'Opt-out' now an option for clinical research

The recent change to chapter 2.3 of the Australian National Statement on Ethical Conduct in Human Research (2007) allows Human Research Ethics Committees (HRECs) to approve the use of ‘opt-out’ approaches to consent for low risk clinical research. That is, for research studies such as those that use clinical registries, participation of individuals is presumed unless they express a wish not to be.

In his recent article in the MJA, Prof Ian Olver, current chair of the Australian Health Ethics Committee (AHEC), states that this change is not intended to replace explicit consent as the most desirable method of obtaining consent to participate in clinical research, but instead provides an ethically defensible option for types of research that require high participation rates.¹

The new guideline requires researchers wishing to use the opt-out system undertake an appropriate strategy to ensure those persons being included are made aware of their inclusion, and so have an option to opt out. Such strategies have already been adopted with success.²

This presents clinical researchers with an opportunity for much better engagement with the general community to highlight the significant improvements to health care that are delivered by research in general.

Visit the NHMRC website to read the latest revision to the National Statement Chapter 2.3: Qualifying or waiving conditions for consent.


  1. Olver I, Opting in for opt-out consent, Med J Aust 2014; 200 (4): 201-202.
  2. Victorian Department of Health. Victorian State Trauma Registry. http:// www.health.vic.gov.au/trauma/trauma-registry.htm (accessed Apr 2013).