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National Statement on Ethical Conduct in Human Research

The National Statement on Ethical Conduct in Human Research (2007) - Updated December 2013 is one of two key national documents* which guide and influence the way research is conducted and managed. Both documents place greater emphasis on institutional responsibilities and accountability in the conduct of ethical research and more clearly outline the responsibilities of researchers.


About the National Statement

This second edition of the National Statement was endorsed by the Federal Government in March 2007. It is a revised edition of the 1999 Statement and has been co-issued by the National Health and Medical Research Council (NHMRC), the Australian Research Council (ARC) and the Universities Australia. The National Statement contains Australia's primary guidelines for the ethical conduct of research involving human participants. The National Statement 2007 consists of five parts:

  1. Values and Principles of Ethical Conduct
  2. Themes in research ethics: risk and benefit, consent
  3. Ethical considerations specific to research methods or fields
  4. Ethical considerations specific to participants
  5. Processes of research governance and ethical review

The main changes from the 1999 National Statement are as follows:

  • 2.1 Risk
  • 3.1 Qualitative methods
  • 3.2 Databanks
  • 3.6 Human stem cells
  • 4.1 Women who are pregnant and the human foetus
  • 4.6 People who may be involved in illegal activities
  • 4.8 People in other countries
  • 5.1 Institutional responsibilities

All chapters have been revised, however, some chapters have significant revisions. These are:

  • 2.2 General requirements for consent
  • 2.3 Qualifying or waiving conditions of consent
  • 4.2 Children and young people
  • 4.7 Aboriginal and Torres Strait Islander Peoples

Section 5 makes provision for institutions to establish different levels of ethical review for research with different levels of risk, namely:

  • 'negligible risk' - no foreseeable risk of harm or discomfort and any foreseeable risk is no more than inconvenience
  • 'low risk' - the only foreseeable risk is discomfort
  • 'more than low risk' - the foreseeable risk is more than discomfort.

 

 

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