1. What is ‘human research’?
2. What is ‘human research ethics’ about?
3. What is a 'human research ethics committee'?
4. Why do I need to get ethics approval? Some background to the development of the HREC system.

1. What is ‘human research’?

According to the National Statement on Ethical Conduct in Human Research 2007, human research is conducted with or about people, their data or tissue.Human participation in research is therefore to be understood broadly, to include involvement of human beings through:

• Taking part in surveys, interviews or focus groups.
• Undergoing psychological, physiological or medical testing or treatment.
• Being observed by researchers.
• Researchers having access to their personal documents or other materials.
• The collection and use of their body organs, tissues or fluids (e.g. skin, blood, urine, saliva, hair bones, tumor and other biopsy specimens) or their exhaled breath.
• Access to their information (in individually identifiable, re-identifiable or non-identifiable form) as part of an existing published or unpublished source or database.

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2. What is ‘human research ethics’ about?

Human research ethics is concerned with the ethical principles and values, which should be central to the involvment of people in research. There are four key principles that inform the National Statment on Ethical Conduct in Human Research 2007, and these should inform all research projects.

Research Merit and Integrity: which means regard for the integrity of the researcher and the research to be undertaken;
Justice: which means asking who ought to receive the benefits of research and bear its burdens
Beneficence: which means the obligation to maximize possible benefits and minimize possible harms;
Respect: for people, which means respect for their dignity and rights;

These principles are discussed in Section 1 of the National Statement on Ethical Conduct in Human Reserach 2007 .

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3. What is a ‘human research ethics committee’?

A Human Research Ethics Committee (HREC) reviews research projects, which involve humans as participants in the research. The HREC considers initial applications and reviews the progress of projects that it has approved. An HREC gives special attention to projects that involve potentially sensitive or contentious areas of study, particular methodologies or particular kinds of people.

Committee membership

The minimum membership of an HREC is 8 men and women, comprising of:

• a chairperson, with suitable experience, whose other responsibilities will not impair the HREC’s capacity to carry out its obligations under this National Statement;
• at least two lay people, one man and one woman, who have no affiliation with the institution and do not currently engage in medical, scientific, legal or academic work;
• at least one person with knowledge of, and current experience in, the professional care, counselling or treatment of people; for example, a nurse or allied health professional;
• at least one person who performs a pastoral care role in a community, for example, an Aboriginal elder, a minister of religion;
• at least one lawyer, where possible one who is not engaged to advise the institution; and
• at least two people with current research experience that is relevant to research proposals to be considered at the meetings they attend. These two members may be selected, according to need, from an established pool of inducted members with relevant expertise.

An HREC is constituted and operates in accordance with the guidelines set down in the National Statement on Ethical Conduct in Human Research 2007, which were developed by the National Health and Medical Research Council (NHMRC). These guidelines are prescriptive in some areas but in other areas allow flexibility in interpretation and decision-making.

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4. Why do I need to get ethics approval? Some background to the HREC system.

HREC process as they exist today have come about in response to some terrible harms that have occurred to very vulnerable people as a result of participation in research. Three famous examples are attrtocities committed in the Nazi concentration camps of the Second world war which resulted in the now famous Nuremberg Trials, which set up the principles for informed consent as it is understood today (1940’s) the Tuskegee Syphilis Experiments (1930-70’s) in the USA, and the New Zealand Cervical Cancer Experiments (1970’s-80’s)

As a reuslt of terrible occurances such as occured in the above examples, the need to protect the rights and interests of people taking part in research research has been recognised internationally in statements such as

• The Nuremberg Code (1949) following the revelation of unethical practices during WWII
• World Medical Assembly’s Declaration of Helsinki (first printed 1965; last revised 1996).
• In Australia a Statement on Human Experimentation was produced initially by the National Health and Medical Research Council (NHMRC) in 1966, based on the Declaration of Helsinki.
• The Statement on Human Experimentation has undergone several revisions and the current edition, the National Statement on Ethical Conduct in Human Research (2007)is a national standard for the conduct of ethical research in Australia.

The HREC system operates to ensure that these guidleines are implemented to protect all people involved in research.The National Statement is intended for use by any researcher conducting research with human participants, any member of an ethical review body reviewing research (HREC), those involved in research governance and potential research participants.

The purpose of the National Statement is to promote ethically good human research. Fulfilment of this purpose requires that participants be accorded the respect and protection that is due to them. It also involves the fostering of research that is of benefit to the community.

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