28.07.2010
14.47 The options for reform to enforce compliance with the National Statement include:
the enactment of legislation to prohibit the conduct of any human genetic research, other than in compliance with the National Statement;
the establishment of a national licensing or registration scheme covering human genetic research in Australia; and
new self-regulatory arrangements applying to research organisations conducting human genetic research.
14.48 These regulatory options, and the views expressed in relation to them in submissions and consultations, are discussed further below.
Legislating for compliance with the National Statement
14.49 In DP 66, the Inquiry proposed that the National Health and Medical Research Council Act 1992 (Cth) (NHMRC Act) be amended to prohibit the conduct of any human genetic research, other than in compliance with the National Statement.[51]
14.50 There is a precedent for enforcing compliance with the National Statement through legislation. As noted above, the Therapeutic Goods Regulations 1990 (Cth) provide that unregistered therapeutic goods may be used in clinical trials only on certain conditions,[52] including a requirement that the use is in accordance with the National Statement.[53] DP 66 asked whether such a regulatory response would be appropriate for regulating the conduct of human genetic research.
14.51 The National Statement comprises broad ethical principles and short statements of considerations relevant in specific research contexts. It offers guidance on, rather than prescription of, ethically sound research design and practice.[54] Whether a research organisation has conducted research in compliance with the National Statement as a whole will generally not be conducive to definitive answer.[55]
14.52 Another difficult issue is the type of penalty that might follow failure to comply with the National Statement. Legislation could be drafted to make both individual researchers and the executive officers of a non-complying institution liable to a criminal penalty, along with the institution itself. The HGSA noted that
a system of fines could be introduced, directed at employing institutions. This would stimulate organisations to invest appropriate resources in ethical oversight of human research.[56]
14.53 Submissions generally supported the policy underlying the proposal to amend the NHMRC Act, namely, that the conduct of all human genetic research in Australia should comply with the National Statement, whether in the public or private sector. With few exceptions, submissions also supported the idea that, at least in relation to human genetic research, legislation should explicitly require compliance with the National Statement.[57] For example, the Australian Academy of Science submitted that all research with human subjects, not only that conducted with NHMRC support or in public hospitals and universities, should be legally required to go before an HREC for approval.[58] The Queensland University of Technology submitted that the National Statement be given further legislative force.[59]
14.54 The Caroline Chisholm Centre for Health Ethics stated that:
The relevant NHMRC guidelines are well constructed and offer quite good advice on the ethically appropriate ways to handle genetic information. However, they lack the force or authority that regulation of this area is likely to require.[60]
14.55 The Australian Red Cross Ethics Committee submitted that:
the ethical oversight of all human genetic research should be strengthened, by prohibiting any genetic research that does not comply with NHMRC standards.[61]
14.56 The Department of Human Services South Australia stated that:
Where any research body fails to comply with national standards regulating genetic research they are damaging not only their own reputation and that of the scientific community in general, but eroding public confidence in a system designed to represent the public interest when such decisions are made. Failure to comply with the national standard should result in any organisation that conducts genetic research being prohibited from conducting any further research.[62]
14.57 However, some submissions questioned whether amendments to the NHMRC Act are the appropriate mechanism by which to require compliance with standards for the ethical conduct of research. Others highlighted more general problems involved with legislating for compliance.
14.58 The Queensland Government expressed reservations about the proposal to amend the NHMRC Act and cautioned that
further careful consideration should be given to the proposal. In addition, it should be recognised that the guidelines in their current form are not appropriate to be enforceable. … Careful consideration of the impact of enforceable re-drafted standards would be necessary to ensure that there were no unintended consequences which may limit the progress of research conducted in an acceptable manner.[63]
14.59 Concerns were also expressed about the implications for the NHMRC, should the NHMRC Act be amended to require the NHMRC to enforce compliance.
If the National Statement became an enforceable document, and the NHMRC a regulatory body, this would represent a significant shift in its role. … It is possible that the existing valued functions of the NHMRC might be adversely affected should it become a regulatory body. Extensive consultation with stakeholders would be required to inform detailed consideration of this proposal.[64]
14.60 More generally, submissions recognised practical difficulties in framing legislation to require compliance. The Commonwealth Department of Health and Ageing stated:
While the Department acknowledges the issues regarding the current system, the establishment of a framework for sanctions would also face complications. Full regulation of the research industry would also require a vast amount of resources.[65]
14.61 The New South Wales Health Department gave in principle support for the proposal to amend the NHMRC Act, but noted that this option ‘may be difficult in practice’.
It is supported for genetic research because of its potential to intrude on privacy and affect the well‑being not only of the individual, but also family, and the fact that there is such a strong private sector involvement. A lot of research goes on in the public sector that is already very well regulated by current legislation. An incremental approach as the need develops may be preferable.[66]
Licensing of human genetic research
14.62 Another option raised in DP 66 was the establishment of a licensing or registration scheme covering human genetic research in Australia. However, there was no significant support in submissions or consultations for the introduction of licensing or registration—provided that regulation of human genetic research could be strengthened through reforms to the ethics review system and through other means to enhance compliance with the National Statement.
14.63 A licensing regime for the conduct of human genetic research could require an undertaking to comply with the National Statement as a condition of a licence to conduct research. A substantial breach of the National Statement could result in conditions being placed on the licence, or suspension or cancellation of the licence.
14.64 Relevant examples of licensing regimes are those established under the Gene Technology Act 2000 (Cth) (Gene Technology Act) in relation to certain dealings with genetically modified organisms, and for research involving embryonic stem cells under the Research Involving Human Embryos Act 2002 (Cth).
Registration of human genetic research
14.65 While licensing generally involves close and ongoing supervision of the regulated activity, a more ‘light touch’ regulatory approach is the establishment of a registration scheme. Under such a scheme there would be a legislative requirement to register research with a regulatory agency, accompanied by penalties for the conduct of unregistered human genetic research. The provisions of the Gene Technology Act and the Gene Technology Regulations 2001 (Cth) concerning ‘notifiable low risk dealings’ are examples of such an approach.[67]
14.66 Alternatively, a registration scheme for human genetic research could focus on HRECs, rather than on the conduct of research itself. The National Statement currently requires the NHMRC, through AHEC, to audit the activities of HRECs to ensure compliance with the National Statement.[68] While not required by the NHMRC Act, HRECs are registered with AHEC and report annually on their membership and other aspects of their operations.
14.67 One option for reform would be to enact legislation that requires human genetic research to be approved by an HREC constituted in accordance with the National Statement, and for HRECs to be registered with AHEC. Non-compliance with these requirements could be punishable by fine or civil penalty.
14.68 A potential advantage of a registration scheme for human genetic research would be the development, for the first time, of a comprehensive database of all human genetic research being conducted in Australia. Depending on the nature of regulation, this database might include information about organisations conducting human genetic research, their HRECs or information about specific human genetic research projects.[69]
Industry self-regulation
14.69 An alternative to legislation might involve new self-regulatory arrangements, under which organisations involved in the conduct of human genetic research might agree to comply with the National Statement or with a code of research ethics that incorporates similar principles of ethical review of research.
14.70 Self-regulatory arrangements sometimes provide for the establishment of industry-specific bodies with varying regulatory functions and powers. These bodies may deal with matters such as developing industry standards and codes of practice, and setting standards of accreditation for members.[70]
14.71 The Inquiry understands that two established industry associations, AusBiotech Limited and Medicines Australia represent virtually all significant private sector players that fund or support human genetic research in Australia. The activities of these bodies might be the appropriate starting point for the development of a self-regulatory scheme.
14.72 However, the ethical conduct of human genetic research may not be an appropriate area for self-regulation, given the potential consequences for research participants and others. There was no support for new self-regulatory approaches in the submissions received by the Inquiry.
[51] Australian Law Reform Commission and Australian Health Ethics Committee, Protection of Human Genetic Information, DP 66 (2002), ALRC, Sydney, Proposal 11–1.
[52]Therapeutic Goods Act 1989 (Cth) s 19; Therapeutic Goods Regulations 1990 (Cth) r 12AD.
[53]Therapeutic Goods Regulations 1990 (Cth) r 12AD(c).
[54] National Health and Medical Research Council, National Statement on Ethical Conduct in Research Involving Humans (1999), NHMRC, Canberra, 1.
[55] However, it would be relatively easy to establish whether an organisation has established and operates an HREC of the prescribed composition.
[56] Human Genetics Society of Australasia, Submission G267, 20 December 2002.
[57] Health Consumers’ Council, Submission G174, 18 September 2002; N Stott Despoja, Submission G198, 27 November 2002; Australian Medical Association, Submission G212, 29 November 2002; Children’s Cancer Institute Australia, Submission G221, 29 November 2002; Centre for Genetics Education, Submission G232, 18 December 2002; J Fleming, Submission G241, 20 December 2002; Human Genetics Society of Australasia, Submission G267, 20 December 2002; Association of Genetic Support of Australasia, Submission G284, 25 December 2002; Law Society of New South Wales, Submission G285, 18 December 2002; Australian Institute of Aboriginal and Torres Strait Islander Studies, Submission G286, 16 December 2002; Department of Human Services Victoria – Metropolitan Health & Aged Care Services Division, Submission G289, 24 December 2002; NSW Health Department, Submission G303, 13 January 2003; Office of the Health Services Commissioner Victoria, Submission G307, 17 January 2003.
[58] Australian Academy of Science, Submission G097, 21 January 2002.
[59] Queensland University of Technology, Submission G109, 14 March 2002.
[60] Caroline Chisholm Centre for Health Ethics, Submission G061, 26 December 2001.
[61] Australian Red Cross Ethics Committee, Submission G292, 6 January 2003.
[62] Department of Human Services South Australia, Submission G288, 23 December 2002.
[63] Queensland Government, Submission G274, 18 December 2002.
[64] Queensland Government, Submission G274, 18 December 2002. It should be noted that the Research Involving Embryos Act 2002 (Cth) establishes a licensing committee under the NHMRC, with a regulatory role.
[65] Commonwealth Department of Health and Ageing, Submission G313, 6 February 2003.
[66] NSW Health Department, Submission G303, 13 January 2003.
[67]Gene Technology Regulations 2001 (Cth) rr 12–13.
[68] National Health and Medical Research Council, National Statement on Ethical Conduct in Research Involving Humans (1999), NHMRC, Canberra [2.46].
[69] However, there are other ways in which such a database might be developed. Centralised collection of data on human research taking place in Australia could be achieved by the NHMRC placing an obligation on HRECs to provide such data to it, without recourse to new legislation. A proposal to establish a centralised clinical trials database has been under discussion within the NHMRC for a number of years.
[70] Examples are the various industry ombudsman offices, professional and trade associations, and industry councils and associations. There is a large number of such schemes: see eg the federal government’s self-regulation website has a directory of 45 national self-regulatory schemes: Department of Treasury, Directory of National Self-Regulatory Schemes, <www.selfregulation.gov.au>, 20 February 2003.