The expectation gap, risk management and the Australian HREC system

Abstract

The Australian HREC system is experiencing increasing workloads and greater public scrutiny. Dr Dodds asks whether the system is sustainable and aims to encourage a constructive critical debate about the system. This article suggests there is a gap between the demands on the system and expectations of researchers, regulators and the community. The evolution of the HREC system reached a significant milestone of the publication of the National Statement on Ethical Conduct in Research Involving Humans. This article argues that there will be increases in HREC workloads and new challenges from human genetic research, commercialisation of research and clinical trials. The Andrews Committee has recommended another independent review of the system. The system is also under review by the joint ALRC/AHEC inquiry into the protection of human genetic information.