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 (NHMRC) 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 Committee

Dr Christopher Cordner (Chair) Member of AHEC 2003 - 2006 triennium Dr Kerry Breen Chair 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, Chair AHEC 2006 - 2009 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 - December 2006
Mr Matthew Sammels May 2006 - March 2007

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, Australian Health Ethics Committee (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 at: http://www.nhmrc.gov.au/ethics/human/ahec/ consultation/submissions/statement.htm

http://www.nhmrc.gov.au/ethics/human/ahec/ consultation/submissions/statementsec.htm.

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 methods of streamlining ethical review of research.

After completion of the final draft and agreement by the AHEC 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.