ACTA comparative effectiveness trials requirements for low risk ethics review


Comparative effectiveness (CE) research and trials (CETs) are recognised across Australia for their importance in generating real-world data that can be readily implemented to improve healthcare outcomes. This type of research often generates information that is central to decision making, implicit in learning health systems, and reinforces high quality, value-based health care resulting in better outcomes for patients.

The purpose of this document is to provide a brief overview of comparative effectiveness research, examining  considerations for the review of such studies by Human Research Ethics Committees (HRECs), and examines the revisions in the National Statement (updated 2018)  that offer the option of a low risk pathway for the ethics review of CETs.

The aim is to encourage wider use of the flexibilities in the NHMRC National Statement which permits a proportionate approach to trial approval and conduct, based on the level of risk. Wider use of these flexibilities has the potential to make well-designed CETs easier and quicker to conduct, which in turn will enable researchers to accelerate the generation of evidence to guide optimal healthcare.