Journal article

Multi-centre ethics and research governance review can impede non-interventional clinical research

Christine Duplancic, Tania Crough, Scott C Bell, Rachel Thomson, Claire Wainwright, Archie Clements, Andres Floto, Geraint Rogers, Peter Sly, Lucy Burr, Iain Feather, Susan Moloney, Keith Grimwood, Peter Bye, Yvonne Belessis, Hiran Selvadurai, Andre Schultz, Siobhain Mulrennan, David Stock, Sean Beggs Show all

Internal Medicine Journal | WILEY | Published : 2019


BACKGROUND: The inter-jurisdictional National Mutual Acceptance (NMA) scheme for Human Research Ethics Committee (HREC) approvals of human research is designed to reduce the reported delays and costs of ethical review. Introduction of the NMA set forth an uncoupling of the ethics and governance review processes, permitting a single ethical review for multiple sites, while continuing separate governance review for each centre covering financial and operational aspects of the research project. AIM: To compare the time required to gain ethics and governance approvals in Australia for a non-interventional investigator-led study from December 2015 to approval times for an earlier pre-NMA study ut..

View full abstract