This section reviews a number of international normative instruments that are relevant for access to biobanks. The documents were selected after a review of the BBMRI report “Biobanks and the public: Governing biomedical research resources in Europe”(124) and an overview article of A. Cambon- Thomson et. al. describing trends in the ethical and legal framework for the use of human biobanks(23):
1. The Universal Declaration of Human Rights, proclaimed by the United Nations General Assembly in Paris on 10 December 1948.
2. The World Medical Association Declaration of Helsinki71 entitled “Ethical Principles for Medical Research Involving Human Subjects72” (hereafter the “Helsinki Declaration”). The Helsinki Declaration contains ethical principles for medical research involving human subjects, including research on identifiable human material and data (§ 1).
3. The UNESCO Universal Declaration of 1997 on the Human Genome and Human Rights (hereafter UNESCO declaration)
4. The OECD Guidelines for Human Biobanks and Genetic Research Databases (2009) (hereafter “OECD Guidelines”)
5. Recommendation of the European Society of Human Genetics, entitled “Data Storage and DNA Banking for Biomedical Research: Technical, Ethical and Social Issues” (2001) (hereafter ESHG Recommendation).
These international normative instruments do not have a binding legal force (except for the Universal Declaration of Human Rights), but they do have an important moral value.
The description and evaluation of the international normative instruments was conducted taken into account the “key access conditions.”
71 The declaration has been adopted by the 18th WMA General Assembly in Helsinki (Finland) in June 1964 and has been amended at several occasions. The last amendments have been adopted by the 64th WMA General Assembly in Fortaleza (Brazil) in October 2013
72 The declaration has been updated on several occasions and the most recent version dates from 2013:
Page | 89 4.1.1 Aims, activities and policies of biobanks
Several international normative instruments suggest that an independent Research Ethics Committee (REC) should review the establishment, governance, management, operation, access to, and use of biobanks and its protocols and processes for research activities (best practice 1.2 OECD Guidelines; see also § 19 ESHG Recommendation).
4.1.2 Custodianship
Custodians of biobanks should develop and maintain clearly documented operating procedures and policies for the procurement, collection, labelling, registration, processing, storage, tracking, retrieval, transfer, use and destruction of HBM, data and/or information (principle 1.F OECD Guidelines). 4.1.3 Evaluation of requests for access to HBM and data for research purposes
The international normative instruments contain an important number of rights and obligations in relation to how access requests should be evaluated.
The custodian should make the access policy and procedures publicly available (best practice 7.1 OECD Guidelines). He should create mechanism to review applications for access to HBM and/or data and the envisaged use of the HBM and/or data for consistency with the types of research uses agreed to by a participant (best practice 7.2-3 OECD Guidelines).
Access to HBM and data should be based on objective and clearly articulated criteria. It should be consistent with the research subjects’ informed consent (principle 7.A. OECD Guidelines; see also § 21 ESHG Recommendation). The custodian of HBM should formulate criteria for prioritizing applications for access to HBM and data (principle 7.E. OECD Guidelines).
The custodian of a biobank has to ensure that any stratified access conditions and fees are fair, transparent and do not inhibit research (best practice 7.4 OECD Guidelines). The conditions of access of researchers to HBM and data should be set out in a material transfer agreement or another appropriate agreement (best practice 7.6 OECD Guidelines).
The researcher should draft a research protocol that describes and justifies the design and performance of the research study. The protocol should furthermore contain information about the funding and/or sponsors of the project, the institutional affiliations of the researcher, potential conflicts of interest, incentives provided to research subjects and information relating to the treatment and compensation of research subject who suffered harm due to the participation in the research study (§22 Helsinki Declaration; see also principle 7.B OECD Guidelines).
Each research protocol and amendments to such protocol have to be submitted for approval to a REC. (§23 Helsinki Declaration; see also art. 5 d) and 16 UNESCO Declaration). Such REC must act in a transparent and independent way and must be duly qualified. The REC can monitor on-going research project (§23 Helsinki Declaration; see also best practice 3.3 OECD Guidelines).
Page | 90
4.1.4 Intellectual property and commercialization
Custodians of biobanks should develop a clearly articulated policy on (i) the commercialization of HBM, associated data and research results and (ii) intellectual property rights (principle 9.D-E OECD Guidelines).
It is generally accepted that the donation, collection and provision of HBM and associated data, as such, should not give rise to any financial gain (125,126). Article 4 of the UNESCO Declaration stipulates in this respect “the human genome in its natural state shall not give rise to financial gains.” 4.1.5 Sharing in the advancement of scientific research and its benefits
Article 27 § 1 of the Universal Declaration of Human Rights states that “everyone has the right (…) to share in scientific advancement and its benefits” (see also art. 12 (a) of the UNESCO declaration and principle 9.B OECD Guidelines).
The best practice 9.1 of the OECD Guidelines stipulates that the custodians of a biobank should develop a clearly articulated policy on benefit sharing.
4.1.6 Sharing and returning of research results
Several international documents promote the sharing of research results with others researcher and the community at large, such as the ‘Bermuda Principles’ (1996)(115), the Fort Lauderdale Agreement (2003)(117), the Toronto Statement on Pre-publication Data Sharing (2009), and the Global Alliance for Genomics and Health’s White Paper (2013)(118).
The Helsinki Declaration and the OECD Guidelines equally address the sharing and returning of research results. Both international normative documents provide that researchers – together with sponsors, editors, publishers and custodians of biobanks – have an ethical obligation to publish and disseminate the results of research studies. Researchers should publish or make available in other ways both positive, negative and inclusive research results. (§35 Helsinki Declaration; see also principle 1.H of the OECD guidelines).
The OECD Guidelines furthermore suggest that custodians of biobanks should have a clearly articulated policy on whether and how the results of research and analyses carried out using HBM and data stored in biobanks should be returned to the biobank and be incorporated into its databases. They should also clearly articulate how access to such results for further research will be managed (principle 5.C OECD Guidelines).
4.1.7 Protection of personal data
Every precaution has to be taken to protect the privacy of the research subjects and the confidentiality of their personal information (§24 Helsinki Declaration; see also principle 1.D OECD Guidelines). 4.1.8 Consent
The international normative instruments contain several principles in relation to the requirement to obtain the informed consent of the donor for the use of his HBM and data for research purposes.
Page | 91 Paragraph 32 of the Helsinki Declaration formulates the general principle that one should seek informed consent for its collection, storage and reuse, when identifiable HBM or data is used in a research project. In case seeking such consent would be impossible or impracticable, the study may be done only after consideration and approval of a REC (see also best practice 3.1 OECD Guidelines and § 12 ESHG Recommendation).
The custodian of a biobank should inform donors of their right to withdraw. Donors should be informed of the nature, modalities, implications and limits to exercise that right. The donors in principles do not have to explain their withdrawal. The withdrawal should not have any negative consequences for the donors or their family in regards to the provision of healthcare services (principle 4.G. and best practice 4.13 OECD Guidelines; see also § 7 of ESHG Recommendation).
4.1.9 Balancing the rights and interests of the donor with the freedom of research
Paragraph 8 of the Helsinki Declaration provides that ‘medical research cannot take precedence over the rights and interests of the research subject/donor’ (see also art. 10 UNESCO Declaration and principle 3.C OECD Guidelines). This is an important principle, since it draws the attention to the fact that the rights of donors should be respected at any time. The principle is however not absolute and has to be weighed against other principles, such as the ‘freedom of research’. Article 12 (b) of the UNESCO Declaration stipulates that the freedom of research “is necessary for the progress of
knowledge” and even declares that such freedom “is part of freedom of thought.”
The legal framework applicable to biobanks should aim to balance both principles. On the one hand, the interests of the donors should be protected in an optimal manner. On the other hand, one should not unnecessary hinder the possibility to use HBM and data in research projects. The optimal balance between both principles cannot be determined in a general way. Such balance can only be determined in each specific situation. One could refer in this respect to the fact that several international normative instruments – such as paragraph 32 of the Helsinki Declaration – require an informed consent of the donor for the use of his HBM and data for research purposes. However, the REC can authorize researchers to use the HBM and data without an informed consent, when it would be impracticable to obtain such consent.
Page | 92
5 Recommendation 2006 (4) of the Council of Europe