National Statement on Ethical Conduct in Human Research

"The National Statement is intended for use by:- any researcher conducting research with human participants- any member of an ethical review body reviewing that research- those involved in research governance- potential research participants.The National Statement is developed jointly by the National Health and Medical Research Council, the Australian Research Council and Universities Australia.The National Statement is subject to rolling review. This means that parts of the National Statement will be updated as needed, rather than reviewing the entire document every 5 years.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 patients.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, 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 widereaching 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." (Preamble)