Consequences of non-compliance with the National Statement

14.3 The National Statement provides that the NHMRC, through the Australian Health Ethics Committee (AHEC), will audit the activities of HRECs to ensure compliance with the National Statement.[2] The National Statement requires institutions and their HRECs to present an annual compliance report on their ethics approval procedures.[3] The requirements for HRECs to register with the NHMRC, report annually and follow the processes in the National Statement (and other guidelines) are not mandated by legislation.

14.4 AHEC presents an annual report of HREC activities to the Council of the NHMRC. The Council in turn reports to the Commonwealth Parliament. The AHEC report includes a statement on the compliance reports received from HRECs in that year. AHEC may name any non-compliant HREC and its institution, although this power has not yet been required to be exercised.

14.5 Despite the lack of statutory powers of enforcement, there has been a high level of voluntary compliance by HRECs with the requirements of the National Statement. The Centre for Law and Genetics observed that

the general acceptance by all research institutions of the National Statement has, in effect, if not in law, created a uniform research regime.[4]

14.6 The power to withdraw funding is the most important and direct mechanism by which the NHMRC may induce compliance with the National Statement. An assessment of the scope and effectiveness of potential withdrawal of NHMRC funding as an incentive to comply requires an understanding of how medical research in general, and human genetic research in particular, is funded in Australia. The funding of medical research and the withdrawal of funding are discussed below.

14.7 Non-compliance with the National Statement may have other consequences for researchers and research organisations. For example, the Human Genetics Society of Australasia (HGSA) noted that other sanctions include:

disciplinary action by the employer, rejection of articles by journals in the absence of ethics committee approval, peer group censure and public disclosure of unethical conduct.[5]

14.8 Some additional factors that encourage compliance with the National Statement are described in more detail below.

Withdrawal of funding

14.9 The NHMRC is one of the major providers of medical research funding to institutions such as hospitals, universities and research institutes. The NHMRC also makes recommendations to the Commonwealth on expenditure for research and training in medicine and public health, including recommendations on the application of the Medical Research Endowment Fund.[6] The National Statement has been endorsed by the Australian Research Council and other bodies that have a role in research, such as the Australian Vice-Chancellors’ Committee and the learned Academies.

14.10 It is a condition of an institution’s continuing eligibility to receive NHMRC funding that all research involving humans conducted in the institution must be approved by an HREC that has been established under, and functions according to, guidelines issued by the NHMRC. Compliance with the National Statement is also a condition of NHMRC grants of research funds. In the event that reporting by research organisations and their HRECs reveals that they have not complied with the National Statement, implementation of NHMRC policy may result in that institution ceasing to be eligible to receive funding for research. The effectiveness of this mechanism has not needed to be tested in Australia, but American experience suggests that withdrawal, or threat of withdrawal, of funding by the peak research funding body has salutary effects upon institutions.[7]

NHMRC funding

14.11 In assessing the scope and effectiveness of potential withdrawal of NHMRC funding as an incentive to comply with the National Statement, it is important to note that the NHMRC is the largest single provider of peer-reviewed health research funds. In 2002, the NHMRC’s research expenditure was $277.1 million.[8] In 2001, funding through NHMRC accounted for 34% of public sector funding, 27% of total government funding and 18% of total expenditure on health and medical research in Australia.[9]

14.12 While it may appear, from the 18% figure, that much health and medical research lies outside NHMRC funding, in practice, the influence of NHRMC funding decisions extends beyond projects that receive direct funding. Researchers and research organisations commonly derive funds from a variety of sources. It is common for research to be supported by private sector funding but conducted at publicly funded institutions that require compliance with the National Statement and other NHMRC guidelines.

14.13 Further, any withdrawal of funding by the NHMRC, once made public, would be likely to be followed by action by other funding bodies,[10] such as those responsible for the allocation of non-NHMRC Commonwealth government research funds or state government funds for hospital research activities.

Private sector funding

14.14 The 1999 Wills Report, which resulted from a major strategic review of health and medical research in Australia, provided the following breakdown of total expenditure on health and medical research.[11] No similar breakdown is available for human genetic research specifically.

Table 14–1 Expenditure on Health and Medical Research by Sector

Commonwealth government and higher education 47.5%

State government 24.5%

Private non-profit 15.9%

Business enterprise 12.1%

TOTAL 100%

14.15 If these figures are assumed to apply to human genetic research as they do to health and medical research generally, between 25% and 30% of research funding may be provided by the private sector and therefore lie beyond the direct reach of the NHMRC.

14.16 However, the distinction between public and private research should not be overstated. Public and private research funding may converge in the same research projects. For example, one feature of medical and other research in Australia is the Cooperative Research Centre Program. Cooperative Research Centres (CRCs) are collaborative research ventures involving researchers from Commonwealth and state government funded organisations (such as universities and university-based research institutes), private non-profit organisations and business enterprise.[12]

Other consequences of non-compliance

14.17 The withdrawal of NHMRC funding remains a powerful incentive for public sector researchers and research institutions to comply with the National Statement. In addition, compliance is required or encouraged by other factors, including privacy laws, therapeutic goods legislation, concern about professional standing and publication, and the threat of potential litigation.

Privacy law

14.18 As discussed in Chapter 15, the Privacy Act 1988 (Cth) (Privacy Act) and other privacy legislation imposes legal requirements to obtain consent to the collection, use or disclosure of personal information, including genetic information. These requirements may be waived where collection of the information is for research purposes and is carried out in accordance with guidelines issued by the NHMRC and approved by the federal Privacy Commissioner under s 95 or s 95A of the Privacy Act (the s 95 and s 95A Guidelines).

14.19 The s 95 and s 95A Guidelines require consideration, by an HREC, of whether the public interest in the research outweighs to a substantial degree the public interest in compliance with privacy principles.[13] In some circumstances, a determination by an HREC to waive consent, made other than in compliance with the National Statement, may constitute a breach of the Privacy Act.

14.20 This may lead to researchers or research organisations being named in the NHMRC’s annual report or in a report to a Commonwealth agency or the federal Privacy Commissioner.[14] Naming can be expected to affect adversely the reputation of the named researchers or research organisations, their employment prospects and capacity to attract future research funding.

14.21 Further, where the conduct of a private sector researcher or research organisation is in breach of the Privacy Act, affected individuals may complain to, and have their complaints investigated by, the federal Privacy Commissioner or by an adjudicator under an approved privacy code.[15] The Privacy Commissioner may make determinations declaring that conduct constituting an interference with the privacy of an individual should cease and that compensation for loss or damage be paid.[16] Such determinations, and similar determinations of adjudicators, are enforceable in proceedings before the Federal Court or Federal Magistrates Court.[17]

Therapeutic Goods Regulations

14.22 The Therapeutic Goods Regulations 1990 (Cth) provide that unregistered therapeutic goods may be used in clinical trials only on certain conditions.[18] These conditions include a requirement that the use is in accordance with the National Statement as published by the NHMRC from time to time.[19] Non-compliance with the National Statement in effect renders unlawful the continued use of unregistered therapeutic goods.[20]

Professional standing and publication

14.23 Non-compliance with accepted ethical standards, including the National Statement, may have consequences for how individual researchers are viewed by their peers.

Professional peer pressures and the need for acceptance of research outcomes in the international scientific community are powerful drivers in this area.[21]

14.24 Compliance with the National Statement and other ethical standards may be a pre-requisite for publication of the results of research and the professional benefits that derive from publication.[22] The World Medical Association’s Ethical Principles for Medical Research Involving Human Subjects(the Helsinki Declaration) states that reports of experimentation not in accordance with the ethical principles laid down in the Declaration should not be accepted for publication.[23] The International Committee of Medical Journal Editors requires authors, when reporting experiments on human subjects, to ‘indicate whether the procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional or regional) and with the Helsinki Declaration’.[24]

The National Statement and litigation

14.25 The principles of ethical conduct and the process for ethical scrutiny of research proposals set out in the National Statement constitute accepted standards of research practice. The conduct of a researcher or research organisation may be compared with these standards in any litigation arising from a research project in which, for example, a question arises as to whether reasonable care was taken. In this context, an analogy may be drawn with clinical practice guidelines,[25] including those issued by the NHMRC itself.

14.26 Courts may take standards for the conduct of human research set out in the National Statement as evidence of accepted professional standards of practice. It has been said that the evidentiary value of clinical practice guidelines depends on their purpose, development, ratification, dissemination, use, and whether they are current.[26] On this basis, a court might find the National Statement influential or even decisive evidence.

[2] Ibid [2.46].

[3] These reporting requirements are discussed in more detail in Ch 17.

[4] Centre for Law and Genetics, Submission G255, 21 December 2002.

[5] Human Genetics Society of Australasia, Submission G267, 20 December 2002.

[6] The Medical Research Endowment Fund is established by the National Health and Medical Research Council Act 1992 (Cth) s 49.

[7] See R Steinbrook, ‘Protecting Research Subjects — The Crisis at Johns Hopkins’ (2002) 346 New England Journal of Medicine 716. The frequency with which these powers are used is an important element in their effectiveness. See the published letters sent by the US Office for Human Research Protections to research organisations: Office for Human Research Protections, Compliance Oversight, US Department of Health and Human Services, <>, 14 March 2003.

[8] National Health and Medical Research Council, Investing in Australia’s Health (2002) National Health and Medical Research Council, 45.

[9] National Health and Medical Research Council, Correspondence, 13 February 2003.

[10] National Health and Medical Research Council Research Committee, Submission G128, 18 March 2002.

[11]Health and Medical Research Strategic Review, The Virtuous Cycle, Working Together for Health and Medical Research (1999), Commonwealth of Australia, Canberra, 166, Exhibit 5.0–5. These figures were based on ABS 1996 data and NHMRC 1994 data.

[12] The total 1999–2000 public and private sector funding for the Gene CRC was $40.6 million of which Commonwealth CRC program funding comprised $13.1 million. The core participants, including the private sector partner (Cerylid), provided the balance of the resources: CRC for Discovery of Genes for Common Human Diseases, CRC for Discovery of Genes for Common Human Diseases, Gene CRC, <>, 3 May 2002.

[13] National Health and Medical Research Council, Guidelines Under Section 95 of the Privacy Act 1988 (2000), NHMRC, Canberra 3.2(b); National Health and Medical Research Council, Guidelines Approved Under Section 95A of the Privacy Act 1988 (2001) National Health and Medical Research Council, D.4.

[14] National Health and Medical Research Council, Guidelines Under Section 95 of the Privacy Act 1988 (2000), NHMRC, Canberra [4.3].

[15] See Privacy Act 1988 (Cth) Pt V.

[16] Ibid s 52.

[17] Ibid s 55A.

[18]Therapeutic Goods Act 1989 (Cth) s 19; Therapeutic Goods Regulations 1990 (Cth) r 12AD.

[19]Therapeutic Goods Regulations 1990 (Cth) r 12AD(c).

[20]Therapeutic Goods Act 1989 (Cth) ss 19–22.

[21] Office of the Federal Privacy Commissioner, Submission G143, 22 March 2002.

[22] Although it is debateable whether, in the case of path-breaking new research results, publishers will be so scrupulous in this regard.

[23] World Medical Association, Ethical Principles for Medical Research Involving Human Subjects (2000), Helsinki, Principle 27.

[24] International Committee of Medical Journal Editors, Uniform Requirements for Manuscripts Submitted to Biomedical Journals, <>, 3 May 2002.

[25] See J Pelly and others, ‘Clinical Practice Guidelines Before the Law: Sword or Shield?’ (1998) 169 Medical Journal of Australia 330, 330–333; B Bennett, ‘Setting the Standard? Clinical Practice Guidelines and Medical Negligence Litigation’ (1997) 20 University of New South Wales Law Journal 707.

[26] F Tito and L Newby, Medico-Legal Implications of Clinical Practice Guidelines (1998) National Breast Cancer Centre.