Consultation on Clinical Trial Research Governance: A Good Practice Process for the Governance Authorisation of Clinical Trials

This submission to the National Health and Medical Research Council (NHMRC) responds to its consultation on ‘A Good Practice Process for the Governance Authorisation of Clinical Trials’, alongside related work on standard clinical trial items and a redesigned National Ethics Approval Form (NEAF). Research Australia links the consultation to the COAG Standing Council on Health’s April 2014 agreement to pursue a national approach to clinical trials, and maintains that the keys to better governance are uniform, ‘trial appropriate’ processes across jurisdictions and wider acceptance of single ethical approval for multi-site trials. It cites the Victorian Specific Module, which must accompany the NEAF for any Victorian site, and the national radiation protection standard’s assumption of site-specific ethics approval as examples of barriers to a national system, and recommends the National Mutual Acceptance scheme between New South Wales, Victoria and Queensland to be extended. It proposes that commercial and non-commercial trials use the same processes and supports a single national electronic database and application system holding site accreditation and ‘smart’ application forms. In answer to specific questions, it recommends that institutions nominate contacts and indicative decision timelines, that the process identify ‘Go/No Go’ decision points, and that a thorough review of national, state and territory requirements be undertaken.