One Key Performance Indicator of The Victorian Government cancer action plan 2008-2011 was to increase regional patient participation in cancer clinical trials from 6% to 15% by 2020 [1]. Warrnambool Oncology Clinical trials unit was established in 2009 to service healthcare needs of the projected population of 115,000 individuals located within the Greater Green Triangle by 2026[2]. We aimed to identify barriers to clinical trial participation, as a unit and identified local governance as a major barrier. This issue is not limited to our site.

A standardised national ethics process (SERP) was implemented throughout the Eastern Seaboard in 2011 in an attempt to meet the target of a 60 day ethics review, however ethics approval remains widely variable[3]. Governance and indemnity remain as barriers to activation of new studies. While trials of parenteral medication are often carried out in public hospitals, with an existing indemnity and oversight process, patients enrolled on a study involving an oral therapy do not require admission to a healthcare organization but may be reviewed by the investigator in a private setting, and thus fall in to a “grey area” of research Governance.

Indemnity becomes the responsibility of the individual investigator, but the lack of local governance oversight then creates a barrier to centralized ethical approval. While a proposed national insurance scheme to mitigate risks and costs for private institutions would aid this, these national standards and processes are yet to be established. A recent Department of Health manual provides a detailed guide to governance and SERP but fails to identify a party for overseeing outpatient trial conduct in accordance with Good Clinical Practice (GCP)[4].

We feel funding and a streamlined approach to research governance at a National level, as for ethics approval, may assist many oncology centres to offer more clinical trials to their patients.