Launched: the guide to avoiding ethical debate

A handbook to help clarify the decision-making process of research ethics committees was today launched by the Federal Health and Ageing Minister.

The weighty Human Research Ethics Handbook was developed by the National Health and Medical Research Council to provide guidance to the 200-plus registered ethics committees working in Australian hospitals, universities, government agencies and within the private sector.

Senator Kay Patterson said the guide was a way to help bioethics committees make decisions that reflected community sentiment towards human trials and research that could lead to new medical treatments.

"Protecting the welfare and rights of participants in these trials is the guiding principle for approval of such research conducted in Australia today," Patterson said.

"While there are many significant advances on our horizon in medical research and biotechnology, there are also serious ethical issues to consider."

The handbook is intended to complement the NHMRC's National Statement on Ethical Conduct in Research Involving Humans, and is divided into sections on research ethics, research law and a commentary on the national statement.

Its development was led by consultant authors including Monash University Associate Professor of Medicine Paul Komesaroff, University of Wollongong Philosophy Program Associate Professor Susan Dodds, Associate Professor of Law and Ethics at the University of New South Wales Paul McNeill and University of Melbourne Professor of Law Loane Skene.

The ethics committee chairman of the Alfred Hospital, which hosted the launch, said the handbook's significance lay in the fact it dealt with complexity and the need for consistency in human research.

Professor John McNeil said ethics committees had to deal with a broad range of issues spanning discarding of patient tissue to the use of patient information, knowledge of laws and insurance implications.

"Now research not only involves patients, but healthy volunteers, students and people who are unable to give consent," McNeil said.

He said the nationwide SAFE study, led by the Alfred and incorporating almost 20 intensive care units across Australia and New Zealand, was a good example of the need for a coordinated approach.

The study, looking at the choice of initial resuscitation fluid for use in critically ill patients, would require informed consent from some 7000 trial participants as well as a consistent approach to the trail across all centres.

The handbook is available at www.nhmrc.gov.au/issues/researchethics.htm, with the hard copy to be sold through AusInfo and Government Info shops.