Human Research Ethics Committee
The ACT Health Human Research Ethics Committee (HREC) is constituted according to the National Statement on Ethical Conduct in Human Research 2007 (revised in 2018). The HREC is certified for single review of multi-centre health and medical research.
The HREC operates in compliance with applicable regulatory requirements and the principles of the International Conference on Harmonization Guidelines on Good Clinical Practice.
Sub-committees
To ensure it provides full and comprehensive review services to the research community, the HREC incorporates specialist sub-committees to advise on the research merit and integrity of proposals.
Clinical Research Sub-Committee
Social Research Sub-Committee
This sub-committee is not an approving committee and review times are incorporated in the HREC submission deadlines.
Low Risk Sub-Committee
The Low Risk Sub-Committee provides an expedited review process for research that meets the National Statement definition of low and negligible risk (see National Statement Chapter 2). For more information about submitting an application to this committee go to Low-Risk Sub-Committee.
Therapeutic Goods Administration authorised prescriber application process
A medical practitioner wishing become an authorised prescriber of an unapproved good, in line with the Therapeutic Goods Act 1989 (the Act) and the Therapeutic Goods Regulations 1990 (the Regulations) must submit an application to the HREC for review and approval prior to the submission of a separate application to the TGA.
Applications must be submitted with the following template forms:
- TGA Authorised Prescriber HREC Application Form
- Authorised Prescriber Patient Information Sheet
- Authorised Prescriber Consent Form
- Authorised Prescriber Consent Form (Guardian-POA)
Email ethics@act.gov.au to submit an authorised prescriber application.