National Statement on Ethical Conduct in Human Research 2007

The National Statement on Ethical Conduct in Human Research 2007 (PDF file, 777kb) 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.

The University's response
About the National Statement

The University's response

The University established the National Statement Steering Committee, which is one of a number of subcommittees reporting to the Research Integrity, Accountability and Compliance Committee. The Steering Committee is responsible for:

overseeing the development of an ethical review structure providing for different levels of ethical review for research with different levels of risk;
managing the implementation of an online research ethics approval system and consideration of issues arising as UniSA moves to a new ethics system;
ensuring that the University is positioned to meet the requirements of the National Statement on Ethical Conduct in Human Research 2007; and
overseeing the changes to current Human Research Ethics Committee business processes.

Membership of the National Statement Steering Committee

Professor Ian Richards (Chair, Chair HREC)
Dr Janet Bryan (Deputy Chair HREC)
Assoc/Professor Bernie Hughes (HREC member)
Dr Margaret Peters (HREC member)
Professor Mary Barton (Chair UniSA Animal Ethics Liaison Committee, Chair Institutional Biosafety Committee)
Dr Mark Hochman (Director RIS)
Ms Sally Carpenter (RIS Manager: Research Performance Monitoring)
Ms Maria Arena (RIS Manager: Research Capacity and Compliance)
Ms Vicki Allen (RIS Ethics and Compliance Officer)
Ms Alice Granger (Executive Officer)

Timeline for implementation

The second edition of the National Statement was effective in 2008 with institutions being required to report on compliance by the end of 2008. The online research ethics approval system is expected to be operational by mid 2009.

Activities of the Steering Committee

View the National Statement Steering Committee presentation to heads of schools and select University committees:

Research ethics and responsible research at UniSA (PPT file, 766kb)

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:

Values and Principles of Ethical Conduct
Themes in research ethics: risk and benefit, consent
Ethical considerations specific to research methods or fields
Ethical considerations specific to participants
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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