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Chalmers, Don --- "Privacy and Biobank Research: Weighing Private and Public Interests" [2006] JlLawInfoSci 3; (2006) 17 Journal of Law, Information and Science 32

Privacy and Biobank Research: Weighing Private and Public Interests

PROFESSOR DON CHALMERS*

1. Introduction: Privacy and Biobanking

Research efforts in the computer industry, in general, and bio-informatics, in particular have concentrated on developing specific privacy enhancement technologies (PETs) to protect personal privacy, prevent unauthorised access to this information and, most importantly, to enable authorised access to information. In the 1970s and 1980s, the informatics era was accompanied by public concerns about telecommunications and the security of personal information held by governments, banks and other credit organisations. These concerns were to the forefront in the introduction of the Commonwealth Privacy Act in 1988.[1]

By the 1990s, privacy concerns extended to electronic record linkage of personal health information in general and genetic information in particular. Developments in bio-informatics have facilitated the linkage of personal information with individual health records. The protection of privacy of genetic information was the driver behind the joint Australian Law Reform Commission and Australian Health Ethics Committee Report, Essentially Yours[2] that examined protection of personal genetic information privacy in genetic testing, health service delivery, insurance, employment, law enforcement and parentage testing. Genetic research has aroused specific concerns centred on privacy. The modern ‘genome era’[3] has seen a rise in community concerns about the potential for personal genetic information to be disclosed to others, such as insurance companies or employers, to the detriment of not only the research participant but also the family members that share the participant’s genetic profile.

A significant feature of the genome era is the creation and use of massive genetic data sets, of which the sequencing of the DNA of the human genome, published in 2001[4] is an example. The scientific effort has moved from sequencing to translating these massive genetic data into a new generation of diagnostic and therapeutic products. These data sets and the equally massive tests and analyses that create them are computer automated.[5] These data are banked, hence the neologism, ‘biobanks’ and are rich resources for gene studies. With data-linkage biobanks provide myriad research opportunities. Data-linkage is enabling researchers to conduct research, in a manner inconceivable as little as a decade ago. Researchers are involved in data-linkage for population health research and epidemiological studies within national and international collaborations.[6] Clearly, data linkage arouses concerns about privacy and the ethical motivation and conduct of such work.

This article examines privacy in the light of the development of biobanks and cross-border collaborations.[7] Biobanks will facilitate genomic research but this must be balanced with the protection of the welfare and privacy of the biobank sample contributors.[8]

Unsurprisingly, the regulation of biobanking has, or is being considered in a number of countries by a range of research or regulatory organisations.[9]

2. What Kind of Biobanks? New Research Paradigms in Human Genetics

The term ‘biobank’ evokes images of human tissue and deposits, withdrawals and investment. Such images are not inaccurate. In the same image, the Estonian Genome Project uses the term ‘genebank’. The term ‘biobank’ is largely synonymous with the term human genetic research database. The OECD[10] generally uses the term ‘genetic databases’ or ‘Human Genetic Research Databases (HGRDs)’ rather than biobanks to describe large-scale collections of human tissue (the Latvian Genome Project has used ‘genome database’).[11] However, the term ‘biobanks’ may sometimes be used to refer to specially established tissue research banks.[12] Biobanks[13] are rich sources for genetics researchers, offering opportunities for medical and health research. The key ingredient of a biobank is the storage of human tissue and data for research purposes.

Biobanks are seen as essential tools for biomedical research to achieve improvements in health care. The German National Ethics Council[14] has noted the potential of biobanks for the identification of causes of disease and for breakthroughs in medical and pharmaceutical research. Biobank represents a significant break from the past by enabling research to be conducted on a grand scale, involving whole populations (with the neologism ‘epigenetic’) rather than individual participants or defined cohorts. Many pharmaceutical companies operate databases for better participant recruitment, minimisation of side effects and better results. However, this optimism is checked by concerns about civil liberties and privacy. So, the German National Ethics Committee has recognised biobanks may arouse ‘anxiety and distrust’ and that donors may also fear ‘… the uncontrolled use of specimens and data, together with the possibility that [they] might be pressurised into assuming unreasonable risks or imprudently divulging personal information’.[15]

Biobanks should be differentiated from other collections of human data and tissue, such as genetic registers[16] of personal and family genetic information and forensic DNA banks, which are established primarily to assist police in criminal investigations and prosecutions.[17] Biobanks should also be differentiated from collections of human tissue developed primarily for clinical and diagnostic purposes (with research a secondary purpose only),[18] such as archived pathology tissue samples; specialist hospital and clinic research collections eg cancer tissue for research;[19] newborn screening tests (Guthrie cards); blood banks, including umbilical cord blood; and stem cell banks.

Some biobanks have been established with a clear international focus, such as the International Haplotype Mapping Project,[20] the Howard University, National Human Genome Centre, African diaspora TgRIAD project to study diseases common amongst African-Americans and other populations of Africa and the Caribbean and the Public Population Project in Genomics (P3G).[21] Biobanks established at the national level include;[22] the Danubian Biobank Foundation (involving six countries in Central Europe); the Karolinska Institutet and LifeGen (both in Sweden)[23]; CARTaGENE (Quebec); the National Heart, Lung and Blood Institute (NIH, USA); the Centre for Integrated Genomic Medical Research (Manchester UK). At the national level, DeCode[24] (Iceland) was the pioneer program that has been followed by GenomEUtwin (Finland); Estonian Genome;[25] KORA-GEN (Germany);); INMEGEN (Mexico); LifeLines (Netherlands); and Biobank (UK)[26] that will enrol some 500,000 recruits. The National Research Council of the USA has even gone on record to suggest the establishment of a worldwide collection of DNA.[27]

There have been some interesting biobanking developments in Australia.[28] Around 2000, a private company, Autogen tried unsuccessfully, with adverse media publicity,[29] to establish a database in the Polynesian kingdom of Tonga. The Western Australia Genetic Health Project aims to enrol most of the State’s population by linking public health records, research databases and a prospective collection of tissue samples. A similar initiative has been reactivated in Tasmania under the leadership of the Menzies Centre for Public Health Research. In Victoria, the Peter McCallum Cancer Institute tissue bank, established in 1998, has links to other cancer clinics. The Queensland Medical Research has a major research effort based on its collection of genetic samples from twins. Finally, the voluntary, not-for-profit Australasian Biospecimen Network is developing standardisation advice[30] on the collection, handling, storage, processing, access and use of samples to avoid human or process error.

3. What are the Unique Challenges of Biobank Research to Privacy?

Biobanks have the potential to pose significant privacy and data protection challenges, particularly, because of long-term data storage. First, tissue (and data derived) collected for one purpose may be used for other future undefined research. In this respect, the German National Ethics Council and the French National Consultative Ethics Committee for Health and Life Sciences produced a joint Declaration highlighting the risk of data/samples being used for ‘purposes other than those for which the donor has consented or to be passed on to third parties’.[31] Secondly, research on biobanked samples and data may involve collaborations and partnerships between public and private institutions, raising concerns about the continuing ‘heavy degree of commercialisation of [medical and genetic] research’.[32] Thirdly, the relative risk involved in dealings with biobank samples/data depends largely on the identifiability of the data.[33] Invariably, tissue samples will be coded, rather than anonymised, making the samples potentially re-identifiable. However, complete de-identification is unrealistic as researchers may require follow up with participants, for example in disease identification studies. Finally, during the extensive public consultations undertaken by the Australian Law Reform Commission in its enquiry on the protection of human genetic information,[34] concerns were expressed about the security of databases from hacking and improper use.

4. Privacy Regulation

Privacy of personal information is an accepted legal and ethical principle. Countries with constitutional guarantees to the right to privacy[35] do not make this right absolute, but subject to exceptions and conditions determined by law.[36] In addition, these constitutional rights to privacy, for historical reasons, usually apply to privacy of communications and not specifically to biobanks.[37] Importantly, it has been recognised that complete guarantees of individual privacy are unrealistic. Equally, in health research, there has to be an effective balance between individual interests in privacy with the public interest in promoting high quality public health research.

Privacy legislation in many countries is based on the influential OECD Information Privacy Principles published in 1980. These principles[38] brought a measure of consistency to the national approaches to privacy by setting standards for the collection, storage, release, access and accountability for personal information. Later European Union (EU) privacy directives, particularly the Directive on data protection on trans-border data flow[39] maintained this principled approach. Australia adopted the OECD Guidelines on the Protection of Privacy and Transborder Flows of Personal Data Guidelines. In Australia, the Commonwealth Privacy Act 1988 introduced Information Privacy Principles (IPPs), covering these principles, but these principles were limited to information held by federal agencies. The remit of this Act was extended significantly by the introduction of National Privacy Principles governing private sector privacy.

Privacy law, though complex, is developing reasonably consistently internationally. European nations have generally introduced personal data protection legislation that has been updated to make it consistent with the EU Data Protection Directive (95/46/EC).[40] The two major North American nations have complex data protection arising from their federal arrangements.[41] The same applies to Australian federal privacy laws[42]. Asian countries also have introduced data protection by legislation.[43]

The Privacy Act 1988 Information Privacy Principles have direct relevance to the regulation of research generally and biobanks, in particular.

• Principle 1 - Manner and purpose of collection of personal information

• Principle 2 - Solicitation of personal information from individual concerned - awareness of purpose at time (or as soon practicable)

• Principle 3 - Solicitation of personal information generally - relevant purpose

• Principle 4 - Storage and security of personal information - ‘safeguards reasonable in the circumstances’

• Principle 5 - Information relating to records kept by record-keeper - existence of record and details about the record

• Principle 6 - Access to records containing personal information

• Principle 7 - Alteration of records containing personal information - by individual and, if not a statement by the individual may be attached

• Principle 8 - Record-keeper to check accuracy etc of personal information before use

• Principle 9 - Personal information to be used only for relevant purposes

• Principle 10 - Limits on use of personal information - consent; threat to life or health; law enforcement; directly related to purpose of collection

• Principle 11 - Limits on disclosure of personal information - individual aware information likely to be passed on; consent; threat to life or health; required by law; law enforcement; directly related to purpose of collection.

Privacy is required in these circumstances and there should be non-disclosure generally unless

• Person consents, expressly or by implication;

• Disclosure necessary to lessen/prevent serious/imminent threat to person (life, health, safety) or serious threat to public health/safety

• Required or authorised by law

• Law enforcement

The legislation is described as ‘light-touch’,[44] allowing the introduction of specific codes developed by the organizations and industries themselves then approved by the Privacy Commissioner. This process is intended to encourage development towards a ‘culture of privacy’ and eschews a strict enforcement regime in the country, as follows:

• Person may complain (no costs) to Privacy Commissioner.

• Privacy Commissioner investigates/ conciliates.

• Privacy Commissioner may impose fine or award compensation for hurt feelings.[45]

The Privacy Act was amended[46] to extend to private sector agencies and applies a range of principles requiring collection of data only for its functions; Use and disclosure for primary purpose (consent; direct marketing; health); Data quality; Data security - reasonable steps; Openness; Access and correction; Identifiers’ use and non-disclosure; Anonymity; Trans-border data flows; and, sensitive information-exceptions. This last principle is important as ‘sensitive information’ covers health information in general.

5. Weighing the Private and Public Interests in Biobanks?

Privacy law is a complex, technical and often arcane area of law, especially when applied to health records and information. The Australian Law Reform Commission and Australian Health Ethics Committee Report on privacy of genetic information[47] reconfirmed general public concerns about privacy of health information. The Report also detailed specific public concerns about the collection, use, comment, interpretation and release of human genetic information. These concerns are heightened by the large-scale storage of genetic information in human genetic research databases. The Report recommended improved regulation of databases.[48]

As noted the OECD Guidelines on the Protection of Privacy and Transborder Flows of Personal Data Guidelines, were incorporated into the Australian Privacy Act 1988. Importantly, this Act recognised that ‘the right to privacy is not an absolute right. In some circumstances, it must be weighed against equally justified rights of others and against matters that benefit society as a whole’.[49] Medical research was recognised as one of the circumstances in which this balancing exercise had to be conducted. However, the application of these provisions was unclear in relation to research, particularly genetic research, on human tissue samples.

The Privacy Act 1988 included a special provision (Section 95) enabling the Privacy Commissioner to issue guidelines ‘for the protection of privacy in the conduct of medical research’ involving federal agencies. These guidelines were to be drafted by the Australian Health Ethics Committee (AHEC). This Section was introduced on the full understanding that:

Medical research is important for providing information to help the community to make decisions that impact on the health of individuals in the community. However, it should be carried out in such a way to minimise the intrusion on people’s privacy. Optimally, obtaining the informed consent of participants prior to using their personal information does this. Where this is not practicable, de-identified information should be used. Where neither of these options are available, it may be that identified information must be used without consent in order for the medical research to proceed. (emphasis added)[50]

Specific Section 95 Guidelines were issued in 1991. Essentially, a researcher was responsible for bringing any breach of an Information Privacy Principle to the attention of the Human Research Ethics Committee (HREC) that was charged with the task of deciding whether ‘the public interest in the proposed research outweighs…to a substantial degree, the public interest in the protection of privacy’.[51] In weighting the public interest, the Guidelines list a range of issues to be considered by the HREC, as follows:

3.3 In reaching a decision…an HREC should consider

(a) the degree to which the medical research is like to contribute to:

• The identification, prevention or treatment of illness or disease; or

• Scientific understanding relating to health;

• The protection of health of individuals and/or communities; or

• The improved delivery of health services, or

(b) any likely benefits to individuals…or the wider community;

(c) whether the medical research design can be satisfied without risking infringement of an IPP…;

(d) the financial costs of not undertaking the medical research…;

(e) the public importance of the medical research;

(f) the extent to which the data being sought are ordinarily available to the public from the Commonwealth agency…;

(g) whether the risk of harm to a person whose personal information is to be used in proposed research is minimal…;

(h) the standards of conduct that are to be observed in medical research including:

(i) the study design and the scientific credentials of the researchers;

(ii) if the research involves contact with participants, the procedures or controls which will apply to ensure that participants are treated with integrity and sensitivity, including whether questions to be asked or procedures to be employed are intrusive;

(iii) whether access to personal information is restricted to appropriate researchers;

(iv) the risk that a person or group could be identified in the published results; and

(v) the procedures that are to be followed at the completion of the research to ensure that all data containing personal information are at least as secure as they were in the sources from which the data were obtained, including the date when the data will be destroyed or returned.

This basic template of considerations was reflected in a further set of guidelines in 2001[52] that were introduced following the passage of the Privacy Amendment (Private Sector) Act 2000 which extended privacy to a range of private sector organisations throughout Australia. The Section 95A Guidelines extend similar requirements to researchers for possible breaches of the National Privacy Principles[53] that must also be brought to the attention of the HREC. The HREC must then determine whether ‘the public interest in the proposed activity substantially outweighs … public interest and protection of privacy’.[54] In cases of research involved in the IPPs or NPPs the HREC is also required to notify the national AHEC, which in turn prepares an Annual Report for the Federal Privacy Commissioner. This provides a national audit point for privacy in medical research.

In addition to the balancing exercise conducted by HRECs under sections 95 and 95A, HRECs may be requested to waive consent in cases where the public interest in the value of the medical research outweighs the requirements of personal privacy.[55] Researchers may request a waiver of consent and it is not uncommon, for example, in epidemiological research. Waivers may have direct relevance to the operation of biobanks and other medical research databases. In such cases, the HREC may waive consent but only after considering carefully a number of matters:[56]

• the nature of any existing consent relating to the collection - the justification presented for seeking waiver;

• the extent to which it is impossible or difficult or intrusive to obtain specific consent;

• the proposed arrangements to protect privacy;

• the extent to which the proposed research poses a risk to the privacy and well being of the individual;

• whether the research proposal is an extension of, or closely related to, a previously approved research project;

• the possibility of commercial exploitation of the sample; and

• relevant statutory provisions.

HRECs must apply these principles to human genetic research using biobank data. Such research will necessarily involve not only the protection of the welfare of the sample participants and the participants’ genetic profile (family and descendants) but also questions about the public value of the research. Waiver considerations will also arise in research applications that involve projects outside the original donor consent. Recognising the potential for complaints, public criticism and loss of public trust through inappropriate uses of samples, the Australian Law Reform Commission recommended that HRECs should provide annual and detailed reports on any research project involving a waiver of individual consent.[57]

6. Towards Solutions

Privacy of biobank samples and data can, and should be, assured by the biobank’s governance arrangements in a number of ways.

Biobanks involved in the transfer of samples or data can protect privacy with consistent policies essential for documented material transfer agreements (MTAs) and proper ethical review and approval. An MTA can set out conditions on the transfer of the data, data security, use and release of the data, approved research uses, intellectual property rights and duties, liability arrangements, termination and, finally, requirements for the data on completion of the project.[58]

Through an MTA all access to and release of samples or data from biobanks can be strictly recorded, tracked and audited.[59]

Secondly, as privacy risk depends on the identifiability of the biobank data, governance policies about the levels of identifiability of the collected tissue samples are important. The levels of identifiability are traditionally listed as:

Unidentified samples: Sometimes termed ‘anonymous’, unidentified human biological specimens.

Unlinked samples: Sometimes termed ‘anonymised’, lack identifiers or codes that can link a sample to an identified human being;

Coded samples: Sometimes termed ‘linked’ or ‘identifiable’, from identified specimens with a code rather than personally identifying information;

Identified samples with a personal identifier (such as a name or patient number) to link the biological information directly to the individual from whom the material was obtained.[60]

As noted, biobank tissue samples will be coded, rather than anonymised, making the samples potentially identified samples because research may require recontact with participants, to update information, collect further samples or seek consent for new uses or research (not within the original consent). However, the use of these terms is not consistent and differing norms of practice may challenge personal privacy and act as barriers to collaboration between biobanks.[61] Biobanks must have procedures for maintaining the privacy of data, including systems for coding of tissue samples.

Thirdly, the ALRC Report included a unique recommendation (Rec 8-1) that genetic samples be included in the general definition of ‘Personal Information’ under the Privacy Act. This recommendation not only acknowledges the scientific fact that a tissue sample analysis provides genetic information on a person but also attracts the protections and enforcement procedures of the privacy regulatory regime to the collection, storage, access to use of and transfer of samples and data. However, this was the only recommendation not accepted by the government, but the new Human Genetics Advisory Committee of the NHMRC should keep it under review.

Fourthly, participants must be free to withdraw from a biobank, in accordance with accepted international ethical research standards. The right to withdraw may occur at different levels.[62] The German National Ethics Council and the French National Consultative Ethics Committee for Health and Life Sciences produced a joint Declaration recognising the risk of data/samples being used for ‘purposes other than those for which the donor has consented or to be passed on to third parties’.[63] This Declaration noted the need for a clear definition of the donor’s free and informed consent.

Finally, biobank governance arrangements should include the appointment of an independent intermediary between the researcher and the data or samples as a practical check and balance in the structure of the biobank. The idea of an independent intermediary has been described by the Ethics and Governance Council of the UK Biobank as acting ‘as the steward [emphasis added] of the resource, maintaining and building it for the public good in accordance with its purpose’.[64]

7. Conclusion-Biobanks and Collective Rights

The half-century since the Second World War has been described as the ‘age of rights’[65] with a rapid expansion of international declarations and organisations devoted to advancing the rights of individuals. To a lesser extent, these international declarations have mentioned the idea of collective or community rights. Biobanking is quintessentially focused on the collective and population research. Traditional notions of individual rights will have to be accommodated in biobank research with weighing private and public interests. The advancement of individual human rights has not been matched by a correlative growth in the rights of groups, though a new vocabulary of human rights of groups is emerging.[66] The terms ‘solidarity’ and ‘benefit-sharing’ used in the UNESCO Universal Declaration of Bioethics and Human Rights (2005) and the UNESCO International Declaration on Human Genetic Data (2003) promote the idea of the collective. Solidarity refers to the social, family, political, legal and other factors that promote and maintain integration and trust in society. Public trust is a fundamental keystone for genetic science and biobanking. Benefit Sharing is emphatically mentioned in UNESCO’s International Declaration on Human Genetic Data and states that ‘benefits...from the use of human genetic data…. should be shared with the society as a whole and the international community’. The principle encourages researchers and research organisations to consider ways in which the benefits of the biobank research may be equitably distributed. However, benefit sharing is novel and less clear than intellectual property protections and licensing.[67] Interestingly, both terms speak to a collective, rather than individualist, view of research. So, it has been argued[68] that benefits from public health research and the specific development of new health care profits represent such benefits.[69]

Human rights language evokes a strong sense of social justice activism, but the language of human rights remains indeterminate. Similarly, ‘solidarity’ and ‘benefit-sharing’ are imprecise terms but they emphasise the need for the potential benefits from the genome era to be shared by the community rather than private commercial interests. A new trilogy of human rights declarations (Convention on Human Rights and Biomedicine; UNESCO Universal Declaration of the Human Genome and Human Rights; and UNESCO Universal Declaration of Bioethics and Human Rights contain references to collective rights.[70] So it has been said that, ‘if societies are to thrive, individual rights must be supplemented by group rights’.[71] This collective rights approach encourages informed debate on the linguistics of duties, as well as rights[72] and also on the duties of individuals to become involved in research from which they will eventually benefit. In this debate, weighing of the public interest in research may not always prefer the participant’s interest to the potential benefits of the research for the community.[73]

Any debate on the collective benefits of biobank research highlight the critical need for public trust in biobanks in a context of increasingly privatised research encouraged by the biotechnology strategies of most developed countries which aim to increase private sector investment in research.[74] The German National Ethics Council Opinion on Biobanks for research recognised that biobanks may arouse ‘anxiety and distrust’.[75] Thus far, the limited empirical studies in Canada,[76] Ireland,[77] Australia[78] and Sweden[79] indicate public confidence in biobanks. Empirical research supporting this view of public support has been undertaken. Recognising that commercialisation challenges public trust in science,[80] a policy of transparency by biobanks in relation to their commercial activities is advisable. Public trust is a fundamental cornerstone in the cultivation and maintenance of trust in genetic science and biobanking. As such, regulation, rather than self-regulation, will be the norm for biobanks[81] to ensure transparency and public scrutiny, particularly, by publication of all results in the public domain.[82]


* Professor and Dean, Faculty of Law, University of Tasmania. Chair Gene Technology Ethics Committee, Deputy Chair Embryo Research Licensing Committee, Member Human Genetics Advisory Committee and past Chair Australian Health Ethics Committee [1]993-2000 This article has been prepared with the support of Australian Research Council Discovery Grant DP 0559760.

1 See ALRC Privacy and Personal Information DP 14, 1980 and also the Report 22 Privacy 1983.

[2] Essentially Yours: The Protection of Human Genetic Information in Australia Report 96 2003.

[3] Comment by Dr Francis Collins of the NIGR, Australian Biotechnology News July 4 2003, 8.

[4] Science: Special Issue (2001) Vol 291, 1145-1344 and Nature: Special Issue (2001) Vol 409, 745-964.

[5] B Knoppers and R Chadwick ‘Human Genetic Research: Emerging Trends in Ethics’ (2005) 6 Nature Reviews Genetics 75-79.

[6] It has been claimed that effective data-linkage may provide effective health surveillance as well as research. For example, the high incidence of coronary attacks suffered by and poor monitoring of users of the arthritis drug, Vioxx could have been detected a number of years before disparate reports were brought together to establish the serious adverse effects of this drug.

[7] J Bovenberg ‘Towards an International System of Ethics and Governance of Biobanks: A “Special Status” for Genetic Data?’ (2005) 15 Critical Public Health 369-383 and D Chalmers ‘Ethical Principles for Research Governance of Biobanks’ (2006) 3 International Journal of Biotechnology Law 221-230. See also J Bovenberg ‘Inalienably Yours? The New Case for an Inalienable Property Right in Human Biological Material’ (2004) 1 SCRIPT-ed 545.

[8] See National Bioethics Advisory Commission Report Research involving Human Biological Materials: Ethical Issues and Policy Guidance Vols 1& II Bathesda, Maryland August 1999 http://www.georgetown.edu/ research/

nrcbl/nbac/pubs.html. See also National Bioethics Advisory Commission Report Ethical and Policy issues in Research involving Human Participants Vols 1& II Bathesda, Maryland August 2001 at http://www.georgetown.edu/research/nrcbl/nbac/human/overvol2.html. See also The European Group on Ethics (EGE) in Science and New Technologies to the European Commission Ethically Speaking Newsletter, Issue 5, August 2005, 27.

[9] Council of Europe, Steering Committee on Bioethics, Draft Recommendations on research on biological materials of human origin, Strasbourg, 28 November 2005; Opinion of the European Group on Ethics in Science and New Technologies to the European Commission, Ethical Aspects of Human Tissue Banking, 21 July 1998; Swedish Medical Research Council (MFR), Research ethics guidelines for using biobanks, especially projects involving genome research, June 1999; Report of the Bioethics Advisory Committee of the Israel Academy of Sciences and Humanities, Population-Based Large-Scale Collections of DNA Samples and Databases of Genetic Information, December 2002; ESRC Research Ethics Framework, Discussion Paper 2: The international dimension to research ethics: the significance of international and other non-UK frameworks for UK social science, April 2004; Department of Health & Human Services, Public Health Service, National Institutes of Health, National Cancer Institute, 133rd National Cancer Advisory Board, Summary of Meeting, February 16-17 2005; ESRC Economic & Social Research Council, Research Ethics Framework (REF), Discussion Paper 2, April, 2004; Working Group on DNA and Epidemiology (TUKIJA) of the National Advisory Board on Health Care Ethics (ETENE), DNA Samples in Epidemiological Research, 26 August 2002; Dr Beata Scholtz, Debrecen Clinical Genomics Center, Biobanks and Scientific Research; German National Ethics Council, Biobanks for Research, 2004.

[10] OECD Committee for Scientific and Technological Policy: Working Party on Biotechnology Tokyo Workshop Report: Human Genetic Research Databases: Issues of Privacy and Security, DSTI/STP/BIO (2005) 14. The OECD Working Party Workshop Report has since been republished as OECD Creation and Governance of Human Genetic Research Databases (2006) available at http://www.oecd.org/document/50/0,3343,en_ 2649_34537_37646258_1_1_1_1,00.html

) The report examines the procedures to establish an HGRD, collect and manage samples, the management and governance of databases and commercialisation aspects.

[11] For a discussion of terminology, see R Tutton and O Corrigan, Genetic Data Bases: Socio-Ethical Issues in the Collection and Use of DNA (2004) 2-4.

[12] See generally, Knoppers B, Laberge C and Hirtle M Human DNA: Law and Policy International and Comparative Perspectives (1997).

[13] B Knoppers, ‘Biobanking: International Norms’ (2005) 33 The Journal of Law, Medicine & Ethics 7; J Kaye ‘Do we need a uniform regulatory system for biobanks across Europe?’ (2006) 14 European J of Human Genetics 245-248.

[14] Nationaler Ethikraat , Opinion on Biobanks for Research (2004).

[15] The European Group on Ethics (EGE) in Science and New Technologies to the European Commission Ethically Speaking Newsletter, Issue 5, August 2005, 27.

[16] Special health registers may include the Perinatal Registers; Cancer Registry and Mental Health Register. Some registers may be governed under specific legislation, which defines the type of data to be collected, the method of collection, and restrictions on its use and availability.

[17] See D Chalmers (Ed) Genetic Testing and the Criminal Law (ed) (2005). On legislation, see, for example, Criminal Investigations (Blood Samples) Act 1995 authorizing New Zealand’s national DNA databank.

[18] In 1998, the former National Bioethics Advisory Committee (NBAC) estimated that there were more than 282 million specimens stored in the United States and further estimated that the accumulation rate from blood tests, surgery and other medical procedures was probably in the region of 20 million specimens per year; National Bioethics Advisory Commission Research Involving Human Biological Materials: Ethical Issues and Policy Guidance Vol I (1999) 13-15. See comments in B Knoppers ‘DNA banking: A retrospective-prospective’ in J Burley and J Harris Companion to Genethics (2002) 379-386.

[19] See generally, B Knoppers, C Laberge and M Hirtle, Human DNA: Law and Policy International and Comparative Perspectives, (1997).

[20] See http;//www.hapmap.org/

[21] http://www.p3gconsortium.org/

The P3G aims to link many national biobanks in a not-for-profit initiative to provide a public and accessible knowledge database for the international population genomics community. P3G aims to facilitate, rather than undertake, international collaboration in large-scale epidemiological studies. Its motto is ‘transparency and collaboration’.

[22] The OECD Working Party Workshop Report has since been republished as OECD Creation and Governance of Human Genetic Research Databases (2006) available at http://www.oecd.org/document/50/0,3343,en_ 2649_34537_37646258_1_1_1_1,00.html

[23] eg Sweden: Biobanks in Medical Care Act 2002 information may only be used for research purposes.

[24] Health Sector Database Act, 1998 (deCODE Genetics). The Icelandic Supreme Court November 27, 2003, judgment No. 151/2003 suggested that the Health Sector Database Act may be unconstitutional. In 2000, the Act on Biobanks No. 110/2000 was introduced for the ‘collection, keeping, handling and utilization of biological samples from human beings’.

[25] Estonia, Human Genes Research Act, 2000.

[26] www.ukbiobank.ac.uk

[27] Cited in D Winickoff and R Winickoff ‘Charitable Trust as a Model for Genomic Biobanks’ (2003) 349 N Eng J Med 12, footnote 26.

[28] For an account of Australian databases see Nicol D ‘Public trust, intellectual Property and human genetic Databases; the need to address benefit sharing’ (2006) 3 J of International Biotechnology Law 89-103 and D Chalmers ‘Ethical Principles For Research Governance Of Biobanks’ (2006) 3 J of International Biotechnology Law 3.

[29] See R Burton, ‘Proposed Genetic Database on Tongans Opposed’ (2002) 324 Brit Med J (7335) 443.

[30] http://www.abrn.net/

[31] The European Group on Ethics (EGE) in Science and New Technologies to the European Commission Ethically Speaking Newsletter, Issue 5, August 2005 27.

[32] D Weisbrot ‘Public Conspiracy, Genetic Counselling and the Required Legal Infrastructure’, Symposium on Taiwan’s Private Project, unpublished paper ALRC Sydney, 8 August 2005 at p19.

[33] See also NBAC Research Involving Human Biological Materials: Ethical Issues and Policy Guidance Vol I (1999) 16-17.

[34] ALRC, above n2.

[35] Belgium: Constitution recognizes the right of privacy (Article 22); Estonia Constitution 1992 recognizes the right of privacy and data protection (Article 42); Finland: Constitution of Finland The right to privacy (Section 10); Iceland: the 1944 Constitution was amended in 1995 for personal privacy (Article 72); Spain: Constitution recognizes the right to personal privacy; UK: The Human Rights Act includes a right of privacy.

[36] See, for example the Belgian Constitution Article 22.

[37] Similarly, freedom of information legislation allows access to government held information but are not, generally relevant to biobanks. The original legislation was in the USA Freedom of Information Act 1966 (FOIA) that allows access to federal government records. See Thailand: Official Information Act 1997 (OIA) rights to government information.

[38] The principles of Collection Limitation; Data Quality; Purpose Specification; Use Limitation; Openness; Individual Participation; Accountability.

[39] 95/46/EC, see also Directive on telecommunications privacy (97/66/EC now 2002/58/EC).

[40] Belgium: : Act concerning the Protection of Privacy with regard to the Treatment of Personal Data Files, December 8, 1992 updated December 11, 1998; Estonia : Personal Data Protection Act, 1996; Finland: Personal Data Act 1999 : France: Data Protection Act 1978 amended by Data Protection Act 2004 for compliance with the EU Directive; Germany: 1997 Federal Data Protection Act (Bundesdatenschutzgesetz or BDSG) amended in 2002 to be in line with the EU Data Protection Directive; Iceland; 2000, Act on the Protection of Individuals with regard to the Processing of Personal Data for compliance with the EU Directive ; Ireland: Data Protection Act, 1998; Spain: Data Protection Act (LOPD) , 1999; Sweden: Personal Data Act (PDA) or personuppgiftslagen (PUL) 1998 ; Switzerland: Federal Data Protection Act 1992; UK: Data Protection Act 1998.

[41] The Privacy Act 1985, Canada regulates the federal public sector. The Personal Information Protection and Electronic Documents Act 2000 (PIPEDA) applies to private sector commercial activities throughout the country, three provinces (Alberta, British Columbia and Quebec) have enacted ‘substantially similar’ provincial legislation. Four provinces have legislation for the protection of health information; Ontario (Personal Health Information Protection Act 2004), Manitoba (Personal Health Information Act), Saskatchewan (Health Information Protection Act) and Alberta (Health Information Act). USA: The Privacy Act 1974 protects records of US government agencies.

[42] www.privacy.gov.au

and http://www.privacy.gov.au/act/index.html

See also Victoria: Information Privacy Act 2000 which applies to public sector; Health Records Act 2000, NSW: Privacy and Personal Information Protection Act 1998 which applies to public sector but with a code with PC approval; Health Records Information Privacy Act 2002 for private records, and ACT: Health Records(Privacy and Access) Act 1997.

[43] Taiwan: Computer-Processed Personal Data Protection Law 1995.

[44] For example, in 2001-02 only146 complaints were registered with 84 under NPPs.

[45] Privacy (Private Sector Amendment) Act 2000 Cth s 52 (1A).

[46] Ibid.

[47] Above, n2.

[48] Ibid, Recommendations 18-1 to 18-4 in Chapter 18 ‘Human Genetic Research Databases’.

[49] NHMRC Guidelines Under Section 95 of the Privacy Act 1988 at 7.

[50] Ibid.

[51] See Ibid Guidelines 2.3 and 3.2.

[52] NHMRC Guidelines approved under Section 95 A of the Privacy Act 1988.

[53] These are essentially the same as the information privacy principles with two major additions, namely, the responsibility of organisations to ensure that privacy principles apply to any transborder data flow to a foreign country (NPP9) and the responsibility of an organisation not to collect ‘sensitive information’ about an individual (NPP10).

[54] See Guideline D.5 NHMRC Guidelines approved under Section 95A of the Privacy Act 1988 29-31.

[55] N Zeps et al ‘Waiver of Individual Patient Consent in Research: When do Potential Benefits to the Community Outweigh Private Rights?’ (2007) 186 Med J Aust 88-90.

[56] See Australia, National Statement on Ethical Conduct in Human Research, Ch 2.3 on qualifying or waiving conditions of consent.

[57] Above n2. Rec 15-1.

[58] First Generation Guidelines for NCI Supported BioRepositories April 2006, National Cancer Institute, National Institutes of Health, U.S Department of Health and Human Services http://biospecimens.cancer.gov/ biorepositories/First%20Generation%20Guidelines%20042006.pdf

Best Practices for Repositories I: Collection, Storage, and Retrieval of Human Biological Materials for Research (2005) International Society for Biological and Environmental Repostitories (ISBER). Cell Preservation Technology 3:1, 2005. http://www.isber.org/Pubs/BestPractices. pdf

[59] See Section I Best Practices for Repositories I: Collection, Storage, and Retrieval of Human Biological Materials for Research (2005) International Society for Biological and Environmental Repostitories (ISBER). Cell Preservation Technology 3:1, 2005. http://www.isber.org/Pubs/Best Practices.pdf

[60] See also above n 33 16-17. The UNESCO International Declaration on Human Genetic Data (2003) adopts accepted distinctions between ‘(ix) Data linked to an identifiable person: (x) Data unlinked to an identifiable person: (xi) Data irretrievably unlinked to an identifiable person’.

[61] B.Elger and A. Caplan ‘Consent and anonymization in research involving biobanks. Differing terms and norms present serious barriers to an international framework’ (2006) 7 EMBO reports , 661-666.

[62] Complete withdrawal including the destruction of samples and data, or non-participation withdrawal allowing retention and use by the biobank of the date/sample but not participating in any other way, or non-contact withdrawal allowing retention of data/sample in an anonymised form with withdrawal from any future contact or projects.

[63] The European Group on Ethics (EGE) in Science and New Technologies to the European Commission Ethically Speaking Newsletter, Issue 5, August 2005 at 27.

[64] See also the ‘custodian’ proposal by the Ireland Law Reform Commission The Establishment of a DNA Database Report 78 (2005) at Chapter 4.

[65] See L Henken The Age of Rights (1990).

[66] See D Thomasma, ‘Proposing a New Agenda Caught on Bioethics and International Human Rights’ (2001) 10 Cambridge Quarterly of Health Care Ethics 299-310. The author proposes some procedural and substantive rules for the basis of an international multicultural bioethics (the rule of peaceful dialogue; rule against xenophobia; rule of respect for cultural pluralism; rule of the common good; rule of cultural apprehension; rule of respect for persons in context; and, rule of existential A Prioris).

[67] R Chadwick and K Berg, ‘Solidarity and Equity: New Ethical Frameworks for Genetic Databases’ (2001) 2 Nature Reviews Genetics 318; K Simm, ‘Benefit-sharing: an Inquiry regarding the Meaning and Limits of the Concept in Human Genetic Research’ (2005) 1 Genomics, Society and Policy 29; B Knoppers, ‘Biobanking: International Norms’ (2005) 33 The Journal of Law, Medicine & Ethics 7; D Nicol, above note 6 89-103.

[68] B Knoppers and L Sheremeta ‘Beyond the Rhetoric: Population genetics and Benefit-sharing’ (2003) 11 Health L J 89.

[69] Nicol D ‘Public trust, intellectual ‘property and human genetic databases; the need to address benefit sharing’ (2006) 3 J of International Biotechnology Law 89-103.

[70] Asian religious and philosophic traditions are different to those on the west and emphasise family/community duties rather than autonomy and individual rights. See R Ida (Ed) Dialogue and Promotion of Bioethics in Asia Manila, Singapore, Seoul and Kyoto, 2003-5, Kyoto University, 2006.

[71] F William Taking Suffering Seriously: The Importance of Collective Human Rights (1996) 180.

[72] R Macklin, ‘Moral Concerns and Appeals to Write Some Duties’ (1996) 6 Hastings Center Report 31-38.

[73] G Harris, ‘Research on Human Subjects’, M Freeman and A Lewis (Eds) Law and Medicine, Current Legal Issues Volume 3 (2000) 379-397.

[74] See B Salter and M Jones, in ‘Regulating Human Genetics: A Changing of Politics, Biotechnology, Covenants in the European Union Human Genetics Project’ ESRC Innovative Health Technologies Program UK 2002; UK Parliament, House of Lords Select Committee on Science and Technology, Science and Society 3rd Report 2000.

[75] Above n14, 27.

[76] See T Caulfield and T Outerbridge ‘DNA Databanks, Public Opinion and the Law’ (2002) 25 Clinical and Investigative Medicine 252-256 and T Caulfield “Perceptions of Risk and Human Genetic Databases: Consent and Confidentiality Policies” in G Armason et al (eds) Blood and Data: Ethical, Legal and Social Aspects of Human Genetic Databases (2002) 283-289.

[77] G Cousins et al ‘Public Perceptions of Biomedical Research: A Survey of the General Population in Ireland’, Health Services Research Centre, World College of Surgeons in Ireland, Dublin 2005.

[78] See Williams ‘Australian Attitudes to DNA Sample Banks and Genetic Screening’ (2005) 21 Current Medical Research and Opinions 1773-1775 and J Fleming ‘Issues with Tissues: Perspectives of Tissue Bank Donors and the Public Towards Biobanks and Related Genetic Research’ in Biobanks Centre for Law and Genetics Symposium, September 2007.

[79] A Kattis-Lindbland et al “Perceptions of Potential Donors in the Swedish Public Towards Information and Consent Procedures in Relation to Use of Human Tissue Samples in Biobanks: A Population-Based Study” (2007) 35 Scandanavian Journal of Public Health 148-156.

[80] D Chalmers and D Nicol ‘Commercialisation of Biotechnology: Public Trust and Research’, (2004) 6 Int J Bbiotechnology 116. See also above at note 19.

[81] D Chalmers ‘Research Involving Humans: A Time for Change?’ (2004) 32 J of Law, Medicine & Ethics (4) 583-495.

[82] This is the policy adopted by the International Haplotype Mapping Project and GenBank -The Human Genome Project’s public domain sequence data site at http://www.ncbi.nlm.nih.gov/Genbank/


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