SECTION 3: ETHICAL CONSIDERATIONS SPECIFIC TO RESEARCH METHODS OR FIELDS

This section discusses various research methods and fields. Some chapters are a result of the further expansion of this revised National Statement beyond health and medical research. The focus is on general principles – the section is not intended to be exhaustive. It reflects the interdisciplinary nature of many types of research and the use, in some research projects, of a number of different research methods.

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 (paragraph 5.1.6). It is also required for research discussed in Chapter 3.3: Interventions and therapies, including clinical and non-clinical trials, and innovations, and Chapter 3.5: Human genetics, as well as for research discussed in several chapters of Section 4.

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.