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Protecting human subjects – the new guide

In brief: Lawyer Damien van der Toorn discusses the new Human Research Ethics Handbook - an ethical guide to research involving humans.

The National Health and Medical Research Council has launched a new Human Research Ethics Handbook. The Handbook provides commentary on the National Statement on Ethical Conduct in Research Involving Humans already developed by the NHMRC in 1999. It is designed to assist Human Research Ethics Committees in deciding the ethical acceptability of research projects involving humans, however it will also assist researchers in designing and conducting ethically sound research.

The National Statement

The National Statement regulates the operation of Human Research Ethics Committees. More importantly however, it sets out the principles of ethical conduct governing research involving humans. The basic principles are integrity of research, respect for persons, beneficence and justice. The purpose of the principles is the protection of the welfare and rights of participants in research.

The National Statement outlines principles of ethical conduct in areas of research involving:

  • children and young people;
  • persons with an intellectual or mental impairment;
  • persons highly dependent on medical care;
  • persons in dependent or unequal relationships; and
  • cultural, ethnic and indigenous persons.

Ethical guidelines are also provided for a diverse range of research areas, including:

  • clinical trials;
  • human genetic research; and
  • use of human tissue samples.

There are also privacy guidelines protecting the use of information relating to participants.

The Handbook

The Handbook provides guidelines for the application of the ethical principles outlined in the National Statement.It is divided into three parts:

  • a commentary on the National Statement - an explanation why ethical principles have been included in the National Statement and suggestions on how the principles might be implemented by an HREC or researcher;
  • a research ethics collection - a collection of opinions on recurrent issues on ethics relevant to research involving humans; and
  • a research law collection - a collection of materials on recurrent legal issues relevant to research involving humans.

The ethics and law collections will be updated from time to time as new issues emerge.

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Who will use the Handbook?


The Handbook will be used principally by Human Research Ethics Committees and researchers.

Currently, there are over 200 HRECs operating in hospitals, universities, Government agencies and the private sector around Australia. Any research proposals involving human participants must be approved by an HREC. Organisations are prohibited from funding research projects without an HREC approval. The committees are also responsible for reviewing and monitoring ongoing projects to ensure compliance.

Researchers will consult the Handbook in seeking approval of HRECs for research involving human participants. Researchers will also use the Handbook for guidance on how to conduct ongoing research projects within ethical principles contained in the National Statement.

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What if you breach an ethical principle?

If an HREC is satisfied that a research project is not being conducted in accordance with the ethical guidelines and that, as a result, the welfare and rights of participants will not be protected, the HREC can:

  • withdraw approval;
  • inform the researchers, institutions or organisations of such a withdrawal; and
  • recommend to the institutions or organisations that the research be discontinued, suspended or that other steps be taken.

If ethical approval is withdrawn, the research must not be continued.

Accordingly, researchers proposing to conduct research involving human participants would be strongly advised to consult the Handbook for guidance on how to formulate their proposals to obtain HREC approval and to conduct their ongoing research. The Handbook gives necessary insight into the likely application of the ethical principles by HRECs.