Feature
The ALRC report into the protection of genetic information - the implications for human genetic research and genetic databases
In brief: In the third article of our current series, lawyers Damien van der Toorn and Erica Davis discuss how the recent ALRC Discussion Paper could affect human genetic research and genetic databases in Australia.
- Introduction
- Implications for human genetic research
- Implications for genetic databases
- Public consultation
Introduction
This is the third in a series of focus articles on the implications of Discussion Paper No. 66 (DP 66) released by the joint Inquiry of the Australian Law Reform Commission and the Australian Health Ethics Committee on 28 August 2002. This article focuses on the implications of DP 66 for human genetic research and genetic databases.
Implications for human genetic research
What is human genetic research and why is it important?
DP 66 uses the term human genetic research to refer to any research that uses genetic samples or genetic information of humans. This definition does not distinguish between genetic samples and information which are identified, potentially identifiable or de-identified. However, this will be relevant in the context of the protection of privacy in genetic samples.
Human genetic research is becoming an increasingly important part of medical research generally. This is hardly surprising, given the knowledge and other benefits potentially generated by such research. Increased understanding of how specific genes and environmental factors interact, for instance, has the potential to improve the diagnosis, prevention and treatment of human diseases.
Current regulatory framework
DP 66 considers the adequacy of the current regulatory framework for human genetic research in the context of ethical, privacy and related issues.
The crux of the current regulatory framework for ensuring ethical conduct of human genetic research is the National Health and Medical Research Council's (NHMRC) National Statement on Ethical Conduct in Research Involving Humans (the National Statement). The privacy of human genetic information is currently protected by privacy laws generally, including the Privacy Act 1988 (Cth), and by the National Statement.
The National Statement, which was the focus of the 26 March 2002 edition of Biotech News, sets out the processes and principles to be followed for the ethical review of human genetic research. Briefly, the National Statement provides for the formation of Human Research Ethics Committees (HRECs) within institutions or organisations and requires human genetic research to be reviewed, approved and monitored by HRECs in accordance with specific requirements.
In relation to privacy protection, the National Statement generally requires consent from research participants for the use of human tissue samples, genetic material and genetic information. However, in certain circumstances, the National Statement currently allows an HREC to waive the need for consent.
The Australian Health Ethics Committee (AHEC) audits the activities of HRECs to ensure compliance with the National Statement. Infringement of the National Statement is not currently an offence, but may result in loss of funding from the NHMRC. However, there is currently no obligation for wholly private research bodies to adhere to the provisions of the National Statement. Notwithstanding this, in many respects compliance with other parts of the current regulatory framework indirectly requires compliance with the ethical requirements of the National Statement. Indirect factors which encourage compliance with the National Statement include privacy laws, therapeutic goods legislation, professional codes of conduct, NHMRC standards for the scientific validity of research and common law duties to exercise reasonable care.
Major proposals for reform
A large number of specific options for reform of the current regulatory framework for human genetic research were suggested by submissions and in consultations. The Inquiry's major proposals in relation to control of human genetic research are:
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Enforcing compliance with the National Statement
The National Health and Medical Council Act 1992 (Cth) (NHMRC Act) should be amended to prohibit any human genetic research that does not comply with the National Statement, in recognition of the increasing commercialisation of such research. Alternatively, the Inquiry proposes to establish a national licensing scheme covering human genetic research in Australia.
In this context, the Inquiry posed the questions of how "human genetic research" should be defined for the purposes of the NHMRC Act and what sanctions should apply for non-compliance with the National Statement.
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Making changes to the National Statement with respect to consent to use genetic material and information
The requirement of consent to use genetic material and information is pivotal to the protection of privacy of such information. The Inquiry proposes changes to the National Statement to provide more guidance on the requirement for consent and to tighten reporting requirements of HRECs in respect of waivers of consent. Further, it is proposed that the National Statement should specifically deal with obtaining consent from prospective research participants for the use of their genetic samples for unspecified future research.
The Inquiry also posed a number of questions in relation to consent, including what sort of information should be required in HREC waiver of consent reports to AHEC and what changes are needed to the National Statement and/or the Guidelines to the Privacy Act in relation to consent.
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Encouraging best practice in human genetic research
The Inquiry proposes that the AHEC should develop model research protocols and consent forms as an adjunct to the National Statement as a "best practice" guide to HRECs, researchers and participants. The research protocols should specifically include guidance on transparent disclosure to research participants of the potential commercialisation of research outcomes. In addition to the disclosure of commercial arrangements, the consent form should cover consent options including withdrawal of consent, proprietary interests in genetic material or information and privacy protection.
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Strengthening ethical review of human genetic research by HRECs
Possible reforms to the current system for ethical review of human genetic research suggested in submissions and consultations included reporting and monitoring by HRECs on the review and conduct of research proposals, the review or accreditation of HRECs and the education and development of HREC members. The Inquiry noted that most of the suggestions raised in submissions and consultations have already been considered, as a result of extensive public consultation prior to release of the National Statement. The Inquiry is interested in further ideas to strengthen the ethical review of human genetic research by HRECs.
Implications for genetic databases
DP 66 also addresses issues relating to the collection and storage of genetic samples in genetic databases and tissue collections.
Genetic databases
Hospitals, public and private research organisations and pathology laboratories use genetic databases for research purposes, particularly in identifying linkages between clinical, personal and genetic information. This can be used to isolate genetic causes of disease and other forms of genetic research.
While the research benefits of these databases can be significant, the Inquiry also recognises the importance of protecting the personal information of individuals and giving them control over how that information is collected, used, and disclosed. Currently, genetic samples and information held in genetic databases are regulated by a patchwork of privacy legislation, human tissue Acts and ethical guidelines. The Inquiry has identified gaps in the existing regulation of human genetic databases and proposes reforms which could significantly affect the obligations of entities using genetic databases.
One regulatory concern is the lack of uniform privacy legislation between the Commonwealth, States and private sector. This lack of unanimity has led, in some instances, to uncertainty among researchers as to their privacy obligations regarding human genetic databases. The Inquiry calls for Governments to pursue harmonisation of privacy legislation.
Concern was also expressed regarding the lack of protection for genetic samples under privacy legislation. The Inquiry calls for the amendment of privacy legislation to cover genetic samples to ensure individual privacy rights in respect of those samples. If implemented, this amendment would broaden the privacy obligations of researchers using genetic databases.
Apart from privacy reform, the Inquiry raises further recommendations, which may affect some researchers, including:
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an extension of the National Statement in relation to the ethical operation of human genetic databases;
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the introduction of a licensing or registration system for genetic databases (enabling a licensing body to closely monitor and control use of genetic databases); and
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the establishment of a "gene trustee" to act as an intermediary responsible for holding codes and linking genetic samples or information with identifiers.
Human tissue collections
DP 66 also discusses the closely related subject of human tissue collections. Tissue collections are held at pathology laboratories which receive blood and other tissues for testing, blood banks which take donations for transfusions and hospitals which remove tissue in the course of surgery, treatment and autopsies.
Guthrie cards, containing blood samples of newborns, are also routinely collected at hospitals around Australia. As well, tissue banks have been established to hold tissue for transplantation and therapeutic uses.
Large amounts of potentially sensitive information about the person from whom the tissue was taken and their family can be obtained from archived tissue. The information derived from the samples can be an important scientific and economic resource. Use of tissue samples in this way also raises privacy and consent issues for the individuals concerned.
Aspects of the collection, use, storage and disclosure of genetic samples and information held in tissue collections are currently regulated by privacy legislation, human tissue Acts, the common law and ethical guidelines. However, the Inquiry has identified some gaps in the existing regulation.
Many of the regulatory issues regarding tissue collections are similar to the issues identified for genetic databases. However, the Inquiry has identified a strong need for nationally consistent policies and practices in relation to the collection, storage, use of and access to pathology samples, tissue banks and Guthrie cards. The Inquiry proposes that the Australian Health Minister's Advisory Council, in collaboration with key professional bodies, have the task of developing these policies.
Ownership of human tissue samples
DP 66 discusses alternative approaches to the protection of human tissue samples. One alternative that is discussed is granting proprietory rights to individuals in their tissue samples.
There is no Australian legislation which makes a determination as to the property status of genetic samples, though there has been limited recognition of proprietary rights in human tissue samples where work or skill has been exercised to preserve them. After considering this alternative, the Inquiry recommends against recognising full proprietary rights in genetic samples, while maintaining common law rights to possession of preserved samples.
The other alternative that is discussed is to extend the scope of the human tissue Acts. This legislation currently provides for consensual donation of blood, tissues and organs for transplantation and for scientific, therapeutic or medical purposes. The legislation does not deal with storage of samples, access to them or future use of samples. However, the Inquiry has concluded that an extension of this legislation to cover genetic samples could lead to overlap or inconsistency with protection under privacy legislation and recommends against any amendment.
Public consultation
If you have an interest in the implications of DP 66 for human genetic research and/or for genetic databases, you should consider making a formal submission to the Australian Law Reform Commission. The closing date for submissions on DP 66 is 29 November 2002.
For further information on the issues raised in this article or for assistance in drafting a submission to the ALRC please contact Peter Allen on +61 7 3334 3351.
