“Research is ‘low risk’ where the only foreseeable risk is one of discomfort. Where the risk, even if unlikely is more serious than discomfort, the research is not low risk” – National Statement on Ethical Conduct in Human Research (2007) (S2.1.6) Read more

A ‘standard risk’ application is, by virtue of its form and content, an activity which constitutes something more than discomfort or inconvenience for study participants. Read more

To submit a Case Report or Series for review by the CHQ HREC, please submit a cover letter, outlining the background and aims of the case report, together with a copy of the Information Sheet and Consent Form which will be provided to the Parent/Guardian. Read more

The National Statement on Ethical Conduct in Human Research (paragraphs 5.1.22 and 5.1.23) defines research that can be exempted from ethics review as negligible risk research that involves the use of existing collections of data or records that contain only non-identifiable data about human beings. Read more

There are circumstances where patients may require access to medicines or medical devices that have not been approved for supply by the TGA. Authorised prescriber applications require formal endorsement from a HREC before submission to the TGA. Read more