Hospital ethics approval for a population-based case-control study of very preterm birth

Aim: To describe the process involved in obtaining ethics approval for a study aiming to recruit women from all maternity hospitals in Victoria, Australia. Design: Observational data of the application process involving 85 hospitals throughout Victoria in 2001. Results: Twenty-three of the 85 hospitals had a Human Research Ethics Committee (HREC) constituted in accordance with the National Health and Medical Council requirements; 27 agreed to accept decisions from other hospitals having HRECs and 27 relied on ethics advisory committees, hospital managers, clinical staff, quality assurance committees or lawyers for ethics decisions. Four of the latter did not approve the study Eight hospitals no longer provided maternity services in the recruitment period. The process took 16 months, 26000 sheets of paper, 258 copies of the application and the cost was about $30 000. Approval was eventually obtained for recruitment at 73 hospitals. Discussion: Difficulties exist in obtaining timely ethics approval for multicentre studies due to a complex uncoordinated system. All hospitals should have explicit protocols for dealing with research ethics applications so that they can be processed in a straightforward and timely manner. To facilitate this, those without properly constituted HRECs should be affiliated with one hospital that has an HREC.