Training sessions are available online on a regular basis. On-site sessions (Victoria only) can be arranged for organisations. To receive the training schedule or arrange a session, email firstname.lastname@example.org. Training is provided by the Coordinating Office for Clinical Trial Research, Victorian Department of Health and Human Services.
For information or support, contact the Coordinating Office for Clinical Trial Research, Victorian Department of Health and Human Services. Phone 03 9096 7394 or email email@example.com.
National Mutual Acceptance
National Mutual Acceptance (NMA) is a national system for mutual acceptance of scientific and ethical review of multi-centre human research projects conducted in publicly funded health services across jurisdictions. The Australian Capital Territory, New South Wales, Queensland, South Australia, Victoria and Western Australia participate in NMA. Single ethical and scientific review for a multi-centre human research project can be provided across the six participating states/territories.
For information on how to make an NMA Ethics application and NMA research governance/site specific assessment (SSA) application, click here.
Further information about the Human Research Ethics Application (HREA) is available on the NHMRC website here.
Human Research Ethics Committees
Human Research Ethics Committee (HRECs) play a central role in the Australian system of ethical oversight of research involving humans. HRECs review research proposals involving human participants to ensure that they are ethically acceptable and in accordance with relevant standards and guidelines.
There are more than 200 HRECs in institutions and organisations across Australia. Many other countries have similar systems.
In undertaking this role, HRECs are guided by relevant standards. Standards include those in the National Statement on Ethical Conduct in Human Research (the National Statement) issued by NHMRC. The National Statement sets out the requirements for the composition of an HREC and the relevant ethical principles and values by which research should be designed and conducted and to which HRECs should refer when reviewing research proposals. It also identifies requirements and responsibilities for:
Institutions/organisations in establishing HRECs
researchers in submitting research proposals to HRECs
HRECs in considering and reaching decisions regarding these proposals and in monitoring the conduct of approved research.
In some circumstances HRECs charge fees for considering research application.
Further information on HRECs is available on the NHMRC website here.
National Statement on Ethical Conduct in Human Research
Click here to access the latest version of the National Statement.
The National Statement on Ethical Conduct in Human Research (National Statement) consists of a series of guidelines made in accordance with the National Health and Medical Research Council Act 1992. It is intended for use by:
any researcher conducting research with human participants;
any member of an ethical review body reviewing that research;
those involved in research governance; and
potential research participants.
The National Statement is developed jointly by the National Health and Medical Research Council, the Australian Research Council and Universities Australia. It replaced the 1999 National Statement on Ethical Conduct in Research Involving Humans.
Compliance with the National Statement is a prerequisite for receipt of NHMRC funding.
inclusion of a a Project Description is a mandatory component of a submission using the HREA;
the purpose of a Project Description is to provide the scientific and academic background and context of a research project;
the section headings in this Project Description template represent a structure for presentation of information about a research project that meets the needs of an ethics review body;
not all headings or sub-headings in this template are relevant for each research project;
submissions of clinical trial proposals may use alternative protocol templates, such as the SPIRIT statement;
researchers may choose to submit an existing document (such as a protocol or project description that has already been developed) instead of developing a new document;
if researchers choose to submit an existing document instead of using one of the templates provided, they may need to provide indications to the ethics review body of where in the submitted document the content corresponding to the relevant fields in the template are located;
there is no need to duplicate information included in the HREA into the Project Description or vice versa; and
language that is understandable to non-technical reviewers should be used.
Researchers are strongly encouraged to address the following headings in their Project Description. Each dot point provides an example of the information that researchers might want to include, if relevant to their project.
Acronym (if appropriate)
Project Team Roles & Responsibilities
Names, affiliations, positions and responsibilities of investigators and other key project team members (as required in addition to that outlined in the HREA)
Identification of research sites or collaborating/contributing services or individuals not otherwise included in the HREA.
Resources necessary for the project to be conducted
Funding/support being sought or secured
Rationale/Justification (i.e. how the research will fill any gaps, contribute to the field of research or contribute to existing or improved practice)
Research project setting (physical sites, online forums and alternatives)
Rationale for choices of method/s (tied to project aims/objectives)
Rationale for the choice of any control arm
Description and number
Inclusion and exclusion criteria
Sample size and statistical or power issues
Participant recruitment strategies and timeframes (as required in addition to that outlined in the HREA)
Approach/es to provision of information to participants and/or consent (as required in addition to that outlined in the HREA)
If necessary, the type, timing and context of consent sought from different participant groups, and any arrangements to confirm or re-negotiate that consent.
If necessary, details of who will be confirming or re-negotiating consent with participants and the process/es that will be undertaken.
Research Activities: What you are going to do?
Data Collection/Gathering: What information are you going to collect/gather? (as required in addition to that outlined in the HREA)
Data collection/gathering techniques: How will you collect/gather the information?
Impact of and response to participant withdrawal
Data Management: How will you store, provide access to, disclose, use/re-use, transfer, destroy or archive the information that you collect/gather? (as required in addition to that outlined in the HREA)
Include a data management plan in accordance with National Statement 3.1.45 and 3.1.56
Data Analysis: How will you measure, manipulate and/or analyse the information that you collect/gather?
Matching and sampling strategies
Accounting for potential bias, confounding factors and missing information
Statistical power calculation
Data Linkage: What linkages are planned or anticipated?
For research involving an investigational drug or device as part of a clinical trial: What is/are the drug(s) and/or device(s):
Trade name (if any)
Supplier of drug/device (e.g. manufacturer/pharmacy)
Approved therapeutic indication, dosage/duration in Australia
Believed mode of action
Mode of excretion
Known adverse events
Known contra-indications or warnings
If arrangements have been made for the Pharmacy Department to receive or dispense the drugs involved in this project, explain how the drugs will be received and dispensed for the purposes of the research project.
Results, Outcomes and Future Plans
Plans for return of results of research to participants
Include an ethically defensible plan in accordance with National Statement 3.1.65 or 3.2.15 or 3.3.36-3.3.61, as appropriate
Plans for dissemination and publication of project outcomes
Other potential uses of the data at the end of the project
Project closure processes
Plans for sharing and/or future use of data and/or follow-up research
Participation of members of defined populations in research occurs as a consequence of recruiting them as a research cohort or as individuals whose participation can be anticipated as being likely or foreseeable. For example, a research project may target people who have a specific disease, disability or impairment or who are migrants from a particular country or it may, because of the setting and nature of the research, be likely to include individuals from these groups.
It is also possible that individuals from a defined population will be recruited into a research project without in any way being targeted by virtue of their being present in the general population from which the participants are being recruited. This is often referred to as ‘incidental’ recruitment.
This distinction is important, as the purpose of considering the ethical implications of recruiting members of defined populations, whether they are considered to be ‘vulnerable populations’ or not, is to address those implications as they relate to the likely or foreseeable recruitment of these individuals, not as they relate to the incidental recruitment of these individuals.
Researchers should use common sense and a ‘project-specific’ approach in applying this principle: if it is foreseeable that a portion of the projected participants in a specific research project will be eligible for recruitment as a result of a defined population being specifically targeted or as a result of demographic or other factors, then those ethical considerations that are specific to that group should be addressed. Whereas, if this is not the case, then the fact that it is conceivably possible that individuals who are members of a group will be recruited, but the project is not directed toward that group and the numbers of these individuals will be small, then the ethical considerations that are specific to that group may not need to be addressed.
In Australia, the issue of intended, likely, foreseeable or incidental recruitment is of particular importance when considering the inclusion of Aboriginal and Torres Strait Islander people in research. The ethics committees that are established to perform review of research that targets or is likely to involve Aboriginal and Torres Strait Islander people have valuable guidance on when and how to apply the guidelines that are appropriate to this research, including definitions that may be useful for researchers.
Researchers and review bodies are jointly responsible for assessing whether recruitment is likely and foreseeable or incidental. Incorrectly designating the recruitment of a specific population as incidental may result in a deficient ethics application, which may be returned to the researcher by the review body for appropriate modification.