The National Statement on Ethical Conduct in Human Research (2007) (National Statement (2007) consists of a series of Guidelines made in accordance with the National Health and Medical Research Council Act 1992 (the Act). The National Statement (2007) is subject to rolling review. This means that parts of the National Statement will be updated as needed, rather than reviewing the entire document every five years. Information about changes to the National Statement can be found below.
The National Statement (2007) 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 replaces the 1999 National Statement on Ethical Conduct in Research Involving Humans.
Compliance with the National Statement is a prerequisite for receipt of National Health and Medical Research Council funding.
Summary of National Statement content
National Statement Updates
Most recent update:
- Chapter 2.3 Qualifying or waiving conditions of consent to include guidance on an opt-out approach
- References to Ethical Considerations in Quality Assurance and Evaluation Activities
- Page number references removed
- Index update
- References to 3.6 have been removed as a result of the December 2013 update
- Chapter 3.4: Human biospecimens in laboratory based research
Previous updates are arranged in the National Statements Amendments Table (available below) with the most recent at the top. Links to other relevant supporting documents and details of amendments are also included in the table.
Keeping Up to Date
To keep apprised of any forthcoming public consultations on proposed changes to the National Statement refer to the NHMRC Public Consultation website. Public consultations are advertised in the NHMRC Research and Health Tracker.
National Statement Rolling Review
The National Statement consists of a series of guidelines made in accordance with the National Health and Medical Research Council Act 1992 and is subject to rolling review. This means that parts of the National Statement will be updated as needed, rather than reviewing the entire document every five years.
AHEC established a sub-group in March 2013 to undertake an appraisal of the National Statement and develop a strategy for its ongoing review. The survey was the first step in developing this strategy.
The Australian Research Council and Universities Australia are represented on this sub-group.
Current Release of the National Statement
NHMRC no longer prints and distributes hard copies of the National Statement. The current version of the National Statement is available from: http://nhmrc.gov.au/guidelines/publications/e72 in both HTML and PDF format.
Researchers, Institutions and Human Research Ethics Committees (HRECs) are advised to use the NHMRC web site to ensure that they are accessing the current version of the National Statement, and to check regularly for updates.
Institutions that provide a copy of the National Statement on their web site are advised to provide a link to the current version of the document on the NHMRC web site, or to update their web pages accordingly.
It is the responsibility all users of the National Statement, including Human Research Ethics Committees, Research Offices and researchers to ensure the current version is being used in establishing research proposals and undertaking any ethical review that occurs on or after the date of release of any update. Archived and revoked versions of the National Statement (2007) are available for reference purposes (see National Statement Updates Table above).
The most current release is available in PDF and HTML: