Appendix: Process Report

Background

The National Statement on Ethical Conduct in Research Involving Humans (‘the National Statement’) 1999 has been revised in line with the National Health and Medical Research Council policy that all its guidelines be reviewed at least every five years. In September 2003 the Australian Health Ethics Committee (AHEC), a principal committee of the NHRMC, established a working committee to review the National Statement. The revision was undertaken jointly by the NHMRC, the Australian Research Council (ARC), and the Australian Vice Chancellors’ Committee (AVCC), and the working Committee consisted of the following members from AHEC, the ARC and the AVCC:

Working Party

Dr Christopher Cordner (Chair)

Member of AHEC 2003 - 2006 triennium

Dr Kerry Breen

Member of AHEC 2003 - 2006 triennium

Mr Christopher Coyne

Member of AHEC 2003 - 2006 triennium, Member of AHEC 2006 - 2009 triennium

Professor Joy Damousi

AVCC Nominee

Associate Professor Terry Dunbar

Member of AHEC 2003 - 2006 triennium, Member of AHEC 2006 - 2009 triennium

Professor Graeme Hugo

ARC Nominee

Reverend Professor John Morgan

Member of AHEC 2003 - 2006 triennium

Professor Elim Papadakis

ARC Nominee

Associate Professor Wendy Rogers

Member of AHEC 2003 - 2006 triennium

Professor Doreen Rosenthal AO

Member of AHEC 2003 - 2006 triennium

Mr Noel Spurr OAM

Member of AHEC 2003 - 2006 triennium

Professor Jane Stein-Parbury

AVCC Nominee.

Ms Fiona Stoker

Member of AHEC 2003 - 2006 triennium

Professor Colin Thomson

NHMRC consultant 2003 - 2006 triennium and Chair AHEC 2003 - 2006 triennium.

Dr Nicholas Tonti-Filippini

Member of AHEC 2003 - 2006 triennium, Member of AHEC 2006 - 2009 triennium

Reverend Bill Uren

Member of AHEC 2003 - 2006 triennium

Secretariat

Ms Nerida Lawrentin

September 2003 - June 2005

Ms Nicola Cooper

June 2005 -

Mr Matthew Sammels

May 2006 -

Consultant

Dr Angela Kirsner

Technical Writer

Process

Following the development of a first draft, and in accordance with section 13 of the National Health and Medical Research Council Act 1992, AHEC undertook public consultation from January to March 2005. This consultation resulted in 178 submissions. A second draft was then prepared taking into account the submissions received. A further consultation was undertaken from January to March 2006, which resulted in 184 submissions. These submissions informed the final draft. Details of the submissions that were not confidential were placed on the website during the revision process.

Experts were consulted throughout the redrafting process on a number of issues. A workshop was also held with several institutions that are known to have developed models for devolving review of low risk research, to determine the best method of streamlining ethical review of research.

After completion of the final draft and agreement by the Australian Health Ethics Committee from the 2006 – 2009 triennium, both the Australian Research Council and the Australian Vice Chancellors’ Committee were invited to approve the final draft. This agreed version was then presented to the Council of the NHMRC at its 164th Session in March 2007 for consideration.

At that Session the Council agreed to advise the CEO that the final draft should be issued.