Abstract
The debate about the requirements of informed consent in research biobanks has been heated in the last few years. This debate originates from the peculiarity that characterises the condition of tissue stored in a biobank. Unlike in the traditional research setting, tissue stored in a biobank is not only collected for a specific research project but for an undetermined future research projects as well. Therefore, it appears difficult to inform the person (from whom tissue is obtained) about all possible research projects in which tissue could be used. Against this backdrop, the ethical and legal scholarship has started to explore if “less informed” consent models could be considered legally and ethically acceptable in the research biobank context. Many models have been proposed. The range varies from fully informed consent to blanket-consent models, passing through partially restricted consent, and the so-called broad-consent models. In these models, it is not only the “level” of information that changes, but also the aims of the informational process. In the model of “fully informed consent”, the core of the informational process is represented by the specific research project, while in the “broad-consent model”, the information provided aims to illustrate the features of the “governance” of the biobank where tissue is stored. Therefore, from consent on the specific research project, we are moving towards consent on a model of governance.
To determine whether this switch can be legally acceptable, it is crucial to analyse the peculiar interests (legally recognised) at stake, in order to identify if a “broader” consent is also adequate to protect the rights of the person involved. In this contribution, I argue that tissue can be viewed via three different dimensions. Firstly, tissue represents a material res that “occupies a space” and has its own consistency. From this point of view, the main issue is to determine if this res can be owned, who assumes its ownership, and more broadly who maintains its control. Second, human tissue can be seen as a source of data, and in particular of genetic data. In this case, the crucial issue is to establish the rights of a person on the data obtained from tissue. It is likewise necessary to establish if the person has the right to consent for the use of these data in biobanking, if they can limit the access to these data, and if they can withdraw their consent. Eventually, it is also necessary to establish the effects of the withdrawal of such consent on the data and tissue. Third, human tissue derives from the human body. The distinction between these three dimensions (that we will call “material”, “informational” and “relational”) is only theoretical, given that in nature these three dimensions of human tissue are inextricably linked to one another and the bundles of rights originated from them overlap. Therefore, to understand the rights of the human subjects, it is not sufficient to study the characteristics of these three dimensions but it is also necessary to analyse how these dimensions are related to each other.
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Notes
- 1.
- 2.
The list is not exhaustive, and in some cases, the same model is differently named.
- 3.
See, Cribbet (1986). Cribbet contends that the question “What is property?” is unanswerable. The problem arises because the legal meaning of “property” is quite different from the common meaning of the term. The ordinary person defines property as things, while the attorney views property as rights.
- 4.
The first proposal was put forward by Sidgwick (1891), p. 70. For the Author, the three components of ownership were, the right of exclusive use, the right to destroy, and the right to alienate. Today, Sidgwick’s analysis is rarely referred to. The most influential analysis is instead Tony Honore’s list of eleven types of legal relations that he considers to be the major components of full liberal types of ownership (Honoré 1961): (a) the right to possess; (b) the right to use; (c) the right to manage; (d) the right to income; (e) the right to capital; (f) the right to security; (g) the incident of transmissibility; (h) the incident of absence of term; (i) the duty to prevent harm; (j) liability to execution; and (k) residuary character. Several scholars have proposed modifications of Honore’s analysis. Lawrence Becker extended the Honoré list with thirteen, instead of 11, components (Becker 1980, p. 187). In particular, he added the right to consume or destroy the object in question, the right to modify it, the right (power) to alienate it through donation, exchange or abandonment. One problem with this approach is that it may pose difficulties in determining which bundles constitute ownership. Most cases of property rights in modern society do not include all types of relations. Honoré’s approach to this problem was to apply Wittgenstein’s notion of “family likeness”. Honoré affirms that “The listed incidents (the 11 components), though they may be together sufficient, are not individually a necessary condition for the person of inherence to be designated the owner of a particular thing”. For an evaluation of the consequence of these theories on property over human tissue, see Bjorkman and Hansson (2006), p. 209.
- 5.
In this theory, there is the replacement of the concept of the “subjective right” with the concept of “juridical relationship”. See Waldron (1985), p. 314. The author provides this easy example to explain this concept “Why has private property been thought indefinable? Consider the relation between a person (call her Susan) and an object—say, a motor car—generally taken to be her private property. The layman thinks of this as a two-place relation of ownership between a person and a thing: Susan owns that Porsche. However, the lawyer tells us that legal relations cannot exist between people and Porsches, because Porsches cannot have rights or duties or be bound by or recognise rules. The legal relation involved must be a relation between persons—between Susan and her neighbours, say, or Susan and the police, or Susan and everyone else”.
- 6.
For the historical reconstruction of the term “ownership”, see Smith (1976), p. 214.
- 7.
See Hoppe (2009), p. 48.
- 8.
See above n. 9.
- 9.
Jonathan Yearworth and others v. North Bristol NHS Trust [2009] EWCA Civ 37. See Quigley (2009).
- 10.
Doodeward v. Spence, High Court of Australia, (1908) 6 CLR 406.
- 11.
Dobson v. North Tyneside Health Authority and Another, [1997] 1 WLR 596. In carrying out a post mortem examination on a woman who had died of a brain tumour, a pathologist removed her brain and fixed it in paraffin pending possible further examination, which in fact was never conducted. The brain was delivered to D2’s hospital for storage. The rest of the woman’s body was buried. Two years later, the next of kin sought to examine the brain to secure evidence in support of their action in negligence case against D1. The brain could not be found so they sued D2 for having destroyed or mislaid it. Their appeal against the dismissal of their action against D2 was likewise dismissed.
- 12.
R. v. Kelly and Lindsay [1999] Q.B. 621.
- 13.
See, Goold (2005), p. 3. The Author has conducted a detailed analysis about the possibility of applying the category of “property rights” to human tissue. The Author concludes that, “there are rather fewer practical legal problems with using property law to regulate human tissue than has perhaps been generally considered. The analysis of the concept of property has demonstrated that human tissue is aptly suited to having property status, and that the various property rights, such as rights to use, to possess, to manage and to the income can almost all be applied to tissue without legal absurdity”.
- 14.
Moore v. Regents of the University of California, 793 P.2d 479 (Cal. 1990).
- 15.
Washington University v. William J. Catalona, U.S. Court of Appeals, 8th Circuit: 490 F 3d 667.
- 16.
Washington University v. William J. Catalona, M.D., United States District Court Eastern District of Missouri Eastern Division, No. 4:03CV1065, E. Dist. Mo. 14 April 2006.
- 17.
For an analysis of the meaning of the “genetic gift” and the possible inconsistencies between this concept and current regulatory views on property in the UK see, Kanellopoulou (2009), p. 36.
- 18.
This theory is widespread not only in the Italian legal system but also in other systems, both in common law and civil law traditions. See, Whitty (2005), p. 199. The author suggests that the detachment of biological materials is a sufficient act to create property rights.
In the common law context see also: Hammond (2002), p. 113; Dworkin and Kennedy (1993), p. 311; Dickens ( 1977 ), p. 183.
- 19.
See, Hardcastle (2007 ), p. 146.
- 20.
Criscuoli (1985), p. 271.
- 21.
As the recent Myriad case showed (United District Court for the Southern District of New York, Association for Molecular Pathology, et al. v. United States Patent and Trademark Office, 09 Civ. 4515, 29 March 2010), the distinction has become relevant even in the case of patentability of DNA. Judge Sweet upheld the idea that DNA has a dual nature: it has a chemical form, but its value lies primarily in the information which it encodes. The Judge held that, as the value of the DNA was primarily informational, and as the information was the same in isolated and natural form, then the substance in question did not have markedly different characteristics and as a result was not patentable. See Hawkins (2010), p. 457.
- 22.
From a descriptive point of view, the double relationship between individuals and their tissues and between individuals and the information related to the samples shares the same scheme. They follow the legal scheme known in the European Continental legal tradition as “subjective rights” (droits subjectifs; subjektives Rechten), a scheme that implies a subject of right and an object of right and both describe a relation of “belonging” (the term “belonging” is proposed here to describe a relationship that includes all possible relationships between a person and their samples. In the Italian literature, the word used to define this relationship is “appartenenza”). However, there is a multitude of different levels of “belonging”, which could be represented as a planetary nebula (see Zatti 2007, p. 3). The legal concept of property, as derived in all continental legal systems from the Roman tradition, would be on the edge of this nebula: in the typical property relationship, it is implied and presupposed that owner and owned object are separate entities. One finds the highest level of “belonging” when the idea of separateness is absent, and the owner and the owned object are indistinguishable. This is also the case of “personality rights”, which are not distinguishable from the individual who holds the rights. In this view, the protection of personal identity, for instance—a typical personality right—is not a right that can be evaluated without considering the person to whom dignity refers. The two elements are inextricably linked to one another.
- 23.
- 24.
The category of personality rights (Persönlichkeitsrechte) appeared in the German legal tradition thanks to Karl Gareis, Otto Friedrich von Gierke, and Joseph Kohler who first elaborated the theory of personality.
- 25.
This legal concept is shaped by the traditional idea of property, which implies an owner of rights who is an entity clearly separate from the object of the rights that the latter owns. See, Coing et al. ( 1959).
- 26.
Even though common law systems do not recognise “personality rights”, despite their widespread recognition in civil law systems, the relationship between the person and his/her personal information is generally not considered a property relationship in common law systems. In English law, the question as to whether personal information is capable of a proprietary characterisation is not settled and English Courts seem to reject the idea that the relationship between the person and his personal information could be classified as property. The reason is clearly explained by Paul Stanley who notes that “English law does not impose duties upon people with respect to confidential information because it recognises some particular relationship between claimant and the information (a right in rem) which requires protection against strangers. Rather it imposes duties between individuals (rights in personam) whose consequence is to protect information”. See Stanley (2008), p. 149.
- 27.
Clearly, this reasoning represents a general approach. Concretely, to establish in which manner personal data are capable of describing something about us, it is necessary to analyse the quality of the data case by case.
- 28.
McCarthy (2005), § 5.59. See also, Solove (2006), p. 477. In this essay the author contends that “[P]rivacy problems are frequently misconstrued or inconsistently recognized in the law” and “[T]he concept of ‘privacy’ is far too vague to guide adjudication and lawmaking”. For this reason, he proposes an interesting framework for how the legal system can come to a better understanding of privacy, through a taxonomy that focuses on the different activities that impinge upon privacy.
- 29.
See Whitman (2004), p. 1160. The Author asserts that “At its conceptual core, the American right to privacy still takes much the form that it took in the eighteenth century: It is the right to freedom from intrusions by the state, especially in one’s own home”. In Europe, the core of privacy protection is the dignity of the person.
- 30.
See Warren and Brandeis (1980), p. 193.
- 31.
See Solove (2002), p. 1087. In this essay, Solove argues that privacy is too complicated a concept to be boiled down to a single essence. Privacy can be best understood as a “family resemblance”-based concept. Solove takes this concept from the philosopher Ludwig Wittgenstein, who affirms that certain things may not share one common characteristic, but they are nevertheless related to one another in different ways. Wittgenstein compared this to members of a family who generally share some traits with each other (eye colour, height, facial structure, hair colour, etc.) although they may not have one common trait. See Wittgenstein ( 1958 ), § 65.
- 32.
See BeVier (1988), p. 455.
- 33.
By virtue of article 6 of the “Lisbon Treaty”, the “Charter of Fundamental Rights of the European Union” has the same legal value as the Treaties. It is important to highlight that the Charter has limited effect in Poland and the UK by virtue of the “Protocol on the application of the Charter of Fundamental Rights of the European Union to Poland and to the United Kingdom”.
- 34.
See Art. 29 Data Protection Working Party 2011. The Working Party contends that “the notion of consent is traditionally linked with the idea that the data subject should be in control of the use that is being made of his data. From a fundamental rights perspective, control exercised through consent is an important concept. At the same time, and from the same perspective, an individual’s decision to accept a data processing operation should be subject to rigorous requirements, particularly taking into account that in doing so, an individual may be waiving a fundamental right”.
- 35.
The term “informational self-determination” was first used by the German Federal Court Constitution in the Judgment/ BVerfGE 65, 1, at para. 154 of 15 December 1983. The Court stated that under Articles 1 and 2 of the Grundgesetz, an individual has “the authority to decide for himself, on the basis of the idea of self-determination, when and within what limits facts about his personal life shall be disclosed.” See, Kommers (1997), p. 324. See also, the Spanish Constitutional Court Judgments/SSTC 290/2000 and 292/2000, of 30 November 2000. In particular, the Spanish Constitutional Court Judgment 292/2000 recognised for the first time the right to the protection of personal data as an autonomous right. See also the Italian Code for Person Data Protection (Legislative Decree 196/2003). See also Art. 29 Data Protection Working Party 2011, which affirms that “Consent is related to the idea of informational self determination. The autonomy of the person is both a pre-condition and a consequence of consent: it gives the data subject influence over the processing of data”.
- 36.
Art. 4 of the Declaration declares that human genetic data have a special status because (i) they can be predictive of genetic predispositions concerning individuals; (ii) they may have a significant impact on the family, including offspring, extending over generations, and in some instances on the whole group to which the person concerned belongs; (iii) they may contain information the significance of which is not necessarily known at the time of the collection of the biological samples; and (iv) they may have cultural significance for persons or groups.
- 37.
- 38.
See Laurie (2002), p. 302. Previous scholars alluded to that nature when maintaining that “the moral significance of body parts remains even when they are separated from their original source”.
- 39.
See, Kirchhoffer and Dierickx ( 2011 ), p. 5. The Authors underline that “even if the samples are anonymised, human dignity is still implicated”.
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This article has been developed in the project “Trentino-PCOFUND-GA-2008-226070” granted by Autonomous Province of Trento and the European Commission.
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Macilotti, M. (2013). Informed Consent and Research Biobanks: A Challenge in Three Dimensions. In: Pascuzzi, G., Izzo, U., Macilotti, M. (eds) Comparative Issues in the Governance of Research Biobanks. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-33116-9_9
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