In addition to the ethical considerations pertaining to all research participants, specific issues arise in the design, conduct and ethical review of research involving the categories of participants identified in this section.

The Introduction to this National Statement contains a definition of participants and notes that the impact of research on wider populations is an important ethical consideration in the design, review and conduct of human research.

Human research may be conducted only with ethical approval. Section 5 describes the processes that institutions may use to provide that approval. Those processes include ethical review by Human Research Ethics Committees (HRECs) or other ethical review bodies, according to the risks of the research (see paragraphs 5.1.6 to 5.1.8).

Ethical review by an HREC is required for any research that involves more than low risk (see paragraph 5.1.6). It is also required for research discussed in several chapters of Section 3, as well as for research discussed in the following chapters of this section: Chapter 4.1: Women who are pregnant and the human fetus, Chapter 4.4: People highly dependent on medical care who may be unable to give consent, Chapter 4.5: People with a cognitive impairment, an intellectual disability, or a mental illness, Chapter 4.6: People who may be involved in illegal activities, Chapter 4.7: Aboriginal and Torres Strait Islander Peoples and Chapter 4.8: People in other countries.

As stated at the end of Section 1, this National Statement does not exhaust the ethical discussion of human research. Even a single research field covers a multitude of different situations about which the National Statement will not always offer specific guidance, or to which its application may be uncertain. Where other guidelines and codes of practice in particular research fields are consistent with the National Statement, researchers and members of ethical review bodies should draw on them when necessary to clarify researchers’ ethical obligations in particular contexts.