Summary of National Statement Content

Section 1: Values and principles of ethical conduct

Sets out values and principles that apply to all human research. It is essential that researchers and review bodies consider these values and principles and be satisfied that the research proposal addresses and reflects them.

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

Discusses the concept of risk in research and the role of participants’ consent – themes in all human research – and is again essential for all users.

  • Chapter 2.1 will help researchers and reviewers to understand and describe the level of risk involved in the planned research, and how to minimise, justify and manage that risk, and (with reference to Chapter 5.1) what level of ethical review is suitable.
  • Chapters 2.2 and 2.3 will help to identify the information that needs to be disclosed to participants. It will help researchers to draft information for participants and plan the consent process (or develop a proposal for waiver of consent). And it will help reviewers to assess the suitability of the proposed consent process. 
  • All of Section 2 will help participants understand what information they are entitled to receive, and what their participation in research will characteristically involve.

Section 3: Ethical considerations specific to research methods or fields

This section will help researchers and reviewers to identify ethical matters specific to the research methods proposed.

  • Chapter 3.1 Qualitative methods will assist in consideration of research that examines experiences, behaviours and relationships.  
  • Chapter 3.2 Databanks discusses the principles to consider in a wide range of data types and methodologies. 
  • Chapter 3.3 Interventions and therapies, including clinical and non-clinical trials, and innovations focuses on human research designed to discover the effects of an intervention, especially randomised clinical trials. 
  • Chapter 3.4 Human biospecimens in laboratory based research provides guidance for institutions and those involved in research using human biospecimens (including human cell lines) with respect to consent, secondary usage and import/export.
  • Chapter 3.5 Human genetics assists with consideration of the ethical issues specific to genetic research. 

Section 4: Ethical considerations specific to participants

This section will help researchers and reviewers to identify ethical matters relating to specific categories of research participants. Participants in these categories will also find this Section valuable.

  • 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 assists in the consideration of the capacity of children, possible coercion and the conflicting values and interests of parents and children. 
  • Chapter 4.3 People in dependent or unequal relationships is about pre-existing relationships between participants and researchers or participants and 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 although their capacity to give consent is limited or non-existent. 
  • Chapter 4.5 People with a cognitive impairment, an intellectual disability, or a mental illness will assist in the design and review of research involving particularly vulnerable people. 
  • Chapter 4.6 People who may be involved in illegal activities will assist with research that exposes illegal activity whether intended or inadvertent. 
  • Chapter 4.7 Aboriginal and Torres Strait Islander Peoples provides guidance to researchers and HRECs concerning research with Aboriginal and Torres Strait Islander peoples. 
  • Chapter 4.8 People in other countries will assist researchers and HRECS reviewing research to be conducted overseas.

Section 5: Processes of research governance and ethical review

This section will help those involved in research governance to understand their responsibilities for research ethics and ethical review and monitoring of human research, and provides criteria for their accountability.

  • Chapter 5.1 Institutional responsibilities provides guidance on research governance, processes for ethical review, HREC establishment and procedures. 
  • Chapter 5.2 Responsibilities of HRECs, other ethical review bodies, and researchers will help researchers and reviewers to identify their responsibilities in relation to the ethical review of research. 
  • Chapter 5.3 Minimising duplication of ethical review provides guidance to institutions for the ethical review of research projects being conducted at multiple institutions, or by a researcher who has affiliations with multiple institutions, or jointly with other institutions. 
  • Chapter 5.4 Conflicts of interest assists individuals, review bodies and institutions in the management of conflicts of interest. 
  • Chapter 5.5 Monitoring approved research provides information regarding the process of verifying that the conduct of research is reliably monitored. 
  • Chapter 5.6 Handling complaints provides information for institutions regarding the handling of complaints about researchers, research, or HRECs. 
  • Chapter 5.7 Accountability assists individuals, review bodies and institutions in the understand lines of responsibility.