Dr Lisa Eckstein1, Dr Rebekah McWhirter, Dr Emma Tumilty, Professor Annette Braunack-Mayer
1Bellberry Ltd, Australia
Biography:
Dr Lisa Eckstein is the Director of Philanthropic Activities, Bellberry Ltd and CT:IQ Programme Director. She is an adjunct senior lecturer in the Faculty of Law at the University of Tasmania, where she publishes on the regulation of clinical trials, genomic privacy, and consent.
Abstract:
Australian human research ethics committees (HRECs) and their international counterparts are accorded considerable discretion in determining the ethical acceptability of human research. There is documented variation in the decisions that HRECs make about research proposals, and researchers have raised such variation as a source of confusion and frustration. The nature of ethical deliberation, which involves expert judgement responsive to particular circumstances means that some variation in this discretionary decision-making is reasonable; others may suggest that variation signals poor ethical analysis or a misapplication of guidance documents such as the National Statement of Ethical Conduct in Human Research (2023). Presently, few mechanisms have been adopted to identify areas of poor analysis or deliberative practices leading to unjustified inconsistencies or to guide HREC decision-making moving forward where issues have been identified and improvements are needed.
To identify and assess the respective benefits of strategies to improve the quality and consistency of Australian HREC reviews, this panel will explore four different approaches:
HRECs as a learning health system, including systemic and systematic self-evaluation, data analysis, and improvement projects
Structured systems for instituting HREC precedent.
Shared ethical decision-making exercises for benchmarking and feedback.
Consensus-based approaches such as the one adopted by the
Bellberry
Policy Committee.
The panel will introduce these approaches in 3x8minute presentations, evaluating each in light of empirical work currently being undertaken, before leading a discussion with attendees on their respective benefits and challenges for both quality and consistency. (30 mins).