot be qualified as research projects per se or are not generally involved directly in the conduction of the research projects that use their content.
I will now provide a general overview of the types and sources of each content of a biobank, highlighting their respective characteristics.
61 As it stems from the definition of biological material provided for in paragraph 3.7 of ISO 20387:2020.
62 Xxxxxxx, Xxxxxxxx X., and Xxxxxxx X., Xxxxxxx “The Use of Human Tissues for Research: What Investigators Need to Know.” Alternatives to Laboratory Animals: ATLA, vol. 50, n. 4, 2022, pp. 265-174.
63 Xxxxxxx, Xxxxxxxx X., and Xxxxxxx X., Xxxxxxx “The Use of Human Tissues for Research: What Investigators Need to Know.”
64 Xxxxxxx, Xxxxxxxx X., and Xxxxxxx X., Xxxxxxx “The Use of Human Tissues for Research: What Investigators Need to Know.”
65 Ibid
2.1.3.1 HUMAN BIOLOGICAL SAMPLES (HBSS)
There are various types of biological samples that may be stored in a biobank. Among the others, tissues, blood, cells and stem cell lines, DNA, RNA are worth mentioning.66 At the same time, possible new sources of human biological samples (HBSs) are imagine techniques such as structural and functional magnetic resonance imaging, positron emission tomography, magnetoencephalography, etc.67
However, the following analysis and this work will not take into consideration samples that may be stored and subsequently used only for reproductive purposes, such as for instance cryopreserved embryos for undergoing an assistive reproductive practice, even though they are included in the category of the HBS on abstract terms. The reason for this choice stems from the assumption, as mentioned earlier, that my research project focuses on research biobanks only, and therefore biobanks whose samples and data are stored and used for future research purposes. In this regard, the possibility of conducting scientific research with and on these biological materials (if it is at all possible to include embryos in this category) is in itself controversial and possibly banned under national or international law. As a consequence, the analysis of the legal issues that such possibility arises are radically different to, and not compatible with the ones that will be the focus of my research question.68
Moreover, I strongly agree with those who believe that also the discussion on the issues that arose in the context of human biological samples should be context-dependent and therefore shall take into consideration the specificities of the case under consideration. In particular, for the purpose of this analysis, as it will be further elaborated in Chapter III, Part A, these core elements of the discussion are the following: (1) the samples under consideration are human biological samples (focus on the type of sample), (2) these
66 Xxxxx, Xxxxxxxxx X., et al. “Biobanks and Personalized Medicine”; Xxxxxxxxx, Judita “Biobanks in the Era of Personalized Medicine: Objectives, Challenges, and Innovation: Overview.”
67 Xxxxxxxxx, Xxxxxx, and Xxxxxx Xxxxxxxx “Biobanks in the Era of Big Data: Objectives, Challenges, Perspectives, and Innovations for Predictive, Preventive, and Personalised Medicine.” the EPMA Journal vol. 11, n. 3, 2020, pp. 333-341.
68 The same approach is adopted by the Recommendation R(2016)6 when in Art. 2 it excludes from its material scope of application “embryonic or foetal biological materials.” More generally on the importance to differentiate the analysis according to the type of biological sample and the purposes for which these samples are used, see Xxxxxx, Xxxxxxx “Verso uno Statuto Giuridico dei Campioni Biologici Umani. Premesse Teoriche.” Lo Statuto Etico-giuridico dei Campioni Biologici Umani, edited by Xxxxxx, Xxxxx, Diritto, Mercato e Tecnologia, 2016, pp. 113-142.
samples are stored in a biobank specifically and only for research purposes (focus on the
final purpose of the use of the samples).69
Furthermore, varied are also the ways possibly used to collect samples,70 which may be mirrored in the following major categorisation: left-over samples, donated samples and samples from deceased persons.71
As far as left-over samples are concerned, those are all the human samples collected during the provision of clinical care, such as for instance the biological material that remains after a surgical operation.72 This specific type of sample was initially considered a “waste” not worth saving or storing, but through time their value as sources of fundamental information and data about participants/patients has been recognised. Today, samples of this kind are usually stored in disease-oriented biobanks. However, precisely because they are initially collected in the context and for the purposes of providing clinical care, problems and difficulties arise with the quality of the samples, the registration of related information and the provision of informed consent.73 In this category, it is possible to include also biological samples donated for transplants and subsequently not used or considered not fit for the purpose.
In particular, from a national point of view, pathologists are under the obligation to retain tissues collected during healthcare activities in diagnostic archives for care and prevention purposes.74 To this end, the Italian Superior Council of Health adopted a set
69 Deplano, Xxxxxxx “Il Xxxxxxxx Biologico di Unidentified Person. Profili di Sistema.” BioLaw Journal, vol. 1, 2022, pp. 45-56; Xxxxx, Xxxxx “Il Corpo e la Nebulosa dell’Appartenenza.” per uno Statuto del Corpo, edited by Xxxxxxx, Xxxxxx Xxxxx, Xxxxxxx Editore, 2008, pp. 69-110; Xxxxxxxx, Xxxxxxxxx, “A Pound of man’s Flesh. Consenso alla Ricerca sui Tessuti Biologici Umani e Teoria dei Beni.” La Ricerca sui Materiali Biologici di Origine Umana: Giuristi e Scienziati a Confronto, edited by Xxxxxxx, Xxxxxxx X., Nuova Editrice Universitaria, 2018, pp. 76-77.
70 On more technical aspects related to the processing of collected biological samples, see Xxxxxxx, Xxxxx, et al. “Biobanking in Health Care: Evolution and Future Directions.”
71 On this categorisation, see Xxxxxxx, Xxxxxxxx X., and Xxxxxxx X., Xxxxxxx “The Use of Human Tissues for Research: What Investigators Need to Know”; Xxxxxx, Xxxxxxx Xx Xxxxxxx Giuridico della Bioinformazione tra Biobanche di Ricerca e Fascicolo Sanitario Elettronico. Also more generally, Xxxxxxxx, Xxxxxxxxxx “Biobanche di Ricerca e Modelli Regolativi.” Comparazione e Diritto Civile, vo. 1, 2018, pp. 1-22; Xxxxx, Xxxxxx “Xxxxxxxx Biologico e Consenso Informato nella Ricerca Genetica: il Possibile Ruolo delle Biobanche.”
72 Xxxxxxx, Xxxxx, and Xx Xxxxx Xxxxxxx, Xxxxxxx, “Secondary use (Part I).” GDPR requirements for biobanking activities across Europe, edited by Xxxxxxxx, Xxxxxxxxx, et al. Springer, pp. 383-388.
73 Xxxxxxxx, Xxxxxxxx “Aspetti Giuridici delle Biobanche”; Xxxxxxxxxx, Xxxxx, et al. “Basic Principles of Biobanking: from Biological Samples to Precision Medicine for Patients.”
74 Xxxxxxxxxx, Xxxxxxxx, “Italy.” GDPR requirements for biobanking activities across Europe, edited by Xxxxxxxx, Xxxxxxxxx, et al. Springer, pp. 531-541.
of Guidelines containing provisions on the term for the duration of the retention obligation and more generally on its implementation.75
Donated samples are those collected specifically for biobanking purposes from participants recruited to this end. In this case, participants are voluntarily providing their samples to the biobank. Donated samples are mostly stored in population biobanks, but they are also frequent in research biobanks as well.
Finally, samples from deceased persons are those obtained after an autopsy.
The analysis in the following pages will only consider the first two categories of human biological samples, because of the substantial differences that exist between these and samples from deceased persons. Indeed, precisely because of the characteristics of a research biobank as highlighted above, collecting, storing and processing biological samples (and also personal data, as it will be extensively discussed) for future and undefined research projects pose questions related to the necessity for the participants to be aware of the purposes of the processing, and the way in which her samples/data are generally stored and used, throughout the life of the biobank. In this scenario, substantially different issues emerge between the case of samples from deceased persons on the one hand, and that of left-over and donated samples on the other. Indeed, for instance, in the first scenario, the rights of the specific person who provided the samples (or the data) are not relevant for the discussion anymore, while the different interests of the descendants of such a person should be considered. However, the same is not true for left-over and donated samples (or at least not in the same way).
Such a distinction is particularly relevant for the analysis of the models for the collection of HBSs, included in Chapter III.
Usually, biological samples collected are linked to health information and data about the participant/patient and precisely this linkage and connection is an important part of the value of the content of a biobank for research,76 especially for the advancement of
75 Ministry of Health, Italian Superior Council of Health (2015) Guidelines on traceability, collection, transport, storage and archiving of cells and tissues for pathological anatomy diagnostic investigations. xxxxx://xxx.xxxxxx.xxx.xx/xxxx/X_00_xxxxxxxxxxxxx_0000_xxxxxxxx.xxx; Xxxxxxxxxx, Xxxxxxxx, “Italy.”
76 Xxxxxxxxx, Xxxx A. A. et al. “Inclusion of Residual Tissue in Biobanks: Opt-in or Opt-out?” PLoS biology, vol. 10, n. 8, 2012, pp. 1-6; Xxxxxxxxx, Xxxxxx, and Xxxxxx Xxxxxxxx “Biobanks in the Era of Big Data: Objectives, Challenges, Perspectives, and Innovations for Predictive, Preventive, and Personalised Medicine”; Xxxxxx, Xxxx, “Biobanche, Consenso e Xxxxx del Diritto: un Caso di Eccezionale Disordine?” Forum Biodiritto 2020. La Disciplina delle Biobanche a Fini Terapeutici e di Ricerca, edited by Xxxxxxxx, Xxxxx, et al. Quaderni del Dipartimento di Scienze Giuridiche, 2012, pp. 117-150; Pacia, Romana “Xxxxxxxx Biologico e Consenso Informato nella Ricerca Genetica: il Possibile Ruolo delle Biobanche.”
precision medicine as it will be highlighted in the following paragraph. As will be extensively analysed in Chapter III, biological samples are most valuable for research biobanks precisely because of the potential information and (health and genetic) data that can be extracted from them.
2.1.3.2 DATA FOR BIOBANKS - THEIR IMPORTANCE FOR PRECISION MEDICINE
The data stored in research biobanks are of different types and collected from various sources as well (for the sake of clarity, all the data stored in the biobank will be referred to collectively as biobank data). Indeed, biobank data include for instance clinical data (demographics, death/survival data, questionnaires), imaging (ultrasound, magnetic resonance), biosamples, data (values from blood, urine, saliva), molecular data (genomics, proteomics), digital pathology data, “omics” data, possibly data from wearable devices, and much more.77
It appears clear already from this non-comprehensive list of sources of data to be collected that the amount of data possibly stored in a biobank is astonishing.78 Moreover, new sources of data are generated continuously by the digitalisation of patient-level data, which are stored in electronic health records and health information exchanges, and by imaging and test results, medical and prescription claims and personal health devices.79 All these data stored in biobanks usually show the characteristics of big data,80 or big health data.81 Through time, Big data have been said to possess multiple characteristics, starting from the notorious 3 Vs (Volume, Variety and Velocity) and arriving at 10 Vs (including Value, Validity, Vagueness, etc).82 As far as biobanking is concerned, it
77 Xxxx, Xxxxxx X., and Xxxxx-Xxxxx, Xxxx “Big-data for Precision Medicine.” Engineering, vol. 1, n. 3, 2015, pp. 277-279; Xxxxxx, Xxx, et al. “From Big Data to Precision Medicine.” Frontiers in medicine vol. 6, n. 34, 2019, pp. 1-14;
78 Xxxxxxxxx, Xxxxxx, and Xxxxxx Xxxxxxxx “Biobanks in the Era of Big Data: Objectives, Challenges, Perspectives, and Innovations for Predictive, Preventive, and Personalised Medicine.”
79 Xxxxxxx, Xxxxxxx, et al. Big Data, Big Analytics: Emerging Business Intelligence and Analytic Trends for Today´s Business, Wiley & Sons, 2013.
80 Xxxxxxxxx, Xxxxxx, and Xxxxxx Xxxxxxxx “Biobanks in the Era of Big Data: Objectives, Challenges, Perspectives, and Innovations for Predictive, Preventive, and Personalised Medicine.”; Guarda, Paolo, Il Regime Giuridico dei Dati della Ricerca Scientifica, Editoriale scientifica, 2021.
81 Xxxxxx, Xxxxx, Health data privacy under the GDPR: Big Data Challenges and Regulatory Responses,
82 On the characteristics of big data, see extensively Xxx, Xxxx et al. “Big Data Application in Biomedical Research and Health Care: a Literature Review.” Biomedical informatics insights vol. 8, 2016, pp. 1-10; Xxxxxx, Xxxx, and Xxxxx, Page “Big Data in Healthcare: Opportunities and Challenges.” Big data, vol. 3,
n. 4, 2015, pp. 209-210; Xxxx, Xxxxxx X. X., and Xxxx-Xxxx, Xxxxx “Data-Intensive Applications,
suffices to underline that Big data are generated faster than normal data, because of the variety of possible sources83 and the fact that they are sometimes collected on a continuous basis.84 Moreover, Big data are usually of a huge volume, because they are collected from a large patient group or from a portion of the population in a given geographical area (while data collected from a single patient are not big data).85 As a consequence, biobanks may sometimes need to work with both “normal” data and Big data, causing difficulties in their management, processing and storing.
Because of their characteristics, Big data make patient stratification possible, which in turn is the foundation of precision medicine (also called personalised medicine, individualised medicine, etc).86 Indeed, precision medicine intends to develop personalised care for each specific patient, in particular causing a paradigmatic shift from treatment to prevention.87 Such a shift, and the very possibility of providing personalised care, is only possible if large quantities of biological samples and data are available.88 In particular, personalised medicine is characterised by four different features and thus it is:
● predictive, i.e. aims at discovering predictive factors for certain diseases;
● preventive, i.e. intends to elevate prognosis values of early symptoms and connect them with genetic data, to increase physicians' chances of discovering diseases on time and provide the most adequate treatment to patients;
Challenges, Techniques and Technologies: a Survey on Big Data.” Information Sciences, vol. 275, 2014, pp. 314–47 for their 3Vs characterisation; Xxxxxxxxxx, Xxxxx, et al. “The Big Data Revolution for Breast Cancer Patients.” European journal of breast health vol. 14, n. 2, 2018, pp. 61-62, for their 5Vs characterisation; Xxxxxx-Xxxxx, Xxxxxx, et al. “Big data for Health.” IEEE Journal of Biomedical and Health Informatics, vol. 19, n. 4, 2015, pp. 1193-1208, for their 6Vs characterisation; the 7 V´s of Big Data. impact. blog post. 2016, for their 7Vs characterisation; Xxxxx, Xxxx “Top 10 Big Data Challenges – a Serious Look at 10 big Data V´s.” MapR, 2014, for their 10Vs characterisation.
83 Xxxxxx, Xxxxx, Health data privacy under the GDPR: Big Data Challenges and Regulatory Responses. 84 Iacomussi, Xxxxx “Regulating Biobanks: an Ethical Analysis of the Spanish Law and the New Challenges of the Bigdata-driven Biomedical Research.” Revista de Bioética y Derecho, vol. 53, 2021, pp. 215-233.
85 Xxxxxxxxx, Xxxxxx, and Xxxxxx Xxxxxxxx “Biobanks in the Era of Big Data: Objectives, Challenges, Perspectives, and Innovations for Predictive, Preventive, and Personalised Medicine.”
86 Xxxxxxx, Xxxx, and Xxxx, Xxxxxxxx “Legal Aspects of Biobanking as Key Issues for Personalised Medicine and Translational Exploitation”; Xxxxxxxxx, Xxxxxx, and Xxxxxx Xxxxxxxx “Biobanks in the Era of Big Data: Objectives, Challenges, Perspectives, and Innovations for Predictive, Preventive, and Personalised Medicine.” Extensively on precision medicine, also from a technical point of view, see Xxxx, Xxxx Advancing Healthcare through personalised medicine, Springer, 2021; Iacomussi, Xxxxx “Regulating Biobanks: an Ethical Analysis of the Spanish Law and the New Challenges of the Bigdata-driven Biomedical Research.”
87 Xxxxxxxxx, Xxxxxx, and Xxxxxx Xxxxxxxx “Biobanks in the Era of Big Data: Objectives, Challenges, Perspectives, and Innovations for Predictive, Preventive, and Personalised Medicine.”
88 Xxxxxxxxx, Xxxxx “Regulating Biobanks: an Ethical Analysis of the Spanish Law and the New Challenges of the Bigdata-driven Biomedical Research”; Xxxxxxxx, Xxxxxxxx “Aspetti Giuridici delle Biobanche.”
● personalised, i.e. featured to provide specific treatments according to the genotypic and phenotypic differences in the human population;
● participatory, i.e. developed for increasing communication between patients and physicians.89
At the same time, biobanks also have a primary role in, and possibly are, the foundation of, the development of precision medicine90 because of the structural link between biological samples and related data collected from participants.91 Indeed, biobanks may possibly “enable investigators in the field of genomics to search, record and analyse phenotypic information pertaining to large numbers of patients in a ‘real world’ context”.92 For these reasons, biobanks have been included among the pillars for precision medicine.93 Indeed, by storing both normal data and Big data, maintaining the mentioned link with the participants’ biological samples, and being able to provide large quantities of samples and data,94 biobanks would be and currently are a fundamental resource for identifying risks associated with disease and thus developing personalised treatments, the final goal of precision medicine. Moreover, given that precision medicine aims at being preventive and personalised for a specific target patient, in supporting its development biobanks are at the same time infrastructures for the common good and the benefits of society at large.95
It contributes to reinforcing the importance of research biobanks for precision and personalised medicine the fact that they store also genetic data, alongside other types of
89 More extensively on the characteristics of personalised medicine, see Xxxxxx, Xxxxxx, et al. “Aspects of Modern Biobank Activity - Comprehensive Review.” Pathology oncology research: POR vol. 24, n. 4, 2018, pp. 771-785.
90 Xxx, Xxxxx, and Xxx, Xxxxxxx “Biobanking for Personalized Medicine.” Biobanking in the 21st Century, edited by Xxxxxx-Xxxxxxx, Xxxxxxxx, Xxxxxxxx International Publishing, 2015, pp. 55-68; Xxxxxxxxx Xxxxxxxx, Xxxxxxxx “Campioni Biologici da Vivente Capace e Biobanche di Ricerca: Raccolta, Utilizzo e Circolazione.” European Journal of Privacy Law and Technologies, vol. 1, 2021, pp. 180-198; Xxxxxx, Xxxxxx X. “Biobanking: The foundation of Personalized Medicine.” Current Opinion in Oncology vol. 23, n. 1, 2011, pp. 112-119.
91 Xxxxx, Xxxxxxxxxxx Xxxxxx, et al. “Personal Medicine – the New Biobank Crisis.” Nature Biotechnologies, vol. 30, n. 2, 2012, pp. 141–147.
92 Xxxxxxx, Xxxx, and Xxxx Xxxxxxxx “Legal Aspects of Biobanking as Key Issues for Personalised Medicine and Translational Exploitation.”
93 Xxxxxxxxx, Xxxxxx “Biobanks in the Era of Personalized Medicine: Objectives, Challenges, and Innovation: Overview.”
94 Xxxxx, Xxxxxx La Donazione dei Materiali Biologici Umani ai Xxxx xxxxx Ricerca Biomedica xxxx’Ambito del Diritto Internazionale e del Diritto dell’Unione Europea; Xxxxxxx, Xxxxxxxx Il Ruolo dei Material Transfer Agreements nel Rapporto tra Biobanche ed Enti di Ricerca: Comparazione tra Diritto Italiano e Statunitense, PhD thesis, Università Xxxxx Xxxxx Xxxxx, Anno Accademico 2014-2015.
95 Fanni, Xxxxxx La Donazione dei Materiali Biologici Umani ai Xxxx xxxxx Ricerca Biomedica xxxx’Ambito del Diritto Internazionale e del Diritto dell’Unione Europea.
personal and non-personal data. Indeed, from the discovery of the structure of the DNA in 1953,96 the discoveries about the human genome that followed brought about new insights on the human body and the developments of diseases, which are nowadays another foundation of a personalised therapeutic response, and thus personalised medicine.97
Among the main consequences of the link between biobanks, Big data and precision medicine,98 two are of particular importance, which will be extensively analysed in the following Chapters, but that I believe are worth mentioning already here.
On the one hand, because of the advancement of precision medicine and the gradual shift in focus in healthcare that it brings with it, biobanks need to start moving towards a patient-centered approach,99 which in turn requires a stronger focus on participants’ trust and greater involvement of patients.100
On the other hand, given that the data stored in research biobanks usually qualify as Big data, to successfully anonymise samples and data is becoming increasingly difficult, if not impossible.101
As for the HBSs, it is possible to categorise the types of data collected to be stored in a biobank as well. In particular, the ways in which the collection and the processing for biobanking purposes may occur permit the following classification:
• Data collected specifically for biobanking purposes, i.e. to be stored in a biobank for future research purposes. This category is somewhat conceptually similar to that of donated samples because in both cases the participant is generally involved for the sole purposes of the biobank (donated data);
96 Xxxxx Xxxxxxxxxx, Xxxxxxxxx, “I test genetici.” Trattato di Biodiritto. Il governo del corpo. Xxxx X, edited by Xxxxxxxxxx, Xxxxxxx, et al. Xxxxxxx, 2011, pp. 371-388.
97 Xxxxx, Xxxxxx La Donazione dei Materiali Biologici Umani ai Xxxx xxxxx Ricerca Biomedica xxxx’Ambito del Diritto Internazionale e del Diritto dell’Unione Europea. Moreover, the UNESCO International Declaration on Human Genetic Data addresses the importance and specificities of genetic data for medical research.
98 Xxxxxxx, Xxxx, and Xxxx Xxxxxxxx “Legal Aspects of Biobanking as Key Issues for Personalised Medicine and Translational Exploitation”; Xxxxx, Xxxxxxxxxxx Xxxxxx, et al. “Personal medicine--the new banking crisis.” Nature biotechnology vol. 30, n. 2, 2012, pp. 141-7.
99 Xxxxxxxxxx, Xxxxx, et al. “Basic Principles of Biobanking: from Biological Samples to Precision Medicine for Patients”; Xxxxxxxx, Xxxxxx, et al. “Biobanking from the patient perspective.” Research involvement and engagement, vol. 1, n. 4, 2015, pp. 1-17.
100 Iacomussi, Xxxxx “Regulating Biobanks: an Ethical Analysis of the Spanish Law and the New Challenges of the Bigdata-driven Biomedical Research.”
101 The analysis of the issue is provided for in Chapter IV.
• Data primarily used for other purposes, for instance for providing medical care or conducting specific scientific research project, and subsequently stored in the biobank. This category is somewhat conceptually similar to that of left-over samples because for both the primary purpose of the collection was not the inclusion in a biobank (left-over data);
• Data extracted from a HBS. This category is conceptually separated from the others because technically data are not collected directly from the person herself, but only indirectly, because they are extracted from a sample collected from the person (HBS data).
Samples and data to be stored in a biobank may be collected in various ways. As a matter of example, a biobank may be implemented within a more extensive scientific research activity, such as before and in view of the conduction of a clinical trial, or in the course of clinical care, with left-over samples and related data being stored in a biobank and subsequently made available for research.102 In the latter case, samples and tissues are usually linked to information about the person.103 As underlined above, such a link, established either before or after the implementation of the biobank, is an important element for qualifying a collection as a biobank.
The existence of different practical modes of collecting samples and data and of implementing the biobank itself may cause some difficulties. In particular, a clear distinction between the primary and secondary uses of what is stored therein is difficult to conceptualise, as well as a homogeneous handling of the different possible situations in this regard. However, untangling the yarn of this issue is of utmost importance for the lawful use and processing of the content of a biobank, in particular when it comes to the legal requirements to be complied with when collecting biological samples and data.104
102 Xxxxxxxx, Xxx “Biobank and Biomedical Research: Responsibilities of Controllers and Processors Under the EU General Data Protection Regulation.” GDPR and Biobanking, edited by Xxxxxxxxxxx, Santa, Springer, 2021, pp. 61-90.
103 Xxxxxxxxx, Xxxx A. A. et al. “Inclusion of Residual Tissue in Biobanks: Opt-in or Opt-out?”
104 In particular, when it comes to the selection of the legal basis for the processing of personal data according to the GDPR. This aspect will be further analysed in the following Chapter.
To help categorise the matter, I believe that a fundamental distinction is possible between the following scenarios:
(a) when samples and data are collected specifically to be stored in a biobank. In this case, being stored in a biobank is the primary use of the samples and data (Scenario 1: collection for biobanking purposes). Participants are thus recruited for this specific purpose or, more generally, they are asked to undergo some kind of procedure (to hand over the data, to undergo a medical procedure in order to obtain the biological samples, etc) only in order to create, or increase the content of, the biobank. These samples and data will be subsequently used for one or multiple scientific research projects by researchers that are separated from the biobank itself and ask the biobank to get access to the samples and data;
(b) when the implementation of a biobank is ancillary to a broader scientific research activity performed on or with samples and data to be subsequently stored in the biobank itself for future use.105 Indeed, the samples and data are collected for a specific research purpose in the first place, and at the same time they are stored in a biobank for future undefined research projects to be conducted by different researchers. Here, the primary use of the collection is to be used in the first scientific research project (Scenario 2: collection for scientific research purposes). In this eventuality, the entity that creates the biobank and conducts the first scientific research project is the same one, while the future research projects will be carried on by other researchers. This is for example the case of a biobank created in the context of a clinical trial;
(c) when the content of a biobank consists of left-over samples and data collected or more generally used for other purposes, for instance in order to provide health care, which represents their primary use. In this scenario, to be stored in a biobank is the secondary purpose of the samples and data, because participants are asked to provide a sample or hand over the data for a different
105 The present work will not consider the case of a biobank built specifically in the context of a research project and exclusively for that purpose, without keeping the collection in place for future use. the reason for this choice relates to acknowledging that biobanks of this kind pose substantially different (and somewhat easier) legal and ethical issues than biobanks that store samples and data (also) for future use.
primary purpose, such as for instance undergoing a surgical procedure (Scenario 3: collection for other purposes).106
In the first scenario (a), samples and data are collected from patients or general donors specifically for the purpose of creating a biobank. Once the biobank is implemented, samples and data stored therein are made available for various research projects, either foreseeable or foreseen at the time of collection or not.
In the second (b), it is decided to organise and store in biobanks samples and data collected throughout a clinical trial or a different scientific research project. The biobank will be kept in place even after the end of the clinical trial, for future, undefined research projects possibly different from the first one.
Finally, scenario (c) concerns the hypothesis of the collection and processing of biological samples and data for various purposes that are different from the previous two, such as for instance for the provision of medical care or healthcare treatment, etc. In this case, left-over samples or already processed data are then stored in a biobank for future use.
As it will become apparent in the following pages, Scenarios 2 and 3 usually entail the same legal and regulatory issues.
I believe this distinction has fundamental consequences for the analysis that follows. In particular, most of the documents applicable to research biobanks, both soft law and hard law instruments, include the “primary-secondary purpose” distinction at the basis of their provisions. Therefore, to exemplify what constitutes a primary and a secondary purpose of the collection of samples and data for biobanking is essential to understand which norms are applicable.
It is now possible to provide an overview of the categorisations discussed above for the modes of collection HBSs and biobank data in Figure 1.
106 A similar categorisation is also included in the Commentary on Guideline 11 of the CIOMS International Ethical Guidelines.
Modes of collection | HBSs | Biobank data |
Scenario 1 - collection for biobanking purposes | Donated HBSs | Donated data HBSs data |
Scenario 2 - collection for scientific research purposes | Left-over HBSs | Left-over data HBSs data |
Scenario 3 - collection for other purposes | Left-over HBSs | Left-over data HBSs data |
Figure 1
2.3 OTHER IMPORTANT TERMINOLOGIES
Other terms frequently used in the field and for the purposes of this analysis are worth being defined.107
First of all, widely used in this work will also be the term biobanking. It identifies the new field of biobank research and covers all the aspects of the biobank functioning, as well as the social, legal and ethical problems raised by it.108 Therefore, while the term biobank refers to the collection itself in its materiality, the term biobanking is related to the field more generally and everything surrounding the activity of a biobank. In particular, biobanking refers to the process of acquisition and storing, together with some or all of the activities related to collection, preparation, preservation, testing, analysing and distributing defined biological material as related information and data.109 Moreover, the term governance will be used in the context of biobanking according to the definition provided in this regard by the European Commission in its study “Biobanking for Europe – A challenge for governance”. Here, governance is defined as “formally-constituted regulatory bodies, statute and other legal instruments, as well as informal mechanisms such as advisory boards, professional guidance, biobank policies and professional values and culture that help to guide decision-making” and the creation
107 Throughout the work, it will be sometimes necessary to define other sectorial concepts related to specific topics or fields of inquiry. These terms will be defined in the related sections.
108 Xxxxxxxxx, Xxxxxxxx, et al. “Biobanks-A Platform for Scientific and Biomedical Research.” Diagnostics (Basel, Switzerland), vol. 10, n. 7, pp. 1-21.
109 Definition of biobanking given by ISO 20387:2020.
of sound governance for biobanks as one of the challenges for the European innovation system.110 The governance of a biobank is especially complicated by technological innovations and the increased necessity for data sharing, both of which raise extremely diverse expectations from and obligations of the different stakeholders involved. Indeed, in the absence of a specific common regulation on the matter, a fixed governance mechanism is necessary for biobanks to guarantee the necessary quality of samples and data, a fair distribution of resources111 and ensure participants' trust.112
Furthermore, the individuals providing samples and data to be stored in the biobank and used for the specific purposes of its existence will be addressed as participants, either when they actively consent to the storage of their samples and data or in case such activity is performed without their explicit consent.113 Participants provide samples and data, which therefore become the content of the biobank itself.
As for the content, as mentioned biobanks store both biological samples and data. For the purpose of this analysis, it does not matter the specific type of biological samples to be stored in the biobank, as long as they are of human origin.
3 THE APPLICABLE LEGAL FRAMEWORK
As previously mentioned, there is no general applicable regulation to research biobanks (nor to biobanks in general, for that matter).114 Therefore, the normative landscape is composed of a constellation of different sectorial regulations or legislative acts applicable to, among others, a specific biobank activity115 or a specific content of the research biobank, either HBSs or biobank data.
Indeed, the applicable regulatory framework derives not only from the specificities of biobanking itself but also from the various fields somewhat involved and the normative interventions that occurred at multiple levels.116 As a consequence, both hard-law and
110 Expert Group on Dealing with Ethical and Regulatory Challenges of International Biobank Research, Biobanks for Europe. a challenge for governance, 2012.
111 Xxxxxxx, Xxxx Biobanche di Ricerca e Xxxxxx xxxxx Persona.
112 CIOMS International Ethical Guidelines. The aspect is further analysed in Chapter II.
113 The specific cases in which this might happen will be explored below.
114 Xxxxxxx, Xxxxxxxxx “La Circolazione dei Dati Genetici e delle Biobanche: Limiti e Prospettive de iure condendo”; Xxxxxxxxx, Xxxxxx “Le Biobanche: Disciplina e Diritti della Persona”; Xxxxxx, Xxxxxxx “Database Genetici, Biobanche e “Health Information Technologies.”
115 Xxxxxxx, Xxxxxxxxx “La Circolazione dei Dati Genetici e delle Biobanche: Limiti e Prospettive de iure condendo.”
116 On the framework applicable to biobanks, through time, Xxxxxx, Xxxxx “Il Modello Italiano di Regolamentazione Giuridica delle Biobanche: alla Ricerca di una Sintesi per una Materia Poliedrica”;
soft-law instruments, as well as guidelines, non-binding self-regulation, soft rules of bioethics and soft modes of governance are included in the following paragraphs.117
The result is a fragmented regulatory landscape118 composed of documents and rules from various sources and issuing bodies, with multiple levels of enforceability, not always clear at first glance.119 This heterogeneity of applicable instruments mirrors the ontological complexity and fluidity of biobanks themselves,120 which I partly described in the previous paragraphs.
This approach, i.e. the adoption of soft-law instruments instead of hard-law treaties, is usually criticised because of its lack of stability and enforceability, and consequently global governance on biobanks has been frequently called for.121
However, a soft-regulation approach on the matter is sometimes welcomed. For instance, as underlined by Xxxxx, the adoption of mainly soft-law instruments better responds to the necessities of bioethics and biolaw. Indeed, the matter is generally characterised on the one hand by fast development and therefore the necessity of a similar fast protection of the rights and interests possibly involved, and on the other hand by a plurality of different national views, which renders it particularly difficult to adopt a strong normative harmonised approach.122
In attempting to provide a comprehensive and clear view on the matter, I will divide the analysis between supranational instruments/acts, virtually applicable to any research
Xxxxxxx, Xxxxxxxxx “La Circolazione dei Dati Genetici e delle Biobanche: Limiti e Prospettive de iure condendo”; Xxxxx-Xxxxx, Xxxxxxxxxx “Bioresearch, Biobanks and Informed Consent from Vulnerable Donors in Spanish Law.” Europa e Diritto Privato, vol. 4, 2013, pp. 1069-1095; Xxxxxxxxx, Xxxxx “Legal Protection and Ethical Management of Genetic Databases: Challenges of the European Process of Harmonization.” Xxxx Xxxxxx Working Paper, vol. 19, 2008, pp. 1-41; Xxxxxx, Xxxxxxxx, et al. “Data Storage and DNA Banking for Biomedical Research: Informed Consent, Confidentiality, Quality Issues, Ownership, Return of Benefits. a Professional Perspective.” European journal of human genetics: EJHG, vol. 11, n. 2, 2003, pp. 88-122.
117 Xxxxxxxxx, Xxxxxxxx and Xxxxxxx, Xxxxxxxxx, “Being a Member of the Club: The Transnational (Self-
)Governance of Networks of Biobanks.” International Journal of Risk Assessment and Management, vol. 12, n. 1, 2009, pp. 64–79.
118 Tzortatou, Xxxx, et al. “Biobanking Across Europe Post-GDPR: A Deliberately Fragmented Landscape”: 119 Indeed, the variety of applicable soft and hard law instruments applicable to biobanking has been defined as a patchwork by Xxxxxxx, Xxxxxx “Biobanche e Consenso Informato tra Finzioni Scientifiche e Finzioni Giuridiche.” Filosofia del Diritto e Nuove Tecnologie. Prospettive di Ricerca tra Teoria e Pratica, edited by Xxxxxx, Xxxxxxxxx, and Xxxxxx, Xxxxx, Xxxxxx Editrice, 2015, pp. 511-524.
120 Xxxxxx, Xxxxx “Il Modello Italiano di Regolamentazione Giuridica delle Biobanche: alla Ricerca di una Sintesi per una Materia Poliedrica.”
121 Xxxx, Xxxxxx, and Xxxx, Xxxxx “A Call for Global Governance of Biobanks.” Bulletin of the World Health Organization, vol. 93, n. 2, 2015, pp. 113-7.
122 Xxxxx, Xxxxxx La Donazione dei Materiali Biologici Umani ai Xxxx xxxxx Ricerca Biomedica xxxx’Ambito del Diritto Internazionale e del Diritto dell’Unione Europea.
biobank (at least if implemented in Europe), and national ones, therefore mainly relevant for Italian research biobanks.
The following paragraphs will therefore present analytically the different sources of obligations, prescriptions or requirements for biobanking, addressing in particular the issue of their theoretical applicability to the field and their enforceability. The aim is to provide a clear overview of the regulatory (albeit fragmented) landscape.
An extensive analysis of the relevant norms or prescriptions of each instrument in the parts relevant to this work will be conducted in Chapter III.
At the supranational level, there are soft law and hard law instruments relevant to research biobanks. In the following paragraphs, I will provide an overview of both.
First of all, there are international soft law instruments devoted to addressing some of the issues of research biobanks, in particular those adopted by Intergovernmental bodies. These instruments establish the principles that should be respected in conducting scientific research, even though they lack legal enforceability, and are primarily enacted by the following bodies or organisations: the World Medical Association (WMA), the Organisation for Economic Co-operation and Development (OECD), the UNESCO and the Council of Europe.
The OECD Recommendations and the UNESCO Declarations intend to provide general principles and a shared basis at the international level for future hard laws regulating the matter. While being non-binding instruments, their relevance to the discourse derives in particular from the fact that they are often cited or more generally considered by hard
123 Xxxxxxxxxxx, Xxxxxx and Xxxx, Azzini “Scienza, Tecnologia e gli Attuali Flussi Giuridici Trasnazionali.” Trattato di Biodiritto. Ambito e Xxxxx del Biodiritto, edited by Xxxxxxxxxx, Mariachiara and Xxxxxxx, Xxxxxx, Xxxxxxx editore, 2010, pp. 731-770; Xxxxxxx, Xxxx Biobanche di Ricerca e Xxxxxx xxxxx Persona.
laws relevant for biobanking or scientific research124 and by the European Court of Human Rights in its judgments.125
The high influence and prevalence of soft law instruments to provide principles and guidance to the field of biobanking have at least the following three reasons, which in turn derive from some characteristics of research biobanks.
First of all, soft law instruments regularly emerge to provide guidance principles for biobanking because of the absence of a binding regulation on the matter and given the need for biobanks to have protocols and guidelines to ethically conduct their activities. As affirmed by Xxxxxxxxx and Xxxxxxxxx this “can be seen as a pragmatic way of self- governance from the side of biobankers for the sake of both their scientific objectives and the reputation of their careers and institutions”.126
Moreover, such an approach to biobanking, i.e. the adoption of principles or best practices approach instead of specific treaties or hard law instruments, supports the open-endedness of the possible scientific purposes of research biobanks.
Finally, this tendency also resembles the more general one adopted for regulating matters related to technology and science, such as biolaw in particular. One of the reasons for such an approach is the so-called law lag, i.e. the (ontological) difficulty of law to keep up with technoscientific advances.127
3.1.1.1 THE DECLARATION OF HELSINKI AND THE DECLARATION OF TAIPEI
The WMA is an international confederation of medical associations whose aim is to protect human rights and values in clinical or research activities.128 The main international
124 Xxxx, Xxxx, and Organisation for Economic Co-operation and Development “Building a Foundation for Biobanking: The 2009 OECD Guidelines on Human Biobanks and Genetic Research Databases (HBGRDs).” European Journal of Health Law, vol. 17, n. 2, 2010, pp. 187-190; Xxxxxxx, Xxxx Biobanche di Ricerca e Xxxxxx xxxxx Persona.
125 On the issue, more extensively, Xxxx, Xxxx X. “The European Court of Human Rights’ Use of Non- Binding and Standard Setting Council of Europe Documents.” Human Rights Law Review, vol. 17, n. 1, 2017, pp. 97–125.
126 Xxxxxxxxx, Xxxxxxxx and Xxxxxxx, Xxxxxxxxx, “Being a Member of the Club: The Transnational (Self-
)Governance of Networks of Biobanks.”
127 Xxxxxxxxxxx, Xxxxxxxxxxx “To Bind or Not Bind? European Ethics as Soft Law.” Science and Democracy. Making Knowledge and Making Power in the Biosciences and Beyond, edited by Xxxxxxxxxx, Xxxxxxx, et al. Routledge, 2015, pp. 156- 175.
128 World Medical Association, Who we are, 2017 available at xxxxx://xxx.xxx.xxx/xxx-xx-xxx/; Xxxxxxxx, Xxxxxxxx, and Xxxxxxxxxx, Real-Sebbag “Research Biobanks and Health Databases: The WMA Declaration of Taipei, Added Value to European Legislation (Soft and Hard Law).”
documents adopted by the WMA and relevant for biobanking are the Declaration of Helsinki and the Declaration of Taipei.
On the one hand, the Declaration of Helsinki – Ethical principles for medical research involving human subjects was enacted in 1964 and last revised in 2013. It focuses exclusively on scientific research and provides a set of ethical principles for medical research involving human subjects, including research on identifiable human material and data involving biobanks. Moreover, some general provisions specifically address the matter of biobanks.129
Therefore, such a Declaration is relevant in the present work not only because of the specific purpose of the type of biobanks under scrutiny here but also because of the Declaration’s general importance in the field. Indeed, it has been defined as a cornerstone130 guideline, the most influential131 and the most significant132 on the ethics of biomedical research and it is frequently cited in legally binding instruments, such as the Clinical Trial Regulation (Regulation (EU) 2014/536) in §43,133 or by other soft-law instruments, such as the UNESCO Universal Declaration on Bioethics and Human Rights in its introduction. Therefore, it is a “basic reference point in the ethics of biomedical research”.134 In its last revision, the updates mainly focused on prioritizing the rights and interests of the research subjects.
On the other hand, the new Declaration on the Ethical Considerations regarding Health Databases and Biobanks (Declaration of Taipei) was adopted in 2016 during the WMA’s 67th General Assembly in Taipei (Taiwan) as an update of the Declaration previously adopted in 2022. Its aim is to establish ethical principles for scientific research activities
129 See for example paragraph 32 on informed consent, which will be analysed in Chapter II.
130 Xxxxxxx, Xxxxxx X., et al. “The Revision of the Declaration of Helsinki: Past, Present and Future.” British Journal of Clinical Pharmacology, vol. 57, n. 6, 2004, pp. 695-713.
131 Xxxxxxxx, Xxxxxxx “The Declaration of Helsinki.” the Oxford textbook of clinical research ethics, edited by Xxxxxxx, Xxxxxxx X., Oxford University Press, 2008, pp. 141–148; Xxxxxxxx, Xxxxxxx X. X., et al. “The Declaration of Helsinki.” BMJ (Clinical research ed.), vol. 335, n. 7621, 2007, pp. 624–625.
132 Xxxxxxx, Xxxx X., et al. “Appendix 1: Declaration of Helsinki.” the Textbook of Pharmaceutical Medicine, edited by Xxxxxxx, Xxxx X. and Xxxx, X’Xxxxx, Xxxxxxxxx Publishing Ltd, 2005, pp. 723-726.
133 In which it is established that “The members of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) have agreed on a detailed set of guidelines on good clinical practice which is an internationally accepted standard for designing, conducting, recording and reporting clinical trials, consistent with principles that have their origin in the World Medical Association’s Declaration of Helsinki.”
134 Xxxx, Xxxx-Xxxxx and Urban, Wiesing “Illegitimate Authorship and Flawed Procedures: Fundamental Formal Criticisms of the Declaration of Helsinki.” Bioethics, vol. 33, n. 3, 2018, pp. 319-325.
involving human participants135, in addition to those included in the Declaration of Helsinki.
When compared to other soft instruments on the matter, the innovation of the Declaration of Taipei rests on its entire focus on regulating biobanks and health databases, contrary to other acts that address scientific research more generally while including certain provisions applicable to biobanks.136 This approach mirrors the one usually adopted at the national level when a specific biobank legislation is adopted,137 and is coherent with the very nature of biobanks, as highlighted before.
Indeed, as mentioned, biobanks are not research projects per se, but they provide samples and data used for research purposes. When the creation of a biobank is a step in a research project, it is usually a tool to support the latter as well as future projects. Addressing biobanking activities enables the recognition of its specificity. The Declaration of Taipei then ensures the respect of the principles applicable to scientific research by establishing its complementarity with the Declaration of Helsinki.
Unlike the Declaration of Helsinki, the Declaration of Taipei adopts an innovative approach and aims to provide principles for a wide range of uses of the content of biobanks (and health databases) other than individual use, thus including non-health- related purposes or commercial purposes and envisioning the possibility of using HBS and data for purposes different from those identified at the time of collection.138
More generally, the Declarations establish that the biobank governance shall be based on the principles of protection of individuals, transparency, participation and inclusion, and accountability.139
3.1.1.2 THE CIOMS INTERNATIONAL ETHICAL GUIDELINES
Lastly revised in 2016, the International Ethical Guidelines for Health-related Research Involving Humans (CIOMS International Ethical Guidelines) was adopted by the Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the
135 Paragraph 1 of the Preamble.
136 Chassang, Xxxxxxxx, and Xxxxxxxxxx, Real-Sebbag “Research Biobanks and Health Databases: The WMA Declaration of Taipei, Added Value to European Legislation (Soft and Hard Law).”
137 See as a matter of example Finland and Sweden.
138 On the issue, see Xxxxxxxxx, Xxxxx “Regulating Biobanks: an Ethical Analysis of the Spanish Law and the New Challenges of the Bigdata-driven Biomedical Research.”
139 Chassang, Xxxxxxxx, and Xxxxxxxxxx, Real-Sebbag “Research Biobanks and Health Databases: The WMA Declaration of Taipei, Added Value to European Legislation (Soft and Hard Law).”
World Health Organization (WHO) and has been defined as the most comprehensive set of ethical guidelines.140
The CIOMS International Ethical Guidelines contain principles applicable to biobanks in Guideline 11 and 12, which establish that biobanks shall have a governance system in place and require informed consent for almost every use for research purposes of the biological samples and health data, with a general strong focus on consent and individual control as the primary ethical values to guide scientific research.141
The International Ethical Guidelines are relevant for research biobanks, independently of the concrete practical scenario for the collection of its content (Scenario 1 - collection for biobanking purposes; Scenario 2 - collection for scientific research purposes; Scenario 3 - collection for other purposes).
Indeed, in the Preamble it is clearly affirmed that “the term ‘health-related research’ in the Guidelines refers to activities designed to develop or contribute to generalizable health knowledge within the more classic realm of research with humans, such as observational research, clinical trials, biobanking and epidemiological studies”. By doing so, the document broadens the meaning of “human subject research” by including also scientific research without the direct involvement of an individual, such as when it is conducted with already available biological samples or health data.142
3.1.1.3 THE OECD RECOMMENDATIONS
Furthermore, two Recommendations from the OECD are particularly relevant for biobanks. First of all, in October 2009 the OECD Council adopted the Recommendation on Human Biobanks and Genetic Research Databases (OECD Recommendation 2009), whose aim is to provide guidelines for the establishment, management, governance, operation, access, use and discontinuation of Human Biobanks and Genetic Research Databases, being research biobanks the focus of the entire document. The document recognises that the primary purpose of these databases is to xxxxxx scientific research and aims at improving advancements in research, through access to the biobanks’ content,
140 For instance, the Pan American Health Association has described the CIOMS International Ethical Guidelines as “the most comprehensive, up-to-date and detailed international consensus guidelines for human research.” Report from Pan American Health Association. January 30, 2018.
141 Xxxxxxxxxx, Xxxxxx “Adjust the Focus: a Public Health Ethics Approach to Data Research.” Bioethics, vol. 33, n. 3, 2019, pp. 357-366.
142 Xxxxxxxxxx, Xxxx “Genetic Research and Consent: on the Crossroads of Human and data research.” Bioethics vol. 33, n. 3, 2019, pp. 347-356.
while at the same time enduring respect for participants, their human dignity, fundamental freedoms and human rights.143
Secondly, in 2017 the Recommendation on Health Data Governance (OECD Recommendation 2017) was adopted, which includes conditions for encouraging greater availability and processing of health data within countries and across borders for health- related public policy objectives while minimizing or managing risks to privacy and security. Therefore, it applies to the access to and processing of personal health data for health-related public interest purposes, such as improving health care quality, safety and responsiveness; reducing public health risks; discovering and evaluating new diagnostic tools and treatments to improve health outcomes, etc.
3.1.1.4 THE UNESCO DECLARATIONS
Moreover, in 1997 UNESCO unanimously adopted144 the Universal Declaration on the Human Genome and Human Rights (UNESCO Universal Declaration on Human Genome), which in its very first article proclaims the value of the human genome, “fundamental unity of all members of the human family”, “recognition of their inherent dignity and diversity” and thus “heritage of humanity”. The Declaration further recognises the importance of freedom of research, especially on the human genome, and the necessity of conducting it to improve public health (art. 12).
Subsequently, UNESCO adopted the International Declaration on Human Genetic Data (UNESCO International Declaration) and the Universal Declaration on Bioethics and Human Rights (UNESCO Universal Declaration on Bioethics) in 2003 and 2005 respectively. As for the first one, the International Declaration aims to ensure in the context of the collection and processing of genetic data and biological samples the protection of human dignity, personal data, and fundamental freedoms, as well as freedom of expression and advancement of scientific research.145 On the other hand, the second has a more general scope, providing that it aims at addressing the ethical issues related to
143 Xxxx, Xxxx, and Organisation for Economic Co-operation and Development “Building a Foundation for Biobanking: The 2009 OECD Guidelines on Human Biobanks and Genetic Research Databases (HBGRDs).”
144 Macillotti, Xxxxxx, et al. “La Disciplina Giuridica delle Biobanche.” Pathologica, vol. 100, 2008, pp. 86-101.
145 Ibid
medicine, life sciences and associated technologies as applied to human beings, taking into account their social, legal and environmental dimensions.146
All three Declarations include a strong focus on informed consent and the information to be provided to participants, as well as the necessity to preserve the right to self- determination of the person whose data and samples are used for research purposes, within a more general balancing of the different public and private interests at stake.147 Moreover, the International Declaration from 2003 also includes an article referred to biobanks stating that “The persons and entities responsible for the processing of human genetic data, human proteomic data and biological samples should take the necessary measures to ensure the accuracy, reliability, quality and security of these data and the processing of biological samples. They should exercise rigour, caution, honesty and integrity in the processing and interpretation of human genetic data, human proteomic data or biological samples, in view of their ethical, legal and social implications” (art. 15).
3.1.1.5 THE RECOMMENDATION R(2016)6
Finally, among the soft law instruments, in 2016 the Council of Europe adopted Recommendation R(2016)6 on research on biological materials of human origin148, which builds on and supersedes the previous Recommendation R(2006)4.149 In the Recommendation of 2016, the Council of Europe stems from the assumption that new developments in biobanking and biomedical research bring along the necessity of a higher level of protection of the dignity and the fundamental rights of the individuals whose biological materials are stored and used for research, while at the same time recognising the freedom of scientific research.150 These difficulties are primarily related to the increasingly diverse origins of biological materials to be stored and used, the difficulty in
146 Art. 1 para. 1
147 Xxxxxxx, Xxxx Biobanche di Ricerca e Xxxxxx xxxxx Persona.
148 Recommendation R(2016)6 of the Committee of Ministers to member States on research on biological materials of human origin.
149 As clearly stated in the Explanatory Memorandum, Recommendation R(2016)6 is the outcome of the re-examination of Recommendation R(2006)4. xxxxx://xxxxxx.xxx.xxx/xx/Xxxxx/xxxxxx_xxxxxxx.xxxx?XxxxxxXxx00000000000x000x. See also on this point Xxxxx, Xxxxxx La Donazione dei Materiali Biologici Umani ai Xxxx xxxxx Ricerca Biomedica xxxx’Ambito del Diritto Internazionale e del Diritto dell’Unione Europea.
150 Explanatory memorandum.
guaranteeing their non-identifiability, and the increasing amount of multicentre research projects using these samples.151
At the same time, the Recommendation recognises the importance of scientific research conducted on and with biological samples and the related information that may be extracted from them. While the Recommendation never explicitly mentions biobanks, its Art. 2 establishes that it applies to specific activities, which include the obtaining and storage of biological materials of human origin and eventually associated data for storage for future research purposes, and the use in a research project of the biological material either already stored or obtained for another purpose. As previously analysed, these activities are those qualifying a research biobank.152
Moreover, the specific applicability of the Recommendation to research biobanks and not research projects more generally is further specified in Art. 2, where “the use in a specific research project of biological materials of human origin removed for the sole purpose of that project” is explicitly excluded from the material scope of application of the document.
As a matter of ethical principles, the Recommendation aims at ensuring that biobanking activities (1) respect the dignity, autonomy, privacy and confidentiality of individuals, and (2) have a public health end and contribute to the benefit of society. The first goal is reached by giving individuals control over the use of their data and biological material, in particular by asking for their consent and providing certain information on the functioning of the biobank itself.
Finally, the Recommendation lists the 4 guiding principles for the development of a trustworthy biobank governance, namely Protection of Individuals, Transparency, Participation and Inclusion, Accountability, and the main governance issues to address. Differently from the previous Recommendation R(2006)4,153 in the new document, the Council of Europe extensively elaborates on the level and type of information to be provided to participants and the provisions surrounding informed consent.
152 Moreover, paragraph 2 of the Recommendation R(2016)6 explicitly excludes from its application “the use in a specific research project of biological materials of human origin removed for the sole purpose of that project).”
153 Recommendation R(2006)4.
Apart from the multiple soft law instruments listed above, there are specific hard law ones devoted to either an activity of the biobank or the processing of its content. Differently from above, all the instruments listed in this paragraph are legally binding in all Member States.
All the following documents do not specifically regulate biobanks, but some of the core activities characterising biobanks, such as the processing of personal information, the use of human biological material, and some of the prerequisites for research involving humans. This is because following the Subsidiarity Principle only Member States have the competence to issue regulations and legislations on health matters, which include biobanking.154
First of all, the Human rights framework applicable to biobanking is composed of the EU Charter of Fundamental Rights and Freedoms of the European Union (EU Charter), the European Convention on Human Rights (ECHR) and the International Convention on Economic, Social and Cultural Rights.
In particular, concerning the first one, the EU Charter was formally proclaimed in Nice in December 2000 by the European Parliament, the Council of the European Union and the Commission and became legally binding in all Member States with the entry into force of the Treaty of Lisbon in 2009. From that moment onwards, the EU Charter has the same legal value as the EU treaties (art. 6 TUE).
More generally, the Charter is considered to contain “several principles which can be relevant in the context of research”155 and establishes multiple rights to be protected.
Both the EU Charter and the ECHR do not address specifically biobanking or scientific research involving biological samples or data, but they provide a number of provisions that shall be respected in performing these activities.156
154 Xxxxxxxxx, Xxxxxxxx and Xxxxxxx, Xxxxxxxxx, “Being a Member of the Club: The Transnational (Self-
)Governance of Networks of Biobanks.” Critical on this, Slokenberga, Santa “Setting the Foundations: Individual Rights, Public Interest, Scientific Research and Biobanking.”
155 European Commission. (2013). Ethics for researchers. Facilitating Research Excellence in FP7: 5. Retrieved March 2, 2018, from xxxxx://xx.xxxxxx.xx/xxxxxxxx/xxxxxxxxxxxx/xxxx/xxx/xx0/00000/xxxxxx-xxx- researchers_en.pdf; Xxxxxxxxxx, Xxxx “Genetic Research and Consent: on the Crossroads of Human and data research.”
156 Xxxxxxxxxx, Xxxx “Genetic Research and Consent: on the Crossroads of Human and data research.”
As for the relationship between these two human rights instruments, art. 52 para. 3 of the EU Charter establishes that “in so far as this Charter contains rights which correspond to rights guaranteed by the Convention for the Protection of Human Rights and Fundamental Freedoms, the meaning and scope of those rights shall be the same as those laid down by the said Convention”, thus referring not only to the Charter itself and its Protocols but also to the by the case-law of the European Court of Human Rights and by the Court of Justice of the European Union.157
Furthermore, and when it comes to the regulation applicable to specific activities or content of the biobank, the General Data Protection Regulation (EU) 2016/679 (GDPR)158 shall be referred to and is applicable to any processing of personal data within the geographical scope of application of the Regulation. Indeed, in Recital 157 the GDPR specifically refers to research based on data registries,159 whose potential for the advancement of research and society as a whole is underlined.
Moreover, in the context of data protection, two other hard law instruments will be relevant for our analysis and have (or will have) an impact on biobanking: Regulation 2022/868 (Data Governance Act - DGA) and Proposal for a Regulation on the European Health Data Space (EHDS).
On the one hand, the DGA is a horizontal regulatory framework entered into force on 23rd June 2022 and is fully applicable in all Member States from September 2023. It is a key pillar of the European strategy for data, whose aim is to create a single market for data in Europe, placing at first the interests of the individual whose data are used for data-
157 See the Explanation to the EU Charter provided by the European Union Agency for Fundamental Rights at xxxxx://xxx.xxxxxx.xx/xx/xx-xxxxxxx/xxxxxxx/00-xxxxx-xxx-xxxxxxxxxxxxxx-xxxxxx-xxx- principles?page=1#explanations.
158 Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data and repealing Directive 95/46/EC (General Data Protection Regulation).
159 Recital 157 GDPR “By coupling information from registries, researchers can obtain new knowledge of great value with regard to widespread medical conditions such as cardiovascular disease, cancer and depression.
On the basis of registries, research results can be enhanced, as they draw on a larger population. Within social science, research on the basis of registries enables researchers to obtain essential knowledge about the long-term correlation of a number of social conditions such as unemployment and education with other life conditions. Research results obtained through registries provide solid, high-quality knowledge which can provide the basis for the formulation and implementation of knowledge-based policy, improve the quality of life for a number of people and improve the efficiency of social services. In order to facilitate scientific research, personal data can be processed for scientific research purposes, subject to appropriate conditions and safeguards set out in Union or Member State law.”
driven innovations that will benefit society as a whole.160 The regulation lays down a horizontal set of rules and conditions relevant to developing all the Common European data spaces as envisioned in the European Data Strategy.161
On the other hand, the EHDS is a health-sector specific regulatory proposal. Indeed, within the European Strategy for data, different Common European data spaces will be developed “in strategic economic sectors and domain of public interest”, within which is listed a Common European health data space. As a sector-specific legislation, it builds upon other horizontal relevant regulations such as the GDPR and the DGA.162 In particular, the “scientific research regime 2.0” derived from the joint application of the GDPR and the EHDS might become “a data research standard within the EU”.163
The EHDS aims to regulate primary and secondary uses of health data, support health research and innovation, personalised medicine, as well as the implementation of some of the data subjects’ rights in the context of health data sharing.164 Provisions of Chapter IV EHDS related to the secondary use of health data are particularly relevant for biobanks and will be further discussed.
Finally, two binding instruments relevant in the context of scientific research are worth mentioning, which however do not apply to research biobanks: Regulation 536/2014 (Clinical Trial Regulation) and Directive 2004/23/EC.
160 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions – a European strategy for data, 2020.
161 Xxxxxx, Xxxxx, et al. White Paper on the Data Governance Act, CiTiP Working Paper, 2021.
162 Xxxxxxx, Xxxxx and Xxxx, Yilmaz “Lawfulness in Secondary Use of Health Data – Interplay Between Three Regulatory Frameworks of GDPR, DGA EHDS.” Technology and Regulation, vol. 2022, 2022, pp. 128–134; EDPS, Preliminary Opinion 08/2020 on the European Health Data Space, 2020.
163 Slokenberga, Santa “Scientific Research Regime 2.0? Transformations of the Research Regime and the Protection of the Data Subject that the Proposed EHDS Regulation Promises to Bring Along.” Technology and Regulation, vol. 2020, 2022, pp. 135–147.
164 Xxxxxxx, Xxxxx and Xxxx, Yilmaz “Lawfulness in Secondary Use of Health Data – Interplay Between Three Regulatory Frameworks of GDPR, DGA EHDS”; Slokenberga, Santa “Scientific Research Regime 2.0? Transformations of the Research Regime and the Protection of the Data Subject that the Proposed EHDS Regulation Promises to Bring Along”; Xxxxxx-Xxxxxx, Xxxxxxx, et al. “The Application of Data Altruism in Clinical Research Through Empirical and Legal Analysis Lenses.” Frontiers in Medicine, 2023, pp. 1-14.
165 See Art. 1 Clinical Trials Regulation for the definition of the purpose and art. 2 for the definition of “clinical trial.”
Regulation is not directly applicable to biobanks, independently of the concrete mode for collection adopted, because biobanks are not research projects per se, as mentioned.
Indeed, it appears evident that on the one hand the collection of HBSs and data for future and undefined research purposes (i.e. biobanking as defined previously in this paragraph) is not a “clinical trial” for the purposes of Regulation 536/2014 and therefore is outside of the scope of its provisions. On the other hand, the biobank or the entity that runs it does not usually directly intervene or participate in the scientific research project identified from time to time (which however may well be regulated by the Clinical Trial Directive, under given circumstances).
On the other, Directive 2004/23/EC on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells specifies in Art. 1 and Art. 2 that it applies to “the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells intended for human applications and of manufactured products derived from human tissues and cells intended for human applications”.166
However, while theoretically its norms might apply to the biobanking field,167 Art. 2 restricts the scope of the Directive to the donation, procurement, testing, etc of human tissues and cells, but only if intended for human applications. Considering that Art. 3 lett.
(l) defines “human application” as “the use of tissues or cells on or in a human recipient and extracorporeal application.” it appears clear that Directive 2004/23/EC cannot be applied to research biobanks, as previously defined.168 Indeed, the biological samples and tissues are stored in the biobank not for future human application, but to be subsequently used for research projects.169
Moreover, Recital 11 of the Directive clearly specifies that “this Directive does not cover research using human tissues and cells, such as when used for purposes other than application to the human body”.
166 Emphasis added.
167 So much so that Art. 3 lett. (o) defined the “tissue establishment” as “a tissue bank or a unit of a hospital or another body where activities of processing, preservation, storage or distribution of human tissues and cells are undertaken.” thus potentially resembling the general definition of a biobank.
168 However, it would apply to different typed of biobanks. On the topic, Xxxxxx, Xxxxx “Il Modello Italiano di Regolamentazione Giuridica delle Biobanche: alla Ricerca di una Sintesi per una Materia Poliedrica.”
169 As a consequence, the corresponding national legislative acts will not be analysed in the paragraph devoted to the discussion of the national legal framework.
A separate analysis is now devoted to the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine (Oviedo Convention) and its Additional Protocols. The Convention entered into force in 1999 and is generally recognised as the first international document in bioethics and the only one binding for the 29 Member States of the Council of Europe that ratified it.170 The Convention aims to establish norms for the protection of human beings in the context of scientific research. Indeed, it builds on the assumption that innovations in biology and medicine might at least theoretically violate human dignity and fundamental rights and freedoms of human beings, being thus necessary to preserve the latter, while at the same time ensuring proper use of scientific innovations for present and future generations.171 To this end, Art. 2172 of the Convention intends to protect human beings on three different levels:
● individual level, by establishing fundamental rights and interests of the individual;
● social level, by including the possibility of balancing private and public interests under specific circumstances, including whenever restricting one’s individual rights is necessary for protecting those of others or other collective interests;173
● universal level, by explicitly protecting the human genome.174
As mentioned, the Convention establishes multiple principles to be followed in the context of the application of biology and medicine (Art. 1). In order to determine whether the Oviedo Convention applies to research biobank, it is first of all necessary to evaluate whether Convention itself and its Additional Protocols are legally binding for Italy.
170 Xxxxx, Xxxxxx La Donazione dei Materiali Biologici Umani ai Xxxx xxxxx Ricerca Biomedica xxxx’Ambito del Diritto Internazionale e del Diritto dell’Unione Europea.
171 In these terms, see the Preamble of the Convention.
172 Art.2 of the Oviedo Convention: “The interests and welfare of the human being shall prevail over the sole interest of society or science.”
173 Art. 26 of the Oviedo Convention. “(1) No restrictions shall be placed on the exercise of the rights and protective provisions contained in this Convention other than such as are prescribed by law and are necessary in a democratic society in the interest of public safety, for the prevention of crime, for the protection of public health or for the protection of the rights and freedoms of others.”
174 Xxxxxxxxx, Xxxxxxxx “Xx Xxxxx Internazionali ed Europee in Materia di Biomedicina.” Le Scienze Biomediche e il Diritto, edited by Xxxxxxxxxxx, Xxxxxx, et al. Ibis, 2010, pp. 61-74.
175 The lack of completion of the ratification process has been defined as “unlikely unintentional.” Xxxxxxxx, Xxxxx Introduzione al Biodiritto, Giappichelli Editore, 2012.
the instrument of ratification was never deposited, an essential and conditioning constitutive element of the ratification process according to the provisions of the Vienna Convention.176 Consequently, neither the Oviedo Convention nor its Additional Protocols entered into force in the Italian legal framework.
Therefore, it remains to be established whether these norms may be considered legally binding for Italy for other reasons, and the following two are particularly relevant.
First of all, on a general level, the Italian Corte di Cassazione established that the Oviedo Convention is to be used to interpret national norms in order to provide an interpretation of the latter in line with the provisions of the Convention, as much as possible. However, in case of contrast between the two, i.e. between national norms and provisions of the Oviedo Convention, the former shall prevail.177
Indeed, the Oviedo Convention cannot benefit from the special regime and legal value applicable to European legal instruments (art. 117 Italian Constitution, but also Art. 10 and 11), because such a Convention pertains to the broader group of international treaties. Nor is it possible to equate it to the ECHR and thus apply its special regime.178 As a consequence, the Convention cannot directly prevail over national provisions.
However, some of its provisions might also be eventually considered either included among the fundamental principles of Art. 2 TUE, binding for the European Union, or the expression of already existing international principles. Both theories are advanced by Xx Xxxxxxx for the requirement of informed consent.179
Therefore, while not being directly binding in Italy per se, the Oviedo Convention might still influence the interpretation or application of national norms (as well as their conceptualisation from the outset) because of its value as interpretative instrument or carrier of international principles.
176 Art. 11 and in particular art. 16 of the Vienna Convention on the Law of Treaties “Unless the treaty otherwise provides, instruments of ratification, acceptance, approval or accession establish the consent of a State to be bound by a treaty upon: (a) their exchange between the contracting States; (b) their deposit with the depositary; or (c) their notification to the contracting States or to the depositary, if so agreed.” On the importance of the deposit of the instrument of ratification, see also Italian Constitutional Court order n. 282/1983 and sentence n. 379/2004. More extensively on this point, Xxxxxxxx, Xxxxx Introduzione al Biodiritto; Xxxxxx, Xxxxxx “Xxxx Ricerca dell'Xxxxxx Mancante: il Deposito dello Strumento di Ratifica della Convenzione xx Xxxxxx.” Forum di Quaderni Costituzionali, 2007, pp. 1-10.
177 Corte di Cassazione sentence of the 16th of October 2007, n. 21748, para.7.2.
178 Xx Xxxxxxx, Xxxxxxxx “Consenso Libero ed Informato: la Convenzione di Xxxxxx xxxx’Articolato Contesto Storico e Giuridico delle Xxxxx.” Medicina e Morale, vol. 65, n. 1, 2016, pp. 57-67.
179 Xx Xxxxxxx, Xxxxxxxx “Consenso Libero ed Informato: la Convenzione di Xxxxxx xxxx’Articolato Contesto Storico e Giuridico delle Xxxxx.”
3.2 (BINDING AND NON-BINDING) INSTRUMENTS AT THE NATIONAL LEVEL
Mirroring the situation at the supranational level, biobanks lack an ad hoc regulation in the Italian national context as well.180 Therefore, the applicable provisions shall be derived from different level sources, both binding and non-binding instruments, in particular those adopted by administrative authorities upon delegation by the legislator. For this reason, the Italian framework has been defined as a “hybrid model”.181
Indeed, at the national level three main regulatory models may be identified when it comes to biobanks: 1) adoption of a specific regulation, which is the model adopted for instance by Spain and Belgium; 2) adoption of a hybrid model,182 i.e. both hard and soft law domestic instruments applicable; 3) reliance on the international guidelines and instruments.183 Indeed, Italy pertains to the second model.
As for the legally binding instruments, it is worth mentioning first of all the Legislative Decree n. 101/2018 whose aim is the alignment of the already existing domestic legislation (in particular Legislative Decree n. 196/2003) to the GDPR.184 In this regard, an important point of reference185 is the General Authorisations issued by the Italian Data Protection Authority (DPA) n. 8/2016 on the processing of genetic data and n. 9/2016 on the processing of personal data for scientific research purposes, as confirmed and modified by Provvedimento n. 146/2019 issued by the Garante according to Art. 21(1) of the Legislative Decree 101/2018.186
180 Xxxxxx, Xxxxxx and Xxxxx, Xxxxxx “The Italian Way for Research Biobanks After GDPR: Hybrid Normative Solutions to Balance the Protection of Individuals and Freedom of Research.” GDPR and biobanking, edited by Xxxxxxxxxxx, Santa, Springer, 2021, pp. 309-322; Xxxxxxxxxx, Xxxxxxxx, “Italy.”
181 See Italian DPA, Decision n. 389, 6 October 2016; Tribunal of Cagliari, Sez. I, decision n. 1569/2017; Italian DPA, Decision n. 561, 21 December 2017. On the topic, Xxxxxx, Xxxxxx and Xxxxx, Xxxxxx “The Italian Way for Research Biobanks After GDPR: Hybrid Normative Solutions to Balance the Protection of Individuals and Freedom of Research.”
182 Xxxxxx, Xxxxxx and Xxxxx, Xxxxxx “The Italian Way for Research Biobanks After GDPR: Hybrid Normative Solutions to Balance the Protection of Individuals and Freedom of Research.”
183 Provvedimento recante le prescrizioni relative al trattamento di categorie particolari di dati, ai sensi dell’art. 21, comma 1 del d.lgs. 10 agosto 2018, n. 101 del 5 giugno 2019, published in G.U. n. 176 of the 29th of July 2019, available at xxxxx://xxx.xxxxxxxxxxxxxx.xx/xxxx/xxxxxx/-
/docwebdisplay/docweb/9124510.
184 Throughout the thesis, the Legislative Decree 196/2003 as subsequently modified, in particular by the Legislative Decree 101/2018 will be referred to as the Italian Privacy Code.
185 Xxxxxx, Xxxxxx and Xxxxx, Xxxxxx “The Italian Way for Research Biobanks After GDPR: Hybrid Normative Solutions to Balance the Protection of Individuals and Freedom of Research.”
186 Under the previous regime and in particular according to Art. 26 of the old version of the Legislative Decree 196/2003 the processing of particularly sensitive categories of data was possible only upon consent of the data subject and after having obtained a specific authorisation to the processing by the Italian DPA.
Moreover, a recent Italian Law n. 3/2018 charged the Italian Government with the task of enacting various Legislative Decrees containing provisions on clinical trials on medicinal products for human use, in particular with the aim of simplifying the processing for research purposes of biological samples previously collected in Scenarios 2 or 3, under the condition of obtaining the patient’s informed consent beforehand.187 Subsequently, the Higher Institute of Healthcare was assigned the task of defining the criteria for such a collection.188
Furthermore, the Italian DPA adopted the “Deontological rules for processing for statistical or scientific purposes) on December 19th, 2018. According to Art. 2 paragraph 1 the Deontological rules refer to “all processing operations carried out for statistical and scientific purposes - in accordance with the methodological standards of the relevant subject area - which are carried out by universities, other research bodies or institutes and scientific societies, as well as by researchers working within such universities, research bodies, research institutes and members of such scientific societies”.
Finally, as far as the Human rights framework is concerned, the Italian Constitution shall be referred to as well.
As for the non-binding instruments, it is worth mentioning the Guidelines for the institution and the certification of biobanks issued by the National Committee for Biosecurity and Biotechnology in 2006, which provides principles and guidelines to implement a biobank.189
to this end, Art. 40 of the old version of the Legislative Decree 196/2003 established that the Italian DPA had the duty to issue the so-called General Authorisations, i.e. administrative provisions which established a set of rules applicable to these types of processing activities. Through time, therefore, the Italian DPA has issued various General Authorisations, including the numbers 8/2016 and 9/2016. However, with the advent of the GDPR, these Authorisations should have been considered abolished. In order for this not to happen, the Italian legislator introduced in Art. 21 of the Legislative Decree 101/2018 the possibility of the Italian DPA to identify with an ad hoc normative act those provisions included in the General Authorisations and referred to processing related to Art. 6(1)(c) and (e), as well as Art. 9(2)(b) and (4) GDPR that were deemed compatible with the GDPR and there that would have continued to be applicable. All the other General Authorisations, as well as the provisions included therein, would have ceased to have any effect under the Italian legal framework. to this end, the Italian DPA adopted the Provvedimento n. 146 of the 5th of June 2019, according to which only the General Authorisations 1/2016, 3/2016, 6/2017, 8/2016 and 9/2016 remained in force. On this, see Xxxxxx, Xxxxxx and Xxxxx, Xxxxxx “The Italian Way for Research Biobanks After GDPR: Hybrid Normative Solutions to Balance the Protection of Individuals and Freedom of Research.”
187 Xxxxxxx, Xxxxxx, et al. “Regulation of Biobanks in Italy.” Frontiers in pediatrics vol. 8 n. 415, 2020, pp. 1-5.
188 Italian Legislative Decree n. 52/2019.
189 For a more comprehensive analysis of the non-binding national instruments, see Calzolari, Alessia, et al. “Review of the Italian Current Legislation on Research Biobanking Activities on the Eve of the
After having clarified some of the fundamental definitions to be used in the following analysis and the applicable fragmented regulatory landscape, the aim of the present work will be to establish how a biobank may lawfully conceptualise its governance to collect for future research purposes human biological samples and personal data.
To this end, various methods are possible, both under a supranational and a national level. Establishing the method for the collection of the content of a biobank is one of the first decisions to be made for the biobanking governance and shapes most of the others to follow. Moreover, as it will be apparent throughout the discussion, it influences to a great extent the relationship between researchers and participants and the impact of scientific research more generally.
The choice between the models available should be made first of all by conducting a balancing test of the various rights and interests at stake, and secondly by evaluating the consequences of each option on participants’ trust, in order to preserve it and enhancing it in the future. Indeed, the very existence of biobanks rests on the willingness of participants to provide samples and data and not to subsequently withdraw them.
The elements for such an evaluation (trust test) will be provided in Chapter II, while Chapter III will be devoted to the extensive analysis of the legal requirements that compose the various possible models for the collection of HBSs and data among which the biobank may choose (namely the necessity-based model and the consent-based model). I will then evaluate the impact and consequences of each identified method of collection firstly on the private and public interest at stake in biobanking, trying to find the balance between them, and then on participants’ trust.
Finally, in Chapter IV I will analyse the issue of the anonymisation of personal (health and genetic) data, usually considered as the technical means to be used to escape regulatory conundrum, but in reality more difficult to be applied than what appears at first glance.
Participation of National Biobanks’ Network in the Legal Consortium BBMRI-XXXX.” Biopreservation and Biobanking, vol. 11, n. 2, 2013, pp. 124-128.
CHAPTER II – TRUST IN BIOBANKING
Summary: 1 Introduction; 2 The importance of trust in biobanking – (A) Practical examples; 3 ... (B) Theoretical analysis: (B1) Hard and soft law instruments; 3.1 ... (B2) Scholars; 4 Trust as a dynamic concept – Relevant factors for the biobank governance; 5 Conclusion
Biobanks rely greatly on public participation and trust,190 so much so that the latter has been defined as a “vital component for biobanking”.191 This is particularly due to the fact that biobanks always depend to a certain extent on the willingness of participants to provide HBSs or personal data and control their use for research purposes, or to not ask for their erasure or destruction.192
190 Xxxxx, Xxxxxx, et al. “Biobanking for Public Health.” Trust in Biobanking: Dealing with Ethical, Legal and Social Issues in an Emerging Field of Biotechnology, edited by Xxxxxxx, Xxxxx, et al. Springer, 2012, pp. 3-20.
191 Xxxxxx, Xxxxxxxxx, et al. “Public Trust and Trustworthiness in biobanking. the Need for More Reflexivity.” Biopreservation and Biobanking, vol. 20, n. 3, 2022, pp 291-296. Similarly, Xxxxxxxx, Xxxx “Biobanks “Engagements”: Engendering Trust or Engineering Consent?” Genomics, Society and Policy, vol. 3, n. 1, 2007, pp. 31-43; Xxxxxxxx, Xxx, et al. “Has the Biobank Bubble Burst? Withstanding the Challenges for Sustainable Biobanking in the Digital Era.” BMC Medical Ethics, vol. 17, n. 1, 2016, pp. 1- 14; Xxxxx, Xxxxx, and Xxxxxxxx, Xxxxx “Can We Know if Donor Trust Expires? About Trust Relationships and Time in the Context of Open Consent for Future Data Use.” Journal of Medical Ethics, vol. 48, 2022, pp. 184-188; Xxxxx, Xxxxx, et al. “Evidence-Based Guiding Principles to Build Public Trust in Personal Data Use in Health System.” Digital Health, 2022, pp. 1-11; Xxxxxx, Xxxxxx, and Xxxx-Xxxxx X., Xxxxxx “Biosamples as Gifts? How Participants in Biobanking Projects Talk about Donation.” Health Expectations: an International Journal of Public Participation in Health Care and Health Policy, vol. 19,
n. 4, 2016, pp. 805-816; xxx Xxxx, Xxxxxx-Xxxxxx, et al. “Big Health Data: The Need to Earn Public Trust.” BMJ, vol. 354, 2016, pp. 1-3; Xxxxx, Xxxxx, and Xxxxxxxx, Xxxxx “Public Trust: Caught Between Hype and Need.” International Journal of Public Health, vol 65, 2020, pp. 233-234.
192 Xxxxxxx, Xxxx X., “Building on Relationships of Trust in Biobank Research.” Journal of Medical Ethics, vol. 31, n. 7, 2005, pp. 415-418.
Indeed, trust has been defined as “the main determinant of participants’ willingness to cooperate with biobanking”193 and more generally one of the key factors in deciding to share personal data for research purposes.194
Indeed, low levels of public and participants’ trust in biobanking activities may decrease their participation rate or encourage “privacy protecting behaviours”, which include providing inaccurate or incomplete information or continuously changing one’s health care provider195 and consequently hinder the sustainability of the biobanking system as a whole.196
In recent years, a growing number of studies focused on the importance of trust not only in the specific context of biobanking197 but also in the more general one of scientific research, especially if data-xxxxxx000 and involving Big data. In particular, studies highlighted a positive general attitude of people in sharing their data for research
193 Xxxxxxxx, Xxxxx, et al. “An Empirical Reappraisal of Public Trust in Biobanking Research: Rethinking Restrictive Consent Requirements.” Journal of Law and Medicine, vol. 17, n.1, 2009, pp. 119-138; Xxxxxx, Xxxxx X., and Xxxxxxxxx, Xxxx “Informed Consent for Biorepositories: Assessing Prospective Participants' Understanding and Opinions.” Cancer Epidemiology, Biomarkers & Prevention: a Publication of the American Association for Cancer Research, Cosponsored By the American Society of Preventive Oncology, vol. 17, n. 6, 2008, pp. 1440-1451.
194 Xxx, Xxxxxxx A. R., et al. “Health Data Research on Sudden Cardiac Arrest: Perspectives of Survivors and Their Next-Of-Kin.” BMC Medical Ethics, vol. 22, n. 7, 2021, pp. 1-15; Xxx, Xxxxxxx X. X., et al. “Towards Trust-Based Governance of Health Data Research.” Medicine, Health Care and Philosophy, vol. 26, 2023, pp. 185-200; Xxxxx, Xxxxxx, et al. “Biobanking for Public Health”; Xxxxxxxxx, Xxxxxxxx “Trust Me, I’m a Researcher! the Role of Trust in Biomedical Research.” Medicine, Health Care, and Philosophy, vol. 20, n. 1, 2017, pp. 43-50.
195 Xxxxxxxx, Xxxxx X., and Xxxx, Xxxx “Building and Maintaining Public Trust to Support the Secondary Use of Personal Health Data.” Eurohealth, vol. 25, n. 2, 2019, pp. 7-11; El Emam, Khaled, et al. “Anonymising and Sharing Individual Patient Data.” BMJ (Clinical Research ed.), vol. 350, 2015, pp. 1-6; Xxxxxx, Xxxxxx X., et al. “Trust Me, I’m a Doctor: Examining Changes in How Privacy Concerns Affect Patient Withholding Behavior.” Journal of Medical Internet Research, vol. 19, n. 1, 2017.
196 Xxxxxx, Xxxxxxxxx, et al. “Public Trust and Trustworthiness in Biobanking. the Need for More Reflexivity”; Xxxxxxxx, Xxxx, “Biobanks “Engagements”: Engendering Trust or Engineering Consent?”
197 Xxxxxxx, X. K, and Xxxxxx, X’Xxxxxxx “Biobank Governance: a Lesson in Trust.” New Genetics and Society, vol. 29, n. 3, 2010, pp. 311-327; Xxxxxxxx, Virginia, et al. “A Trust-Based Pact in Research Biobanks. From Theory to Practice.” Bioethics, vol. 30, n. 4, 2016, pp. 260-271; Xxxxxxx, Xxxxx, et al. Trust in Biobanking: Dealing with Ethical, Legal and Social Issues in an Emerging Field of Biotechnology, Springer, 2012.
198 Xxxxx, Xxxxx, and Xxxxxxxx, Xxxxx “Limits of Data Anonymity: Lack of Public Awareness Risks Trust in Health System Activities.” Life Sciences, Society and Policy, vol. 17, n. 7, 2021, pp. 1-8; Xxxxxx, Xxxx, et al. “A Roadmap for Restoring Trust in Big Data.” the Lancet. Oncology, vol. 19, n. 8, 2018, pp. 1014-1015.
purposes199 if they perceive they can trust researchers in handling their data.200 It is precisely this particular trust that should be preserved and enhanced by biobanks.
Examples of successful biobanks or data-drive projects based on a solid trust relationship are the electronic health records built to improve health management and quality of care,201 and the collection of data to curb the coronavirus pandemic in 2019,202 while at the same time examples exist of the failure of analogous projects in case of low level of public trust (as analysed below).
Indeed, confirmation of the value of trust for biobanking stems also from the development of the charitable biotrust as a possible governance model for biobanks by Xxxxx Xxxxxxxxx,203 which is increasingly mentioned in the literature about data governance for research, especially in common law systems.204 More in detail, this model replicates the general structure of a charitable trust:
● Participants identify as settlors and would donate their data to the biobank, usually by providing consent to their processing;
● The biobank assumes the role of the trustee (called Biotrust foundation), which is the independent structure with the duty to share the data in a fair, safe and equitable way205 and it is thus invested with a legal fiduciary duty;
● The biobank would share the data with researchers in the interest of the beneficiary, i.e. society as a whole, for purposes identified in the trust charter, which also includes provisions related to the ethical principles guiding its
199 Xxxxxxxxx, Xxx X., et al. “A Review of Attitudes Towards the Reuse of Health Data Among People in the European Union: The Primacy of Purpose and the Common Good.” Health policy (Amsterdam, Netherlands), vol. 123, n. 6, 2019, pp. 564-571.
200 TEHDAS, Healthy Data, an online citizen consultation about health data reuse – intermediate report, 2022; TEHDAS, Qualitative study to assess citizens’ perception of sharing health data for secondary use and recommendations on how to engage citizens in the EHDS, 2023.
201 Xxxx, Xxxxxxx, and Xxxxx, Xxxxx-xxxxx “The Xxxx.Xxxx Consensus? a Qualitative Analysis of Opinions Expressed on Twitter.” BMC Public Health, vol. 15, n. 838, 2015, pp. 1-13.
202 Xxxxx, Xxxxxxxx, and Xxxx, Vayena “On the Responsible Use of Digital Data to Tackle the COVID-19 Pandemic.” Nature Medicine, vol. 26, n. 4, 2020, pp. 463-464.
203 Xxxxxxxxx, Xxxxx X, and Xxxxxxx X., Winickoff “The Charitable Trust as a Model for Genomic Biobanks.” the New England Journal of Medicine, vol. 349, n. 12, 2003, pp. 1180-1184; Xxxxxxxxx, Xxxxx
X. “From Benefit Sharing to Power Sharing: Partnership Governance in Population Genomics Research.” Principles and Practice in Biobank Governance, edited by Xxxx, Xxxx, and Stranger, Xxxx, Routledge, 2009; Xxxxx, Xxxxxxx, et al. "What Can Data Trusts for Health Research Learn from Participatory Governance in Biobanks?” Journal of Medical Ethics, vol. 48, n. 5, 2022, pp. 323-328.
204 Xxxxx, Xxxxxxx, et al. "What Can Data Trusts for Health Research Learn from Participatory Governance in Biobanks?”
205 Hall, Xxxx Xxxxx, and Xxxxxx, Xxxxxxx “Growing the Artificial Intelligence Industry in the UK.” London Department for Digital, Culture, Media & Sport and Department for Business, Energy & Industrial Strategy, 2017.
activities, the rights and duties of the parties involved, the consequences of withdrawing from the trust, etc.206
For the mentioned activities, the Biotrust foundation collaborates with
● the Ethical Review Committee (ERC), responsible for evaluating the research project that could get access to the content of the biobank, according to ethical parameters, and in which participants’ representatives participate,
● and the Donor Advisory Committee (DAC), composed exclusively of participants’ representatives and whose primary aim is to maximise the use of the content of the biobank for the public good.207
The applicability of the biotrust model to European biobanks is controversial, because of the difficulties of implementing in civil law systems the model of trust, traditionally developed in common law environments208 and possible issues related to the risks of diminishing the collective and solidarity dimension of biobanking.209
However, what can be inferred from the theories that claim the applicability of this model to biobank governance is the at least theoretical possibility of building the biobank- participant relationship as a fiduciary relationship210 based on trust.211
Therefore, it is fundamental in general for the well-functioning of a biobank to understand which biobank activities broadly considered, or elements of the biobank governance, may somehow impact on participants’ trust, either positively or negatively, and consequently identify various practices (defined as vital components of biobanking success)212 that may be included in the biobank governance itself to help protect or enhance participants’ trust.
206 Extensively on the topic, Xxxxxxxxx, Xxxxx X, and Xxxxxxx X., Xxxxxxxxx “The Charitable Trust as a Model for Genomic Biobanks”; Xxxxx, Xxxxxxx, et al. "What Can Data Trusts for Health Research Learn from Participatory Governance in Biobanks?”; Xxxxxx, Xxxxxxx, La Disciplina Giuridica delle Biobanche di Ricerca, PhD thesis, Università Trento, Anno Accademico 2009-2010; Xxxxxxx, Xxxx Biobanche di Ricerca e Xxxxxx xxxxx Persona.
207 Xxxxxx, Xxxxxxx, La Disciplina Giuridica delle Biobanche di Ricerca.
208 Xxxxxxx, Xxxxxxxxx “La Circolazione dei Dati Genetici e delle Biobanche: Limiti e Prospettive de iure condendo”; Xxxxxx, Xxxxxxx, La Disciplina Giuridica delle Biobanche di Ricerca; Xxxxxxxxx, Xxxxxx, et al. “Legal Issues in Governing Genetic Biobanks: The Italian Framework as a Case Study for the Implications for Citizen’s Health Through Public-Private Initiatives.” Journal of Community Genetics, vol. 9, n. 2, 2018, pp. 177-190.
209 Xxxxxxxxx, Xxxxxxx “Ipotesi per una Gestione Partecipata delle Biobanche Genetiche Concepite Come Beni Comuni.” BioLaw Journal, vol. 2, 2023, pp. 383-410.
210 Xxxxxxxxx, Xxxxx X., and Xxxxxxx B., Xxxxxxx “Towards a Social Contract for Genomics: Property and the Public in the “Biotrust” Model.” Genomics, Society and Policy, vol 1, n. 8, 2005, pp. 8-32.
211 Xxxxx, Xxxxxxx, et al. "What Can Data Trusts for Health Research Learn from Participatory Governance in Biobanks?”
212 Xxxxxx, Xxxxxxxxx, et al. “Public Trust and Trustworthiness in Biobanking. the Need for More Reflexivity.”
Indeed, despite there being various trust mechanisms, i.e. reasons behind the decision to trust someone or an institution,213 as well as moral components, through time studies have been conducted to identify various factors that may influence the level of participants’ trust in the biobanking activities.
The focus of my analysis in this context will be restricted to those elements of participants’ trust that may be influenced directly by biobank’s governance choices related to the models for the collection of HBSs and personal data for their future use.214 Moreover, the aim is thus to develop an additional tool for the choice of the governance measures to be adopted in the biobank when choosing the model for the collection of its content in order to be (also) trustworthy.215 He mentioned analysis would be conducted keeping in mind that an appropriate biobank governance is already considered as a “trustworthy framework” per se, especially when it addresses issues such as unforeseeable consequences of biobanks, controlling vested interests, managing the
213 To this end, Xxxxxxx et al. speak about deterrence-based trust, calculus-based trust, relational trust, and institution-based trust. Xxxxxxx, Xxxx, et al. “Patient Perspectives on Sharing Anonymized Personal Health Data Using a Digital System for Dynamic Consent and Research Feedback: a Qualitative Study.” Journal of Medical Internet Research, vol. 18, n. 4, pp. 1-11. On the same topic, Xxxxxx et al. speak about “rational decision making, knowledge-based trust rooted in previous experience and/or identification-based trust that relates to emotional ties, shared values.” Xxxxxx, Xxxxxxxxx, et al. “Public Trust and Trustworthiness in biobanking. the Need for More Reflexivity.”
214 An example may help clarify the issue. The DGA for instance establishes in Recital 46 that “[i]n order to assist data subjects and data holders to easily identify, and thereby increase their trust in data intermediation services providers recognised in the Union, a common logo recognisable throughout the Union should be established.” It can thus be inferred from this provision the European legislator believes in the value of recognisable logos to increase data subjects’ trust over data intermediations services providers. The same line of reasoning could in principle be applied to biobanking, by recommending the adoption of a logo to enhance participants’ trust in the biobanking activities. However, such a recommendation and the recommended activity itself do not have anything specifically to do with the collection of the content of the biobank, or with the provisions to include in the biobank governance in this regard. As a consequence, their analysis and their inclusion in the trust test is outside of the scope of this work, given its exclusive focus on the models for collection of the content of the biobank and its consequences for the biobank governance.
215 Xxxxx, Xxxxxxx, et al. “Demonstrating Trustworthiness When Collecting and Sharing Genomic Data: Public Views Across 22 Countries.” Genome Medicine, vol. 13, n. 92, 2021, pp. 1-12. Moreover, Xxxxxx, Xxxxxxxxx, et al. “Public Trust and Trustworthiness in Biobanking. the Need for More Reflexivity” speak about “the formalization of trustworthiness as a set of governance structures” and stress on the importance of avoiding reducing trustworthiness only to a series of governance mechanisms, without concretely acting according to them. On the need to act in a trustworthy manner, see also Xxxxxxx, Xxxxxxxx “Biobanking. Trust as Basis for Responsibility.” Trust in Biobanking: Dealing with Ethical, Legal and Social Issues in an Emerging Field of Biotechnology, edited by Xxxxxxx, Xxxxx, et al. Springer, 2012, pp. 43-68. Moreover, in Xxxxx, Xxxxxxx, et al. “Demonstrating Trustworthiness When Collecting and Sharing Genomic Data: Public Views Across 22 Countries.” The authors highlighted that placing blind trust on persons or institutions that do not act in a trustworthy manner may be detrimental for both the trustor and the trustee.
potential public benefits of biobanks, the potential misuse of the data, results and technology, and jurisdiction and boundaries of biobanks.216
Indeed, similarly to the provision of health care, where it has been proven that trust increases with the duration of the physician-patient relationship,217 I believe it is possible to identify some specific elements that should be considered while conducting when weighing possible alternatives for specific issues of the biobank governance model to be adopted, in particular the issue of collecting the samples and data for future research use.218 The evaluation of these elements in the described context will be used to develop what I will call the trust test.
To this end, simply applying the results of the studies conducted on trust in health care to the context of biobanks is not possible, because of the differences in the relationship that binds the various entities,219 and therefore because of the necessity to valorise the characteristics of biobanking as opposed to more traditional forms of scientific research. Indeed, while the doctor-patient relationship is direct and personal and usually built via in-person encounters, the one among participants, the biobank and researchers is usually anonymous, conducted via rare physical encounters and communications, established via electronic means, which is also a more general characteristic of data-driven research.220 Therefore, this Chapter is devoted to trying to understand which elements should be considered when addressing the issue of participants’ trust in biobanking activities. These elements will be included in a trust test to be conducted whenever the applicable legal framework leaves to the biobank the choice among various equally lawful possibilities on a specific governance element (for the purposes of this work, among various models for the collection of HBSs and personal data). Indeed, the trust test will make it possible to consider and address the possible impact of a governance decision on the model for collecting the biobank content on participants’ trust and consequently choose the option that either preserves trust the most or does not excessively impact on it.
216 Xxxxxxx, X. K, and Xxxxxx, X’Xxxxxxx “Biobank Governance: a Lesson in Trust.”
217Stepanikova, Xxxxx, et al. “Trust in Managed Care Settings.” Whom Can We Trust? How Groups, Networks, and Institutions Make Trust Possible, edited by Xxxx, Xxxxx X., et al. Xxxxxxx Xxxx Foundation, 2009; Xxx, Xxxxxxx A. R., et al. “Towards Trust-Based Governance of Health Data Research.”
218 Other issues might be related to other aspects, such as the return of results.
219 Xxx, Xxxxxxx A. R., et al. “Towards Trust-Based Governance of Health Data Research.”
220 Ibid
However, this test should and will not prevail over the careful balancing exercise of the various rights and interests at stake in the concrete scenario under consideration (balancing test) which should always be the first and preferred method for the mentioned choice. Therefore, the trust test may be used in two cases with different aims. Whenever the balancing test does not reach a decisive conclusion because there is no prevailing right or interest in the concrete situation under consideration, the trust test may help choose one of the options. On the contrary, if the balancing test provides for a definite answer, conducting the trust test may help assess whether such a conclusion might negatively impact participants’ trust. This in turn would entail the necessity for the biobank to implement other governance mechanisms or measures for enhancing it.221
As a consequence, throughout this work, whenever a choice between various lawful alternatives is possible, both criteria will be applied, i.e. the balancing of fundamental rights on the one hand (balancing test) and evaluating the impact on trust on the other (trust test). Even though in case of contrast between the results of the two tests, the balancing test should and will prevail, I believe that adding the trust test to the analysis will provide an additional criterion for structuring complex decisions and preserving the existence of biobanks, as well as their role for the development of scientific research.
This approach is justified by considering that, as mentioned, biobanks are fundamental infrastructures for the development of science, medicine and ultimately society, and their very existence depends on the willingness of participants to be involved in research, which in turn depends on their level of trust in the system. Striving to improve public trust in their activities is “unquestionably important for biobanks”,222 but restoring trust is considerably more challenging than preserving it from the beginning.223 Therefore, it is important to include an evaluation of the impact on trust in the procedure for deciding on the specific model for collection to be included in the governance model.
221 The same can be done whenever the choice is made ab origine by the legislator, because there is no room left for biobanks to choose between alternatives.
222 Xxxxxx, Xxxxxxxxx, et al. “Public Trust and Trustworthiness in biobanking. the Need for More Reflexivity.”
223 Xxxxxxx, Xxxx, et al. “Patient Perspectives on Sharing Anonymized Personal Health Data Using a Digital System for Dynamic Consent and Research Feedback: a Qualitative Study.”
Indeed, the idea of implementing trust as a fifth principle in clinical research224 or as a priority-setting value225 is not new and has been extensively studied. In particular, Xxxxxx conducted research on trust in research on human subjects, and I agree with Xxx on the possibility of applying the same logic also in non-interventional research,226 and particularly in the biobank field, which may be considered a peculiar type of non- interventional, data-driven research.
From a methodological point of view, the elements included in the trust test are chosen by combining 1) the identified reasons for the failure of some biobanking projects, mentioned above, 2) the analysis of the relevant literature on the matter, as well as studies/projects conducted specifically to this end, and 3) the solutions to the issue of trust identified by the European legislator in selected fields relevant to biobanking, and therefore in the applicable regulations and/or documents, as identified in Chapter I. Even though some differences may exist between European countries on how trust is perceived, established and enhanced,227 I believe in the possibility of finding some general common traits to be included in the analysis.
The Chapter will therefore be structured as follows. I will begin by providing two concrete examples of the importance of trust for biobanks, i.e. two projects that failed because of a lack of public trust, and also trying to identify the reasons behind it.
I will then proceed to identify the core elements of participants’ trust, which will include not only those responsible for the failure of the mentioned projects but also an analysis of the soft and hard legal instruments applicable to biobanks that include preserving trust among their objectives, and the norms and requirements provided for therein to this end. Finally, I will include the results of sociological studies on the matter and influential scholars' opinions, especially on the reasons for participating in or withdrawing from biobanking activities.
224 Xxxxxx, Xxxxx X., the Ethics of Research with Human Subjects. International Library of Ethics, Law, and the New Medicine, Springer, 2018.
225 Xxx, Xxxxxxx A. R., et al. “Towards Trust-Based Governance of Health Data Research.”
226 Ibid
227 Ibid. In particular, see the work of Xxxxxx et al. that demonstrated how a trust-based governance approach is more likely to succeed in countries like the Netherlands instead of the United Kingdom. Xxxxxx, Xxxxxxx X. X., et al. “Comparative Institutional Analysis for Public Health: Governing Voluntary Collaborative Agreements for Public Health in England and the Netherlands.” European Journal of Public Health, vol. 28, 2018, pp. 19–25.
The last paragraph aims at collecting the most shared elements with a possible impact on participants’ trust, in order to establish the content and functioning of the trust test for the mentioned use.
2 THE IMPORTANCE OF TRUST IN BIOBANKING – (A) PRACTICAL EXAMPLES
At least the following two examples may be provided to prove the importance of participants’ trust for the existence and functioning of biobanks: the UK Xxxx.xxxx project and the Digital Data Grab project.
First of all, the Xxxx.Xxxx project was a project carried out by England’s National Health Service (NHS) in 2013, which aimed to collect patients’ data from general practitioners through the General Practice Extraction Service and store them in a central database. Those data were then to be used in anonymised form by healthcare researchers outside the (NHS), including commercial companies. In this project, the collection of data was based on an opt-out system, and therefore patients’ data registered with a general practitioner were to be uploaded in the database unless the person concerned had objected to such a processing.
On their website, the NHS stated that the project aimed at ensuring that the best possible evidence was available to improve the quality of healthcare for all, by providing data for identifying patterns in diseases and discovering possible treatments.228 Thus, the project was developed for the public good, at least theoretically.
However, from the beginning, it faced a lot of opposition, both from general practitioners and patients, who started opting out. According to commentators on the matter, the project “failed to win the public’s trust and lost the battle for doctors’ support”,229 and was thus abandoned.230
Indeed, among the critical elements of the initiative was the implementation of an opt-out system and the “toxic possibility”231 of data being accessed by private commercial
228 Xxxxxxx, Xxxxxx, et al. “You Hoped We Would Sleepwalk into Accepting the Collection of Our Data”: Controversies Surrounding the UK xxxx.xxxx Scheme and Their Wider Relevance for Biomedical Research.” Medicine, Health Care and Philosophy, vol. 19, 2016, pp. 177–190.
229 Xxxxxx, Xxxxx “What Can We Salvage from xxxx.xxxx?” BMJ, vol. 354, 2016; xxx Xxxx, Xxxxxx-Xxxxxx, et al. “Big Health Data: The Need to Earn Public Trust.”
230 Xxxxxx, Xxxxx, et al. “The Evolution of Withdrawal: Negotiating Research Relationships in Biobanking.”
231 Xxxxxx, Xxxxx “What Can We Salvage from xxxx.xxxx?”
companies, which were characteristics of the project that made patients and participants lose trust in the transparency of the activity of the biobank and in particular in its aim of processing the data for public food purposes. This substantial decrease in participants’ trust has been identified as the main cause of the failure of the project.232
This belief was partially caused and reinforced by the failure of those in charge of the project to engage in communication with the public to ensure the trustworthiness of the database and the project more generally and explain the benefits of its implementation.233 According to commentators, a substantial decrease in public trust derived from concerns about informed consent, data security and privacy risks, lack of communication and involvement of private companies with commercial interests.234 As it has been affirmed by commentators, “The program aimed at securing the bare minimum of trust while maximising potential returns on investment. It thus quickly dismissed privacy and respect for individual autonomy as individualistic rights opposing wider prosperity, rather than seeing them as principles of social trust and public engagement”.235
More recently, a different UK project was put on hold for reasons related to lack of trust. Indeed, the NHS Digital Data Grab project envisioned the collection of patient data, at least partially anonymised, to develop health and social care policies, and enable research and other services. The system established an opt-out system, which was activated by over a million people in one month,236 mainly because of the fear of their data being shared with private companies,237 and thus mainly for problems of transparency and communication.
232 Xxxxxxx, Kare, et al. “Patient Perspectives on Sharing Anonymized Personal Health Data Using a Digital System for Dynamic Consent and Research Feedback: a Qualitative Study”; Xxxxxx, Xxx et al. “The Social Licence for Research: Why xxxx.xxxx Ran into Trouble.” Journal of Medical Ethics, vol. 41, n. 5, 2015, pp. 404-409.
233 Xxxxxx, Xxxxx, et al. “The Evolution of Withdrawal: Negotiating Research Relationships in Biobanking.”
234 Xxxxxxxx, Xxxxx, et al. “Public Views About Involvement in Decision-Making on Health Data Sharing, Access, Use and Reuse: The Importance of Trust in Science and Other Institutions.” Frontiers in Public Health, vol. 10, 2022, pp. 1-11; Xxxxxxxxx, Xxx X., et al. “A Review of Attitudes Towards the Reuse of Health Data Among People in the European Union: The Primacy of Purpose and the Common Good”; Xxxxxx, Xxx et al. “The Social Licence for Research: Why xxxx.xxxx Ran into Trouble.”
235 Vezyridis, Xxxxxxxxxx, and Xxxxxxx, Xxxxxxx “Resisting Big Data Exploitations in Public Healthcare: Free Riding or Distributive Justice?” Sociology of Health & Illness, vol. 41, n. 8, 2019, pp. 1585-1599.
236 Xxxxxxxxx, Xxxxxxxx “NHS Data Grab on Hold as Millions Opt Out.” the Guardian, 2021. xxxxx://xxx.xxxxxxxxxxx.xxx/xxxxxxx/0000/ aug/22/nhs-data-grab-on-hold-as-millions-opt-out. (accessed 16 January August 2024)
237 Xxxxxxx, Xxxxxxxx “Millions Opt Out of England’s Health Data-Sharing Plan.” Open Democracy, 2021. xxxxx://xxx.xxxxxxxxxxxxx. net/en/ournhs/millions-opt-out-of-englands-health-datasharing-plan/. (accessed 16 January August 2024)
2.1 ... (B) THEORETICAL ANALYSIS: (B1) HARD AND SOFT LAW INSTRUMENTS
As mentioned, the importance of the preservation of trust in the biobanking activities is also frequently underlined in the applicable hard and soft law instruments, listed in Chapter I.
Among the soft law instruments analysed, the notion of trust is mentioned by the Declaration of Taipei, the CIOMS International Ethical Guidelines, and Recommendation R(2016)6.
As for the first one, the Declaration of Taipei explicitly establishes four guiding principles that should govern biobanking in order to xxxxxx the trustworthiness of the system:
● protection of individuals – the biobanking governance should always prioritise the interests of participants over those of science or the other stakeholders;
● transparency – any relevant information on the biobank should be made available to the public;
● participation and inclusion – individuals and their communities should be consulted and engaged in the biobanking decisions and activities;
● accountability – those responsible for the biobank should also be accessible and responsive to all the stakeholders involved.
The matter is also extensively addressed by the CIOMS International Ethical Guidelines. In particular, the Guidelines focus on the importance of public engagement and community involvement to build trust between the participants and researchers, as specifically addressed in Guideline 7.238
Furthermore, Recommendation R(2016)6 underlines already in the preamble that it is important for biobanks to earn trust and consequently it stresses on the role of “good and transparent governance” of the HBSs and data stored to this end.
Taking into account the hard law instruments, trust is often cited as a value to be preserved by regulations on data protection or the processing of health data. In particular, in the European strategy for data, the European Commission first of all underlines that citizens’ trust in data-driven innovations rests on their trust in compliance with general data
238 CIOMS International Ethical Guidelines - Guideline 7 “Researchers, sponsors, health authorities and relevant institutions should engage potential participants and communities in a meaningful participatory process that involves them in an early and sustained manner in the design, development, implementation, design of the informed consent process and monitoring of research, and in the dissemination of its results.”
protection rules, and to this end, the GDPR constitutes “a solid framework for digital trust”.239
Indeed, in this regard, data protection and security are also essential for maintaining trust, because individuals’ decision to share their data is directly influenced by the level of safety and protection of their data.240
Moreover, both the DGA and the EHDS aim to preserve trust in the sharing and processing of data. On the one hand, the DGA aims to “develop further the borderless digital internal market and a human-centric, trustworthy and secure data society and economy”,241 and is based on the assumption that transparency may increase trust and encourage data subjects to share personal data for altruistic purposes, which is indeed as a form of data collection. On the other, the EHDS aims at creating “a common space where natural persons can easily control their electronic health data” and “researchers, innovators and policy makers [may use] electronic health data in a trusted and secure way that preserves privacy”, by “enhancing security and trust in the technical framework designed to facilitate the exchange of electronic health data for both primary and secondary use”.
In particular, in Recital 5 the DGA expressly underlined the necessity to increase trust in data sharing “by establishing appropriate mechanisms for control by data subjects (...) over the data that relates to them” and affirmed that “[a] Union-wide governance framework should have the objective of building trust among individuals and undertakings in relation to data access, control, sharing, use and re-use, in particular by establishing appropriate mechanisms for data subjects to know and meaningfully exercise their rights, as well as with regard to the re-use of certain types of data held by the public sector bodies, the provision of services by data intermediation services providers to data subjects, data holders and data users, as well as the collection and processing of data made available for altruistic purposes by natural and legal persons” and that “[i]n particular, more transparency regarding the purpose of data use and conditions under which data is stored by undertakings can help increase trust”.
239 European Commission, a European strategy for data, Brussels, 2020.
240 EDPB-EDPS, Joint Opinion 03/2022 on the Proposal for a Regulation on the European Health Data Space, 2022; European Commission, Assessment of the EU Member States’ rules on health data in the light of GDPR, 2021.
241 Emphasis added.
More generally, for what is relevant in our analysis, the DGA’s framework as a whole is built in order for people and stakeholders to trust the data altruism organisations and to this end, the DGA includes numerous requirements that these organisations should comply with. Such compliance should “bring trust that the data made available for altruistic purposes is serving an objective of general interest” and that “trust should result in particular from having a place of establishment or a legal representative within the Union, as well as from the requirement that recognised data altruism organisations are not-for-profit organisations, from transparency requirements and from specific safeguards in place to protect rights and interests of data subjects and undertakings”.242 It appears thus clear that the DGA not only considers trust a fundamental element in the processing and sharing of data but also establishes that trust is enhanced and preserved by a) providing adequate information to the data subjects on the processing and use of their data, especially if made available for altruistic purposes, b) establishing adequate mechanisms for control that may be used by the data subject, c) preserving and/or increasing the overall transparency of the processing, and d) having adequate measures in place to protect the data subjects. As mentioned, the focus on the control of the data subject over the processing of the data and on the protection of her rights and interests is also included in the EHDS.
Finally, the importance of transparency, accountability and communication to ensure public trust and trustworthiness “in the responsible and effective stewardship of patient data” by the NHS in the UK has also been underlined by an Academic of Medical Sciences report in 2018.243
Various studies have been conducted on participants' trust in the field of scientific research, personalised medicine, data-driven research and biobanking. Specifically for biobanking, BBMRI affirmed that trust should be not only referred to and placed in the characteristics and arrangements of a given project but also in “the broader organisational framework into which a given biobank project is embedded”.244
243 Xxxxxxx, Xxxx, et al. “Trust, Trustworthiness and Sharing Patient Data for Research.” Journal of Medical Ethics, vol. 0, 2020, pp. 1-4.
244 BBMRI “Biobanks and the Public. Governing Biomedical Research Resources in Europe. a Report from the BBMRI Project.” 2013.
Studies specifically focused on trust in biobanking and biobank research frequently highlight the existence of a strong link between public trust, transparency and the level of information provided to participants.245 In particular, providing adequate information to participants may help xxxxxx “acceptance of the ways a biobank is developed and used”246 and addressing participants’ concerns focus on the conditions for sharing their data with third parties, the possible purposes of processing activities by the latter, and in general,247 and on privacy and data security.248 Precisely concerns about privacy and confidentiality have been identified as being related to lower participation rates.249
245 Xxxxxxx, Xxxx X., “Building on Relationships of Trust in Biobank Research”; Xxxxx, Xxxxx, et al. “Transparency About Governance Contributes to Biobanks’ Trustworthiness: Call for Action.” Biopreservation and biobanking, vol. 19, n.1, 2021, pp. 83-85; Xxxxxx, Xxxxxx, et al. “Biobanking for Europe.” Briefings in Bioinformatics, vol. 9, n. 1, 2008, pp. 14-24; Xxxxx, Xxxx et al. “«If You Give Them Your Little Finger, They’ll Tear Off Your Entire Arm»: Losing Trust in Biobank Research.” Medicine, Health Care, and Philosophy, vol. 23, n. 4, 2020, pp. 565-576; Xxxxxxxx, Xxxxxx, et al. “Biobanking from the Patient Perspective.”
246 Xxxxxxxx, Xxxxxx, et al. “Biobanking from the Patient Perspective.”
247 Xxxxx, Xxxxxxx, et al. “Demonstrating Trustworthiness When Collecting and Sharing Genomic Data: Public Views Across 22 Countries”; Xxxxxxx, Xxxx X., “Building on Relationships of Trust in Biobank Research”; Xxxxx, Xxxxx, et al. “Transparency About Governance Contributes to Biobanks’ Trustworthiness: Call for Action”; Xxxxx, Xxxxx, et al. “Evidence-Based Guiding Principles to Build Public Trust in Personal Data Use in Health System.”
248 Xxxxxxx, Xxxxxx, et al. “Publics and Biobanks: Pan-European Diversity and the Challenge of Responsible Innovation.” European Journal of Human Genetics: EJHG vol. 21, n. 1, 2013, pp. 14-20; Xxxxx, Xxxxx, et al. “Evidence-Based Guiding Principles to Build Public Trust in Personal Data Use in Health System”; Xxxxxxxx, Xxxxx, et al. “An Empirical Reappraisal of Public Trust in Biobanking Research: Rethinking Restrictive Consent Requirements.”
249 Xxxxxxxxx, Xxxxxxx, et al. “Motives for Withdrawal of Participation in Biobanking and Participants’ Willingness to Allow Linkages of Their Data.” European Journal of Human Genetics, vol. 30, 2022, pp. 367–377; Xxxxxxx, Xxxxx X., et al. “Public Opinion About the Importance of Privacy in Biobank Research.” American Journal of Human Genetics, vol. 85, n. 5, 2009, pp. 643-54.
250 Xxxxx, Xxxxx, et al. “Towards a broader conceptualization of “public trust” in the health care system.” Social Theory & Health, vol. 15, 2017, pp. 25-43; Xxxxx, Xxxxx, et al. “Transparency About Governance Contributes to Biobanks’ Trustworthiness: Call for Action”; Xxxxx, Xxxxx, Theory and conceptualisation of public trust in the health care system: Three English case studies: xxxx.xxxx, biobanks and 100,000 Genomes Project, PhD thesis, London School of Hygiene & Tropical Medicine, 2017. the importance of providing information to participants and the public is frequently underlined by soft law instruments, especially those listed in Chapter I. See, for instance, the Declaration of Taipei and the Declaration of Helsinki.
trust”.251 Ideally, such communication, and therefore the format with which information is provided, is tailored to the participants and the other relevant stakeholders to which they should be communicated.252 Participants’ trust is usually not directly affected by the communication of risks or uncertainties, which have been proven to only have a minor impact on trust.253
Moreover, providing information and more generally implementing measures and conducting activities to ensure transparency are not only important for biobanks at the moment of asking for consent or at the first encounter between participants and the biobank itself but should also be constantly present throughout the entire duration of the participants-biobank relationship.254
However, it has been highlighted that transparency alone is not enough to ensure trust, if not coupled with “adequate oversight mechanisms holding organisations accountable for their operations”.255
At the same time, engaging with participants and the donor community more generally is another element frequently mentioned, as well as granting donors’ autonomy, maintaining donors’ privacy and an active regulatory system.256
Finally, and coherently with the studies and authors already taken into consideration, BBMRI established that to build trust the biobank should provide participants “with sufficient transparency and accountability, while also offering a certain degree of participation”, not only at the moment of recruiting them, but also throughout the entire
251 Xxxxx, Xxxxx, et al. “Evidence-Based Guiding Principles to Build Public Trust in Personal Data Use in Health System.”
252 Xxxxx, Xxxxx, et al. “Transparency About Governance Contributes to Biobanks’ Trustworthiness: Call for Action.”
253 xxx xxx Xxxx, Xxxx Xxxxxx, et al. “The effects of communicating uncertainty on public trust in facts and numbers. Proceedings of the National Academy of Sciences.” vol. 117, n. 14, 2020, pp. 7672–7683; Xxx, Xxxxxxx X. X., et al. “Towards Trust-Based Governance of Health Data Research.”
254 Xxxxx, Xxxxxxxxx, et al. “Beyond consent: Building trusting relationships with diverse populations in precision medicine research.” American journal of bioethics, vol. 18, n. 4, 2018, pp. 3-20; Xxxxxxx, Xxxx, et al. “Patient Perspectives on Sharing Anonymized Personal Health Data Using a Digital System for Dynamic Consent and Research Feedback: a Qualitative Study.”
255 Xxxxx, Xxxxx, et al. “Transparency About Governance Contributes to Biobanks’ Trustworthiness: Call for Action.”
256 BBMRI Biobanks and the Public. Governing Biomedical Research Resources in Europe. a Report from the BBMRI Project. 2013; Xxxxx, Xxxxx, et al. “What is public trust in the healthcare system? a new conceptual framework developed from qualitative data in England.” Social Theory & Health, vol. 19, 2021, pp. 1-20; Xxxxx, Xxxxx et al. “Transparency About Governance Contributes to Biobanks’ Trustworthiness: Call for Action.”
lifecycle of the biobank, via ongoing communication and constant dialogue.257 BBMRI goes on to clarify that “the governance principle for biobanks is not so much “informed consent”, but rather “informed trust” – a long-term relationship of trust between biobanks and donors that is based on, and motivated by, a continuous stream of information about the activities of a biobank project and, in some cases, ways for donors to, at least, partly influence the governance and directions of a biobank effort”.258 To this end, biobanks should find “innovative ways to interact with, and engage their donors and even consult with donors on such questions and issues as “governance”, “access” to biobank resources, or the “benefits” created by biobank research”.259 Along the same line, it has also been suggested that the biobank may develop a more patient-centred governance, involving patients as active participants in biobanking, to help address the needs of personalised medicine and move towards greater public involvement in research.260
Coherently with this approach, Xxxxxxx and Xxxxxxx affirmed that building a biobank governance that addresses the specific concerns of participants represents “a way to achieve public trust through accountability, transparency and control”,261 thus indirectly underlying how these are measures to be adopted to preserve participants’ trust.
Finally, it has been shown that biobank participation is correlated with institutional trust.262 However, while it is possibly a determinant factor, there is little or nothing that the biobank could implement at the level of its governance for the collection of HBSs and personal data to influence the general level of participants’ institutional trust.
Studies focusing on sharing data for scientific research purposes highlighted the importance of transparency and patient involvement for maintaining participants’ trust as
257 Raivola, Xxxx, et al. “Attitudes of blood donors to their sample and data donation for biobanking.”
European journal of human genetics, vol. 27, 2019, pp. 1659-166.
258 BBMRI “Biobanks and the Public. Governing Biomedical Research Resources in Europe. a Report from the BBMRI Project.” 2013.
259Ibid
260 Xxxxxxxx, Xxxxxx, et al. “Biobanking from the patient perspective.” The authors here also provide insights on patient-led and patient-run biobanks, by focusing especially on three case studies, such as the Chordoma Foundation Biobank in the U.S.A., the Patients’ Tumor Bank of Hope in Germany and the Italian Biobank AHC in Italy.
261 Xxxxxxx, X. K, and Xxxxxx, X’Xxxxxxx “Biobank Governance: a Lesson in Trust.” The authors underline how this approach is consistent with political science literature on how to ensure public trust within society more broadly. Indeed, they affirm that “governance is seen as the solution to concerns raised by biobanks” and that this “reflects the notion that governance mechanisms mediate relationships of trust in modern democratic societies.”
262 Raivola, Xxxx, et al. “Attitudes of blood donors to their sample and data donation for biobanking.”
European journal of human genetics, vol. 27, 2019, pp. 1659-1667.
well. In particular, Xxxxxxx et al. in their study confirmed a general positive attitude of patients towards sharing their data for scientific research purposes, and that a major role in taking this decision is played by social responsibility and trust.263 In order to maintain the latter, important prerequisites have been identified in transparency and engagement.264 These findings are confirmed by Xxxxx et al. in their survey “Your DNA, Your say”, where it is also established that participants value the possibility of being able to communicate directly with the gatekeepers of genomic and health data collections.265 Furthermore, the possibility of exercising personal autonomy via retaining a certain degree of control over one’s data is affirmed as a further element of maintaining participants' trust in scientific research.266
Moreover, studies are almost unanimous in highlighting that participants are usually concerned about the sharing of their data with private entities or for-profit organisations and that this may also diminish their general trust in the system.267
3 TRUST AS A DYNAMIC CONCEPT – RELEVANT FACTORS FOR THE BIOBANK GOVERNANCE
Trust is a dynamic concept possibly affected by multiple factors, as previously described. Indeed, it has been defined as “multifaced and contextual”, because it may differ
263 Xxxxxxx, Xxxx, et al. “Patient Perspectives on Sharing Anonymized Personal Health Data Using a Digital System for Dynamic Consent and Research Feedback: a Qualitative Study.”
264 Ibid. The same conclusion is also confirmed by Xxxxxx, Xxxx X, and Xxxxxx, Xxxxxxx, “Health research access to personal confidential data in England and Wales: assessing any gap in public attitude between preferable and acceptable models of consent.” Life sciences, society and policy, vol. 10, n. 15, 2014, pp. 1- 24; xxx Xxxx, Xxxxxx-Xxxxxx, et al. “Big Health Data: The Need to Earn Public Trust.”
265 Xxxxx, Xxxxxxx, et al. “Demonstrating Trustworthiness When Collecting and Sharing Genomic Data: Public Views Across 22 Countries.”
266 Xxxxx, Xxxxx, et al. “Evidence-Based Guiding Principles to Build Public Trust in Personal Data Use in Health System.”
267 Xxxxxxxxx, Xxxxxxxxx, et al. “The impact of commercialisation and genetic data sharing arrangements on public trust and the intention to participate in biobank research.” Public health genomics, vol. 18, n. 3, 2015, pp. 160-72; Xxxxxxx, Xxxxxx, et al. “Publics and biobanks: Pan-European diversity and the challenge of responsible innovation”; Xxxxxxxx, Xxxxx X., and Xxxx, Xxxx “Building and Maintaining Public Trust to Support the Secondary Use of Personal Health Data”; Xxxxx, Xxxxxxx, et al. “Demonstrating Trustworthiness When Collecting and Sharing Genomic Data: Public Views Across 22 Countries”; Xxxxx, Xxxx et al. “«If You Give Them Your Little Finger, They’ll Tear Off Your Entire Arm»: Losing Trust in Biobank Research”; Xxxxxxxx, Xxxxx, et al. “An Empirical Reappraisal of Public Trust in Biobanking Research: Rethinking Restrictive Consent Requirements.”
according to the situation or discipline in which it is considered,268 and requires constant “effort and responsiveness to changes”.269
However, some common traits may be identified from the analyses provided above.
In particular, systemic elements or personality or psychological traits may influence the people’s willingness to exhibit trusting attitudes.270 These, however, cannot be taken into consideration here because are not directly related to the biobank governance and are inherently subjective.
It can be inferred from the analysis conducted above that participants’ trust seems to be preserved and/or enhanced by (1) transparency aspects, and (2) participation aspects of the biobank governance.
(1) As for the transparency aspects, it seems that trust appears to be influenced and thus may possibly be preserved and enhanced by maintaining or implementing an adequate level of transparency in the biobank governance and providing participants with information on the biobank activities and functioning. In particular, both transparency and the provision of information should address the issues mentioned above that are sources of concern for participants. In particular, they should be related to (a) the functioning of the biobank, (b) the characteristics of the processing of the HBSs and data stored therein, as well as the purposes of the processing activities, (c) the safeguards adopted to protect the rights and interests of participants, as well as the security of the content of the biobank, and (d) accountability. This in turn entails that the biobank should have implemented concrete measures to protect the fundamental rights of participants, be compliant with the applicable framework, have in place oversight and accountability mechanisms, etc, about which subsequently provide transparent information to participants. Moreover, it stems from this that the model for the collection of HBSs and personal data should preserve such transparency, or enable it.
268 Xxxxxx, Xxxxxxxxx, et al. “Public Trust and Trustworthiness in biobanking. the Need for More Reflexivity”; Xxxxx, Xxxxxxx, et al. “Demonstrating Trustworthiness When Collecting and Sharing Genomic Data: Public Views Across 22 Countries.”
269 Xxx, Xxxxxxx A. R., et al. “Towards Trust-Based Governance of Health Data Research”; xxx xxx Xxxx, Xxxxxx, “Dynamic Ethics.” Journal of Value Inquiry, vol. 37, 2003, pp. 13–34.
270 Xxxxx, Xxxxx X., et al. “Public Trust in Health Information Sharing: a Measure of System Trust.” Health Research and Educational Trust, vol. 53, n. 2, pp. 824-845.
As frequently mentioned in the previous paragraphs, the information should preferably be provided with ongoing communication between the biobank and the participants tailored to the characteristics of at least the general group of participants considered.
(2) Moreover, participants should be involved in the functioning of the biobank. As mentioned earlier, in order for their trust to be maintained it is important to provide participants with a certain degree of control over the use of their biological samples and personal data for research purposes, and this level of control should not be fictional or purely theoretical. Therefore, it appears that on a general level, measures to ensure public involvement in the biobank activities should also be included in the governance mechanism, and on a more specific one that the governance model for the collection of the biobank’s content should be designed as to ensure or preserve the mentioned trust. This does not necessarily mean that the biobank should choose the model for collection that guarantees the highest level of participants’ control, but that the chosen model should not either completely eliminate such control or disproportionately restrict it.
Finally, it is worth mentioning X’Xxxxx’x concerns about the soundness of the opinion according to which the implementation of the principles of accountability, openness and transparency is actually a method to “reduce uncertainty, lower the risk of harm and maintain control”, thus in turn preserving trust.271 Indeed, the author claims that this approach may prevent trust instead of preserving and enhancing it because it “removes the conditions required for trust” itself.272 This objection may be broadened up to include any biobank governance measure adopted to enhance or preserve trust, because by doing so it automatically eliminates the very conditions for trusting.
While recognising the value of X’Xxxxx’x approach, I agree with Xxxxxxx et al. in believing that any of the mentioned measures may and should still be adopted to demonstrate trustworthiness and reliability.273 Being trustworthy does not guarantee trust by participants, nor is the opposite true (i.e. that trust is only placed on trustworthy entities
271 X’Xxxxx, X., a Question of Trust: BBC Xxxxx lectures, Cambridge: Cambridge University Press, 2002.
272Ibid
273 Xxxxxxx, Xxxx, et al. “Trust, Trustworthiness and Sharing Patient Data for Research.” It is important to stress here that I agree with Xxxxxxx et al. that in public health literature, the “distinction between trust and reliance (...) is entirely lost” and that the terms trust, reliance, confidence, etc. are used interchangeably. On this Xxxxxxx, Xxxxxxx, et al, “Trust and the Acquisition and Use of Public Health Information.” Health Care Analysis, vol. 30, 2022, pp. 1-17.
or people), but it may well be considered a first valuable step in this direction and, therefore, a valid reason for adopting the approach described above.
In this Chapter I have analysed the issue of trust in biobanking, focusing in particular on the elements of the biobank governance that are more likely to have an impact on participants’ trust in the biobank activities and the processing of HBSs and personal data for future research purposes. The examples provided attempt to demonstrate such importance.
Therefore, and considering that preserving trust is generally easier than restoring it, I suggested including a trust test in the decision-making process for the choice of the model to be adopted for the collection and subsequent use of the content of the biobank for concrete future research purposes.
Such a test will take into consideration the elements highlighted and in particular the transparency aspect and the participatory aspect of the biobank governance, developed through the analysis not only of the concrete examples of failure of biobank projects because of decreased or not sufficient level of participants’ trust, but also of the relevant literature and applicable framework on the matter.
As a consequence, the trust test will be used alongside the balancing test whenever the applicable legal framework leaves the biobank with the choice between various alternatives for collecting HBSs and personal data for future research purposes, other requirements being equal, and always letting the balancing test prevail over the trust one. However, even if conceptualised as subordinated to the formed, I believe the trust test might provide a valuable tool for the decision-making process for addressing complex issues of the biobank governance, in particular that of the chosen model for the collection of its content.
.
CHAPTER III – PROPOSED MODELS FOR THE COLLECTION OF HUMAN BIOLOGICAL SAMPLES AND BIOBANK DATA
Summary: Structure of Chapter III – General introduction; Part A – Human Biological Samples 1. Introduction; 2. Relevant conceptual distinctions and scope of the analysis; 3 The framework applicable to the collection of HBSs for biobanking purposes – Consent at the supranational level; 3.1 ...and the national level; 4 The Dual nature of HBSs – (A) The material nature, or Human biological samples as detached parts of the human body;
4. Informational nature – Human biological samples as sources of personal data and parts of; 4.1 ... (B) The informational nature, or Human biological samples as sources of personal data and parts of the identity of the person; 5. Developing a framework for HBSs
– On the unitarian consideration of their dual nature; 5.1 Assessing the applicability of the relational-control model to the unitarian consideration of HBSs; 6 Conclusion; Part B – Biobank Data 1 Introduction; 2 Types of biobank data; 3 Preliminary considerations
– (A) The actor classification system applied to biobanking; 3.1 ...(B) Biobanking purposes v. Scientific research purposes; 4 Collecting biobank data – (I) The legal framework at the supranational level; 4.1 Consent-based model – 4.1.1 Withdrawal of consent; 4.2 ... and the Necessity-based model; 4.2.1 The legal bases of Art. 6(1) GDPR;
4.2.2 The exemptions of Art. 9(2) GDPR; 4.2.2.1 Art. 9(2)(i) Public interest in the area of public health; 4.2.2.2 Art. 9(2)(j) Scientific research; 4.2.3 Possible consequences of the Necessity-based model; 4.2.3.1 (A) Derogations derived from provisions of the GDPR; 4.2.3.2 (B) Derogations derived from enacted Union or Member States law; 5
...(II) The legal framework at the national level; 6 The secondary use of personal data in biobanking; 6.1 The supranational level – Art. 5(1)(b) and 6(4) GDPR; 6.2 The national level – Art. 110 and 110-bis Italian Privacy Code and the General Authorisations; 6.3 The duty to provide information according to Art. 14(4) GDPR in case of further processing of personal data; 7 Assessing the framework for the biobank choice; 7.1 The participants’ right to data protection; 7.2 The choice at the supranational level – Between the necessity- based model and the consent-based model; 7.3 The choice at the national level – Alternative models for collecting informational consent; 7.3.1 Broad consent model; 7.3.2 Dynamic consent model; 7.3.3 Choosing an alternative model for collecting informational consent for biobanking; 7.3.4 An alternative solution . Specific informational consent for biobanking; 8 The DGA and the EHDS; 8.1 Data Governance Act; 8.1.1 Specificities of the DGA system for data altruism; 8.1.2 Applying the DGA’s data altruism mechanism to biobanks; 8.2 The European Health Data Space; 8.2.1 Applying the EHDS to biobanks;
8.2.2 The proposed amendments to the EHDS Proposal
STRUCTURE OF CHAPTER III – GENERAL INTRODUCTION
After having provided a general overview of the legal documents applicable, having circumscribed the matter of the analysis, and having identified the foundations of the trust test to be included in the following pages, I will now describe the possible legal approaches for the collection and storage of HBSs on the one hand and biobank data on the other for biobanking purpose, i.e. for future undefined research purposes.
The choice of the concrete modalities and the general approach to be adopted, within the limits provided for by law, for collecting both samples and data highly influences the very existence of the biobank and the scientific research that may be conducted thanks to it, and should be made carefully balancing the various rights and interests at stake and with the aim of protecting and enhancing the trust of participants in the biobanking activities and in scientific research more generally.
The traditional approach to scientific research and to the mentioned balancing exercise in this field is constantly changing both because of the peculiar characteristics of biobanks and because of the advancement in research that constantly modifies the legal approach to its content.
On the one hand, biological samples are nowadays not only used for scientific research because of their nature as parts of the original human body but also because of the valuable genetic information that may be extracted therefrom. As it will be further explained, this raises new instances of protection that should however be balanced against the interest of society in conducting research on this limited and perishable resource.274 In this regard, Part A will be devoted to the description of the two theoretically applicable frameworks, namely one that protects and concerns the material nature of HBSs and the other focused on their informational nature, to attempt to determine whether is sufficient to consider either one of them or it is compulsory a unitarian consideration of both natures. It is worth anticipating that the conclusion will be on the prevalence of the informational nature, given the fact that HBSs are mostly collected and processed for the genetic data they may provide, and because the only instances of protection of fundamental rights that may arise from their processing relate to their informational nature.
274 Xxxxx, Xxxxxx La Donazione dei Materiali Biologici Umani ai Xxxx xxxxx Ricerca Biomedica xxxx’Ambito del Diritto Internazionale e del Diritto dell’Unione Europea.
Consequently, this generates the duty to process the HBSs as genetic data, raising some issues related to the interplay between the data protection legal framework and some soft law instruments applicable to HBSs.
Part B will be thus devoted to the analysis of the various provisions at the supranational and national levels to be complied with in order to collect and store personal data for biobanking purposes, including health-related data and genetic data. As mentioned, the analysis will be conducted taking into consideration the supranational level first, and the national one subsequently. A comparison between the two will be conducted whenever relevant.
The aim of the analysis in Part B will therefore be to provide an overview of the possible models for the collection of the biobank data, when applied to the peculiar processing activity of biobanking, and establish a method for choosing among various alternatives whenever the biobank might be left with different possible equivalent governance pathways.
In particular, the choice should be made first of all by balancing the public and private interests at stake in the given situation, and afterwards in case equal alternatives still exist by including the trust test, i.e. the evaluation of the choice that better protects participants’ trust in biobanking. Indeed, in the various regulations and documents currently under development or last issued there is a clear tendency towards increasing the sharing of data among stakeholders and their re-use for purposes of general public interests, among which scientific research is frequently included, while at the same time carefully protecting the rights of the data subjects.
As for the concrete analysis of Part B, I will first of all extensively analyse the two possible approaches envisioned by the GDPR, namely the consent-based model (i.e. collecting and processing personal data with the consent of the data subject) and the necessity-based model (i.e. collecting and processing personal data based on the necessity of the processing), and the possible consequences of choosing one or the other. Afterward, I will conduct the same analysis under the national data protection regime, in order to present the choice of the Italian legislator, focused on acquiring the informational consent especially when data are processed for scientific research purposes, I will then provide an overview of the legal framework for the secondary use of personal data, i.e. the processing of the latter for purposes different from the original one. Indeed, the matter is
relevant for biobanking, where personal data are stored to be processed multiple times for different purposes, and is subject to specific legal provisions, which are often difficult to interpret and apply. Finally, I will analyse how the processing of personal data for biobanking purposes is influenced by two further regulations: the DGA, which is already fully applicable but only hypothetically relevant for biobanks, and the EHDS, which is currently under development but will be of compulsory application in the biobanking field once enacted.
A preliminary general consideration is necessary for the sake of clarity and in order to better proceed in the discussion. Both Part A and Part B will extensively discuss consent as the main requirement for the collection and storage of HBSs (Part A) or as one of the models for the collection and storage of personal data (Part B). However, these two types of consent are substantially different from one another and also compared to the type of consent usually required specifically for scientific research in general.
On the one hand, the participants’ consent to the processing of personal data according to the GDPR will be hereinafter referred to as informational consent, adopting the nomenclature of Gefenas et al..275 This consent is one of the legal bases available according to the GDPR and aims at ensuring the protection of the right to data protection and informational self-determination of the data subject.
On the other, the collection of HBSs is usually allowed after having acquired the informed consent of the patient to the medical procedure, which will be addressed as interventional consent.276 Interventional consent is the participant’s consent to an intervention that affects her physical integrity, which cannot lawfully be undergone otherwise unless in exceptional circumstances. As will be extensively discussed in the following pages, interventional consent is a basic principle and requirement of any medical intervention, even if not associated with scientific research, i.e when the medical intervention is necessary to safeguard or restore the health of the person concerned. Each type of consent highlighted above protects different rights and interests of the participant, from physical integrity (interventional consent) to information self-determination (informational consent).
275 Xxxxxxx, Xxxxxxxxx “Controversies Between Regulations of Research Ethics and Protection of Personal Data: Informed Consent at a Cross-Road.” Medicine, health care and philosophy, vol. 25, 2022, pp. 23-30. 276 Nomenclature of Gefenas, Xxxxxxxxx ibid
In the context of research with biological samples, whether traditional or biobank research, this consent is somehow coupled with the decision of the participant on how to use the sample:
• If the sample is collected for a specific research project, I will refer to this as
interventional research consent;
• If the sample is to be stored in a biobank for future research uses, I will refer to this as interventional biobank consent.
As a consequence, what is traditionally referred to as “informed consent” for scientific research is somehow composed of two distinct parts: (a) consent to the medical intervention itself and (b) consent to the processing of the detached sample for a given purpose.277 This purpose may be (b1) a specific research project (interventional research consent) or (b2) to be stored in a biobank for future use (interventional biobank consent). These two parts of consent ((a) to the detachment and (b) to the processing of the HBS) may be collected from the participants simultaneously or at different times. This may happen in two different cases in biobanking. For instance, in Scenario 1, participants undergo a medical procedure for the sole purpose of donating the biological sample to be collected and presumably the two parts of consent will be asked simultaneously. Differently, in Scenarios 2 and 3 where the intervention is conducted for purposes other than storing the sample in a biobank, and left-over samples are only subsequently stored in the biobank, the participants’ consent on the use of these samples, when relevant, is usually asked on a later stage and by a different entity. The same may be said for left- over data or HBSs data.
Here, it suffices to highlight that the interventional consent asked in the context of biobanking and for biobanking purposes was built by applying by way of analogy the same requirements of and ratio behind the interventional consent asked in the more general context of the traditional scientific research. However, biobanking research is characterised by distinctive features, which in turn raise instances of protection different
277 This dual nature of the participants consent asked in the context of scientific research that involves biological samples is highlighted by Xxxxxxxx, Xxxxxxxxxx “Biobanche di Ricerca e Modelli Regolativi”; Xxxxxxx, Xxxxxxx, “Campioni Biologici e Big Data: l’Evoluzione del Consenso.” Diritto di Famiglia e delle Persone, vol. 2, n. 3, 2022, pp. 1061-1095; Pacia, Romana “Xxxxxxxx Biologico e Consenso Informato nella Ricerca Genetica: il Possibile Ruolo delle Biobanche.”
from traditional scientific research. From, and because of, this some of the issues around the consent to be asked in biobanking arise.
Figure 2 will help clarify these distinctions.
in general
for the collection of HBSs
for a specific research
project
es
for biobanking purpos
Interventional research consent
Interventional biobank consent
for research, coupled with a consent "for the processing"
d
ata
for the collection an
processing of personal d
Interventional consent
Informational consent
Informed consent
Figure 2
The consequences of this categorisation will be addressed whenever relevant throughout the discussion.
PART A – HUMAN BIOLOGICAL SAMPLES
Summary of Part A: 1. Introduction; 2. Relevant conceptual distinctions and scope of the analysis; 3 The framework applicable to the collection of HBSs for biobanking purposes
– Consent at the supranational level; 3.1 ...and the national level; 4 The Dual nature of HBSs – (A) The material nature, or Human biological samples as detached parts of the human body; 4.1 ... (B) The informational nature, or Human biological samples as sources of personal data and parts of the identity of the person; 5. Developing a framework for HBSs – On the unitarian consideration of their dual nature; 5.1 Assessing the applicability of the relational-control model to the unitarian consideration of HBSs
Advancements in science and technology enabled researchers to understand the importance of biological samples, previously ignored or considered merely organic waste especially in the case of left-over samples.278
Indeed, contrary to the past, the importance of HBSs for the advancement of scientific research is nowadays clearly recognised by most soft law instruments, such as Recommendation R(2016)6 when it acknowledged in the Preamble “the value of biomedical research for the advancement of health care and for the improvement of the quality of life and the potential of collections of biological materials of human origin to facilitate the realisation of these benefits”.
The reason for such gained importance in research is mainly due to the discovery of the possibility of extracting personal data out of HBSs, which therefore became fundamental sources of valuable genetic data about the person they belong to, her health and lifestyle in general.279 Indeed, these data may be used to study the origin of various genetic diseases or to develop new diagnostic methods. In particular, genetic data extracted from
278 Xxxxxxxxx Xxxxxx, Xxxxxxx Xxxxx “Regolare le Biobanche tra Interessi Pubblici e Xxxxxxx: il Nodo dei Campioni Biologici”; Xxxxx, Xxxxxx La Donazione dei Materiali Biologici Umani ai Xxxx xxxxx Ricerca Biomedica xxxx’Ambito del Diritto Internazionale e del Diritto dell’Unione Europea.
279 Pacia, Romana “Xxxxxxxx Biologico e Consenso Informato nella Ricerca Genetica: il Possibile Ruolo delle Biobanche.”
biological materials may be used for the development of -omic sciences280 and personalised medicine,281 which includes pharmacogenetics, somatic genetic therapies, etc,282 because of the special relationship that bonds the HBS, the genetic data and the donor. For these reasons, HBSs are nowadays said to be at the centre of a new gold rush.283 Precisely because of their newly discovered value (and nature) as sources of genetic data, HBSs are now considered not only in their material nature as detached parts of one’s body, but also for the information they may provide about the person, and thus in their immaterial284 or informational nature.285 The analogy is frequently built by comparing the biological samples to a document with information on a specific person written on it,286 or to vessels of the data included therein.287
This dual nature of HBSs and the link between them, the data possibly extracted therefrom and the donor contributed to the development of new instances of protection. Indeed, originally, research and biobank research processed samples only considered in their material nature. In this case, the detachment from the participants’ body creates the HBS as an autonomous object and destroys the ontological and material connection between the HBS and the participant’s body. As a consequence, any processing or intervention on the HBS does not have any direct consequences on the physical integrity of the person, and the remaining issues to resolve are those related to the legal nature and qualification of the samples and the limits and conditions for their sharing, circulation and processing.
280 Xxxxxxxxx Xxxxxx, Xxxxxxx Xxxxx “Regolare le Biobanche tra Interessi Pubblici e Xxxxxxx: il Nodo dei Campioni Biologici.”
281 Xxxxxxxx, Xxxxx, “Il Principio di Gratuità, Biotecnologie e Atti di Disposizione del Proprio Corpo.”
Europea e Diritto Privato, 2002, pp. 771-780.
282 Xxxxx, Xxxxxx La Donazione dei Materiali Biologici Umani ai Xxxx xxxxx Ricerca Biomedica xxxx’Ambito del Diritto Internazionale e del Diritto dell’Unione Europea.
283 Xxxxxx, Xxxxxxx, and Xxxx, Xxxxxxx “Il Mercato del Corpo.” Il Commercio dei Tessuti Xxxxx xxxx’Era Biotecnologica, edited by Xxxxxxx, Xxxxx Xxxxxxx and Xxxx, Xxxxxxxx, Xxxxxxx 2002; Xxxxxxx, Xxxx Xxxxxxxxx di Ricerca e Xxxxxx xxxxx Persona; Xxxxx, Xxxxxx La Donazione dei Materiali Biologici Umani ai Xxxx xxxxx Ricerca Biomedica xxxx’Ambito del Diritto Internazionale e del Diritto dell’Unione Europea.
284 Xxxxxxxxx Xxxxxx, Xxxxxxx Xxxxx “Regolare le Biobanche tra Interessi Pubblici e Xxxxxxx: il Nodo dei Campioni Biologici.”
285 Among many others Pacia, Romana “Xxxxxxxx Biologico e Consenso Informato nella Ricerca Genetica: il Possibile Ruolo delle Biobanche”; Xxxxx, Xxxxxx “Corpo e Property Rights: Limiti Criticità nel Bilanciamento tra Interessi Individuali e Collettivi.” Revista de Bioética y Derecho, vol. 42, 2018, pp. 143- 161.
286 Xxxxxxx, Xxxxxxx “Campioni Biologici e Atti di Disposizione del Corpo.” Lo Statuto Etico-Giuridico dei Campioni Biologici Umani, edited by Xxxxxx, Xxxxx, Diritto, Mercato e Tecnologia, 2016, pp. 207-223; Xxxxxxxxx, Xxxxxx “Campioni Biologici tra Bioetica E Biodiritto.” Lo Statuto Etico-Giuridico dei Campioni Biologici Umani, edited by Xxxxxx, Xxxxx, Diritto, Mercato e Tecnologia, 2016, pp. 145-158.
287 Xxxxxxx, Xxxx Biobanche di Ricerca e Xxxxxx xxxxx Persona.
In particular, the question in this regard is whether it is possible to apply the rules governing property, with the necessary limits and adaptation.288
On the other hand, however, precisely from the moment of collection and the detachment of the sample from the participant’s body, a new informational connection is built, one that did not exist before. Indeed, HBSs contain genetic data and information of the participant, which are ontologically linked to the donor’s genetic identity for possibly an undefined period of time.
It is precisely this two-faced nature289 that complicates the definition of the legal nature and qualification of a HBS, and consequently the possibility of it being shared and circulating in biobanking.
Indeed, as it has been pointed out, differently from the biological characteristics, the genetic traits of a person transcend the individual under both a spatial and a temporal dimension, because they are shared among all the people that pertain to a specific group or family and are inherited by the descendants.290 The informational nature of HBSs contributes then to the development of what has been authoritatively defined as the electronic body,291 which raises instances of protection that are different from those concerning the physical body.
As mentioned, the possible future application for research of HBSs considered now in this dual dimension raised new concerns that are related to the need to protect the person as a functional unit in which the body in its integrity and the samples that may be obtained from it are considered as a unicum worth of protection independently of their spatial location,292 and of their nature as samples (materiality) or data (information).
In this context, only the protection of the person in her entirety allows a full exercise of her fundamental right of self-determination.293 It is precisely the existence of this new permanent link between the samples (in their dual nature) and the person that calls into
288 Pacia, Romana “Xxxxxxxx Biologico e Consenso Informato nella Ricerca Genetica: il Possibile Ruolo delle Biobanche.”
289 Xxxxxxxxx, Xxxxxx “Proprietà, Informazione ed Interessi nella Disciplina delle Biobanche a Fini di Ricerca.” Nuova Giurisprudenza Civile Commentata, vol. 7-8, 2008, pp. 222-235.
290 Xxxxxxx, Xxxx Biobanche di Ricerca e Xxxxxx xxxxx Persona.
291 Xxxxxx, Xxxxxxx “Il Corpo “Giuridificato.” Trattato di Biodiritto. Il Governo del Corpo. Xxxx X, edited by Xxxxxxxxxx, Xxxxxxx, et al. Xxxxxxx, 2011, pp. 51-76.
292 Xxxxxx, Xxxxxxx, La Xxxx x xx Xxxxxx. Tra Diritto e non Diritto, Feltrinelli, 2018.
293 Ibid
question the possibility of granting participants extended control not only over their body but also over any parts separated from it and their possible future use in research.
From the dual nature of the HBS (material and informational), a double need for the protection of the human dignity of the person concerned arises. On the one hand, dignity declined as physical integrity, whenever the material dimension of the HBS is under scrutiny, and on the other as personal identity, if the processing concerns the personal (genetic) data extracted from the HBS.294
However, at the same time, HBSs and the related data are incredibly valuable resources for scientific research and as such the instances of individual protection should be balanced against the interests of society as a whole in the advancement of research, and ultimately -omic sciences and precision medicine. Indeed, granting participants full control would limit the possibility of researchers to freely use the HBSs for the research projects they consider valuable the most and fundamental for protecting and advancing collective health.
Therefore, the difficulties in finding a fair balance among the various instances at stake originate from the complexity of defining the legal qualification of HBSs and consequently the regime applicable to their collection and processing.
Both aspects, the legal qualification of HBSs and the regime applicable to their collection, influence the governance choice of the way of collecting them for biobank purposes. Indeed, the biobank should carefully evaluate the alternatives and balance the various and possibly contrasting interests and rights of participants on the one hand and society as a whole and scientific research on the other for lawfully conducting its activities and protecting participants’ trust.295
On the one hand in order to protect the individual rights possibly affected by the processing of the material part of the HBS, soft law instruments generally establish the duty to ask for the informed consent of the participant (interventional biobank or research consent). On the other hand, the informational nature of the HBS requires the interpreter
294 Xxxxxxxxx Xxxxxx, Xxxxxxx Xxxxx “Regolare le Biobanche tra Interessi Pubblici e Xxxxxxx: il Nodo dei Campioni Biologici”; Xxxxx, Xxxxxx “Xxxxxxxx Biologico e Consenso Informato nella Ricerca Genetica: Il Possibile Ruolo delle Biobanche.”
295 It is worth anticipating here that the protection of participants’ trust in the handling of HBSs is also included in Recommendation R(2016)6 in the Preamble: “Emphasising the importance of earning trust and stressing the role of good and transparent governance of biological materials of human origin stored for research purposes, including the establishment of an appropriate feedback policy.”
to consider the HBS also as personal data and comply with the norms provided for by the relevant national and supranational legislation on data protection. Therefore, it will be paramount to understand whether these requirements are cumulative or alternative.
To this end, in the following paragraphs, after having deeply analysed the requirements provided for by the applicable soft law instruments for the processing of biological samples, I will describe separately and in detail both the material and the informational nature. I will then present the issue to be addressed when deciding the model for collecting HBSs, namely whether the two natures of the samples should be addressed alternatively or cumulatively when choosing how to collect HBSs to be stored in a biobank and what is the relationship between the biobank and the participant in this regard. The answer to the question may be found only by considering the different rights and interests at stake in this type of collection.
2 RELEVANT CONCEPTUAL DISTINCTIONS AND SCOPE OF THE ANALYSIS
First of all, to delimit the scope of the analysis it is of paramount importance here to clarify a preliminary distinction. Indeed, one of the main characteristics of biobanks has been identified in the fact that these are collections of HBSs and data to be used for future research purposes (the purpose element of biobank, as described in Chapter I). In this regard, the biobank usually stands somewhat in between participants and researchers and provides various services, which include preserving a certain quality of the samples and data and regulating access by researchers.296
As a consequence, I believe in the necessity to separate the various purposes of the processing of the HBSs when it comes to identifying the requirements for their collection. Indeed, the collection and storage of the content of the biobank is an activity ontologically different from that of using the HBSs and data for research purposes and, to this end, should be subject to autonomous requirements, tailored on the selected rights and interests to be protected in a given scenario, and therefore on the specificities of the activity under consideration. Proceeding otherwise, and thus imposing on the sole biobanking activity (i.e. collection and storage of samples and data) the same requirements provided for
296 In a more limited number of cases, the biobank may also be the entity that directly conducts the future research projects, but as mentioned this scenario will not be directly taken into consideration.
research would mean duplicating the duties and responsibilities, even in cases where this would not be necessary for the protection of a specific fundamental right or interest, and possibly at the (unjustified) expenses of freedom of scientific research at large and thus society.
Therefore, the following analysis of the requirements for the collection of HBSs provided for by hard and soft law instruments will focus only on those related to the storage of the samples in the biobank for future research purposes and, for instance, I will not include any provision of hard or soft law instruments that requires consent for the use in a research project of the HBS or establishes specific requirements for scientific research,297 unless otherwise provided by hard law instruments or case law.
Another distinction should be kept in mind for the purposes of this Part A.
Samples are divided among left-over samples, donated samples and samples from deceased persons, with only the first two being relevant to the present work. As previously mentioned in Chapter I, the difference between the two rests on the fact that in the first case (left-over samples) the participant originally agreed to undergo a medical procedure or asked for medical assistance more generally, which resulted in the collection of one or more biological samples. Here, storing these HBSs in a biobank constitutes secondary use, i.e. a processing of the samples different from the one for which they were originally collected and, possibly, of which the participant was originally informed. The sample is then considered valuable for research and therefore qualifies for being stored in a biobank for future research use. In the second (donated samples), the participant consents to undergo a medical intervention with the sole purpose of collecting a biological sample to be stored in a research biobank.
As already mentioned and also extensively described in the following pages, collecting and storing biological samples in a biobank for future research purposes usually requires the consent of the participant, which in the biobanking context I have identified as interventional biobank consent. As previously highlighted, this consent is different from
● on the one hand, informational consent, which is relevant in the context of the collection, storage and use of personal data according to the GDPR (and further elaborated in Part B);
297 This approach will also be the one adopted for biobank data, in Part B.
● on the other, interventional research consent, which is usually asked for specific research projects. However, for both interventional consents (research and biobank) the participants had to previously consent to the medical procedure for collecting the biological sample (i.e. interventional consent).
Interventional consent was first introduced by the Nuremberg Code in 1947,298 and subsequently by most hard and soft law instruments at the supranational level,299 which provide for the duty of physicians and researchers to acquire specific informed consent to the medical procedure and for participating in the research project. Asking for the interventional consent of the participant represented the first step away from a paternalistic consideration of patients, according to which physicians were considered to know what was in the best medical interest of patients, and towards a more active role and participation of patients in the protection of their health.300
At the national level, providing interventional consent qualifies as a right according to articles 2, 13 and 32 paragraph 2 of the Italian Constitution, and it is provided for by other sectorial regulations such as Law No. 219/2017 entitled “Provisions for informed consent and advance treatment directives”.
Interventional consent has thus become an act both of legal and ethical-deontological relevance, at the national and supranational level, and “one of the primary principles on which the framework of protections for human subjects in research is built”.301 Similarly, the original aim of asking for interventional research consent is to respect the autonomy and physical integrity of the patient,302 in her decision on whether to undergo a medical procedure and participate in a research project that had a direct impact on her
298 Xxxxxxxx Xxxxxx, Xxxxxxx, and Xxxx, Xxxx “Informed Consent in International Normative Texts and Biobanking Policies: Seeking the Boundaries of Broad Consent.” Medical Law Journal, vol. 15, n. 4, 2015, pp. 216-245. For a deeper analysis of the origin of this consent, see Xxxxxxxxx, Xxxx, et al. “The Origins of Informed Consent: The International Scientific Commission on Medical War Crimes, and the Nuremberg Code.” Bulletin of the History of Medicine, vol. 75, no. 1, 2001, pp. 37-71; Xxxxxx, Xxxx X., et al. “Informed Consent in Biomedical Research.” Computational and Structural Biotechnology Journal, vol. 17, 2019, pp. 463-474; Xxxxxx, Xxxx X., and Xxxxx, X’Xxxx Rethinking Informed Consent in Bioethics, Cambridge University Press, 2007.
299 Among others, the Oviedo Convention; Declaration of Helsinki; CIOMS International Ethical Guidelines; UNESCO International Declaration; EU Charter of Fundamental Rights.
300 Fanni, Xxxxxx La Donazione dei Materiali Biologici Umani ai Xxxx xxxxx Ricerca Biomedica xxxx’Ambito del Diritto Internazionale e del Diritto dell’Unione Europea.
301 Xxxxxxx, Xxxxx A, et al. “A Modern History of Informed Consent and the Role of Key Information.”
Xxxxxxx Journal, vol. 21, 2021, pp. 81–85.
302 Xxxxxxxxx Xxxxxx, Xxxxxxx Xxxxx “Regolare le Biobanche tra Interessi Pubblici e Xxxxxxx: il Nodo dei Campioni Biologici.”
physical integrity and possibly health. For these reasons, the requirements applicable to this type of consent were particularly stringent especially as for the information to provide to the participant in order to ensure that her decision was really informed, based on a careful evaluation of all the characteristics of the concrete procedure or project and of the risks and benefits of her participation. Almost the same requirements are also applicable to research conducted on biological samples, even though no direct physical harm or risk to the person is envisioned.
However, as mentioned, this consent does not refer to the storage of the samples (both left-over and donated) in a biobank or their subsequent use for future research.303 Indeed, this decision requires a different manifestation of consent, i.e. the interventional biobank consent in the context of biobanking.304
Biobanking is a peculiar way of conducting research, understood in a broader sense, with different characteristics and risks if compared to the more traditional way of conducting research. Indeed, as will be further explained, on the one hand, biobanks process HBSs (and also data) for the purpose of making them available for future undefined research projects (and not for directly conducting one). Moreover, and also consequently, there is little or no harm possible to the physical integrity of the person, and the risks related specifically to biobanking activities are relatively low. Most of the risks, possibly to the self-determination of the participant, her genetic identity or right to data protection and privacy, are related to the future use of the HBSs by researchers, to whom the biobank granted access to the data but that are separated from it.
As a consequence, the interventional biobank consent, i.e. consent to the collection of the samples in order to store them in a biobank for future use, usually required by the soft law instruments analysed in detail in Chapter I and referred to in the next paragraphs, is conceptually different from the traditional interventional research consent, also and in particular because of the different risks posed by the two activities (research and biobanking).
303 Xxxxxxxxx, Xxxxxx “Reshaping Informed Consent in the Biobanking Context.” European Journal of Health Law, vol. 19, 2012, pp. 271-288.
304 Indeed, in this regard, Xxxxxxxx affirms that this “second” consent is the one that confers value to a biological sample that would otherwise be discarded, and therefore would not be the object of any right, proprietary or otherwise. Xxxxxxxx, Xxxxxxxxx, “A Pound of Man’s Flesh. Consenso alla Ricerca sui Tessuti Biologici Umani e Teoria dei Beni.”
However, through time interventional biobank consent has been conceptually developed from the traditional version of interventional research consent, i.e. the consent to participate in research on human subjects, also attempting to apply the same requirements. Only in limited cases the norms relevant on the matter have acknowledged the mentioned difference, especially in terms of the information to be provided to the subject when sking for consent.
In this specific context and referring to the various ways of collecting HBSs and data, it is important to underline that in Scenario 1 (where donated samples are collected), interventional biobank consent is the only type of consent required for the collection and storage in a biobank of HBSs. Such consent, as mentioned, includes not only the interventional consent necessary to authorise the medical procedure for the detachment of the sample but also that for further processing it for biobanking purposes. Both elements of the interventional biobank consent will probably be collected at the same time.
In Scenarios 2 and 3 (where for our purposes, left-over samples are collected), processing the HBSs for biobanking purposes is a secondary processing of samples previously collected for different purposes (and gain such collection had been authorised by the participant via the provision of the interventional consent). Consequently, in both Scenarios the consent to the medical procedure and for storing HBSs in the biobank might be asked separately, possibly after a long time and almost always by separate entities.
I will now analyse the specific requirements for the collection of HBSs in the biobanking context, as provided in the applicable framework described in Chapter I, and thus in the various hard and soft law instruments applicable to biobanking.
First of all, at the supranational level, the participant’s informational biobank consent is asked as a requirement by the Declaration of Taipei,305 which lists the information to be
305 When it comes to informed consent, paragraphs 11-19 of the Declaration of Taipei are relevant. as for the Declaration of Helsinki, consent is usually required for scientific research involving humans, and research with biological samples is only addressed in Paragraph 32 “For medical research using identifiable human material or data, such as research on material or data contained in biobanks or similar repositories, physicians must seek informed consent for its collection, storage and/or reuse. There may be exceptional
provided in order for this consent to be informed. In particular, paragraph 11 of the Declaration of Taipei clearly affirms that the specific, voluntary, free and informed consent of the participant shall be provided for the collection, storage and use of biological material.
In order for consent to be informed when biological materials are stored in the biobank for future undefined research uses, the participant should be adequately provided with the specific information listed in paragraph 12. Therefore, in this case, the Declaration of Taipei seems to acknowledge the specific characteristics of the biobanking field, as opposed to the more classical way of conducting scientific research, and thus in particular the fact that HBSs may be stored for future research purposes, which are undefined at the time of the collection and subsequently.306
In order to adequately protect the right to be informed of the participant, in this case, the Declaration adapts the information that the Declaration of Helsinki requires to be provided when asking for specific consent (rectius interventional research consent). Indeed, the information on the research project is substituted with corresponding information on the functioning or governance of the biobank. For instance, the risks and burdens to be informed about will be those of the process of collection and storage of the HBSs and not those associated with the research project. Moreover, the duty to inform about sources of funding and any possible conflicts of interest related to the project is substituted by information about the possible commercial use and benefit sharing, as well as intellectual property issues.
Finally, participants shall receive information about how their privacy is protected, their fundamental rights, and the consequences of their samples being made non-identifiable,
situations where consent would be impossible or impracticable to obtain for such research. In such situations, the research may be done only after consideration and approval of a research ethics committee.” However, as explained at the beginning of this Chapter, asking for consent to the research project (interventional research consent) is not the same as asking for biobanking purposes, i.e. to include the samples in the biobank for future use (interventional biobank consent). Indeed, the same Declaration of Taipei highlights such a difference when in paragraph 11 it establishes that “[t]he collection, storage and use of data and biological material from individuals capable of giving consent must be voluntary” but that “[i]f the data and biological material are collected for a given research project, the specific, free and informed consent of the participants must be obtained in accordance with the Declaration of Helsinki.” Emphasis added.
306 Chassang, Xxxxxxxx, and Xxxxxxxxxx, Real-Sebbag “Research Biobanks and Health Databases: The WMA Declaration of Taipei, Added Value to European Legislation (Soft and Hard Law)”; Xxxxxxxx, Xxxx “Broad Consent Under the GDPR: an Optimistic Perspective on a Bright Future.” Life Sciences, Society and Policy, vol. 16, n. 1, 2020.
in particular the fact that they might not be able to be aware of the various uses of their materials and to withdraw the provided consent.
Such consent may be withdrawn at any time, and therefore, the participant might ask for her samples not to be stored “for future use” anymore.307 This last specification, i.e. that withdrawing consent is only valid pro futuro and therefore ex nunc, enables researchers to complete ongoing research projects and avoid negative consequences on them.
Finally, the requirement of consent may be waived in exceptional circumstances, such as when “a clearly identified, serious and immediate threat” is identified and “anonymous data will not suffice”.308 Processing the samples for biobanking purposes in these circumstances would require a careful evaluation conducted by an independent ethics committee.309
Moreover, informational biobank consent is specifically required by the CIOMS International Ethical Guidelines, and may be waived by the research ethics committee if
(1) the research would not be feasible or practicable to carry out without the waiver;
(2) the research has important social value; and (3) the research poses no more than minimal risks to participants or to the group to which the participant belongs. Here, the Guidelines seem to acknowledge the possibility of balancing the rights of the participant and the interests of research and society at large. Indeed, a third impartial entity, the ethics committee, may evaluate whether the value of research for society is high enough to accept a certain degree of risk for the rights of participants at risk, which however shall be minimal. The Guidelines, however, further explain that such an option should not be feasible, among others, when controversial or high-impact techniques are used, when research is conducted on certain tissue types, for example gametes.
Moreover, OECD Recommendation 2009 establishes in principle 4.B the necessity for the operators of the biobank to acquire prior, free and informed consent. The information to be provided in this regard is related to the risks and benefits of the participation, and should interestingly cover not only the biological sample, but also the intended use and storage of the “data to be collected, data anticipated to be derived from the analysis of
307 Paragraph 15 of the Declaration of Taipei.
308 Paragraph 16 of the Declaration of Taipei.
309 in these terms, paragraph 32 of the Declaration of Helsinki and paragraph 16 of the Declaration of Taipei. In particular, according to paragraph 32 of the Declaration of Helsinki, this may be done when asking for consent is impractical. On the possible meanings of this term, see Xxxxxxxxxx, Xxxx JM, et al. “When is it impractical to ask informed consent? a systematic review.” Clinial trials, vol. 19, n. 5, 2022, pp. 545-560.
samples, and the health and other records to be accessed” (emphasis added).310 Therefore, the consent requested by the OECD Recommendation 2009 intends to cover not only the actual collection of samples and data, but also those data that might be possibly derived from the samples.
Differently from other instruments, OECD Recommendation 2009 addresses specifically the collection and processing for biobanking of left-over HBSs, and in this case if subsequent use of the HBSs was not envisaged at the time of the provision of the first interventional consent, the OECD Recommendation 2009 recommends asking for new consent, unless authorised otherwise by a research ethics committee or an appropriate authority, provided that adequate protection of the participant’s rights is ensured.311 In order to understand if re-consenting is necessary, it should be evaluated whether the new scopes and purposes are consistent with the original one and only in case of a negative answer re-contacting participants is required.312
For the consent to be informed, participants should in particular be aware of the possibility of withdrawing consent,313 how their samples and data will be protected,314 and be provided with extensive information on the functioning of the biobank and possible uses of their materials.315 In this case as well, information should be provided on the functioning of the biobank and not on the specific research project, thus tailoring the requirements applicable to interventional biobank consent to the specific context.
As far as the right to withdraw consent is concerned, paragraph 42 of the Annotations to the OECD Recommendation 2009 provides for the possibility of exercising it gradually. Indeed, the participant may decide not to be further contacted, but (a) to permit the continued retention and use of the already collected and stored samples and data, (b) to ask for the destruction or anonymisation of the samples and data, or (c) to ask specifically for their destruction (complete withdrawal). Finally, information should be provided to participants on possible limitations of such a right, i.e. when withdrawing is not possible,
310 Best practice 4.4 OECD Recommendation 2009.
311 Best practice 4.5 OECD Recommendation 2009.
312 Paragraph 33 of the Annotations to the OECD Recommendation 2009.
313 Best practice 4.13 OECD Recommendation 2009.
314 Principle 6.C OECD Recommendation 2009.
315 Paragraph 35 and 36 of the Annotations to the OECD Recommendation 2009.