The need for reform

14.36 The Inquiry recognises that the National Statement continues to have an important and valued influence on the way in which research involving humans is conducted in Australia. The National Statement has played an important role in regulating research, even in the absence of an explicit legal basis.^[41] The National Statement has been said to command ‘profound moral authority in the community, independently of the theoretical sanction of the loss of NHMRC funding support’.^[42] Indeed, many HRECs have been created in institutions that do not receive NHMRC funding.

14.37 Some submissions suggested that legislation to extend the scope or enforceability of the National Statement was not necessary.^[43] However, most submissions to the Inquiry supported strengthening the mechanisms by which compliance with the National Statement is enforced—to require all researchers and research organisations to comply.^[44]

14.38 In particular, submissions questioned the effectiveness of the existing legal status of ethics review requirements, in view of increasing private sector involvement in the funding of research. For example, Jennifer Fleming stated:

The increasing commercialisation of human genetic research and clinical research overall requires a strengthening of the mechanisms to ensure compliance irrespective of whether the research is conducted by public or private research bodies or in collaboration with overseas sponsors.^[45]

14.39 Similarly, Privacy NSW submitted:

The commercial context in which the vast majority of research occurs undermines the traditional justification for the largely self-regulatory framework underpinning research involving humans. With reductions in public funding, even universities and public hospitals now compete for private industry involvement and funding of their activities.^[46]

14.40 The New South Wales Genetics Service Advisory Committee also referred to the need to monitor the ethical performance of research that is not dependent on public funding or carried out through the public health system. The Committee stated that regulators should have power to review and oversee research undertaken by private organisations, and it supported sanctions where there has been unethical conduct.^[47]

14.41 The Inquiry recognises the importance of private sector investment in Australian human genetic research. As the Australian Academy of Science has observed:

No significant political or academic group argues against the underlying principle of commercial involvement in research, because ending this involvement would require a corresponding injection of several hundred million dollars per annum into biomedical research by the Australian government.^[48]

14.42 At present, most privately funded human genetic research in Australia is associated in some way with a university, public hospital or public agency (such as the CSIRO). Similarly, many individual researchers have ongoing employment or professional relationships with public bodies, or membership of professional associations that expect (and in some cases require) compliance with the National Statement and other NHMRC guidelines.

14.43 The Inquiry has not been made aware of any privately funded genetic research in Australia that does not comply with the requirements of the National Statement. Indeed, some private sector organisations involved in research have voluntarily adopted the National Statement as an organisational policy^[49] and some, including private hospitals, submit research proposals for ethics review by HRECs registered with AHEC.

14.44 Submissions acknowledged that there is no evidence that private sector research is being conducted other than in accordance with accepted ethical standards. Nevertheless, mechanisms to ensure private sector compliance were supported. For example, the Australian Medical Association stated that:

Although private sector research should not be stereotyped as being conducted in an ‘ethical vacuum’, there is certainly more scope for unethical conduct in that sector, and this certainly means that greater scrutiny of the private sector is required.^[50]

14.45 The potential for withdrawal of funding, the inability to publish research, and peer pressure from within the scientific and medical community, are powerful incentives for researchers and research organisations to comply with the National Statement. However, these incentives may be attenuated in relation to private sector research.

14.46 The Inquiry has concluded that there should be more formal requirements for private sector genetic research involving humans to comply with the National Statement and, in particular, with requirements for ethical review by an HREC constituted and operating in accordance with the National Statement.