Abstract
In response to the various questions that have arisen around the biobanking of human biological materials (HBMs) and information, two strategies have been adopted in the US and in Europe; these are distinguished by their respective focus on two main legal concepts: individual property rights and individual autonomy—or the right to privacy.
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Notes
- 1.
DHHS (2004): “No informed consent, whether oral or written, may include any exculpatory language through which the subject is made to waive or appear to waive any of the subject’s legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence.” 45 CFR 46.116. Examples of exculpatory language By agreeing to this use, you should understand that you will give up all claim to personal benefit from commercial or other use of these substances; I voluntarily and freely donate any and all blood, urine, and tissue samples to the U.S. Government and hereby relinquish all right, title, and interest to said items”.
- 2.
At the end of the 1990s the National Bioethics Advisory Committee (NBAC 1999), which was the first permanent ethics committee in the United States, was the first to clarify that only the samples that were originally unidentified remain that way once destined for research, while all samples identified at the moment they were taken, even if they were subsequently coded oranonymised, still maintain a certain level of re-identifiability. The NBAC thus unequivocably established that all identifiable materials and information are connected to a subject—and therefore must be treated according to the principles of research on subjects—and that only those that are totally anonymous from the start are pure data objects.
Section 45 of the Code of Federal Regulations (CFR, at 46.102(f)) from the 2004 guidelines of the US Department of Health and Human Services (DHHS) further reinforced the point, affirming that “to gain private identifiable information or biological samples identifiable for research purposes integrates the extremes of research on human subjects” (DHHS 2004).
The most recent proposals for standardisation of practices, for example that of the International Conference for Harmonisation between the United States, Europe and Japan (ICH 2007), have introduced a distinction between single coded and double coded samples—to be inserted between the definitions of coded and unlinked—in which codified materials are recodified and the two codes are then linked by a third code. The codes are entrusted to different subjects and, in order to re-identify the individual, it is necessary to possess all the codes.
- 3.
Moore v. Regents of University of California, Cal. App. 2 Dist. 1988; Regents of University of California v. Moore 51 Cal. 3d 1990.
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Lori Andrews cites on this matter: York v. Jones, 717 F. Supp. 421, 426 (E.D. Va. 1989), where “proprietary interest” was recognised for a couple for their own pre-embryos, thus limiting the powers of the clinic where the pre-embryos were deposited; Hecht v. Superior Court of Los Angeles County, 16 Cal. App. 4th 836, 850 (Cal. Ct. App. 1993), which recognised the inheritants’ ownership of the seminal liquid of the deceased; and Whaley v. County of Tuscola, 58 F. 3d 1111 (6th Cir. 1991), relative to the proprietary interests of a relative to the body of the deceased.
- 5.
EGE (1998, 8): “The information provided to the donor should concern:
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the procurement arrangements, in particular concerning the free nature of the donation, and the extent of its anonymity.
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possible tissue storage time and conditions, and conditions of registration of data in databases, in conformity with requirements of private life protection and medical confidentiality.
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foreseeable use of the tissues (diagnostic, allograft or autograft, pharmaceutical products, research, production of cellular lines for various uses, etc.). The donor may at any time withdraw her/his consent”.
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- 6.
Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004.
- 7.
DG Enterprise (2004, 6): “Ownership of the cells and tissues after donation: as legislation differs from one Member State to another, it is recommended that the regulation should provide clarity on this issue”.
- 8.
Rec(2006)4, Article 15—Right to change the scope of, or to withdraw, consent or authorisation—“(…) When identifiable biological materials are stored for research purposes only, the person who has withdrawn consent should have the right to have, in the manner foreseen by national law, the materials either destroyed or rendered unlinked anonymised”. And the Explanatory Report states at 73: “The individual has the right to withdraw from the research and the right to destruction of his/her biological materials and data. In the case where a person withdraws and the research has already generated findings, these findings ought to be rendered unlinked and anonymised, unless they have already been published or it is otherwise impossible to withdraw them from the research”.
- 9.
Hansson (2009, 9): “Making autonomous decisions in accordance with the Kantian tradition thus involves taking into account the well-being of others through a judgment of how one’s own decisions affect other people’s ability to act in a morally responsible way and to attain their own goals. Autonomy in the Kantian tradition is inherently social, with the implication that the working out of legal protections for self-determination and privacy in association with biobank research must simultaneously do justice to both the research subject’s independence and to this individual’s dependence on others for fulfilling mutual interests such as new biomedical knowledge and new treatment opportunities”.
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Tallacchini, M. (2015). A Participatory Space Beyond the “Autonomy Versus Property” Dichotomy. In: Mascalzoni, D. (eds) Ethics, Law and Governance of Biobanking. The International Library of Ethics, Law and Technology, vol 14. Springer, Dordrecht. https://doi.org/10.1007/978-94-017-9573-9_3
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