14.73 The Inquiry has concluded that, given the existing and likely future extent of private sector research, especially that which is not carried out in conjunction with public sector researchers or research institutions, new mechanisms are required to achieve compliance with the National Statement.
14.74 However, the Inquiry does not recommend the immediate enactment of new legislation to enforce compliance with the National Statement or to subject human genetic research to a new licensing or registration regime.
14.75 There are many issues involved in the design and implementation of an effective regulatory scheme for human genetic research and these need to addressed in more detail. These include:
- How should human genetic research be defined for the purposes of the regulatory scheme? This is important to the coverage of the regulatory scheme and has to take into account other regulatory regimes in areas such as human cloning and stem cell research.
- Who would be the target of regulation? Regulation could apply to individual researchers, research organisations or their HRECs, specific human genetic research projects or to specific collections of genetic samples or information.
- What agency should have responsibility for operating the regulatory scheme? Regulatory responsibility could be given to an existing agency, such as the NHMRC, but this might signal a significant shift in its functions and have resource implications.
- What investigative, enforcement or other functions and powers should be given to the agency with responsibility for operating the new regulatory scheme?
- How can an effective regulatory scheme be designed and implemented so as to preserve the intrinsic nature of ethical obligations and not engender a literal or legalistic attitude toward compliance?
14.76 Many other issues arise, including questions about how new regulation would be funded, the compliance costs for research organisations and how the scheme may affect the international competitiveness of Australian human genetic research.
14.77 Constitutional limits on federal legislative power are an important consideration. The most obvious head of federal legislative power appears to be the corporations power, but amendments to the NHMRC Act may be insufficient to regulate effectively all human genetic research. Corresponding legislation may have to be enacted by the Commonwealth, States and Territories.
14.78 These problems are not insurmountable and options for further regulation should be thoroughly reviewed. The Inquiry believes that the NHMRC is the appropriate body to advise government on options for regulating human genetic research conducted in the private sector. Accordingly, the Inquiry recommends that the NHMRC, as part of its review of the National Statement in the 2003–2005 triennium, should review the mechanisms for achieving compliance with the National Statement, with particular regard to human research conducted wholly within the private sector.
Recommendation 14–1 The National Health and Medical Research Council, as part of its review of the National Statement on Ethical Conduct in Research Involving Humans (the National Statement) in the 2003–2005 triennium, should review the mechanisms for achieving compliance with the National Statement, with particular regard to human research conducted wholly within the private sector.
 Leaving aside existing or augmented requirements for HRECs to be registered with AHEC. An exception to this position involves the establishment and operation of standing human genetic research databases. The registration of research databases is discussed in Ch 18.
 Human genetic research is defined in the National Statement as a process which enhances ‘understanding of how genes and environmental factors interact to influence the health of individuals and populations and in doing so, generates knowledge with the potential to improve individual and community health’: National Health and Medical Research Council, National Statement on Ethical Conduct in Research Involving Humans (1999), NHMRC, Canberra, Ch 16.
 Australian Constitution s 51(xx).