Australia to allow xenotransplant research providing scientists follow stringent guidelines.

Xenotransplantation research should go forward in Australia providing stringent guidelines are followed, according to a government council convened to issue the guidelines.

A working party of the Australian National Health and Medical Research Council (NHMRC) recommended that clinical research proceed cautiously under centrally administered guidelines that cover ethical issues, research participant protection, animal welfare and public safety.

The group emphasized that there are concerns about animal infections being transmitted to humans, public acceptability, effectiveness and cost.

Kerry Breen, chair of the xenotransplantation group, said a centralized national committee will require extensive information before approving human clinical trials.

"Produce evidence that it works in animals, produce evidence that as far as we know it is reasonable and safe, and produce evidence that we have very good processes in place for monitoring the recipients and close contacts," Breen said. He added the committee will be able to judge whether the research is in the public's interest by weighing the risks versus the benefits for all people waiting for organ transplants.

Public meetings on the 221-page guideline and discussion paper will be held in Sydney, Melbourne and Perth in August. Written comments are due September 6.

The full report is available online at www.health.gov.au/nhmrc.issues/xeno.pdf. Q&A and Fact Sheets are also available.