Section 5: Processes of research governance and ethical review

Human research encompasses a wide range of activities with an equally wide range of risks and potential benefits. The National Statement allows for different levels of ethical review of research, reflecting the difference in degree of risk involved (see Chapter 2.1: Risk and benefit).

This Section sets out the processes by which institutions establish, conduct and oversee those different levels of ethical review, and includes the operations of Human Research Ethics Committees (HRECs). The section also describes other processes of research governance that must be in place if the ethical review of research is to be undertaken well. These are considered only briefly, as they are more fully set out in the Australian code for the responsible conduct of research.