Ethical background

All human interaction, including the interaction involved in human research, has ethical dimensions. However, ‘ethical conduct’ is more than simply doing the right thing. It involves acting in the right spirit, out of an abiding respect and concern for one’s fellow creatures. This National Statement on ‘ethical conduct in human research’ is therefore oriented to something more fundamental than ethical ‘do’s’ and ‘don’ts’ – namely, an ethos that should permeate the way those engaged in human research approach all that they do in their research.

Human research is research conducted with or about people, or their data or tissue. It has contributed enormously to human good. Much human research carries little risk and in Australia the vast majority of human research has been carried out in a safe and ethically responsible manner. But human research can involve significant risks and it is possible for things to go wrong. Sometimes risks are realised despite the best of intentions and care in planning and practice. Sometimes they are realised because of technical error or ethical insensitivity, neglect or disregard. On rare occasions the practice of research has even involved the deliberate and appalling violation of human beings – notoriously, the Second World War experiments in detention and concentration camps.

This range of possibilities can give rise to important and sometimes difficult ethical questions about research participation. Two considerations give further weight to those questions. First, research participants may enter into a relationship with researchers whom they may not know but need to trust. This trust adds to the ethical responsibility borne by those in whom it is placed. Secondly, many who contribute as participants in human research do so altruistically, for the common good, without thought of recompense for their time and effort. This underscores the importance of protecting research participants.

Since earliest times, human societies have pondered the nature of ethics and its requirements and have sought illumination on ethical questions in the writings of philosophers, novelists, poets and sages, in the teaching of religions, and in everyday individual thinking. Reflection on the ethical dimensions of medical research, in particular, has a long history, reaching back to classical Greece and beyond. Practitioners of human research in many other fields have also long reflected upon the ethical questions raised by what they do. There has, however, been increased attention to ethical reflection about human research since the Second World War. The judgment of the Nuremberg military tribunal included ten principles about permissible medical experiments, since referred to as the Nuremberg Code. Discussion of these principles led the World Medical Assembly in 1964 to adopt what came to be known as the Helsinki Declaration, revised several times since then. The various international human rights instruments that have also emerged since the Second World War emphasise the importance of protecting human beings in many spheres of community life. During this period, written ethical guidelines have also been generated in many areas of research practice as an expression of professional responsibility.

But what is the justification for ethical research guidelines as extensive as this National Statement on Ethical Conduct in Human Research (‘National Statement’), and for its wide-reaching practical authority?

The National Statement has been extended to address many issues not discussed in the previous version, or discussed in less detail. This is in response to requests for clearer guidance for those conducting research and those involved in its ethical review. At the same time, without compromising the protection of participants, the revised National Statement provides for greater flexibility in the practice of ethical review, depending on the type and area of research and the degree of risk involved.

Research often involves public interaction between people that serves a public good. There is, therefore, a public responsibility for seeing that these interactions are ethically acceptable to the Australian community. That responsibility is acknowledged and given effect in the wide-reaching authority of this National Statement, which sets out national standards for the ethical design, review and conduct of human research. Its content reflects the outcome of wide consultation with Australian communities who participate in, design, conduct, fund, manage and publish human research.

Research governance

The National Statement should be seen in the broader context of overall governance of research. It not only provides guidelines for researchers, Human Research Ethics Committees (HRECs) and others conducting ethical review of research, but also emphasises institutions’ responsibilities for the quality, safety and ethical acceptability of research that they sponsor or permit to be carried out under their auspices.

Responsibility for the ethical design, review and conduct of human research is in fact exercised at many levels, by: researchers (and where relevant their supervisors); HRECs and others conducting ethical review of research; institutions that set up the processes of ethical review, and whose employees, resources and facilities are involved in research; funding organisations; agencies that set standards; and governments. While the processes of ethical review are important in this field, individual researchers and the institutions within which they work hold primary responsibility for seeing that their research is ethically acceptable.

In addition to this National Statement, the Australian code for the responsible conduct of research [1] (‘the Research Code’) has an essential role in promoting good research governance. That Research Code sets down the broad principles of responsible and accountable research practice, and identifies the responsibilities of institutions and researchers in areas such as data and record management, publication of findings, authorship, conflict of interest, supervision of students and research trainees, and the handling of allegations of research misconduct.

Authors of this National Statement

This National Statement has been jointly developed by the National Health and Medical Research Council (NHMRC), the Australian Research Council (ARC) and the Australian Vice-Chancellors’ Committee (AVCC). This joint undertaking reflects a widely shared conviction that there is a need for ethical guidelines that are genuinely applicable to all human research; and it gives expression to the shared responsibility for ethically good research described above.

The National Health and Medical Research Council Act 1992 (NHMRC Act) establishes the NHMRC as a statutory body and sets out its functions, powers and obligations. Section 10(1) of the Act requires the Chief Executive Officer to issue human research guidelines precisely as developed by the Australian Health Ethics Committee (AHEC) and provided to the CEO by the Council. AHEC is established by the NHMRC Act as a Principal Committee of the NHMRC. All the guidelines in this National Statement that are applicable to the conduct of medical research involving humans are issued by the NHMRC in fulfilment of this statutory obligation.

The Australian Research Council Act 2001 (ARC Act) establishes the ARC to provide the responsible Minister with advice and recommendations about research, including which research programs should receive financial assistance. The functions of the ARC also include administering the regimes of financial assistance for research and providing for the funding of research programs.

The Australian Vice-Chancellors’ Committee (AVCC) is the council of Australia’s university vice-chancellors (or presidents). Its purpose is to advance higher education through voluntary, cooperative and coordinated action, and to serve the best interests of Australia’s universities and, through them, the nation. The AVCC acts as a consultative and advisory body for all university affairs, making submissions to public inquiries of interest to the university sector, and preparing statements on major issues.