28.07.2010

Present regulatory framework for research ethics

The NHMRC

13.17 The NHMRC is the statutory authority that governs the principles and procedures applicable to medical research and ethical matters relating to health. The National Health and Medical Research Council Act 1992 (Cth) (NHMRC Act) establishes the NHMRC as a statutory corporation and prescribes its membership.[18]

13.18 The functions of the NHMRC are to inquire into, issue guidelines on, and advise the Commonwealth, the States and the community on matters relating to the improvement of health; prevention, diagnosis and treatment of disease; provision of health care; public health and medical research; and ethical issues relating to health.[19]

The National Statement

13.19 In relation to medical research, the NHMRC Act requires the NHMRC to issue guidelines for the conduct of medical research on humans, which are to be issued precisely as developed by the Australian Health Ethics Committee,[20] one of its principal committees. The present National Statement was issued by the NHMRC on 28 June 1999 in exercise of these statutory obligations.[21] It is the successor document to the NHMRC Statement on Human Experimentation, first issued in 1966.

13.20 The National Statement is endorsed by the Australian Vice-Chancellors’ Committee, the Australian Research Council, the Australian Academy of the Humanities, the Australian Academy of Science, and the Academy of the Social Sciences in Australia. Briefly, the National Statement:[22]

    • contains ethical principles relevant to all research involving humans;

    • requires that particular matters are to be addressed when research involves children and young people, persons with an intellectual or mental impairment, persons highly dependent on medical care, those in dependent or unequal relationships, collectivities, and Aboriginal and Torres Strait Islander people;

    • requires that specific matters be addressed in the consideration and approval of research involving radiation, assisted reproductive technology, clinical trials, epidemiology, human tissue samples, genetics, or deception in the conduct of research; and

    • sets out the formation, membership and functions of HRECs.

Human Research Ethics Committees

13.21 The primary function of an HREC is to protect the welfare and rights of participants in research. An often overlooked secondary purpose of the National Statement and thus of HRECs is to ‘facilitate research that is or will be of benefit to the researcher’s community or to humankind’.[23]

13.22 The National Statement provides that research proposals involving human participants must be reviewed and approved by an HREC. The National Statement sets out requirements that must be followed by institutions or organisations in establishing HRECs, by researchers in submitting research proposals to HRECs, and by HRECs in considering and reaching decisions regarding those proposals and in monitoring the conduct of approved research.[24] The National Statement places clear responsibilities upon institutions and researchers as well as providing the framework upon which the Australian system of research ethics review by HRECs is based.[25]

Other regulatory mechanisms

13.23 In addition to the role of the NHMRC, HRECs and the National Statement, the ethical and legal framework for conducting research in Australia includes the following:[26]

    • relevant statutory restrictions on dealing with personal information (which may include genetic information), including those under the Privacy Act 1988 (Cth) and related guidelines;[27]

    • the common law duty to exercise reasonable care, which is owed by researchers, research organisations and HRECs to participants in research;[28]

    • standards for the scientific validity of research, notably the Statement and Guidelines on Research Practice issued by the NHMRC and the Australian Vice-Chancellor’s Committee;[29] and

    • NHMRC guidelines applying to specific types of research, such as the NHMRC Guidelines for Ethical Review of Research Proposals for Human Somatic Cell Gene Therapy and Related Therapies.[30]

[18] National Health and Medical Research Council Act 1992 (Cth) ss 6, 20–21.

[19] Ibid s 7.

[20] Ibid s 8.

[21] The National Statement does not include updated references to the new private sector provisions of the Privacy Act (and the NPPs), particularly in relation to consent and collection issues.

[22] National Health and Medical Research Council, National Statement on Ethical Conduct in Research Involving Humans (1999), NHMRC, Canberra.

[23] Ibid Preamble.

[24] Ibid [2].

[25] Selected issues concerning the membership and functions of HRECs are discussed in more detail in Ch 17.

[26] This regulatory framework was described in more detail in Australian Law Reform Commission and Australian Health Ethics Committee, Protection of Human Genetic Information, IP 26 (2001), ALRC, Sydney, Ch 6. The National Statement is supplemented by commentary in the National Health and Medical Research Council, Human Research Ethics Handbook (2002), NHMRC, Canberra.

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

[28] In accordance with the common law relating to the tort of negligence. The Law Institute of Victoria noted that the ‘proximity’ of the relationship is no longer seen as the unifying criterion of duties of care: see the decision of the High Court in Perre v Apand Pty Ltd (1999) 198 CLR 180, 209. Researchers, research organisations and HRECs may be liable to third parties, including families, relatives and other parties who suffer reasonably foreseeable loss or damage: Law Institute of Victoria, Submission G275, 19 December 2002.

[29] National Health and Medical Research Council and Australian Vice Chancellors’ Committee, Statement and Guidelines on Research Practice (1997), NHMRC, Canberra.

[30] National Health and Medical Research Council, Guidelines for Ethical Review of Research Proposals for Human Somatic Cell Gene Therapy and Related Therapies (1999), National Health and Medical Research Council, Canberra.