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Publication date: 12 November 2018

Bernice Davies, Anona Armstrong and Maree Fitzpatrick

In 2013, the National Mutual Acceptance (NMA) of single ethical review was introduced into the Australian public health sector to address the timeliness of multisite…

Abstract

In 2013, the National Mutual Acceptance (NMA) of single ethical review was introduced into the Australian public health sector to address the timeliness of multisite clinical trials. A clinical trial is usually designed to test the effects of an experimental therapeutic product. While all research involving humans must comply with ethical guidelines, clinical trials testing products in Australia are also subject to stringent regulatory controls making the need to meet trial milestones critically import. Commercial clinical trials offer participating research sites substantial financial and clinical advantages. Concerns that bureaucratic processes have impeded commercial investment have influenced countries, including Australia, to introduce single ethical review, where one ethics review is accepted at multiple sites participating in the same research project. Although a central tenet of the NMA is the standardization of the behaviors and procedures of research review, concerns of inconsistency remain. This raises the question of whether the NMA does lead public healthcare agencies to adopt similar research governance practices.

A questionnaire survey was undertaken to explore the current experiences (n = 149) of the NMA in Victorian public health agencies, and 21 semi-structured interviews were conducted to explore expectations of the future of the NMA. The findings indicated that, while there was conformity to many of the process requirements of the NMA, a persistent focus on the needs of each individual healthcare agency rather than on complying with the national system weakened pressure on agencies to adopt standardization.

The NMA has the capacity to be a powerful tool in delivering quality clinical trial outcomes, maximize research resources and create dependable performance metrics if consistent policies and governance are followed.

Details

Applied Ethics in the Fractured State
Type: Book
ISBN: 978-1-78769-600-6

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Click here to view access options
Book part
Publication date: 12 November 2018

Abstract

Details

Applied Ethics in the Fractured State
Type: Book
ISBN: 978-1-78769-600-6

Abstract

Details

Applied Ethics in the Fractured State
Type: Book
ISBN: 978-1-78769-600-6

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