Human research ethics committees

Research involving humans must be conducted in an ethical manner. All proposals for research involving human participants must be reviewed and approved by a Human Research Ethics Committee (HREC). There are also guidelines about accessing existing information and how it can be used by researchers.

An international code
The need for international standards governing the treatment of humans in research was highlighted after World War II. The Nuremberg military tribunal on war crimes set the foundation for ethical principles and many countries have since established their own guidelines. In most cases, the laws and codes are influenced by the 1964 Declaration of Helsinki, published by the World Medical Association and revised on numerous occasions since.

Guidelines for Australian research
The National Health and Medical Research Council (NHMRC) in Australia first published research ethics guidelines in 1999. These were revised in 2007 and the National Statement on Ethical Conduct in Human Research was fully implemented on 1 January 2008.

Each research application submitted to an HREC is now vetted to ensure that the proposed research is consistent with two sets of national Australian guidelines: the National Statement on Ethical Conduct in Human Research (2007) and the Australian Code for the Responsible Conduct of Research (2007). All research projects involving humans must be reviewed by a human research ethics committee and must not be undertaken until approval has been granted.

The DHS Human Research Ethics Committee
There are approximately 70 HRECs at various institutions (for example, in hospitals or universities) across Victoria. These review and approve research in their institutions. The Department of Human Services HREC reviews research proposals which:

• Involve human participants in research being undertaken by DHS
• Are undertaken by other agencies throughout Victoria that are funded by DHS but do not have their own HREC or access to a more appropriate HREC
• Involve the clients of agencies throughout Victoria that are funded by DHS but do not have their own HREC or access to a more appropriate HREC.

• Pregnant women and the human foetus
• Children and young people
• People in dependent or unequal relationships
• People highly dependent on medical care who may be unable to consent for themselves
• People with an intellectual or mental impairment
• People involved in illegal activities
• Aboriginal and Torres Strait Islander people
• People in other countries.

• Qualitative methods
• Databanks
• Interventions and therapies, including clinical and non-clinical trials, and innovations
• Use of human tissue samples
• Human genetic research
• Human stem cell research.

• A participant in any research project must be treated with respect as an autonomous human being.
• The research must be justifiable.
• The intended research must contribute to knowledge, using appropriate and honest methods, with a commitment to the pursuit and protection of truth.
• The potential for harm must be minimised, whether the harm is physical, psychological, emotional, economic, legal or social. The benefits likely to arise as a result of the research must justify any potential risks of harm or discomfort to participants.
• The research must take into account and respect individual and group beliefs, perceptions, customs and cultural heritage.
• The research must be fair and just and participants should have access to timely and clear research outcomes.
• Discussion of legal requirements is limited but it is highlighted that researchers and institutions should be aware of both general and specific legal requirements, wherever these are relevant.

• The research proposal must be based on a thorough study of current literature, prior observation, approved previous studies and, if relevant, laboratory and animal studies.
• The research must be conducted or supervised only by people or teams with experience, qualifications and competence appropriate to the research.
• Research must only be conducted using facilities appropriate for the research and where there are appropriate skills and resources for dealing with any contingencies that may affect the participants.
• The results of the research and the methods used should be published in ways that permit scrutiny and contribute to public knowledge.

• Executive Officer, Human Research Ethics Committee, Department of Human Services Tel. (03) 9096 5239 or email:

• Research involving humans must be conducted in an ethical manner.
• All proposals for research involving human participants must be approved by a Human Research Ethics Committee.
• Each research application is vetted to ensure that the proposed research conforms to the National Statement on Ethical Conduct in Human Research, published by the National Health and Medical Research Council in 2007.

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