Summary of National Statement Content

Section 1: Values and principles of ethical conduct

This Section sets out the values and principles that apply to all human research. Researchers and review bodies must consider these values and principles when designing, reviewing and conducting research. Review bodies must be satisfied that each research proposal addresses and reflects each of the values and principles.

Section 2: Themes in research ethics: risk and benefit, consent

This Section discusses the concept of risk in research and the requirements for participant consent that apply to all human research.
Section 2 provides guidance for researchers and reviewers on:

  • assessing, justifying and managing risk
  • the components of valid consent, and
  • choosing appropriate consent strategies, or alternatives to consent.

Section 2 can also help participants understand what providing consent means and what information they can expect to receive to help them decide whether to agree to participate in a research project.

Section 3: Ethical considerations in the design, development, review and conduct of research

Section 3 provides guidance on the ethical considerations that are relevant to the way that research is designed, reviewed and conducted.

Section 3 is organised around seven ‘elements’ that are common to most forms of research and includes a chapter that applies to all types of research. Section 3 also provides specialised guidance for laboratory based research involving human biospecimens, genomics research and animal-to-human xenotransplantation research.

Section 4: Ethical considerations specific to participants

Section 4 discusses ethical matters that can arise from the inclusion of specific participants, communities or groups in research.

  • Chapter 4.1 Women who are pregnant and the human fetus provides guidelines for the ethical conduct of research involving women who are pregnant, the human fetus (ex utero), and human fetal tissue (after the separation of the fetus from the woman). 
  • Chapter 4.2 Children and young people addresses decision making capacity, requirements for consent and other issues in research involving children or young people. 
  • Chapter 4.3 People in dependent or unequal relationships discusses the impact of pre-existing relationships between participants and researchers or others involved in facilitating or implementing the research. 
  • Chapter 4.4 People highly dependent on medical care who may be unable to give consent describes conditions under which research involving people highly dependent on medical care might proceed even when their capacity to provide consent is limited or non-existent. 
  • Chapter 4.5 People with a cognitive impairment, an intellectual disability, or a mental illness addresses considerations related to research involving participants whose cognitive capacities may be temporarily, periodically or permanently compromised. 
  • Chapter 4.6 People who may be involved in illegal activities addresses research that intentionally or inadvertently exposes illegal activity by participants or others. 
  • Chapter 4.7 Aboriginal and Torres Strait Islander Peoples provides guidance to researchers and HRECs concerning research involving Aboriginal and Torres Strait Islander peoples. 
  • Chapter 4.8 People in other countries discusses research to be conducted overseas that may require review in Australia.

Section 5: Processes of research governance and ethical review

Section 5 establishes requirements for HRECs and addresses the responsibilities of institutions, ethics review bodies and researchers for monitoring human research. This Section also provides guidance on conflicts of interest and accountability.

  • Chapter 5.1 Institutional responsibilities provides guidance on research governance, processes for ethics review and the establishment and operation of HRECs. 
  • Chapter 5.2 Responsibilities of HRECs, other ethical review bodies, and researchers describes the responsibilities of ethics review bodies and researchers related to ethics review. 
  • Chapter 5.3 Minimising duplication of ethical review provides guidance to institutions on the requirement to eliminate unnecessary duplication of ethics review and how to achieve that outcome. 
  • Chapter 5.4 Conflicts of interest provides guidance to institutions and ethics review bodies on the management of conflicts of interest. 
  • Chapter 5.5 Monitoring approved research provides information for institutions, researchers and ethics review bodies on responsibilities for monitoring approved research. 
  • Chapter 5.6 Handling complaints provides information for institutions on handling complaints about researchers, individual research projects, or HRECs. 
  • Chapter 5.7 Accountability provides information on accountability for research and required reporting.