National Statement on Ethical Conduct in Human Research

Public consultation on National Statement content

The public consultation on the revised Sections 4 and 5 of the National Statement on Ethical Conduct in Human Research closed in late 2020. NHMRC staff and the relevant working groups have commenced an analysis of the submissions and a revision of the relevant sections. This is likely to be a lengthy process and may take up to a year and as such, we have no fixed timeline at this point for when the release of the revised sections will occur. We thank everyone who provided a submission to this process.

The public consultation documents are available from NHMRC’s Online Services portal.

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 on the NHMRC consultations portal.

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.

• National Statement on Ethical Conduct in Human Research - summary of updates version 7.0 (PDF 148KB)

NHMRC no longer prints and distributes hard copies of the National Statement. The current version of the National Statement is available in both HTML and PDF format.

• National statement on ethical conduct in human research 2007 (updated 2015)
• National statement on ethical conduct in human research 2007 (updated 2018)

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 Summary of 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 Online Services portal. Public consultations are advertised in the NHMRC Research and Health Tracker.

History

Australian activity in ethical review of human research began during the 1960s and was related closely to the federal funding of medical research. Through the passage of the Medical Research Endowment Fund Act 1937, the Commonwealth Parliament had established the Medical Research Endowment Fund. Responsibility for the fund was vested in the Minister for Health, who could determine its use for medical research and in the training of persons in medical research, acting on the advice of the National Health and Medical Research Council, constituted in 1936.

In 1966, the Council issued the Statement on Human Experimentation that expressly drew on the Helsinki Declaration. In 1972, the Council appointed the Ethics in Clinical Research Subcommittee to examine the need to revise the Statement. Their report recommended peer group assessment of experiments involving human subjects and, in 1976, Supplementary Note 1 was added to the Statement, to make the requirement for review by an institutional ethics committee (IEC) explicit. The opening paragraphs were also amended to indicate that the Statement was applicable to all human subject research, encompassing medical, social and behavioural research.

In October 1982, the Council established the Medical Research Ethics Committee to assist the Council by keeping under review and making recommendations to Council on ethical principles in human experimentation and to facilitate, keep under review and report to the Council on the work of IECs, and respond to questions raised by them.

In November 1985, the Council adopted a recommendation that any institution that conducts research on humans must conform to Supplementary Note 1 in order to be eligible to receive funds for research from the Council. The risk of ineligibility to receive Council funds was an effective inducement for institutions to establish IECs. By 1990, it was estimated that there were over 100 IECs throughout Australia and in 2005, there are more than 220. (IECs are now known as Human Research Ethics Committees.)

The National Health and Medical Research Council Act 1992 establishes the Role of the CEO whose functions include the issue of "guidelines for the conduct of medical research involving humans". These guidelines must be issued precisely as developed by the principal committee of Council known as the Australian Health Ethics Committee (AHEC).

In 1994, the Commonwealth Minister for Human Services and Health commissioned a review of the role and functioning of Institutional Ethics Committees. In March 1996, the report of that review recommended that the existing guidelines be reviewed. Between 1996 and July 1999, AHEC developed the guidelines that were contained in the National Statement on Ethical Conduct in Research involving Humans (1999)(National Statement), issued by the NHMRC and endorsed by major research and academic institutions.

The next revision of the National Statement was undertaken in 2005 and resulted in the release of the National Statement on Ethical Conduct in Human Research, 2007.