National Statement on Ethical Conduct in Human Research (2007) - Updated 2018

Summary information

Publishing date: 
2007
Status: 
Current
Reference number: 
E72
Available in print: 
No - PDF only
Further information: 

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 National Statement 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.

Synopsis

The National Statement 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.

Compliance with the National Statement is a prerequisite for receipt of NHMRC funding.

Summary of National Statement content

Current Release of the National Statement

The National Statement released in July 2018 includes a fully revised Section 3. Changes have also been made to Chapters 5.1, 5.2 and 5.5 in Section 5, the Glossary and the Index as a consequence of revisions to Section 3.

Chapter 3.2: Human biospecimens in laboratory based research (formerly Chapter 3.4) was not revised; however, the Australian Health Ethics Committee (AHEC) approved minor amendments to this chapter to align it with the new structure in Section 3. Further information on the changes to Chapter 3.2 is available here.

It is the responsibility of all users of the National Statement, including HRECs, research offices and researchers to ensure that the current version is being used in developing research proposals, making submissions for ethics review and undertaking ethics review that occurs on or after the date of release of any update.

However, as a consequence of the revisions to Section 3 we expect that users of the National Statement will gradually integrate these revisions into their proposals, submissions and review over the period from July to December 2018, with full implementation expected by 1 January 2019. This timeline is intended to give researchers and HRECs an opportunity to familiarise themselves with the new guidance prior to the revocation of the version of the National Statement updated most recently in 2015.

Previous updates to the National Statement are described in the National Statement - Summary of Updates (see link to table below) with the most recent updates at the top.

NHMRC no longer prints and distributes hard copies of the National Statement. The current version of the National Statement is available below 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 using 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.

Archived and revoked versions of the National Statement are available for reference purposes (see National Statement Updates Table above).

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.


Online (html) version of the National Statement

HTML version of the National Statement on Ethical Conduct in Human Research (2007) incorporating all updates as at May 2015

Download a PDF of the guideline

Related information: 

Enquiries

For general enquiries about this document, please contact ethics@nhmrc.gov.au.

For media enquiries about this document, please contact media@nhmrc.gov.au.