Abstract
The potential use for research, under the General Data Protection Regulation (GDPR), of archived tissue specimens obtained in a diagnostic or therapeutic context is a topic of interest. This chapter explores the concept of an ‘archive’ and its legal implications in the context of the GDPR. While the GDPR provides limited definitions, European legislation refers to archives as records of historical or administrative value. In the medical field, archiving involves preserving diagnostic reports and related documents, including tissue specimens. The chapter discusses different types of archives, including historical and current ones, and their relevance to the use of biological material for research. Informed consent plays a crucial role in research biobanks, but consent for healthcare treatment does not necessarily cover consent for research purposes under the GDPR. The chapter examines the challenges of obtaining consent for the use of archived materials, particularly for historical archives where obtaining consent may be impractical or impossible. It also explores exceptions to the consent requirement under certain circumstances. The implications for current tissue archives and the conservation obligation are also discussed. Overall, the chapter provides insights into the potential uses of archived tissue specimens, and the legal considerations surrounding their use for research, under the GDPR.
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Notes
- 1.
See, for example, of Recommendation 4/2006 of the Council of Europe, Committee of Ministers Recommendation Rec(2006)4 of the Committee of Ministers to member states on research on biological materials of human origin and its Explanatory Memorandum, Article 21 entitled ‘General rule,’ with reference to the use of biological material in research projects.
- 2.
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) (Text with EEA relevance), O.J. 4.5.2016 L 119/1.
- 3.
And even in the previous Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data O.J. 23.11.1995 L 281/31.
- 4.
This term could literally be translated into the English term ‘archive’.
- 5.
Also in the previous legislation, the concept of ‘personal data filing system’ was, for example, translated to “archivio di dati personali” (Article 2(1)(c) Directive 95/46/EC) in the Italian version.
- 6.
On 10 July 2018, the Grand Chamber of the CJEU also ruled on the concept of ‘filing system’ in the Jehovan todistajat case, Case C- 25/17, Tietosuojavaltuutettu vs Jehovan todistajat — uskonnollinen yhdyskunta [2018] ECLI 551. The Grand Chamber ruled that there is a filing system: ‘if those data are structured according to specific criteria which, in practice, enable them to be easily retrieved for subsequent use. In order for such a set of data to fall within that concept, it is not necessary that they include data sheets, specific lists or other search methods’.
- 7.
See, for example, Council Regulation (EEC, Euratom) No 354/83 of 1 February 1983 concerning the opening to the public of the historical archives of the European Economic Community and the European Atomic Energy Community O.J. 15.2.1983 L 43/1, as last amended by the Council Regulation (EU) 2015/496 of 17 March 2015.
- 8.
Article 7 of Council Regulation (EEC, Euratom) No 354/83, referring to the establishment of historical archives, indeed says that ‘Each institution shall transfer to its historical archives all documents contained in their current archives no later than 15 years after their date of creation. According to the criteria laid down by each institution pursuant to Article 9, there shall be an initial sorting process with the purpose of separating documents that are to be preserved from those that have no administrative or historical value’.
- 9.
The authors actually make a tripartition of archives: current, deposit and historical.
- 10.
The European Commission has established the European Archives Group (EAG) with Council Recommendation 2005/835/EC on priority actions to increase cooperation in the field of archives in Europe of 14 November 2005 O.J. 29.11.2005 L 312/55. The ECG is composed of experts designated by the Member States and the institutions of the Union with the mission to ensure cooperation and coordination on general matters relating to archives. Within its attributions, the EAG has also developed guidelines for the implementation of the GDPR by archives services. https://ec.europa.eu/info/sites/default/files/eag_draft_guidelines_1_11_0.pdf.
- 11.
The 1964 Declaration of Helsinki ‘Ethical Principles for Medical Research Involving Human Subjects’ of the World Medical Association—available at https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/—as last amended in 2013, provides in Article 26 that: ‘In medical research involving human subjects capable of giving informed consent, each potential subject must be adequately informed of the aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and potential risks of the study and the discomfort it may entail, post-study provisions and any other relevant aspects of the study. The potential subject must be informed of the right to refuse to participate in the study or to withdraw consent to participate at any time without reprisal. Special attention should be given to the specific information needs of individual potential subjects as well as to the methods used to deliver the information. After ensuring that the potential subject has understood the information, the physician or another appropriately qualified individual must then seek the potential subject’s freely-given informed consent, preferably in writing. If the consent cannot be expressed in writing, the non-written consent must be formally documented and witnessed. All medical research subjects should be given the option of being informed about the general outcome and results of the study.’
- 12.
Informed consent relating to clinical trials on medicinal products for human use is governed by Article 29 of Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medical products for human use, and repealing Directive 2001/20/EC O.J. 27.5.2014 L 158/1. This Regulation, however, has as its scope that of clinical trials. In general, the establishment of biobanks does not imply any clinical trials as defined in Article 2 of the aforementioned Regulation, but the rules contained therein are applicable by analogy (where compatible) to this field.
- 13.
Article 9 of the Prime Ministerial Decree of 20 February 1984 stated that the minimum retention period for cytological and histological slides and paraffin inclusions was 5 years. However, the subsequent circular No. 61 of 19 December 1986 on the retention period of health documentation in public and private hospital and care institutions, stated a minimum period of 20 years for other diagnostic documentation, by analogy with the provisions on x-rays.
To resolve this conflict, the opinion of 14 October 1987 intervened, highlighting the third section of the Superior Health Council. In that opinion, the Italian Superior Health Council observed that: ‘only the histological diagnostic material (consisting of the preparation and its inclusion), regardless of the positivity or negativity of the report, is to be considered an integral part of the remaining diagnostic documentation as set out in circular no. 61 of 19.12.86, concerning the period of conservation of health documentation in public and private institutions of hospitalisation and care and therefore conserved for 20 years; considers that the directives expressed in circular no. 61 are extended to the provisions contained in the D.P.C.M. of 10.2.84 only for histological preparations and relative inclusions, that the cytological preparations must be retained for a period of 5 years.’
- 14.
According to Section 630f BGB, entitled ‘Documentation of treatment’, ‘(1)... the practitioner is obliged to keep medical records in paper or electronic form in direct temporal connection with the treatment. [...](3) The curator must retain the medical record for a period of 10 years after the end of the treatment, unless other retention periods exist in accordance with other provisions.’ Longer retention periods exist, for example, for records of treatment with radiation or x-rays pursuant to § 72 (1) no. 2b) in conjunction with § 85 (2) no. 1 StrlSchG (30 years) or for the use of blood products pursuant to § 14 (3) TFG (15 years or 30 years for certain data specified in § 14 (2) TFG). If the doctor does retain keep the medical records until the end of the retention period, they may have to prove in a possible medical liability case that they have actually taken the medically necessary measures (cf. 4.1.a.E. of the recommendation on professional secrecy, etc. 3 BGB). In this regard, possible liability actions can be asserted up to 30 years (pursuant to §§ 197 para. 1, 199 para. 2, para. 3 no. 2 BGB).
- 15.
Council of Europe, Committee of Ministers Recommendation CM/Rec(2016)6 of the Committee of Ministers to member States on research on biological materials of human origin.
- 16.
The ability to identify an individual using their anonymous genome sequence, using a clever algorithm and data from public databases, threatens the principle of subject confidentiality.
- 17.
Pursuant to section 13 of Biobank Act (law 688/2012), clinical and research samples that have been collected before the Biobank Act comes into force (i.e., September 1, 2013) can be transferred to a biobank as a result of a specific notification procedure and subsequent opt-out principle. On this point, see J. Nergelius’s national report on Finland in this handbook.
- 18.
It should be noted, however, that this framework could be modified if the EU directive, currently the subject of a proposal in the European Parliament for the establishment of the ‘European Health Data Space,’ were to be adopted. This proposal, among other things, aims to resolve the problems connected to the ‘secondary use of health data’ and to the fragmentation of the national policies on this point. The basic idea would seem to be that of ‘data altruism,’ which would allow health data to be used or re-used for research purposes in a more flexible manner.
- 19.
Particular reference is made to Article 2, entitled ‘Primacy of the human being’, which states that ‘The interest and welfare of the human being shall prevail over the sole interest of society or science’.
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Mirabile, A. (2023). Archived Tissue. In: Colcelli, V., Cippitani, R., Brochhausen-Delius, C., Arnold, R. (eds) GDPR Requirements for Biobanking Activities Across Europe. Springer, Cham. https://doi.org/10.1007/978-3-031-42944-6_6
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